Insert assembly

Abstract

An insert assembly comprising: a first unit comprising a deflector member and a trigger actuation protrusion; and a second unit accommodated within the first unit and including: a body including a cavity and an elastic arm aligned with the deflector member; a tip holder having an insertion tip thereon, the tip holder being at least partially disposed in the cavity; a biasing member held in an energy storage state by the trigger; and an insert kit base including an adhesive and releasably coupled to the body; when adhering the adhesive to the skin and withdrawing the insert assembly from the user, in a first stage of actuation, the first unit and the second unit move together, pull the skin away from the user until a force applied by the elasticity of the skin overcomes the elasticity of the arm by pressing the arm into the deflector, and in a second stage of actuation, the force applied by the elasticity of the skin does not overcome the elasticity of the arm by pressing the arm into the deflector. The trigger is displaced and energy stored in the biasing member is released to urge the tip holder toward the skin.

Description

[0001] Divisional application

[0002] This application is a divisional application of Chinese Patent Application No. 202310906394.6, filed on February 21, 2020, entitled "Infusion Set and Insertion Assembly System and Method". Chinese Patent Application No. 202310906394.6 is itself a divisional application of Chinese Patent Application No. 202080015878.6, also filed on February 21, 2020, entitled "Infusion Set and Insertion Assembly System and Method". Technical Field

[0003] This application generally relates to infusion sets and insert assemblies for infusion sets, and more specifically, to infusion sets and insert assemblies and methods of using them. Background Technology

[0004] Many potentially valuable drugs or compounds (including biologics) lack oral activity due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. Furthermore, some therapeutic compounds, while capable of oral administration, sometimes require frequent dosing, making it difficult for patients to maintain the required schedule. In these cases, parenteral delivery is often used or may be used.

[0005] Effective parenteral delivery routes for drugs, other fluids, and compounds (e.g., subcutaneous, intramuscular, and intravenous (IV) administration) involve puncturing the skin with a needle or catheter. Insulin is an example of a therapeutic fluid that millions of diabetic patients self-inject. Users of parenteral delivery medications may benefit from wearable devices that will automatically deliver the desired medication / compound over a period of time.

[0006] Therefore, efforts have been made to design portable wearable devices for the controlled release of therapeutic agents. Such devices are known to have storage compartments such as cartridges, syringes, or pouches, and are electronically controlled. These devices have several drawbacks, including a high failure rate. Reducing the size, weight, and cost of such devices remains an ongoing challenge. Furthermore, these devices are typically applied to the skin, presenting the challenge of frequent repositioning for application. Summary of the Invention

[0007] According to embodiments of this disclosure, the insert assembly may include a casing. The insert assembly may also include a body including a cavity disposed within the casing. The insert assembly may further include a sharpholder attached to an insert sharp. The sharpholder may be at least partially disposed within the cavity. The insert assembly may also include a biasing member located within the cavity. The biasing member may be positioned between the sharpholder and a wall of the cavity. The insert assembly may further include a trigger having a first state and a second state, in which the biasing member is maintained in an energy-storing state and in which the biasing member is released from the energy-storing state. The biasing member may be configured to push the sharpholder when released from the energy-storing state to remove the insert sharp from the casing. The insert assembly may further include an infusion set base that engages with the body. The infusion set base may have an adhesive included on its bottom surface. The insert assembly may also include a trigger actuation protrusion extending from the cover and arranged such that when the adhesive adheres to the skin, causing the cover to shift away from the body and the skin has been pulled a certain distance away from the body, the trigger actuation protrusion actuates the trigger from a first state to a second state.

[0008] In some embodiments, the cover may include a housing and a retaining base coupled to the housing for movement as a unit. In some embodiments, a trigger actuation protrusion may be included on the retaining base. In some embodiments, the trigger may include a latch. In some embodiments, the latch may include a gripper disposed on the body that engages a flange formed on a cantilevered arm of the tip retainer. In some embodiments, the bottom surface of the infusion set base may be substantially flush with the skin contact surface of the cover before the insert assembly is applied to the skin. In some embodiments, the insert assembly may further include a cannula subassembly through which the insert tip extends. In some embodiments, the cannula subassembly may be detachable from the infusion set base when the trigger is in a first state. In some embodiments, the cannula assembly may include a cannula integrated with a septum housing. In some embodiments, the cannula assembly and the infusion set base may include a cooperating coupling feature that engages to connect the cannula assembly and the infusion set base when the cannula assembly is moved into the infusion set base. In some embodiments, the energy storage state of the first bias member is a compressed state. In some embodiments, the insert assembly may further include a second biasing member. In some embodiments, the second biasing member may be configured to be released from its energy-storage state as the insert tip moves out of the cover. In some embodiments, when the second biasing member is released from its energy-storage state, the second biasing member may push the tip holder and the insert tip to a retracted position within the cover.

[0009] According to another embodiment of this disclosure, the insert assembly may include a first unit comprising a deflector member and a trigger actuation protrusion. The insert assembly may also include a second unit housed within the first unit. The second unit may include a body comprising a cavity and a resilient arm. The arm may be aligned with the deflector member. The second unit may also include a tip retainer having an insertion tip thereon. The tip retainer may be at least partially disposed within the cavity. The second unit may also include a bias member held in an energy-storage state by a trigger. The second unit may also include an insert kit base. The insert kit base may contain an adhesive. The insert kit base may be releasably coupled to the body. When the adhesive is applied to the skin and the insert assembly is removed from the body, in a first phase of actuation, the first and second units may move together, pulling the skin away from the body until a force exerted by the skin's elasticity overcomes the arm's elasticity by pressing the arm into the deflector. In a second phase of actuation, the trigger may be displaced, and the energy stored in the bias member may be released to push the tip retainer toward the skin.

[0010] In some embodiments, the first unit may include an outer housing and a retainer base coupled to the outer housing. In some embodiments, the retainer base may include a deflector member and a trigger actuation protrusion. In some embodiments, the trigger actuation protrusion includes a finger-like portion having wings. The wings may extend from a portion of the retainer base into the second unit. In some embodiments, the trigger may include a gripper of the body that engages with a flange included on a deflectable member of the tip retainer. In some embodiments, the first unit may include a second deflector member. In some embodiments, the body of the second unit may include a second arm having a second arm resilient to the second arm. In some embodiments, the second arm may be aligned with the second deflector member. In some embodiments, the infusion set base may be arranged such that it disengages from the body when the tip retainer is pushed toward the skin. In some embodiments, the biasing member may be a compression spring. In some embodiments, the deflector member may include a tilting deflector surface disposed opposite to a tilting arm surface included on the arm. In some embodiments, the infusion set base may be releasably coupled to the body via a set of cantilever arms. In some embodiments, the cantilever arm may be configured such that, when the tip retainer is pushed by the biasing member, the cantilever arm is displaced to an open state via the ear of the cannula subassembly carried by the insertion tip to release the infusion set base. In some embodiments, the insertion assembly may further include a cannula subassembly carried by the insertion tip, and spaced apart from the infusion set base during a first phase of actuation. In some embodiments, during a second phase of actuation, the cannula assembly may be coupled to the base.

[0011] According to another embodiment of this disclosure, the insert assembly may include a cover including a skin contact surface. The skin contact surface may surround an opening in the cover. The insert assembly may also include a tip retainer including an insert tip. The insert assembly may also include a cannula subassembly carried by the insert tip. Both the insert tip and the cannula of the cannula subassembly may have a skin-penetrating end disposed above the skin contact surface. The insert assembly may also include an infusion set base disposed within the opening in the cover and having a bottom surface substantially flush with the skin contact surface. The infusion set base may include a cannula subassembly receiving gap sized to receive the cannula subassembly and prevent finger entry. The insert assembly may also include an insertion biasing member. The tip retainer may be configured to be displaced by a transition from an insertion energy storage state to a relaxed state via the insertion biasing member to drive the insert tip and cannula at least partially out of the cover and engage the cannula subassembly with the infusion set base.

[0012] In some embodiments, the insert assembly may further include a plurality of standoffs that position the infusion set base flush with the skin contact surface prior to actuation. In some embodiments, the cannula subassembly may include a cannula, a diaphragm, a diaphragm retainer, and a diaphragm housing. In some embodiments, the diaphragm housing and the cannula are formed as a continuous, integral, or one-piece portion. In some embodiments, the cannula subassembly receiving gap and the cannula subassembly include cooperative coupling features that interact to connect the infusion set base and the cannula assembly to each other when the cannula assembly is advanced into the cannula assembly receiving gap. In some embodiments, the cooperative coupling features may include a cantilever arm with a protuberance on the infusion set base and a receiving recess on the cannula assembly for receiving the protuberance. In some embodiments, the insert assembly may further include a sharp retractor and a retractor biasing member configured such that the retractor biasing member is released from a retracted energy-stored state in response to a protrusion on the cannula subassembly disengaging from a latch as the sharp retainer is displaced by the shift of the insert biasing member. In some embodiments, the retractor biasing member may be configured to move the sharp retractor away from the skin contact surface as the retractor biasing member transitions from a retracted energy-stored state to a relaxed state. In some embodiments, the sharp retainer may include at least one flange, and the sharp retractor includes at least one stop. A dwell distance may exist between the at least one flange and the stop when the retractor biasing member is released from the retracted energy-stored state.

[0013] According to another embodiment of this disclosure, the insert assembly may include a cover. The insert assembly may also include a tip retainer having: an insert tip coupled to the tip retainer; and a cantilever arm having a protrusion defining a flange. The insert assembly may also include a tip retractor having a cavity at least partially receiving the tip retainer, and a stop configured to engage the flange. Furthermore, the tip retractor may have a gripper configured to engage the flange and hold the insert spring in a biased state. The insert assembly may also include a cannula subassembly carried by the insert tip. The insert assembly may also include an infusion set base releasably coupled to the tip retractor and holding a compression spring in a biased state while releasably coupled to the tip retractor. The insert spring may be configured to drive the tip retainer along the insertion path when the flange disengages from the gripper. The infusion set base can be disengaged from the tip retractor, the cannula assembly can be attached to the infusion set base, and the flange can be spaced apart from the stop by a certain distance as the tip retainer passes the end of the insertion path. The retraction spring can be configured to move the tip retractor, together with the tip retainer, into the cover after the tip retractor has passed the distance and the stop has engaged with the flange.

[0014] In some embodiments, the infusion set base can be releasably coupled to a set of cantilever arms extending from the tip retractor. In some embodiments, the cannula subassembly may include a pair of ears configured to open the set of arms to release the infusion set base as the tip retainer passes an end of the insertion path. In some embodiments, the tip retainer may include a second cantilever arm having a second ridge defining a second flange. In some embodiments, the cavity may include a second stop configured to engage the second flange. In some embodiments, the cannula subassembly may include a notch. The notch may be configured to engage a ridge included in the infusion set base as the tip retainer passes an end of the insertion path. In some embodiments, the cannula subassembly includes a salient configured to engage a ridge included in the infusion set base as the tip retainer passes an end of the insertion path. In some embodiments, the cannula and diaphragm housing of the cannula subassembly may be formed together as an integral part in a straight-pull die. In some embodiments, the cover may include an outer housing and a retainer base. The infusion set base may be disposed within an opening in the retainer base and flush with the skin contact surface of the retainer base before the insert assembly is actuated. In some embodiments, an adhesive may be included on the bottom surface of the infusion set base, and the flange may disengage from the gripper by lifting the insert assembly from the skin patch to which it has been applied.

[0015] According to another embodiment of this disclosure, the insert assembly may include a first unit including a skin contact surface surrounding an opening. The insert assembly may also include a second unit housed within the first unit. The second unit may include an infusion set base disposed within the opening and having a bottom surface substantially flush with the skin contact surface and at least partially covered by adhesive. The second unit may also include a spring-biased insert assembly. The second unit may also include a cannula subassembly carried by an insertion tip of the insert assembly. The cannula of the spring-biased insert assembly and the cannula subassembly may be configured to be driven into the skin, and the cannula subassembly may be configured to be spring-coupled to the infusion set base by an insertion spring configured to release from an energy-storage state after the skin has been pulled upwards by the adhesive beyond a certain distance when the insert assembly is withdrawn.

[0016] In some embodiments, the insert assembly may further include a pointed retractor and a retractor spring configured to retract the pointed retractor together with the insert assembly away from the skin contact surface. In some embodiments, the insert assembly may include at least one latch configured to maintain the retractor spring in an energy-stored state. The latch may disengage when the cannula subassembly is displaced into engagement with the infusion set base. In some embodiments, the at least one latch may include a set of cantilever arms included on the pointed retractor. In some embodiments, the cantilever arms may each include a flange that engages with a corresponding protrusion on the infusion set base. In some embodiments, the corresponding protrusion on the infusion set base may be part of a guide for a portion of the tubing kit connector. In some embodiments, the infusion set base may include a cannula subassembly receiving gap extending through the infusion set base and sized to receive the cannula subassembly but prevent finger entry. In some embodiments, the cannula assembly and the cannula assembly receiving gap include cooperative coupling features that interact to connect the infusion set base and the cannula assembly to each other.

[0017] According to another embodiment of this disclosure, the insert assembly may include a first unit. The first unit may include an infusion set base with an adhesive on its bottom surface. The first unit may also include an insert tip drive assembly releasably coupled to the infusion set base and including an insert tip, a drive spring, an elastic member, and a latch arrangement configured to hold the drive spring in an energy-storage state in an engaged state. The insert assembly may also include a cover. The infusion set base may be disposed within an opening in the cover. Displacement of the insert assembly away from the body when the adhesive is in adhesion to the skin pulls the skin away from the underlying structure in a first stage. In a second stage, the force exerted by the elasticity of the skin overcomes the elasticity of the elastic member, displacing the cover relative to the first unit and disengaging the latch arrangement. The drive spring may be arranged to remove the insert tip from the cover upon transition to a relaxed state.

[0018] According to another embodiment of this disclosure, an insert assembly for placing an infusion set on an infusion site in the body may include a cover having an actuating protrusion. The insert assembly may further include a first unit located within the cover and movable relative to the cover. The first unit may include an infusion set base with an adhesive. The first unit may also include a tip retainer including an insertion tip. The first unit may further include a body including a cavity in which the drive spring and the tip retainer are at least partially disposed. The tip retainer may be moved from a raised state to a forward state by the drive spring. The first unit may also include a drive spring release latch arrangement. The actuating protrusion may be configured to disengage from the drive spring release latch arrangement after a relative displacement between the cover and the first unit exceeds a threshold. The adhesive may be configured to anchor the first unit to the body as the cover is pulled away from the body and the relative displacement between the cover and the first unit increases.

[0019] In some embodiments, the first unit may further include an elastic member. In some embodiments, the elastic member may be aligned with a deflector on the cover. In some embodiments, the elastic member may be configured to abut a portion of the cover to suppress relative displacement between the cover and the first unit until a force threshold is exceeded. In some embodiments, a portion of the cover may be a deflector member, and the elastic member may be an elastic arm included on the body. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, before the relative displacement exceeds the threshold, the skin of the body is lifted at least a certain distance from the underlying body structure due to adhesive adhesion. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, before the relative displacement between the cover and the first unit begins, the skin of the body is lifted at least a certain distance from the underlying body structure due to adhesive adhesion. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, the skin of the body is lifted at least a certain distance from the underlying body structure due to adhesive adhesion. In some embodiments, the infusion set base may be releasably coupled to the body. In some embodiments, the infusion set base may be arranged such that: when the tip retainer is displaced to a forward position, the infusion set base is released from the body. In some embodiments, the insert assembly may further include a retraction spring. The tip retainer can be displaced from a forward position to a retracted position via the retraction spring. In some embodiments, the insert assembly may further include a retraction spring-release latch arrangement configured to disengage when the tip retainer is displaced to the forward position via a drive spring. In some embodiments, the retraction spring-release latch arrangement can releasably connect an infusion set base to a body. When the spring-release latch arrangement is disengaged, the infusion set base can be released from the body. In some embodiments, a cannula subassembly may be carried on the insert tip.

[0020] According to embodiments of this disclosure, a cannula subassembly for an infusion set may include a continuous, integral body comprising a cannula and a diaphragm housing. The diaphragm housing may have a diaphragm receiving portion with a raised region at its bottom. The lumen of the cannula may be continuous with a pointed guide included in the raised region. The cannula subassembly may further include a diaphragm including a diaphragm recess having a centering wall section formed as a negative version of the raised region. The cannula subassembly may further include a diaphragm retainer comprising a body having latching arms extending through the diaphragm housing and each including a latching surface that, in an engaged state, engages cooperative features of the diaphragm housing to capture the diaphragm within the diaphragm housing.

[0021] In some embodiments, the diaphragm housing may include a convex angle arranged to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base. In some embodiments, the top surface of the wall of the diaphragm receiving portion may include a recessed slot therein. In some embodiments, the slot may include two slots arranged opposite each other. In some embodiments, the diaphragm retainer may also include a set of protrusions. In some embodiments, the set of protrusions is sized to receive within the slot recessed into the top surface of the wall defining the diaphragm receiving portion. In some embodiments, the set of protrusions, when received in the slot, only obstructs the top of the slot, thereby leaving the bottom portion of the slot open and exposing the sidewalls of the diaphragm at a location flush with at least a portion of the diaphragm recess. In some embodiments, the protruding portion of the diaphragm receiving portion has a truncated conical outer wall. In some embodiments, the diaphragm housing may include a recess in its sidewall configured to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base. In some embodiments, the integral body may be formed via straight-draw molding. In some embodiments, the monolithic body may lack an undercut feature. In some embodiments, the monolithic body may be made of polypropylene. In some embodiments, the monolithic body may be made of PTFE. In some embodiments, the body of the diaphragm retainer may include a channel extending through the body and sized to receive a nub on the diaphragm surface. In some embodiments, the pointed guide may be surrounded by a substantially flat peripheral edge at the uppermost portion of the protruding segment.

[0022] According to another embodiment of this disclosure, the housing for an infusion set with a cannula may include a continuous, integral body. The continuous, integral body may include a cannula. The continuous, integral body may also include a diaphragm housing having a diaphragm receiving portion defined by sidewalls and a bottom wall. The diaphragm housing may include raised regions, and the lumen of the cannula is a continuous surface having the raised regions. The sidewalls may have at least one guide that extends the length of the diaphragm receiving portion and is aligned with an aperture extending through the bottom of the diaphragm housing.

[0023] In some embodiments, the diaphragm housing may include a protruding corner on the outer surface of the sidewall, the protruding corner being arranged to engage a latch of the infusion set base to retain the cannulated housing within the infusion set base. In some embodiments, the top surface of the wall of the diaphragm receiving portion may have a recessed slot therein. In some embodiments, the slot may include two slots that may be arranged opposite to each other. In some embodiments, the slot may be configured to receive a set of protrusions included in the diaphragm retainer, such that the bottom portion of each slot is open and provides a path for the volumetric space of the diaphragm receiving portion. In some embodiments, the protruding portion of the diaphragm receiving portion may have a truncated tapered outer wall. In some embodiments, the diaphragm housing may include a recess on the outer surface of the sidewall, the recess being configured to engage a latch of the infusion set base to retain the cannulated housing assembly within the infusion set base. In some embodiments, the monolithic body may be formed via straight-draw molding. In some embodiments, the monolithic body may not have an undercut feature. In some embodiments, the monolithic body may be made of polypropylene. In some embodiments, the monolithic body may be made of PTFE. In some embodiments, the cannula may include a pointed guide surrounded by a generally flat peripheral edge at the uppermost portion of the protruding section. In some embodiments, a flange may be provided on the outer surface of the aperture adjacent to the bottom wall. In some embodiments, the wall of the aperture may form a gripping element configured to engage a protrusion of a portion of the diaphragm retainer. In some embodiments, the guide may be recessed into the sidewall.

[0024] According to embodiments of this disclosure, a method of placing an infusion set on a user's body may include adhering an infusion set base releasably coupled to an insert assembly to the body. The method may further include pulling the insert assembly away from the body. The method may further include: as the insert assembly is pulled away from the body, lifting the skin from an underlying structure of the body via the adhesion of the infusion set. The method may further include: after the skin has been lifted at least a certain distance, moving a trigger actuator into a trigger of the insert assembly. The method may further include driving an insert tip through the skin.

[0025] In some embodiments, the method may further include releasing a biasing member from an energy-storage state to drive the insertion tip through the skin. In some embodiments, the method may further include releasing the infusion set base from the insertion assembly. In some embodiments, the method may further include removing a locking member from the insertion assembly and removing an adhesive backing from the infusion set base. In some embodiments, the method may further include releasing an anti-retraction latch and driving the insertion tip in a direction away from the skin. In some embodiments, the method may further include driving a cannula subassembly carried by the insertion tip 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, the method may further include suppressing relative movement between the cover of the insertion assembly and the remainder of the insertion assembly at least as the skin begins to be lifted.

[0026] According to another embodiment of this disclosure, a method of placing an infusion set on a user's body may include adhering an infusion set base, releasably coupled to an insert assembly, to the body. The method may further include pulling the insert assembly away from the body. The method may further include displacing the skin from its resting position via the adhesion of the infusion set when the insert assembly is pulled away from the body. The method may further include disabling the actuation trigger until the skin has displaced to a point where the skin's elasticity exerts a force exceeding a threshold on the infusion set base. The method may further include shifting a trigger actuator into a trigger of the insert assembly. The method may further include driving the insert tip through the skin.

[0027] In some embodiments, the method may further include releasing a biasing member from an energy-storage state to drive the insertion tip through the skin. In some embodiments, the method may further include disengaging the infusion set base from the insertion assembly. In some embodiments, the method may further include removing a locking member from the insertion assembly and removing an adhesive backing from the infusion set base. In some embodiments, the method may further include driving a cannula subassembly together with the insertion tip toward the skin such that the cannula subassembly is driven into an anti-retraction latch. The method may further include driving the insertion tip in a direction away from the skin. In some embodiments, the method may further include driving the cannula subassembly carried by the insertion tip into the infusion set base. In some embodiments, driving the cannula assembly into the infusion set base may include driving the cannula of the cannula subassembly through the skin. In some embodiments, preventing actuation of the trigger may include: suppressing relative movement between the cover of the insertion assembly and the remainder of the insertion assembly, at least when skin displacement begins.

[0028] According to another embodiment of this disclosure, the insert assembly may include a first unit including a cover. The insert assembly may also include a second unit including an infusion set base with an adhesive. The second unit may further include a tip retainer including an insertion tip. The second unit may also include a trigger. The second unit may further include a body including a cavity, a drive spring, and the tip retainer at least partially disposed within the cavity. When the trigger is actuated from a first state to a second state, the tip retainer may be displaced from an elevated state to a forward state by the drive spring. The adhesive may be configured to anchor the second unit to the body while pulling the cover away from the body. Actuation of the trigger may be prevented until the relative displacement between the cover and the second unit reaches a threshold.

[0029] In some embodiments, the second unit may further include an elastic member aligned with a deflector on the cover. In some embodiments, the second unit may further include an elastic member configured to abut a portion of the cover to suppress relative displacement between the cover and the second unit until a force threshold is exceeded. In some embodiments, a portion of the cover may be a deflector member, and the elastic member may be an elastic arm included on the body. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, the skin of the body is lifted at least a certain distance from its rest position due to adhesive adhesion before the relative displacement exceeds the threshold. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, the skin of the body may be lifted at least a certain distance from its rest position due to adhesive adhesion before relative displacement between the cover and the first unit begins. In some embodiments, the force threshold may be selected such that: when the cover is pulled away from the body, the skin of the body is lifted at least a certain distance from its rest position due to adhesive adhesion. In some embodiments, the infusion set base may be releasably coupled to the body. In some embodiments, the infusion set base may be arranged such that the infusion set base is released from the body when the tip retainer is moved to the forward position.

[0030] In some embodiments, the insert assembly may further include a retraction spring. The tip retainer can be displaced from a forward position to a retracted position via this retraction spring. In some embodiments, the tip retainer may be in a different position in the retracted state than in its raised position. In some embodiments, the insert assembly may further include a retractable spring-release latch arrangement configured to disengage when the tip retainer is displaced to the forward position. In some embodiments, the retractable spring-release latch arrangement releasably connects the infusion set base to the body. When the spring-release latch arrangement disengages, the infusion set base can be released from the body. In some embodiments, the cannula subassembly may be carried on the insert tip.

[0031] According to another embodiment of this disclosure, a cartridge for a reusable insert assembly may include an outer housing. The cartridge may also include an inner housing releasably coupled to the outer housing. The cartridge may further include an infusion set base holder on which an infusion set base is held. The cartridge may also include a tip holder on which an insert tip is coupled. The cartridge may further include a cannula subassembly mounted on the insert tip such that the insertion end of the insert tip extends from the cannula outlet end of the cannula subassembly. The insertion end of the insert tip may be within the inner housing.

[0032] In some embodiments, the cartridge may further include a removable barrier member. In some embodiments, the barrier member may be disinfectant-permeable. In some embodiments, the outer housing may be shaped as a cup. In some embodiments, the outer housing may include at least one receptacle, while the inner housing may include at least one displaceable protrusion. In some embodiments, the inner housing may be releasably coupled to the outer housing via engagement of each of the at least one protrusion with a corresponding receptacle of the at least one receptacle. In some embodiments, each of the at least one protrusion may be included on the unsupported end of a cantilever arm. In some embodiments, each cantilever arm may include a tilting protrusion at its unsupported end. The tilting protrusion may be configured to interact with a deflector member on the reusable insert assembly such that, after the cartridge is coupled to the reusable insert assembly, the deflector member deflects the cantilever arm and displaces the associated protrusion from engagement with the receptacle of the at least one receptacle. In some embodiments, the cartridge may further include a set of mating pins. In some embodiments, the mating pins may be configured such that, when the cartridge is coupled to the reusable insert assembly, the mating pins are received in a retaining shoe of the reusable insert assembly. In some embodiments, the tip retainer may include a terminal flange extending from the inner housing. In some embodiments, the terminal flange may have an elongated oval cross-sectional shape. In some embodiments, an adhesive may be included on the surface of the infusion set base. The adhesive is covered by a liner or backing. In some embodiments, the inner housing may include a recess providing a recess in which a liner pull tab is positioned. In some embodiments, the infusion set base retainer may include a cavity in which a majority portion of the tip retainer is disposed. In some embodiments, the cavity may include a guide and the tip retainer may include a track that cooperates with the guide to constrain displacement of the tip retainer within the cavity to a predetermined path.

[0033] According to embodiments of this disclosure, a cartridge for a reusable insert assembly may include a container. The cartridge may also include a housing releasably coupled within the container. The housing may include a bay. The cartridge may also include an infusion set base disposed within the bay. The cartridge may further include a retainer body comprising a set of cantilever arms and a cavity. The infusion set base may be releasably coupled to the retainer body via the cantilever arm assembly. The cartridge may also include a tip retainer to which an insert tip is coupled. The tip retainer may be configured to displace along a guide included in the cavity. The cartridge may further include a cannula subassembly mounted on the insert tip such that an end of the cannula subassembly is adjacent to a first end of the tip retainer.

[0034] In some embodiments, the cartridge case further includes a barrier member that may surround the housing together with the container. In some embodiments, the cartridge case may also include a set of mating pins. In some embodiments, the mating pins may be configured such that when the cartridge case is coupled to a reusable insert assembly, the mating pins are received in a retaining shoe of the reusable insert assembly. In some embodiments, a pointed retainer may include a terminal flange extending from the housing. In some embodiments, the terminal flange may have an elongated oval cross-sectional shape. In some embodiments, the compartment may include at least one recess, and the infusion set base may include at least one tube retainer. Each tube retainer of the infusion set base may be disposed within one of the recesses of the compartment. In some embodiments, the cannula subassembly may include a convex angle arranged to engage a latch of the infusion set base to retain the cannula subassembly within the infusion set base when it is displaced into a receiving gap in the infusion set base. In some embodiments, the cannula subassembly may include a notch arranged to engage a latch on the infusion set base to retain the cannula subassembly within the infusion set base as it is displaced into a receiving gap in the infusion set base. In some embodiments, the retainer body may be coupled to the housing via a snap-fit ​​engagement. In some embodiments, the cantilever arm may be configured such that, as the cannula subassembly is displaced toward the infusion set base, the cantilever arm is displaced to an open position via an ear of the cannula subassembly to release the infusion set base. In some embodiments, the housing may include a recess in which a pull tab of an adhesive-backed liner covered with adhesive on the infusion set base is disposed. In some embodiments, the housing may include at least one set of stop surfaces.

[0035] According to another embodiment of this disclosure, a cartridge for a reusable insert assembly may include a container. The cartridge may also include a housing comprising a spring-loaded tab. The housing may be engaged within the container when the spring-loaded tab is in a first state and disengaged from the container when the spring-loaded tab is deflected from the first state to a deflected state. The cartridge may also include a retainer body comprising a cavity, an end plate, and a set of retainer arms, the end plate having mating pins projecting therefrom. The cartridge may also include a medical device. At least a portion of the medical device may be held by the retainer arms. The cartridge may also include an insert tip. The cartridge may also include a tip retainer configured to displace along a guide included in the cavity. The insert tip may be coupled to the tip retainer.

[0036] In some embodiments, the spring-loaded tab may be included on a resilient cantilever arm. In some embodiments, the cartridge may also include a second spring-loaded tab opposite to the spring-loaded tab. In some embodiments, the medical device may be an analyte sensor. In some embodiments, the medical device may be a physiological monitor. In some embodiments, the medical device may be an infusion set. An infusion set may include an infusion set base and a cannula subassembly. In some embodiments, the infusion set base may be held by a retainer arm, and the cannula subassembly may be disposed at an insertion tip and detachable from the infusion set base. In some embodiments, the cannula subassembly may include a set of ears. The retainer arm may be configured such that when the tip retainer is moved toward the infusion set base, the retainer arm is moved to an open state through the ears of the cannula subassembly to release the infusion set base. In some embodiments, the infusion set base may include a through-hole. In some embodiments, the infusion set base may have an adhesive thereto. The adhesive may be covered by an adhesive backing. At least one of the adhesive and the adhesive backing may extend through and cover the through-hole. In some embodiments, the tip retainer may include a terminal flange configured to mate with an insertion actuator of a reusable insert assembly. In some embodiments, a mating pin may be configured to mate with a retaining boot included in the insert assembly. In some embodiments, the cartridge may also include an adhesive backing that covers an adhesive portion of the medical device. The housing may include a recess in which a pull tab of the adhesive backing is disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with a locking member of the insert assembly once the insert assembly and the housing are coupled to lock the housing from rotational displacement. In some embodiments, the container may be configured to displace the locking member when it is pressed against the insert assembly to unlock rotational displacement of the housing. In some embodiments, a spring-loaded tab may be configured to displace to a deflected state when the cartridge is coupled to the insert assembly. In some embodiments, the medical device may include an adhesive patch attached thereto. The adhesive patch may be covered with a peel-off liner.

[0037] According to another embodiment of this disclosure, the insert assembly may include a first unit. The insert assembly may also include a second unit. The first unit may be displaceable relative to the second unit. The insert assembly may also include an insertion biasing member configured to transition to a compressed state when the first unit is pressed against the second unit. The insert assembly may also include a retainer configured to engage a first latch when the first unit is displaced toward the second unit beyond a first threshold distance, thereby retaining the insertion biasing member in the compressed state. The insert assembly may also include an insertion driver included in the second unit and displaceable from a first position to an extended position. The insert assembly may also include a release finger included on the first unit. The release finger may be configured to disengage the insertion driver from an insertion driver latch when the first unit is pulled away from the second unit beyond a second threshold distance, thereby releasing the insertion biasing member from the compressed state. When the insertion biasing member is released from the compressed state, it can advance the insertion driver from the first position to the extended position. When the insertion driver is moved to the extended position, it can disengage from the first latch.

[0038] In some embodiments, the insert assembly may be needle-free. In some embodiments, the insert assembly may not include an insert tip. In some embodiments, the insert assembly may further include at least one retraction biasing member. In some embodiments, the at least one retraction biasing member may be configured to transition to a compressed state when the first unit is pressed against the second unit. In some embodiments, the at least one retraction biasing member may be held in the compressed state when the retainer engages with the first latch. In some embodiments, the at least one retraction biasing member may be released from the compressed state when the first latch disengages as the insert driver is advanced to an extended position. In some embodiments, the insert driver may be displaced to a first position when the at least one retraction biasing member transitions from the compressed state to a relaxed state. In some embodiments, the release finger may include a paddle having a first side and a second side. The first side may be closer to the longitudinal axis of the insert assembly. In some embodiments, the second unit may include a guide wedge that protrudes into the displacement path followed by the release finger when the first unit is displaced relative to the second unit. In some embodiments, the first and second sides of the paddle may include inclined portions. At least one of the inclined portions may be configured such that, when the first unit is pressed toward the second unit, at least one of the inclined portions contacts a guide wedge and deflects the release finger away from the insertion driver latch. In some embodiments, the first and second sides of the paddle may include inclined portions, and at least one of the inclined portions may be configured such that, when the first unit is pulled away from the second unit, at least one of the inclined portions contacts a guide wedge and deflects the release finger into the insertion driver latch. In some embodiments, the insertion driver may include a port configured to mate with an insertion tip retainer. In some embodiments, the second unit may include a receiving body coupled thereto. The receiving body may be disposed at an end of the second unit. In some embodiments, the receiving body may include at least one retention interface configured to engage with a mating protrusion of a disposable cartridge. In some embodiments, the first latch may include a pair of arms, each arm having a latch flange. The pair of arms may extend cantileveredly from a main portion of the latch body. In some embodiments, the insertion driver latch may include a protrusion extending into a recess in a cantilevered arm extending from the body of the insertion driver. In some embodiments, a second threshold distance can be measured from the position of the first unit after the first unit has been shifted by a first threshold distance. In some embodiments, the second unit may include a receiving body configured to match any one of an infusion set cartridge, a sensor cartridge, and a lancet cartridge.

[0039] According to embodiments of the present disclosure, the insert assembly may include an outer housing and a cap coupled to an end of the outer housing. The insert assembly may also include an inner housing. The outer housing and the cap may be displaceable relative to the inner housing. The insert assembly may further include an insertion driver included in the inner housing and capable of displacement from a retracted position to an extended position. The insert assembly may further include an insertion biasing member received in a portion of the insertion driver and configured to transition to a compressed state when the outer housing and the cap are displaced toward the inner housing. The insert assembly may further include a retainer configured to engage a first latch, thereby holding the insertion biasing member in a compressed state when the outer housing and the cap are displaced toward the inner housing to a ready position. The insert assembly may further include a release finger projecting from the cap, configured such that when the outer housing and cap are pulled from the ready position beyond a threshold distance, the release finger disengages the insert driver from the insert driver latch, thereby releasing the insert biasing member from the compressed state. When the insert biasing member is released from the compressed state, it can advance the insert driver from a first position to an extended position. When the insert driver moves to the extended position, it can disengage from the first latch.

[0040] In some embodiments, the insert assembly may not include an insert tip. In some embodiments, the insert assembly may be needle-free. In some embodiments, the insert assembly may further include at least one retraction biasing member. In some embodiments, the at least one retraction biasing member may be configured to transition to a compressed state when the outer housing and cap are pressed against the inner housing. In some embodiments, the at least one retraction biasing member may be held in the compressed state when the retainer is engaged with the first latch. In some embodiments, the at least one retraction biasing member may be released from the compressed state when the first latch is disengaged. In some embodiments, the insert actuator may be displaced to a retracted position when the at least one retraction biasing member transitions from the compressed state to a relaxed state. In some embodiments, the release finger may include a paddle having a first side and a second side. The first side may be closer to the longitudinal axis of the insert assembly. In some embodiments, the inner housing may include a guide wedge that protrudes into the displacement path followed by the release finger when the outer housing and cap are displaced relative to the inner housing. In some embodiments, the first and second sides of the paddle may include inclined portions. At least one of the inclined portions may be configured such that when the outer housing and cap are pressed toward the inner housing, at least one of the inclined portions contacts a guide wedge and deflects a release finger away from the insertion driver latch. In some embodiments, the first and second sides of the paddle may include inclined portions. At least one of the inclined portions may be configured such that when the outer housing and cap are pulled away from the inner housing, at least one of the inclined portions contacts a guide wedge and deflects a release finger into the insertion driver latch. In some embodiments, the insertion driver may include a port configured to mate with an insertion tip retainer. In some embodiments, the inner housing may include a receiving body coupled thereto. The receiving body may be disposed at an end of the inner housing. In some embodiments, the receiving body may include at least one retaining interface configured to engage with a mating protrusion of a disposable cartridge. In some embodiments, the receiving body may include at least one retaining boot configured to engage with a mating pin of a disposable cartridge. In some embodiments, the first latch may include a pair of arms, each having a latch flange, extending cantileveredly from a major portion of the latch body. In some embodiments, the insert driver latch includes a protrusion extending into a recess in the cantilevered arm extending from the body of the insert driver.

[0041] According to embodiments of this disclosure, the insert assembly may include a first portion. The insert assembly may also include a second portion. The first portion may be displaced relative to the second portion. The insert assembly may also include an insert driver included in the second portion. The insert assembly may also include an insert biasing member included in the second portion, configured such that when the insert biasing member is in a compressed state, the insert biasing member pushes the insert driver from a retracted state to an extended state. The insert assembly may also include a retainer included in the second portion. The insert assembly may also include a first latch included in the second portion. The insert assembly may also include an insert driver latch included in the second portion. The insert driver may be releasably engaged with the insert driver latch. Displacement of the first portion toward the second portion and into a ready position may apply pressure to the insert biasing member and engage the retainer with the first latch to hold the insert biasing member in a compressed state. The first part's displacement beyond the threshold distance from the ready position can expel the insert driver from the insert driver latch and release the insert bias member from the compressed state.

[0042] In some embodiments, the first latch may include a set of cantilever arms with catch ledges. In some embodiments, the insert driver may include a body wider than the spacing between the arms in the cantilever arm set. This body can open the arms when the insert driver is in an extended position. In some embodiments, the insert driver may include a body wider than the spacing between the arms in the cantilever arm set. This body may be configured to actuate the cantilever arms to disengage from the retainer when the insert driver is in an extended position. In some embodiments, the insert biasing member may be housed within a portion of the insert driver. In some embodiments, the insert driver may include a port configured to mate with an insert tip retainer from which the insert tip extends. In some embodiments, the insert driver may include at least one cantilever arm. The at least one cantilever arm may include a notch. In some embodiments, the insert assembly may be tipless. In some embodiments, the insert assembly may not include an insert tip. In some embodiments, the insert driver latch may be a protrusion extending from the housing of the second portion. This protrusion may extend into the notch. In some embodiments, the first portion may include a release finger, and the second portion may include a deflector wedge. The deflector wedge may be configured to deflect the release finger into a portion of the insertion driver when the first portion has shifted beyond a threshold distance, thereby disengaging the insertion driver from the insertion driver latch. In some embodiments, the second portion may include a receptacle for one of the following: a disposable infusion set cartridge, a disposable analyte sensor cartridge, and a lancet syringe. In some embodiments, the second portion may include a receptacle including at least one mating interface for a mating protrusion of a disposable cartridge. In some embodiments, the insertion biasing member may be in a relaxed state when the insertion assembly is in a stored state. In some embodiments, the insertion biasing member may be a polymer spring. In some embodiments, the insertion biasing member may be an injection-molded spring. In some embodiments, the insertion biasing member may be a compression spring. In some embodiments, the insertion assembly may further include at least one retraction biasing member. In some embodiments, the at least one retraction biasing member may be configured to transition to a compressed state as the first portion shifts to a ready position. In some embodiments, the at least one retractable biasing member can be held in a compressed state when the retainer is engaged with the first latch. In some embodiments, the at least one retractable biasing member can be released from the compressed state when the first latch is disengaged. In some embodiments, the insertion driver can be displaced to a retracted state when the at least one retractable biasing member transitions from a compressed state to a relaxed state.

[0043] According to embodiments of this disclosure, a method of placing an infusion set may include attaching an infusion set cartridge to an insert assembly. The method may further include adhering a portion of the infusion set contained within the cartridge to an infusion site. The method may further include locking an insertion biasing member of the insert assembly in a compressed state by displacing a first portion of the insert assembly toward a second portion of the insert assembly. The method may further include releasing the insertion biasing member from the compressed state by moving the first portion of the insert assembly away from the second portion of the insert assembly. The method may further include advancing an insert driver and an insertion tip of the infusion set cartridge coupled to the insert driver toward the infusion site. The method may further include releasing the infusion set from the cartridge.

[0044] In some embodiments, locking the insertion biasing member in a compressed state may include pressing a first portion of the insert assembly against a second portion of the insert assembly. In some embodiments, locking the insertion biasing member in a compressed state may include pressing the first portion of the insert assembly toward the infusion site. In some embodiments, displacing the first portion of the insert assembly toward the second portion of the insert assembly may apply pressure to the insertion biasing member. In some embodiments, releasing the insertion biasing member from the compressed state may include pulling the first portion of the insert assembly away from the infusion site. In some embodiments, the method may further include lifting the skin at the infusion site from the underlying body structure before advancing the insert driver and insert tip of the infusion set cartridge toward the infusion site. In some embodiments, advancing the insert driver and insert tip toward the infusion site may further include advancing the cannula subassembly toward the infusion site. In some embodiments, the method may further include coupling the cannula subassembly of the infusion set to the base of the infusion set. In some embodiments, attaching a portion of the infusion set to the infusion site may include attaching the base of the infusion set to the infusion site. In some embodiments, coupling the infusion set cartridge to the insert assembly may include displacing a mating protrusion included in the cartridge into a retaining interface on the insert assembly. In some embodiments, coupling the infusion set cartridge to the insert assembly may include removing the outer housing of the infusion set cartridge. In some embodiments, the method may further include removing the infusion set cartridge from the insert assembly, and removing the infusion set cartridge from the insert assembly may include reattaching the outer housing to the infusion set cartridge. In some embodiments, the method may further include removing the infusion set cartridge from the insert assembly once it has been used. In some embodiments, releasing the infusion set from the cartridge may include deflecting a retaining arm of the infusion set cartridge out of engagement with a portion of the infusion set. In some embodiments, deflecting the retaining arm may include driving an ear of the cannula subassembly of the infusion set into the retaining arm as the cannula subassembly is advanced to engage with the infusion set base of the infusion set. In some embodiments, coupling the infusion set cartridge to the insert assembly may include rotatably locking the infusion set cartridge into place on the insert assembly. In some embodiments, the method may further include retracting the insert driver and insert tip to a retracted state. In some embodiments, coupling the infusion set cartridge to the insert assembly may include mating the insert tip retainer of the infusion set cartridge into a port of the insert driver. In some embodiments, displacing a first portion of the insert assembly toward a second portion of the insert assembly may apply pressure to at least one contraction spring. In some embodiments, the method may further include releasing at least one contraction spring from a compressed state and pushing the insert driver and insert tip away from the infusion site. In some embodiments, releasing at least one contraction spring from a compressed state may include advancing the insert driver into a portion of the latch body to disengage the latch.

[0045] According to embodiments of this disclosure, an insert system may include an insert assembly including a receptacle comprising at least one retaining interface and an aperture through the receptacle. The insert assembly may further include an insert actuator displaceable through the aperture and displaceable between a retracted position and an extended position. The insert assembly may further include at least one spring-biased locking member displaceable from a retracted position to an extended position. The system may also include a disposable cartridge including at least one mating protrusion, a medical device, and at least one set of stop surfaces. Each of the at least one mating protrusion is configured to rotate to engage a corresponding retaining interface of the at least one retaining interface. The at least one set of stop surfaces is configured to be located on the side of the at least one locking member when the locking member is in the extended position, which prevents rotation of the disposable cartridge.

[0046] In some embodiments, the at least one locking member may be a resilient cantilever member. In some embodiments, the medical device may be an infusion set. In some embodiments, the infusion set may include an infusion set base and a cannula subassembly. The cannula subassembly may be separable from the infusion set base. In some embodiments, the medical device may be a lancet. In some embodiments, the medical device may be an analyte sensor. In some embodiments, each of the at least one mating protrusion may be a mating pin with a head having a cross-sectional area larger than the rod portion of the mating pin that connects the head to the cartridge. In some embodiments, the at least one retaining interface may be a retaining boot. In some embodiments, each of the at least one retaining interface may be configured to prevent translational displacement of the corresponding one of the at least one mating protrusion along the longitudinal axis of the insert assembly when the corresponding mating protrusion engages with the retaining interface. In some embodiments, the cartridge may be configured to displace the at least one locking member to the retracted position when the at least one mating protrusion disengages from the at least one retaining interface and the cartridge abuts against a receiving portion. In some embodiments, the cartridge may include an inner housing including tabs disposed on a cantilevered portion of the inner housing. The housing may further include an outer housing including a receiving slot for the tab. An inner housing may be coupled to the outer housing when the tab is at least partially disposed within the receiving slot. In some embodiments, the receiving portion may include a deflector member. In some embodiments, the deflector member may be configured to deflect a cantilevered portion of the inner housing when the mating protrusion engages with the retaining interface. When the cantilevered portion of the inner housing is in the deflected state, the outer housing is disengaged from the inner housing. In some embodiments, the at least one set of stop surfaces may be defined by an edge wall on either side of at least one of the cantilevered portions. In some embodiments, the insertion driver may include a port. In some embodiments, the cartridge may include a tip retainer coupled to the insertion tip. The tip retainer may be configured to engage with the port when each of the at least one mating protrusion engages with a corresponding retaining interface of the at least one retaining interface. In some embodiments, the cartridge may include a tip retainer with a terminal flange shaped such that the terminal flange can be displaced into the port when the cartridge is in a first orientation on the receiving portion, and can remain in the port when the cartridge is in a position where each of the at least one mating protrusion engages with a corresponding retaining interface of the at least one retaining interface. In some embodiments, the cartridge may include a tip retainer coupled to a tip. In some embodiments, the cartridge may include at least one guide.At least a portion of the medical device may be configured such that when the insertion driver is moved from a retracted position to an extended position, at least a portion of the medical device moves along a guide. In some embodiments, the cartridge may include a first housing and a second housing releasably coupled to the first housing. When the second housing abuts against the receiving portion, the second housing may move at least one locking member to the retracted state. In some embodiments, the insertion assembly may further include an insertion biasing member and an insertion driver latch. The insertion biasing member may be configured to push the insertion driver to the extended position when the insertion driver is disengaged from the insertion driver latch.

[0047] According to embodiments of this disclosure, an infusion set base for an infusion set may include a platform portion having a first surface and a second surface on its opposite side. The infusion set base may also include a set of connector finger receptacles extending from the second surface of the platform portion. The infusion set base may also include a set of guides rising from the second surface of the platform portion. Each guide may include a guide recess recessed into the guide from the surface of the guide furthest from the second surface of the platform portion. The infusion set base may also include a cannula subassembly receptacle defined by an aperture in the platform portion, a receptacle wall rising from the second surface of the platform, and a portion of each guide including the guide recess. The infusion set base may also include a cantilever arm included as a segment of the receptacle wall, the cantilever arm having a bulge at its unsupported end.

[0048] In some embodiments, the first surface of the platform portion may include an adhesive adhered thereto. In some embodiments, the adhesive may be covered by an adhesive backing. In some embodiments, the adhesive backing may extend through and cover the orifices. In some embodiments, the first surface of the platform portion may include two annular ridges and a plurality of radially arranged ridges at the periphery of the first surface. In some embodiments, a substrate to which adhesive is applied may be bonded to the annular ridges and the radially arranged ridges. In some embodiments, the substrate may be welded to the annular ridges and the radially arranged ridges. In some embodiments, the platform may include a plurality of through holes extending through the platform. In some embodiments, the platform portion may include at least one tube retainer extending from the periphery of the platform portion. In some embodiments, each connector receptacle may include a latch for engaging a protrusion on a connector finger of an infusion tubing connector. In some embodiments, at least one of the portions defining the receptacle of the receptacle wall or guide may include a tapered portion at its furthest point from the second surface of the platform portion. In some embodiments, the cantilever arm may be configured such that: when the cannula subassembly is moved into the cannula subassembly receptacle, the cantilever arm deflects, and when the cannula subassembly is in a mounting orientation within the cannula subassembly receptacle, the cantilever arm elastically returns to a relaxed state, such that the protrusion engages a flange of a convex angle on the cannula subassembly. In some embodiments, the cantilever arm may be configured such that: when the cannula subassembly is moved into the cannula subassembly receptacle, the cannula subassembly deflects, and when the cannula subassembly is in a mounting orientation within the cannula subassembly receptacle, the protrusion engages a wall of an opening in the housing of the cannula subassembly. In some embodiments, the cantilever arm may be configured such that: when the cannula subassembly is moved into the cannula subassembly receptacle, the cannula subassembly deflects, and when the cannula subassembly is in a mounting orientation within the cannula subassembly receptacle, the protrusion engages a wall of a cannula housing slot in the housing of the cannula subassembly. In some embodiments, each guide may define a flange, at least a portion of which is parallel to the second surface of the platform portion. In some embodiments, each flange may be closer to the second surface of the platform portion than the portion of each notch closest to the second surface of the platform portion. In some embodiments, the cannula subassembly receiving portion may be centrally disposed on the platform portion. In some embodiments, the orifice may include a convex corner receiving region for receiving a convex corner of the cannula subassembly housing. In some embodiments, each guide may include a first partial flange and a second partial flange, each flange extending from a main portion of the respective guide. The first partial flange may be substantially parallel to the second surface of the platform portion, and the second partial flange may be angled relative to the first partial flange.In some embodiments, as the second partial flange extends distally relative to the first partial flange, the distance between the surface of the second face of the second partial flange closest to the platform portion and the second face of the platform portion increases. In some embodiments, the guides may extend parallel to each other, and each guide may include an inner side and a side side. The inner side may be closer to the midplane of the infusion set base than the side side. In some embodiments, the guides may include a guide flange disposed on the outer side of each guide and an additional guide flange on the inner side of each guide.

[0049] According to embodiments of this disclosure, a tubing connector for fluidly connecting a flow lumen of an infusion tubing segment to the cannula of an infusion set may include a flow hub having a channel passing through it. The infusion tubing segment may be connected to a first end of the channel, and a tip may be connected to an opposite second end of the channel. The tip lumen of the tip may be in fluid communication with the flow lumen. The tubing connector may also include a pair of alignment channels. One of the alignment channels may be recessed into a first side of the flow hub. The other of the alignment channels may be recessed into an opposite second side of the flow hub. The alignment channel may include a variable-width section and a constant-width section near the second end of the channel. The tubing connector may also include a pair of cantilever connector fingers. A first connector finger of the pair of connector fingers may be connected to a first side via a first tubing connector body portion, and a second connector finger of the pair of connector fingers may be connected to an opposite second side via a second tubing connector body portion. Each connector finger may include a latching protrusion. The tube connector may also include at least one sharpflanking projection that extends from the hub parallel to the axis of the sharp point.

[0050] In some embodiments, the at least one pointed side protrusion may include a centrally located side protrusion extending from the top surface of the hub over at least a portion of the pointed tip. In some embodiments, the at least one pointed side protrusion may include a set of pointed side protrusions disposed on the side of the pointed tip. In some embodiments, the at least one pointed side protrusion may include a first pointed side protrusion and a second pointed side protrusion disposed on the side of the pointed tip and in the plane extending from the connector finger. In some embodiments, the first pointed side protrusion may extend from a first tube connector body portion parallel to the axis of the pointed tip, and the second pointed side protrusion may extend from a second tube connector body portion parallel to the axis of the pointed tip. In some embodiments, the first pointed side protrusion and the second pointed side protrusion may each have a protruding end. The protruding end may be further away from the hub than the terminal portion of each connector finger. In some embodiments, the first pointed side protrusion and the second pointed side protrusion may each include a curved end region. In some embodiments, the curved end region may each have a curvature of an arc with an oscillation greater than 90°. In some embodiments, the radius of curvature may be variable. In some embodiments, each of the curved end regions may include a substantially straight extension at its endpoint. In some embodiments, the curved end region may be curved in front of and around the terminal portions of the respective connector fingers in the pair of connector fingers. In some embodiments, a first tip side projection may extend from a first side of the flow hub parallel to the axis of the tip, and a second tip side projection may extend from a second side of the flow hub parallel to the axis of the tip. In some embodiments, each of the pair of alignment channels may be configured to ride along a guide flange of the infusion set base. In some embodiments, the tip may include an end. During assembly of the tubing connector, this end may be clocked to a predetermined rotational orientation. In some embodiments, the end may be magnetically clocked to a predetermined rotational orientation.

[0051] Details of one or more embodiments are set forth in the accompanying drawings and the following description. Other features and advantages will become apparent from the specification, drawings, and claims. Attached Figure Description

[0052] These and other aspects will become more apparent from the following detailed description of various embodiments of the present disclosure with reference to the accompanying drawings, in which: Figure 1A An exploded view of an exemplary insert component is shown; Figure 1B An exploded view of another exemplary insert component is shown; Figure 1C An exploded view of another exemplary insert component is shown; Figure 2 An exploded view of another exemplary insert component is shown; Figure 3 An exploded view of another exemplary insert component is shown; Figure 4A A perspective view of an exemplary infusion set base is shown; Figure 4B It is illustrated Figure 4A Another perspective view of an example infusion set base; Figure 5A An exploded view of an exemplary cannulation sub-assembly is shown; Figure 5B It is illustrated Figure 5A A cross-sectional view of the example cannulation subassembly shown; Figure 6 A perspective view of an example infusion set and tubing connector is shown; Figure 7A A perspective view of another exemplary infusion set base is shown; Figure 7B It is illustrated Figure 7A Another perspective view of an example infusion set base; Figure 8A An exploded view of an exemplary cannulation sub-assembly is shown; Figure 8B It is illustrated Figure 8A A cross-sectional view of the example cannulation subassembly shown; Figure 9 Another example of an infusion set and tubing connector is shown in perspective view; Figure 10A A perspective view of an example infusion set base is shown; Figure 10B It is illustrated Figure 10A Another perspective view of the infusion set base; Figure 11A A perspective view of an example infusion set base is shown; Figure 11B It is illustrated Figure 11A Another perspective view of the infusion set base; Figure 12A A perspective view of an example infusion set base is shown; Figure 12B It is illustrated Figure 12A Another perspective view of the infusion set base; Figure 13A A perspective view of an example infusion set base is shown; Figure 13B It is illustrated Figure 13ABottom plan view of the infusion set base; Figure 14A A perspective view of an example infusion set base is shown; Figure 14B It is illustrated Figure 14A Bottom plan view of the infusion set base; Figure 15A A side view of an example infusion set base is shown; Figure 15B It is illustrated Figure 15A Another side view of the example infusion set base; Figure 15C It is illustrated Figure 15A A perspective view of an example infusion set base; Figure 16A A perspective view of an example infusion set is shown; Figure 16B It is illustrated Figure 16A Another perspective view of an example infusion set; Figure 17A A side view of an example insert assembly in which an exemplary locking component is installed is illustrated; Figure 17B The illustration shows another side view of the example insert assembly in which the example locking component is installed; Figure 18A A top view of an example insert assembly with its outer casing removed is shown; Figure 18B A perspective view of an example insert assembly with its outer casing removed is shown; Figure 18C It is illustrated Figure 18B A detailed view of a portion; Figure 19 A top view of an example locking component is shown; Figure 20A A cross-sectional view of an example insert assembly in which an example locking component is installed is shown; Figure 20B It is illustrated Figure 20A A detailed view of a portion; Figure 21 A perspective view of an example locking component is shown; Figure 22 A flowchart detailing several actions that can be used to actuate the insert assembly is shown; Figure 23 A top view of the example insert component is shown; Figure 24A , Figure 24B A cross-sectional view of an exemplary insert component to be applied to a user's skin is shown; Figure 25A side view of an exemplary pointed retainer is shown; Figure 26 Another side view of the exemplary pointed retainer shown in Figure 18 is illustrated; Figure 27 Another side view of the example pointed retainer shown in Figure 18 is illustrated; Figure 28 A perspective view of the example pointed retainer shown in Figure 18 is illustrated; Figure 29 A perspective view of the tip retainer, tip, and cannulation assembly is shown. Figure 30 A side view of an example pointed retainer is shown; Figure 31 It is illustrated Figure 30 Another side view of an example pointed retainer; Figure 32 It is illustrated Figure 30 An example perspective view of a pointed retainer; Figure 33 It is illustrated Figure 32 A detailed view of the indicator area; Figure 34 A perspective view of the example retainer base is shown; Figure 35A A perspective view of an example pointed retractor is shown; Figure 35B It is illustrated Figure 35A Another perspective view of the exemplary pointed retractor shown; Figure 35C It is illustrated Figure 35B A detailed view of a portion; Figure 36 A cross-sectional view of an example insert assembly is shown, with the arm included on the pointed retractor of the insert assembly cut through it. Figure 37 A perspective view of the example's outer casing is shown; Figure 38A , 38B It depicts including Figure 37 A cross-sectional view of an example insert assembly of the outer housing is shown in the figure. Figure 39A , 39B A cross-sectional view of an example insert component being removed from the user after being applied to the skin is shown; Figure 39C , 39D A cross-sectional view of an exemplary insert assembly including an additional spring is illustrated; Figure 40A , 40BA cross-sectional view of an example insert component being removed from the user after being applied to the skin is shown; Figure 41A , 41B The illustration shows a cross-sectional view of an example insert component after the tip of the insert component has pierced the user's skin; Figure 42A , 42B A cross-sectional view of an example insert assembly is shown after the pointed retractor has been released and retracted; Figure 43A , 43B A cross-sectional view of an example insert assembly is shown during the retraction of the pointed retractor; Figure 43C A cross-sectional view of an alternative embodiment of the insert assembly is illustrated; Figure 44A , 44B A cross-sectional view of the insert assembly is shown after the insert assembly actuation is complete; Figure 45 A perspective view of the example retainer base is shown; Figure 46 A bottom view of the example insert component is shown; Figure 47 The illustration shows Figure 46 A sectional view taken at the cutting plane shown; Figure 48A , 48B A cross-sectional view of another exemplary insert component that will be applied to a user's skin is shown; Figure 49A A side view of an alternative embodiment of the pointed retainer is shown; Figure 49B It is illustrated Figure 49A Perspective view of the pointed retainer shown; Figure 49C It is illustrated Figure 49A Another side view of the pointed retainer shown; Figure 50 A perspective view of an exemplary retainer cap is shown; Figure 51 The illustration shows a cross-sectional view of an example retainer cap and a pointed retainer; Figure 52 It is illustrated Figure 51 A detailed view of a portion; Figure 53A A perspective view of an exemplary pointed retractor is shown; Figure 53B It is illustrated Figure 53A Another perspective view of the pointed retractor shown; Figure 54A perspective view of an example insert component, including a button, is shown; Figure 55A It is illustrated Figure 54 A top view of the insert component shown; Figure 55B The illustration shows Figure 55A A sectional view taken at section 55B-55B; Figure 55C The diagram shows the route Figure 55A A three-quarter perspective section view taken from 55C-55C. Figure 56 A perspective view of an example outer casing including an insert component with buttons is shown; Figure 57 A perspective view of an example insert assembly with its outer housing removed is shown. Figure 58 A perspective view of an example insert assembly with its outer housing removed is shown. Figure 59 It is illustrated Figure 58 A detailed view of the indicator area; Figure 60 A perspective view illustrating an exemplary skid that may be included in the insert assembly is shown; Figure 61 A perspective view of an example outer housing for an insert assembly including deformable regions is shown; Figure 62 A perspective view of another example outer housing for an insert assembly is shown, the insert assembly including protrusions on its inner surface; Figure 63 A flowchart illustrating in detail several actions that can be used to assemble insert components is provided; Figure 64 A side view of an example insert component and an example cartridge that can be attached to the insert component is shown; Figure 65A An exploded view of the example cartridge is shown; Figure 65B It is illustrated Figure 65A Another exploded view of the example cartridge shown; Figure 66 A perspective view of an exemplary infusion set base holder is shown; Figure 67 A perspective view of the example internal casing of the example cartridge is shown; Figure 68 A bottom plan view of the example cartridge is shown; Figure 69A The illustration shows Figure 68 A sectional view taken at section 69A-69A; Figure 69B The illustration shows Figure 68 Another sectional view taken at section 69B-69B; Figure 70A An exploded view of a reusable example insert component is shown; Figure 70B It is illustrated Figure 70A Another exploded view of the example insert component; Figure 71A An exploded view of another example reusable insert component is shown; Figure 71B It is illustrated Figure 71A Another exploded view of the example insert component; Figure 72 A cross-sectional view of the example insert component is shown; Figure 73 The diagram shows a view of the sample insert components disassembled from the sample cartridge; Figure 74 It is illustrated Figure 73 A detailed view of the indicator area; Figure 75 It is illustrated Figure 73 A detailed view of the indicator area; Figure 76 A perspective view of an example insert assembly with a cartridge attached is shown; Figure 77 A cross-sectional view of the example insert component is shown; Figure 78 A perspective view of an example locking component is shown; Figure 79 A perspective view of the retracted latch body is shown; Figure 80 A cross-sectional view of the example insert component is shown; Figure 81 A cross-sectional view of the example insert component is shown; Figure 82 A view of an example reset body connected to an example retraction spring retainer is shown; Figure 83 A top view of the example internal housing of the example insert component is shown; Figure 84 The diagram shows the route Figure 83 84-84 sectional view; Figure 85 A cross-sectional view of the example insert component is shown; Figure 86 A cross-sectional view of the example insert component is shown; Figure 87 A top plan view of the example insert component is shown; Figure 88 The illustration shows Figure 87 A sectional view taken at position 88-88; Figure 89 A cross-sectional perspective view of an example insert component is shown; Figure 90 It is illustrated Figure 89 A detailed view of the indicator area; Figure 91 A perspective view of the sample internal housing of the sample insert component is shown; Figure 92 A cross-sectional perspective view of an example insert component is shown; Figure 93 A cross-sectional view of the retainer cap of the example insert assembly is shown; Figure 94 It is illustrated Figure 93 A detailed view of the indicator area; Figure 95 A cross-sectional view of the example insert component is shown; Figure 96 A cross-sectional view of the example insert component is shown; Figure 97 A cross-sectional view of the example insert component is shown; Figure 98 A cross-sectional view of the example insert component is shown; Figure 99A A cross-sectional view of the example insert component is shown; Figure 99B A cross-sectional view of the example insert component is shown; Figure 100 A cross-sectional view of the example insert component is shown; Figure 101 A perspective view of the cartridge attached to the insert assembly is shown, with the outer casing of the cartridge removed; Figure 102 A perspective view of an example tube connector is shown; Figure 103A It is illustrated Figure 102 The bottom view of the tube connector shown; Figure 103B It is illustrated Figure 103A A detailed view of a portion; Figure 104 A perspective view of a tube connector in place on a mounting device is shown; Figure 105 It is illustrated Figure 104 The bottom view of the fixing device shown; Figure 106 A perspective view of a tube connector being aligned for installation into a mounting device is shown. Figure 107 A cross-sectional view of a fixing device on which a tube connector is mounted and whose tip is inserted into the tube connector is shown. Figure 108 A cross-sectional view of the fixing device is shown, on which a tube connector is mounted and the tip is positioned and clocked to a predetermined position within the tube connector; and Figure 109 Flowcharts detailing several example actions that can be used to assemble tube connectors are shown. Detailed Implementation

[0053] In various embodiments, the infusion set can be used in conjunction with infusion devices, systems, and related methods, as well as with insert components. In various embodiments, the example infusion set can be configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the example infusion set can be fluidly connected to a section of tubing and / or an infusion device. Infusion devices include any infusion pump and may include, but are not limited to, the various infusion devices described in the following patents: U.S. Patent Application Serial No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly," now published April 17, 2014, U.S. Publication No. US-2014-0107579 (Attorney-at-Law File No. K40); U.S. Patent No. 8,491,570, published July 23, 2013, entitled "Infusion Pump Assembly" (Attorney-at-Law File No. G75); U.S. Patent No. 8,414,522, published April 9, 2013, entitled "Fluid Delivery Systems and Methods" (Attorney-at-Law File No. E70); and U.S. Patent No. 13 / 788,260, filed September 11, 2012, entitled "Infusion Pump Assembly." U.S. Patent No. 8,262,616 (Attorney’s File No. F51) entitled “Assembly”; and U.S. Patent No. 7,306,578 (Attorney’s File No. C54) entitled “Loading Mechanism for Infusion Pump”, issued on December 11, 2007; all of these patents are incorporated herein by reference in their entirety.

[0054] Various embodiments are described and illustrated herein. Each embodiment of each element of each device can be used in any other device embodiment. Each embodiment of the insert assembly can be used with any embodiment of the infusion set.

[0055] Figure 1A An exploded view of an embodiment of an example insert assembly 100 is illustrated. Insert assemblies such as insert assembly 100 can be used to place an infusion set 102 onto a patient's infusion site and to introduce the cannula 104 of the infusion set 102 into the patient's body. In some embodiments, insert assembly 100 can be used to place other patient care components onto the patient's body. For example, certain insert assemblies 100 can be operated to place a physiological monitor in working relation with the patient's body. In some examples, an analyte sensor can be placed onto the patient via insert assembly 100. Infusion set 102 can be used to supply medication from an infusion pump to a specific location (e.g., subcutaneously) within the patient's body.

[0056] The supplied medications may include those typically supplied as a continuous or substantially continuous infusion, but other medications may also be used. This may include small molecules, biologics, recombinant-produced drugs, and their analogues. Hormones such as insulin or glucagon may be administered via infusion set 102. Other medications such as peptides (e.g., amylin) may be provided. Medications affecting the cardiovascular system may also be provided via infusion set 102. As another example, vasodilators such as treprost may be delivered to the patient via infusion set 102. Chemotherapy drugs may also be used. Exemplary physiological monitors may include blood glucose monitors, such as continuous glucose monitors. Any other type of body analyte monitor may also be used, such as interstitial fluid analyte monitors.

[0057] In some embodiments, the insert assembly 100 may place the infusion set 102 on a site and at least partially assemble the infusion set 102. For example, the infusion set 102 may be configured as multiple parts (e.g., separate components, sub-assemblies, or combinations thereof) within the insert assembly 100. Actuation of the insert assembly 100 may cause each part of the infusion set 102 to engage together to complete the assembly of the infusion set 102. For example, the assembly of the infusion set 102 may occur as an initial phase of actuation of the insert assembly 100, or as part of an insertion phase that leads to the introduction of the cannula 104 into the patient.

[0058] like Figure 1AAs shown in the exploded view, the insert assembly 100 includes components of the infusion set 102. The insert assembly 100 may not have an assembled infusion set 102 mounted therein. The infusion set 102 may include a first part and a second part that are separate from each other but are coupled together during actuation of the insert assembly 100 to form the infusion set 102. The first part may include a base 106 that can be applied to a patient's skin and can be coupled to a fluid passage (e.g., via a terminal connector on the passage) that is part of or extends from an infusion pump. Example infusion pumps may include any one or more disclosed in the various references incorporated above by reference, but any infusion pump may be used in various embodiments. The base 106 may be provided with an adhesive (e.g., an adhesive pad) that holds the infusion set 102 in place on the patient. The adhesive may be covered by an adhesive backing 111, liner, or membrane, which is removed before use to expose the adhesive.

[0059] The second part of the infusion set 102 may be a sub-assembly 114 of two or more components of the infusion set 102. For example, the second part may include a cannula 104, a diaphragm housing 108, a diaphragm 110, and a diaphragm retainer 112. In some embodiments, though not all, one or more components of the second part may be provided integratedly with each other, such that the components are manufactured as a single integral part during, for example, a single molding operation. Therefore, any attachment, fastening, bonding, fitting together, or other assembly of these parts after manufacturing can be avoided. In an exemplary embodiment, the cannula 104 and the diaphragm housing 108 are shown as such a single continuous integral part. The housing with the cannula may be a molded part made of a single material such as, for example, PTFE, Teflon, polypropylene, etc. Some components may also be joined together during manufacturing. For example, the diaphragm retainer 112 may be overmolded onto the diaphragm 110, and vice versa.

[0060] like Figure 1AAs shown, the insert assembly 100 may include multiple additional components. For example, the insert assembly 100 may include an outer housing 116. The outer housing 116 may enclose various components of the insert assembly 100 and serve as the portion of the insert assembly 100 that a user grips during operation. The outer housing 116 in the exemplary embodiment has a circular cross-sectional shape, but other embodiments may have different shapes, such as any type of polygonal shape. In some examples described elsewhere in the specification, a rectangular cross-sectional shape that fits easily within a pouch may be used. The cross-sectional area in the exemplary embodiment also varies as the bottom section of the outer housing 116 (which is closest to the skin during use) is wider than the top. The outer housing 116 may include various ergonomic features that facilitate gripping of the insert assembly 100 contained within the outer housing 116. For example, textures or finger or thumb recesses may be included on the outer surface of the outer housing 116. Alternatively or additionally, the width of one region of the outer housing 116 may be narrower than the width of the rest of the outer housing 116. This can make a firm grip on the insert assembly 100 easier.

[0061] The outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, raised areas, color codes, decals, or other markings for indicating the position and / or orientation of the infusion set 102 within the insertion assembly. For example, Figure 1A The outer housing 116 includes raised ribs 118 on its outer surface. In the example, the raised ribs 118 extend substantially parallel to the elongation direction of the outer housing 116; however, in alternative embodiments, the raised ribs 118 may be located on or partially on any one or more of the outer surfaces of the outer housing 116. The ribs 118 are arranged to indicate the orientation of a portion of the infusion set 102 to which a fluid conduit from the infusion device can be connected. This allows the user to position the insert assembly 100 in a desired orientation so that once the infusion set 102 is attached to the user, a section of infusion tubing can be arranged in a planned manner.

[0062] The insert assembly 100 may further include an inner housing 120. When the insert assembly 100 is assembled, the inner housing 120 may be disposed inside the outer housing 116. Various inner housings 120 may have at least one asymmetrically designed segment. Figure 1AIn the exemplary embodiment shown, the inner housing 120 includes a rail section 122 comprising a plurality of guide rails 124. The guide rails 124 extend substantially parallel to each other and may have at least two different widths. The inner surface of the outer housing 116 may include tracks or slots cooperating with the guide rails 124. Due to the different widths of the guide rails 124, a keyed arrangement can be provided, allowing the inner housing 120 to be nested within the outer housing 116 only in a predetermined orientation. The interaction of the guide rails 124 within the tracks can also inhibit rotation of the inner housing 120 and the outer housing 116 relative to each other. Although the guide rails 124 are shown on the inner housing 120 in the example, in some embodiments the guide rails 124 may alternatively exist on the inner surface of the outer housing 116. In such examples, the tracks may be located on the inner housing 120. Additionally, as shown, at least some of the guide rails 124 may also form channels or tracks in the inner surface of the inner housing 120.

[0063] In other embodiments, guide rails and track-type arrangements may not be used. One of the inner housing 120 or the outer housing 116 may include at least one protrusion, such as a tab, which abuts against a recess or guide in the other of the inner housing 120 or the outer housing 116. This can 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 allow components to be placed together in only one orientation and may suppress any relative rotation. For example, the cross-section may be teardrop-shaped or various asymmetrical polygonal shapes.

[0064] The inner housing 120 may also include an infusion set base interface section 126. This base interface section 126 may include a plurality of protrusions 352 that ensure the base 106 can be inserted into the insert assembly 100 only in the desired orientation. The protrusions 352 may also optionally help retain the base 106 within the insert assembly 100, and some friction may exist between the protrusions 128 and the surface of the base 106 when the base 106 is installed in the insert assembly 100. For example, the base 106 may form a press fit with the protrusions 352. The tightness of this fit may be minimal to allow the base 106 to be removed from the base interface section 126 with very little force. The protrusions 352 may also help maintain the flush orientation of the base 106 within the base interface section 126.

[0065] The insert assembly 100 may also include a tip retainer 130. The tip retainer 130 may retain the insert tip 132 thereon. The insert tip 132 may be glued or otherwise incorporated into the tip retainer 130 for fixed positioning relative to the tip retainer 130. Any suitable type of tip 132 may be used. For example, the tip 132 may be a hollow or solid needle, a core needle, or other sharp member, which may be made of a metallic material such as steel. A tip retractor 134 and a plurality of springs 136, 138 may also be included in the insert assembly 100. A retainer base 140 may be used to attach to the bottom of the insert assembly 100 to hold various components in place within the insert assembly 100. In this example, the retainer base 140 includes a retaining interface 142 that can snap into a cantilever retainer arm 144 included on the outer housing 116. Other connections are also possible, such as bayonet mounts, interference fits, snap-fits, adhesives, glues, threads, solvent bonding, welding, etc. When joined together, the outer housing 116 and the retainer base 140 can form a cover for the insert assembly 100.

[0066] As will be further described later in this specification, a latching arrangement may be included in the insert assembly 100, and the latching arrangement may hold the tip retainer 130 and the tip retractor 134 in place before and during partial actuation of the insert assembly 100. This latching arrangement may include multiple grippers. When free to move, springs 136, 138 may displace the tip retainer 130 and the tip retractor 134, as well as the parts held thereon, to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 may also occur as part of actuation to move the tip 132 to a point where it is pulled out of the infusion set 102 and prevents contact with the user.

[0067] When a user opens the packaging, the insert assembly 100 may be provided with a locking member 146. The locking member 146 may be inserted through openings 148, 150 in the outer housing 116 and the inner housing 120, respectively, to span at least a portion of the width of the inner housing 120. When present in the insert assembly 100, the locking member 146 may prevent actuation of the insert assembly 100. Example: The locking member 146 may mechanically prevent displacement of one or more components of the insert assembly 100 that would trigger actuation of the insert assembly 100. In an exemplary embodiment, the locking member 146 includes a flange 152 that can be gripped by the user during removal of the locking member 146.

[0068] As shown, the locking member 146 may include a plurality of raised segments 154 (e.g., ridges or protrusions). These raised segments 154 may provide material that can facilitate bonding to a portion of the adhesive backing 111 during the welding operation. As a result, the locking member 146 can be attached to the adhesive backing 111, providing the user with a visual cue if one of the locking member 146 or the adhesive backing 111 is removed while the other remains in place. This can help encourage the removal of both components before attempting to actuate the insert assembly 100, making the device more intuitive.

[0069] Still referencing Figure 1B and Figure 1C In some examples, the insert assembly 100 may include one or more additional springs 156, 158. For example... Figure 1C As shown, the additional spring 158 can be a conventional metal spring. Alternatively, such as Figure 1B As illustrated, a plastic spring 156 may be used. In some embodiments, the plastic spring 156 may be injection molded, cut from a tube (e.g., by laser cutting), manufactured by additive manufacturing, or any other suitable method. Such springs 156, 158 will be further described later in the specification.

[0070] Still referencing Figure 2 Another insert component 100 is shown. Figure 2 The insertion assembly 100 includes an outer housing 116 that may surround various components of the insertion assembly 100 and serve as a part of the insertion assembly 100 that is gripped by the user during operation. Although depicted as circular, the outer housing 116 may have other cross-sectional shapes or various ergonomic features as described above. The outer housing 116 includes position markings in the form of raised ribs 118 that extend from the outer surface of the outer housing 116. The ribs 118 may be arranged to indicate the orientation of a portion of the infusion set 102 contained within the insertion assembly 100.

[0071] The inner housing 120 is also included Figure 2 It can also be bonded to ensure that it is assembled into the insert assembly 100 in a specified orientation and to prevent relative rotation. For example, in Figure 2 In this case, the inner housing 120 may be made asymmetrical by including at least one protrusion 400, such as a tab, which engages with a recess or guide 402 in the outer housing 116. In this example, the guide 402 is provided by a channel formed by a raised rib 118 on the inner surface of the outer housing 116. Figure 2The protrusion 400 on the insert assembly 100 is included on the spacer 404, which ensures that the inner housing 120 fits snugly within the outer housing 116. The infusion set base interface section 126 is also included. Figure 2 The example shown is on the inner shell.

[0072] A pointed retainer 130, which can be attached to the insert pointed tip 132, is shown in the example embodiment. Additionally, a pointed retractor 134 and multiple springs 136, 138 may be included. A retainer cap 406 may be used to attach to the top of the insert assembly 100 to hold various components in place within the insert assembly 100. In this example, the retainer cap 406 includes a cantilevered retainer arm 408 that snaps into a retaining interface 411 included on the outer housing 116. Other connections are also possible, such as bayonet mounts, interference fits, snap-fit ​​fits, adhesives, glues, threads, solvent bonds, welding, etc. When joined together, the outer housing 116 and the retainer cap 406 may form a cover for the insert assembly 100.

[0073] As described in detail elsewhere herein, a latching arrangement may be included in the insert assembly 100 to hold the tip retainer 130 and the tip retractor 134 in place before and during partial actuation of the insert assembly 100. This latching arrangement may include multiple latches. Upon free movement, springs 136, 138 may displace the tip retainer 130 and the tip retractor 134, as well as the components held thereon, to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 may also occur as part of actuation.

[0074] exist Figure 2 In the illustrated exemplary embodiment, the insert assembly 100 does not include the locking member 146. However, in various embodiments, a similar locking member may be included in the outer housing 116 and the inner housing 120. Figure 1A-1C The openings 148 and 150 are provided to receive the locking member 146. In these embodiments, the adhesive backing 111 may be attached to the locking member 146. However, in an exemplary embodiment, the adhesive backing 111 includes two pull tabs 410 (although any suitable number may be included). These pull tabs 410 can be gripped by a user to facilitate the removal of the adhesive backing 111. Figure 2 It also includes Figure 1C Additional spring 158 is shown in the drawing.

[0075] Now for reference Figure 3 This illustrates another example embodiment of the insert component 100. As shown, Figure 3 The insert component 100 includes with Figure 2The illustrated example shows similar outer housings 116 and inner housings 120. The pointed retainer 130 and pointed retractor 134 differ from... Figures 1A to 2 Those shown. The retaining cap 406 can be used to attach to the top of the insert assembly 100 to retain various components in place within the insert assembly 100 and to form a cover for the insert assembly 100. The retaining cap 406 is configured to... Figure 2 The described embodiment is coupled to the outer housing 116 in a similar manner; however, any other type of coupling may be used in alternative embodiments. The retainer cap 406 also includes a protrusion 412 that can engage within a portion of the tip retainer 130 when the insert assembly 100 is fully assembled and ready to be actuated.

[0076] As described in detail elsewhere herein, a latching arrangement may be included in the insert assembly 100 to hold the tip retainer 130 and the tip retractor 134 in place before and during partial actuation of the insert assembly 100. This latching arrangement may include multiple latches. Upon free movement, springs 136, 138 may displace the tip retainer 130 and the tip retractor 134, as well as the components held thereon, to complete the insertion of the cannula 104 into the patient and the attachment of the infusion set 102 to the infusion site. Retraction of the tip 132 into the insert assembly 100 may also occur as part of actuation.

[0077] exist Figure 3 In the example embodiment shown, the insert assembly 100 does not include the locking member 146. However, in various embodiments, a similar locking member may be included in the outer housing 116 and the inner housing 120. Figure 1A-1C The openings 148 and 150 are provided to receive the locking member 146. In these various embodiments, the adhesive backing 111 may be attached to the locking member 146. However, in an exemplary embodiment, the adhesive backing 111 includes two pull tabs 410. These pull tabs 410 can be gripped by a user to facilitate the removal of the adhesive backing 111. Figure 3 It also includes Figure 1C Additional spring 158 is shown in the drawing.

[0078] Now for reference Figure 4A -B shows top and bottom perspective views of the infusion set base 106, respectively. As shown, the base 106 may have a platform portion 160. The platform portion 160 can be positioned against the patient's skin while the infusion set 102 is in place at the infusion site. In an exemplary embodiment, the platform portion 160 has a generally circular, and in this case, a generally circular, disc-shaped space. The platform portion 160 is also substantially flat. However, this is not necessarily the case in all embodiments.

[0079] In various embodiments, the adhesive may be applied to the bottom surface 162 of the platform portion 160. Adhesive backing 111 (see, for example...) Figure 1A The adhesive can be applied. In an exemplary embodiment, the bottom surface 162 of the platform portion 160 includes a plurality of raised segments 164. Exemplary raised segments 164 are illustrated as radially arranged ridges spaced at substantially regular angles on a portion of the bottom surface 162. Two concentric raised rings are also present around the periphery of the bottom surface 162. In other embodiments, raised segments other than ridges may be included, and / or the raised features may not be radially arranged or regularly spaced. The raised segments 154 may allow the adhesive to be bonded (e.g., ultrasonically or high-frequency welded) onto the bottom surface 162. For example, the adhesive may be contained on the substrate, and the adhesive may be a plastic, such as polypropylene or any other plastic that will be processed by the welding operation. The raised segments 164 and the substrate may be gradually mixed together during the welding operation to form a bond that holds the adhesive on the bottom surface 162 of the infusion set base 106.

[0080] In various embodiments, platform portion 160 may include a plurality of through holes 166. Figure 4A -B shows three circular through-holes 166, but in other examples any number of through-holes and their shapes may differ. Through-holes 166 can be provided to facilitate manufacturing because they allow protrusions on a portion of the assembly line to mate with them. During manufacturing operations, this interface can aid in the orientation or centering of the base 106 or any infusion set 102 sub-assembly including the base 106. Where through-holes 166 aid in orientation, it may be desirable for the through-holes 166 to be arranged asymmetrically (although symmetrical arrangements of the through-holes 166 are also possible). In this example, the through-holes 166 are arranged in a triangular pattern such that the base 106 will mate with only one set of corresponding protrusions in one orientation. Furthermore, in some embodiments, any adhesive and adhesive liner 111 may include holes aligned with the position of the through-holes 166. Thus, through-holes 166 can be used to aid the manufacturing process even when the insert assembly 100 is fully assembled and ready to trigger. Through-holes 166 can also engage with a portion of any package in which the insert assembly 100 is disposed to help hold the insert assembly 100 in place.

[0081] While the through-hole 166 may be helpful during manufacturing, it can also provide other benefits. For example, the through-hole 166 can provide a window to observe the skin around the infusion site. Therefore, the user may be able to assess signs of skin irritation or inflammation (e.g., redness or swelling). Furthermore, the through-hole 166 can provide a pathway through which ambient air communicates with the space between any protruding segments 164 on the bottom surface 162 of the infusion set base 106. This can help allow the area beneath the infusion set 102 to breathe while the infusion set 102 adheres to the skin.

[0082] Multiple tubing retainers 184 can extend from the periphery of the platform portion 160. The tubing retainers 184 allow the infusion tubing 366 to be wound around and held in place around a portion of the infusion set 102. This helps to prevent kinking of the tubing 366 and helps the user to easily arrange the infusion tubing 366 as needed.

[0083] Still referencing Figure 6 The top surface 168 of the platform portion 160 may include various receiving features extending therefrom, which may mate or dock with a connector 368 included at the end of an infusion tubing 366 extending from the infusion pump. In various embodiments, the infusion tubing 366 may be coupled to an infusion pump reservoir, such as a syringe or infusion pump outlet. The infusion tubing 366 may be coupled to the infusion pump via a Luer lock or other mechanical connection, adhesive, solvent bonding, or any other suitable method. The base 106 may include a connector receiver 170, around which cantilevered fingers 370 on the tubing kit connector 368 may deflect when the connector 368 slides onto the base 106. Once past the connector receiver 170, the cantilevered fingers 370 may return to their undeflected position, and protrusions or gripping projections on the cantilevered fingers 370 may be displaced into latching engagement with cooperating features of the connector receiver 170. Side protrusions 372 may also be present on the connector 368. These side protrusions 372 may extend substantially parallel to the tip included on the connector 368 and may include a barrier that helps prevent accidental contact between the tip and the user. A shielding wall 169 may be provided on the base 106 and may help prevent fingers or objects from accidentally disengaging the cantilevered finger 370 from engagement with the connector receiver 170. The shielding wall 169 may be continuous with the connector receiver 170.

[0084] The device may also include a guide 172 for each of the connector fingers 370 and the side protrusions 372, and in an exemplary embodiment defines a plurality of slots along which the connector fingers 370 and the side protrusions 372 can slide when the connector 368 is displaced to engage with the infusion set 102. The guide 172 makes it easier for the user to engage the infusion set 102 and the connector 368. Furthermore, the guide 172 helps ensure that the tip on the connector 368 is introduced into the infusion set 102 along or near the desired insertion axis. In this example, the guide 172 includes a notch 174. Each notch 174 may be sized to receive a protrusion on a component of the insert assembly 100. The notch 174 may also be sized to receive at least a portion of a protrusion included on the cannula subassembly 114 (see, for example...). Figure 5A When connector 368 is attached to infusion set 102, side protrusion 372 can be sized to extend a shorter distance from connector 368 than the location of recess 174. As described in further detail later in this specification, recess 174 can help facilitate release of base 106 from insert assembly 100 during actuation.

[0085] In various embodiments, the base 106 may also include a cannulation subassembly 114 for connection with the infusion set 102 (see, for example...). Figure 5A A matching receiving portion 176. In this example, the receiving portion 176 is generally centrally located on the base 106, and the receiving portion 176 is laterally connected to the guide 172 on each side. The receiving portion 176 may be at least partially surrounded by a receiving portion wall 178 that projects upward from the top surface 168 of the platform portion 160. Thus, portions of the receiving portion wall 178 and the guide 172 including the notch 174 may define the receiving portion 176. A portion of the receiving portion wall 178 may include a cantilevered section 180. The cantilevered section 180 may include a bulge (e.g., a barb or ramp) 182. In some embodiments, a portion of the receiving portion wall 178 and / or the guide 172 may include a tapered section (see, for example...). Figures 10A-10B (The embodiment illustrated in the figure). A tapered section may be included at the portion of the receiving wall 178 and / or the guide 172 furthest from the platform 160. This tapered section can facilitate guiding the cannula assembly 114 into place when the infusion set 102 is assembled by assembling the cannula subassembly 114 into the receiving portion 176 in a funnel form.

[0086] Still referencing Figure 5AAn example cannula subassembly 114 is illustrated. As shown, the diaphragm housing 108 may include a notch 186. The notch 186 may be recessed into the outer surface of the diaphragm housing 108. During the insertion of the cannula subassembly 114 into the receiving portion 176 of the base 106, the cantilevered portion 180 of the base 106 may deflect about the diaphragm housing 108 until the protrusion freely springs into the notch 186. Once the cantilevered protrusion 180 has returned to its undeflected state and the protrusion 182 is disposed within the notch 186, the cannula subassembly 114 can be held within the base 106. In the held state, the ear or nodule 204 of the diaphragm housing 108 may be at least partially located within the notch 186 of the base 106 (e.g., Figure 6 (As shown).

[0087] Now refer to another source Figure 5B The diagram illustrates a cross-sectional view of the assembled cannulation subassembly 114, which in some embodiments may further include a diaphragm 110 and a diaphragm retainer 112. The diaphragm housing 108 may include a cup-shaped receiving section or receptacle 192 therein into which the diaphragm 110 can be introduced. The receiving section 192 may include a raised region 194 at its center. In this example, the raised region 194 may have a truncated cone shape, but other shapes are also possible. The diaphragm 110 may also have a cup-shaped diaphragm recess 196 included in its bottom surface. The diaphragm recess 196 may include an enlarged or flared section 198 formed as the opposite version of the raised region 194 in the receiving section 192 of the diaphragm housing 108. Thus, when the diaphragm 110 is introduced into the receiving section 192, the enlarged section of the diaphragm recess 196 may self-center relative to the diaphragm 110 and may be referred to herein as a centering wall of the diaphragm recess 196. The second segment 200 of the diaphragm recess 196, furthest from the bottom surface of the diaphragm 110, may at least partially define a fluid introduction volume into which a needle or tip included on the tubing connector 368 can penetrate to deliver fluid to the infusion set 102. Fluid can flow from the fluid introduction volume to the lumen 202 of the cannula 104 and into the patient's body. The second segment 200 of the diaphragm recess 196 may have any suitable cross-section, but in this example has a generally circular cross-section. The diaphragm housing 108 may include connector needle channels 222 (e.g., ...) in its sidewalls. Figure 6 As shown, the connector pin channel 222 allows the pins or tips of the connector 368 to enter the fluid introduction volume. In the example embodiment, the connector pin channel 222 is illustrated as an opening extending through the diaphragm housing 108. The connector pin channel 222 and the notch 186 may (although not required) be present on opposite sides of the diaphragm housing 108 to allow the insertion subassembly 114 to be mounted into the base 106 in both directions. This simplifies the assembly of the insertion assembly 100.

[0088] The receiving section 192 of the diaphragm housing 108 may also receive a portion of the diaphragm retainer 112. The diaphragm retainer 112 may be configured with a body 206 from which at least one cantilevered protrusion 188, including a terminal bulge or latching member 190, extends. In this example, the body 206 is substantially planar. Furthermore, there are two cantilevered protrusions 188 disposed opposite each other and extending substantially perpendicular to the body 206. These cantilevered protrusions 188 may engage within guides 208 included on the inner surface of the receiving section 192 of the diaphragm housing 108. The guides 208 shown are recessed into the inner surface of the receiving section and are substantially coplanar with the ear portion 204. The guides 208 are angled such that the distance between the two guides 208 decreases as the distance from the cannula 104 decreases. When the diaphragm retainer 112 is advanced into the receiving section 192, this allows the cantilevered protrusion 188 of the diaphragm retainer 112 to deflect toward the extension axis of the cannula 104. Figure 5B As shown, once the diaphragm retainer 112 has been advanced a certain distance into the diaphragm housing 108, the cantilever protrusions 188 can spring outwards, such that the protrusions 190 on each cantilever protrusion 188 latch into engagement with the latching members 210 on the diaphragm housing 108. In some embodiments, a portion of the cantilever protrusion 188 may extend into or through an aperture included in the bottom of the diaphragm housing 108 and enter into latching engagement with a latching member adjacent to or formed by the wall of the aperture. As the diaphragm retainer 112 is latched in place within the cannula subassembly 114, the diaphragm 110 can form a sealing relationship with the diaphragm housing 108. Thus, a sealed fluid flow path can be provided for the fluid contained in the fluid introduction volume of the diaphragm 110 to the outlet 212 of the cannula 104.

[0089] As shown, the diaphragm retainer 112 includes a channel 218 extending therethrough. Example: The channel 218 is substantially located at approximately the center of the body 206. When the diaphragm retainer 112 is locked in place within the cannula subassembly 114, the nodule or protrusion 220 of the diaphragm 110 can extend into the channel 218. Therefore, the channel 218 can provide access for the insertion tip 132 of the insert assembly 100 to extend through the infusion set 102 and out from the outlet 212 of the cannula 212.

[0090] The cannula 104 may include an insertion tip guide segment 216 that helps guide the insertion tip 132 into the lumen 202 of the cannula 104. The insertion tip guide segment 216 may have a funnel-like shape, but other shapes are also possible. In an example embodiment, the insertion tip guide segment 216 includes relatively steep sides and is surrounded by a flat (or possibly chamfered or rounded) peripheral edge that forms the wall of the fluid introduction volume within the infusion set 102. In some embodiments, this peripheral edge may be the uppermost part of a raised section 192. The insertion tip guide segment 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 tip guide segment 216 may also be continuous with a raised region 194 in the receiving section 192 of the diaphragm housing 108.

[0091] Main Reference Figure 5B The diaphragm housing 108 may include a recess 214 that surrounds or at least partially surrounds the cannula 104. This recess 214 may not be covered by adhesive when it is applied to the infusion set base 106. The recess 214 can provide space for the cannula 104 to move relative to the base 106 if the infusion set 102 or a part of the patient's body causes force to be applied to the cannula 104. This minimizes shearing forces on the cannula 104. Furthermore, the recess 214 can serve as a volume for containing medication. For example, antiseptics, disinfectants, anti-inflammatory agents, anesthetics, or other topical medications such as ointments may be contained in the recess 214. The medication may be pharmaceutical, nutritional, or some other type of medication. Therefore, when the infusion set 102 is applied, the medication can be introduced into and remain in contact with the patient's skin. In some examples, the medication may remain in contact with the recess 214. This may be desirable or beneficial for a variety of reasons, including helping to prevent infection, inflammation, or pain and providing a convenient way to administer medication. In an exemplary embodiment, the recess 214 is shaped as a tapered cross-section (e.g., a hyperbola or parabola) that rotates about the central axis of the cannula 104.

[0092] In various embodiments, the cannula 104 may be tapered or non-tapered. In some embodiments, the cannula 104 may include one or more tapered segments and one or more non-tapered or straight segments. Any tapered segment may extend at an angle to the major axis of the cannula 104. In some embodiments, instead of a constant angle to the axis, curvature may exist. The angle or degree of curvature on the tapered segment may also vary within the range of the tapered segment.

[0093] In some embodiments, the first portion of the cannula 104 near the outlet 212 is tapered. The tapering at this section results in a reduction in wall thickness as the cannula 104 approaches the outlet 212. Furthermore, the second portion of the cannula 104 adjacent to the point from which it extends on the diaphragm housing 108 is also tapered. In some embodiments, the tapering angle of the second portion may be substantially equal to the angle of the insertion tip guide section 216. The tapering at the second portion reduces the width of the cannula 104 at that section without significantly reducing the wall thickness of the cannula 104 surrounding the lumen 202. In an example embodiment, a straight section may be positioned between the first and second portions of the cannula 104. Alternatively, a slightly tapered section may be used as the intermediate section. This section may taper to a lesser extent than the first and second portions of the cannula and may or may not tape in a manner that maintains a constant wall thickness along the length of the intermediate section.

[0094] Now for reference Figures 7A to 9 Another example infusion set 102 is illustrated. As shown, the cannula subassembly 114 of the example infusion set 102 is designed to allow production via straight-draw molding. No features of the mold that would require lateral action or other special characteristics are present on the example cannula assembly 114. For example, in some embodiments, undercut features may be absent. This allows the cannula assembly 114 or its components to be constructed from a variety of different materials.

[0095] As shown, the cannulation assembly 114 includes similar components. Figures 5A to 5B The diaphragm 110 is shown. The diaphragm housing 108 does not include a notch 186. Instead of a notch 186, the diaphragm housing 108 includes a convex angle 388 extending outward from the outer surface of the diaphragm housing 108. During the connection of the cannula assembly 104 to the infusion set base 106, for example, one of the convex angles 388 can deflect the cantilevered section 180 of the base 106 until the bulge 182 springs back to its cantilevered position from the convex angle 388. Once the cantilevered protrusion 180 returns to its undeflected state and the bulge 182 is above the convex angle, the cannula subassembly 114 can be held within the base 106. In this held state (see, for example...), Figure 9 The ear or nodule 204 of the diaphragm housing 108 may be at least partially located within the recess 186 of the base 106. The receiving portion 176 of the infusion set base 106 is relative to... Figure 4AThe portion shown in -B is widened to accommodate the larger space occupied by the cannula subassembly 114. Additionally, the receiving portion 176 includes a convex angle receiving area 398 opposite the cantilevered protrusion 180 to receive the convex angle 388 not engaged by the protrusion 182. This allows the cannula subassembly 114 to be manufactured symmetrically and allows it to be mounted into the infusion set base 106 in two orientations. This can help simplify manufacturing and assembly. In other embodiments, the convex angle 388 may be included only on one side of the cannula assembly 114, and the convex angle receiving area 398 of the base 106 may be omitted.

[0096] Furthermore, in an exemplary embodiment, the diaphragm housing 108 does not include connector pin channels 222 formed in its sidewalls (see, for example...). Figure 6 ( ) opening. Figures 8A to 9 The diaphragm housing 108 includes a slot 390 in a sidewall 392 of the diaphragm housing 108, the slot 390 being recessed into a top surface 394 of the sidewall 392. The diaphragm retainer 112 may include a protrusion 396 that aligns with the slot 390 when a cantilevered protrusion 188 is fitted into a guide 208 included on the inner surface of the receiving section 192 of the diaphragm housing 108. When the cannula subassemblies 114 are coupled together (see, for example...), Figure 8B The protrusion 396 can occupy a portion of the slot 390. Therefore, an access port for a tip or needle included on the tube connector 368 can be provided in the cannula subassembly 114. The diaphragm retainer 112 also includes a plurality of through holes 397. Similar to the through holes 166 in the infusion set base 106, the through holes 397 facilitate manufacturing and assembly.

[0097] In some embodiments, slots 390 in the sidewalls 392 of the diaphragm housing 108 may replace the protrusions 388 as a retaining arrangement, cooperating with ridges included as part of the base 106. These ridges may grip or engage the wall of one of the slots 390, thereby preventing removal of the cannulation subassembly 114. In such embodiments, the protrusions 388 may not be included on the diaphragm housing 108. This can help further simplify the production of the cannulation assembly 114.

[0098] Now for reference Figure 10A and Figure 10B Another example base 106 is illustrated. (See diagram 106.) Figure 6 As shown, the top surface 168 of the platform portion 160 may include various receiving features extending therefrom, which may mate or dock with the connector 368. The base 106 may include a connector receiver 170, which may allow the base 106 to engage with a cantilevered finger 370 on the tube kit connector 368 as described above (see, for example...). Figure 6(Description of the example). In the exemplary embodiment, a guide 172 may also be included for each connector finger 370. As shown, the exemplary guide 172 includes a first segment 171 and a second segment 173. The first segment 171 of each guide 172 may be configured to have a portion extending substantially parallel to the plane of the platform 160 of the base 106. The second segment 173 of each guide 172 may include a portion angled relative to the first segment 171. In the example, each of the first portion 171 and the second portion 173 includes a flange projecting from the main portion of the guide. As the second segment 173 extends distally from the flange of the first portion of the guide 172, the distance between the proximal surfaces of the platform 160 and the flange of the second segment 173 of the guide 172 can increase. This allows the tube kit connector 368 to be initially introduced at a considerable angle to the plane of the platform 160 of the base 106. Further introduction can cause the connector fingers 370 to contact the platform 160 and be reguided to the appropriate displacement path for coupling the tube kit connector 368 to the base 106. Therefore, when coupling the base 106 and the tube kit connector 368 is performed, the guide 172 can help allow the user to blindly insert the connector fingers 370 into the connector receiver 170. As shown, a second set of additional guide flanges 175 can be included on the receiving wall extension 179. These additional guide flanges 175 can extend to the periphery of the base 106. In the example embodiment, the second set of guide flanges 175 extends substantially vertically from the inner side 179 of the guide 172 and toward the tip 482 of the tube kit connector 368 (see, for example...). Figures 102-106 The cannula is inserted into the cannula subassembly 114 along an axis. Each of the second set of guide flanges 175 may include a sloped region on its face, which is disposed near the end of each guide 172 closest to the periphery of the base 106.

[0099] Still referencing Figures 11A to 11B The tube kit connector 368 may include a flow hub 377, a tube 366, and a tip 482 (see example). Figures 102-106 The connector 368 can be connected to the flow hub 377. Fluid flowing through the connector 368 can pass through the tube 366 and the tips 482, respectively, within the cavities 514 and 516 of the flow hub 377 (see example...). Figures 102-106 ).like Figures 11A to 11BAs shown, the flow hub 377 may include a recessed alignment channel 375. As illustrated, the alignment channel includes a constant width section 373 and a variable width section 379. When the tubing kit connector 368 and the infusion set 102 are coupled, the alignment channel 375 may interact with a second set of guide flanges 175 of the base 106. The inclined sections of each of the second set of guide flanges 175 and the variable width section 379 of the alignment channel 375 allow the tubing tip connector 368 to be initially introduced at a considerable angle to the plane of the platform 160 of the base 106. Further introduction may allow the second set of guide flanges 175 to contact the walls of their respective alignment channels 375 and redirect the tubing kit connector 368 toward the appropriate displacement path to engage the tubing kit connector 368 to the base 106. Therefore, the second set of guide flanges 175, in conjunction with the alignment channel 375, may help allow a user to blindly connect the base 106 and the tubing kit connector 368.

[0100] Now for reference Figures 12A to 12B and Figures 13A to 13B In some embodiments, the pointed side projection 372 may be included as part of the tube kit connector 368. As shown, the pointed side projection 372 may extend parallel to the axis of the tip 482 (e.g., see...). Figures 102-106 The tip 482 may be included in the tube kit connector 368. The tip side protrusion 372 can help prevent any user contact with the tip 482 by providing a barrier to prevent fingers from reaching it. The tip side protrusion 372 may include a centrally located protrusion 372 extending from the top surface of the tube kit connector 368 onto the tip 482. The tip side protrusion 372 may also include a set of protrusions in the same plane as the connector fingers 370 of the tube kit connector 368, but arranged more centrally than the connector fingers 370. In an example embodiment, the connector fingers 370 and the set of protrusions 372 are aligned with the bottom surface of the tube kit connector 368. Each of the protrusions 372 may be arranged to extend from a point on the body of the tube kit connector 368, located midway between the hub 377 and the connector fingers 370. These protrusions 372 can be arranged to interact with the guides 172 of the base 106 during the coupling of the tube kit connector 368 to the corresponding base 106. In such an embodiment, the connector fingers 370 may not interact with the guides 172 on the base 106.

[0101] In some embodiments, and as Figures 13A to 13BAs shown, a pair of pointed side protrusions 372 located in the plane of the connector finger portion 370 may extend beyond the end 381 of the connector finger portion 370. These protrusions 372 may include a bent end region 383 located at the end of the protrusion 372 opposite to the end of the body attached to the tube kit connector 368. The bent end region 383 may be bent in a transverse direction to the axis of the tip 482 of the tube kit connector 368 (see, for example...). Figures 102-106 In this example, the bent end region 383 may have a curvature with an arc swinging greater than 90°. In this example, the curvature of the bent end region 383 causes it to begin extending back toward the body of the tube kit connector 368. The radius of the bent end region 383 may or may not be constant. Furthermore, the bent end region 383 may include one or more straight extensions. Figure 13B As best shown, the portion of the curved end region guiding the protrusion's terminal portion can be substantially straight. In this example, the curved end region 383 curves around and forward of a portion of the corresponding connector finger 370. The distance between the protrusions 372 can be slightly smaller than the spacing between the guides 172 of the corresponding base 106. However, the distance between the protrusions 372 at the curved end region 383 can be slightly larger to facilitate maneuvering the protrusions 372 into their respective guides 172. Once the protrusions 372 are within the guides 172, advancement of the tube kit connector 368 can cause the protrusions 372 to elastically open. Due to the elasticity of the protrusions 372, they press against the surface of the guides 172, ensuring a tight and substantially free-swinging fit. This can help further limit the displacement of the tube kit connector 368 along the desired path when engagement with the base 106 is complete.

[0102] In some examples, and now referencing Figures 14A-14B A set of pointed side protrusions 372 aligned with the connector fingers 370 can extend from the hub 377. This reduces the gap between the pointed side protrusions 372 of the tube kit connector 368 and helps to further minimize the user's fingers from entering the tips 482 (see example). Figures 102-106 The ability to access nearby space. Figures 14A-14BIn the exemplary embodiment depicted, a set of pointed side protrusions 372 are included, which extend laterally along and from an opposing surface of the flow hub 377 relative to the axis of the protrusion 482. Each of these protrusions 472 may include a support segment 385. These support segments 385 may be located in a region of the pointed side protrusion 372 that extends beyond a surface 387 of the flow hub 377 from which the protrusion 482 extends. As shown, the support segment 385 is disposed in the portion of this region closest to the flow hub 377. In the example embodiment, the support segment 385 includes an arched surface that can provide additional robustness to the set of pointed side protrusions 372. The surface 387 of the flow hub 377 from which the protrusion 482 extends may also be arched, which can further increase the robustness of the protrusion 372.

[0103] Still referencing Figures 15A to 15C Another example base 106 is illustrated. Example base 106 can be coupled to, for example... Figure 14A and Figure 14B The tube kit connector 368 is shown. The base 106 may include a connector receiver 170 that allows the base 106 to engage with cantilevered fingers 370 on the tube kit connector 368, as described elsewhere herein. Although not shown in the example embodiment, it may include features such as... Figure 6 and Figure 10A Guides 172 for each of the connector fingers 370 shown. As shown, a base 106 may define a receiver track 189 that receives a set of pointed side projections 372 located in the plane of the connector fingers 370. As shown, the parallel-extending portions of the receiving wall extension 179 and the receiving wall 178 may be separated from each other by a channel. The receiver track 189 is recessed into the receiving wall extension 179 and into the parallel-extending portions of the receiving wall 178 near the platform 160. Therefore, the width of the channel between the portions of the receiving wall extension 179 and the receiving wall 178 may be maximized near the platform 160. The width of the channel may decrease with increasing distance from the platform 160. As shown, each receiver track 189 may include a sloping wall 191. The sloping wall 191 helps to position the pointed side projections 372 of the tube kit connector 368 within the receiver track 189. Additionally, the base 106 may include an inclined section 193 located at the open end of the receiver track 189. Similar to... Figures 10A-10BThe second section 173 of the guide 172, and the inclined section 193, allow the tube kit connector 368 to be initially introduced at a considerable angle to the plane of the platform 160. Further introduction can cause the side protrusion 372 to be reguided into the receiver track 189. Thus, the inclined wall 191 and the inclined section 193 can facilitate blind insertion of the tube kit connector 368 into a connection relationship with the base 106.

[0104] Now for reference Figure 16A and Figure 16B In some embodiments, the base 106 may not include a receiving wall 178 having a cantilevered protrusion 180 defined therein (see example...). Figure 4A ).like Figure 16A and Figure 16B As shown, in some examples, the base 106 may include a retaining member 195 extending from the platform 160. The retaining member 195 may be independent and not supported by or continuous with the receiving wall 178. Figure 16B and Figure 16B In this illustration, the retaining member 195 is depicted as a hook extending from the platform and located in an opening between two segments of the receiving wall 178. In other examples, the hook may not be used. Instead, a cantilevered member including a protrusion 182, such as a barb or ramp engaging a portion of the cannula subassembly 114, may be used. The hook may include a handle region 197 attached to and continuous with the platform 160. The handle region 197 may extend from the platform 160 to a bend region 199. The handle region 197 may be perpendicular to the platform 160 or may be inclined to extend toward the receiving portion 176. The hook may also include a gripping segment 201 extending from the bend region 199. The gripping segment may be positioned perpendicular to the handle region 197. In this example, the gripping segment 201 extends at an acute angle relative to the handle 197. For example, the gripping segment 201 may be positioned at an angle of 35-40° relative to the handle 197.

[0105] When the cannulation assembly 114 is introduced into the base 106, the diaphragm housing 108 (see, for example) Figure 8AThe retainer member 195 can be contacted by the gripping segment 201 and elastically deformed, causing the gripping segment 201 to bend to avoid an obstacle. After the cannula subassembly 114 has been advanced into the receiving portion 176 beyond a certain point, the engagement surface of the diaphragm housing 108 can pass through the end of the gripping segment 201. At this point, the gripping segment 201 can freely spring back from its deflected position. The gripping segment 201 may include at least a portion that, once springed back to its unpressurized state, hangs over the engagement surface of the diaphragm housing 108. Therefore, the gripping segment 201 can prevent the cannula subassembly 114 from being removed from the base 106. The engagement surface of the diaphragm housing 108 can be any suitable engagement surface on any part of the cannula assembly 118. For example, the engagement surface can be a notch 186 in the diaphragm housing 108 (see, for example, see...). Figure 5A ), the walls of the openings in the diaphragm housing (see, for example) Figure 6 The connector pin channel 222), the wall of the slot 390 included in the diaphragm housing 108, or the protrusion 388 included as part of the diaphragm housing 108.

[0106] Now for reference Figure 17A and Figure 17B The illustration shows two side views of the insert component 100. Figure 17B The insert component 100 in the middle has been removed from its in Figure 17A The orientation is rotated 90° clockwise. Example insert component 100 is... Figure 1AThe exploded view shown is an assembled version. These two views represent the appearance of the insert assembly 100 before use and after it has been removed from its shipping / storage packaging. As shown, the outer housing 116 of the insert assembly 100 is visible and the locking member 146 is in place. Additionally, an adhesive backing 111 is present and covers an 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 flange, tab, or other protrusion of backing material extending beyond the area occupied by the insert assembly 100. This gripping area 224 can be gripped by the user and used to peel the adhesive backing 111 off the infusion set 106. Once the backing 111 has been removed, the insert assembly 100 can be positioned against the desired infusion site using raised ribs 118 to aid alignment. The locking member 146 can then be pulled out of the insert assembly 100 to allow actuation of the insert assembly 100. When the example adhesive backing 111 is attached to the locking member 146, removal of the locking member 146 completes the separation of the adhesive backing 111 from the insert assembly 100. If the user is not satisfied with the placement of the insert assembly 100, the user can leave the locking member 146 in the insert assembly 100 and pull the insert assembly 100 away from the body. The presence of the locking member 146 prevents actuation in this situation and allows the user to select an alternative infusion site.

[0107] Still referencing Figures 18A to 19 Various views of the insert assembly 100 with the outer housing 116 removed and views of the individual locking members are shown. Figure 19 As shown, when in place within insert assembly 100, locking member 146 can function as a safety device. Insert assembly 100 can be designed such that it cannot be fired until locking member 146 has been removed. Locking member 146 can extend across the entire width of inner housing 120 and is positioned above other components of insert assembly 100. Locking member 146 can be directly adjacent to at least one of the other components to prevent its movement.

[0108] The locking member 146 may include a flange 152 that can be gripped to aid in extraction. The locking member 146 may also include a lever 226 projecting away from the flange 152. The lever 226 may support a plurality of arms 228, 230. In an exemplary embodiment, the arms 228, 230 are arranged in an "H" pattern, and the lever 226 is connected to the arms 228, 230 via crossbars of the "H". The arms 230 may be located in an opening 150 of the inner housing 120 furthest from the flange 152. The arms 230 may also include a chamfered feature 232 that may help guide the locking member 146 during installation into the insert assembly 100.

[0109] As shown, the arms 228 can be cantilevered to allow inward deflection toward the rod 226. The distance between the outer edge arms 228 can be greater than the width of the opening 150 through which the outer edge arms 228 pass when the locking member 146 is installed into the insert assembly 100. During installation, the arms 228 can deflect toward the rod 226 to allow the arms 228 to pass through the opening 150. Once through the opening 150, the arms 228 can spring back outward to their unpressurized state. Thus, as Figure 18C Ideally, when the locking member 146 is in place, the width between the outer edges of the arm 228 can be wider than the width of the opening 150. This ensures that some force may be required to remove the locking member 146 from the insert assembly 100 and prevents the locking member 146 from being unintentionally driven out. As shown, the arm 228 may include a chamfered region 234. The chamfered region 234 may abut the wall of the opening 150 of the inner housing 120 closest to the flange 152. During the removal of the locking member 146 from the insert assembly 100, the chamfered region 234 can help deflect the arm 228 toward the rod portion 226. Although an angled chamfer is shown, in alternative embodiments, a rounded or curved region may be included.

[0110] In various examples, at least one component of the insert assembly 100 may include at least one locking member restraining member, such as a raised buffer 238. In an example embodiment, the buffer 238 is included on the needle retractor 134 and extends from the top plate 328 of the needle retractor 134. The raised buffer 238 may be located on the side of or adjacent to at least a portion of the locking member 146. Thus, the buffer 238 can prevent any swinging or pivoting of the locking member 146 within the insert assembly 100. If the locking member 146 is bent into the insert assembly 100, the buffer 238 may also facilitate reguiding of the locking member 146 during installation. The buffer 238 may also be provided to limit the depth to which the locking member 146 can be pressed into the insert assembly 100.

[0111] Still referencing Figure 20A-21 Various views of the insert assembly 100 with the alternative locking member 146 and views of the individual alternative locking member 146 are illustrated. Figure 21 As described above, when in place within the insert assembly 100, the locking member 146 can function as a safety device to prevent activation until the locking member 146 has been removed. Example locking member 146 extends across a portion, but not the entire width, of the inner housing 120, and this example locking member 146 is positioned above other components of the insert assembly 100 to prevent movement. The inner housing 120 may include only one opening 150 instead of a set of opposing openings 150.

[0112] Locking member 146 may include a flange 152 that can be gripped to aid in extraction. Locking member 146 may also include an attachment 376 projecting away from flange 152. Teeth 378 may be included within attachment 376. Teeth 378 cantilever to attachment 376 at the portion of teeth 378 furthest from flange 152. Teeth 378 are also configured to naturally project over face 380 of attachment 376, but are flexible when force is applied to the unsupported end of teeth 378. As shown, the unsupported end of teeth 378 includes a sloped region 382. The end of attachment 376 furthest from flange 152 may also include a chamfered feature 384 that may help guide locking member 146 during insertion into insert assembly 100. When the locking member 146 is installed into the insert assembly 100, the top wall of the opening 150 can deflect the teeth 378 toward the surface of the attachment 376, allowing the teeth 378 to pass through the opening 150. After the locking member 146 is fully inserted, the teeth 378 can spring back toward their initial unpressurized state. Therefore, as Figure 20B As shown, when the locking member 146 is in place, a portion of the fangs 378 may be positioned above the top wall of the opening 150. This ensures that some force may be required to remove the locking member 146 from the insert assembly 100 and prevents the locking member 146 from being unintentionally driven out. As shown, the angled section 382 may abut the top wall of the opening 150. The angled section 382 may assist the fangs 378 in deflecting toward the surface 380 of the attachment 376 during the removal of the locking member 146 from the insert assembly 100. Although the angled section 382 is shown, in alternative embodiments it may include a circular or curved region. It may also include similar... Figure 18A-19 The locking member constraint feature of the raised buffer 238 shown.

[0113] Now for reference Figure 22 A flowchart 240 is shown describing several example actions that can be performed to place the infusion set 102 on a patient using the insert component 100. Such as Figure 1A Some of the insert components 100 shown can be placed on the skin, and some insert components 100 are designed to prevent actuation before the skin has shifted from its normal resting position on the body. Actuation of the insert components 100 can be prevented until some degree of skin shift has occurred. Actuation of the insert components 100 can be disabled until a certain amount of relative displacement has occurred between the parts of the insert components 100. This relative displacement can be achieved when the skin is lifted and the insert components 100 are removed from the body. When the user removes the insert components 100, the adhesion of the base 106 of the infusion set 102 to the skin may restrict the displacement of certain parts (e.g., at least one part attached to the base 106). When the insert components 100 are removed, the elasticity of the skin can exert a force on the base 106 (and any attached parts), pulling it toward or keeping it closer to the body. When insert assembly 100 is removed, at least one other component of insert assembly 100 may be freely displaced or have greater degrees of displacement freedom. In some examples, relative movement may be suppressed until the skin applies a certain force to base 106. The trigger of insert assembly 100 may be prevented from actuating until the skin is pulled away from the rest of the body a distance sufficient to generate the force required to initiate relative movement. Triggering may fail until the necessary amount of relative displacement occurs.

[0114] In some embodiments, the insert assembly 100 may be placed on the skin and actuated as it is lifted for removal. Actuation may not require further pressing, twisting, squeezing, etc., by the user on triggers, buttons, housing sleeves, or other parts of the insert assembly 100; however, actuation is still under user control. Actuation may be triggered by relative movement of one or more free parts of the insert assembly 100 relative to one or more restricted parts, for example, by moving or disengaging a latch and releasing one or more biasing members to initiate actuation. Therefore, triggers within the insert assembly 100 may be actuated as a result of the removal of the insert assembly 100 from the body. From the user's perspective, this insert assembly 100 can be simply placed on the skin and then withdrawn to perform placement of the infusion set 102.

[0115] In alternative embodiments, actuation of the insert assembly 100 can be triggered by discrete manual triggering actions. Any arrangement readily apparent to those skilled in the art can be used to facilitate manual triggering. The insert assembly 100 may include, for example, one or more buttons that, when displaced, can trigger actuation by disengaging a latch within the insert assembly 100. Alternatively, a portion of the insert assembly 100 may be deformable, and pressing the insert assembly 100 can press a protrusion that moves together with the deformable portion into the latch to disengage the latch. For example, in some examples, a button or deformable portion may be included on the outer housing 116. Actuation of the insert assembly 100 can be triggered by a torsional action. Such a torsional action of one portion (e.g., a cover) of the insert assembly 100 relative to another portion (e.g., the remainder of the insert assembly 100) can sweep a protrusion of the insert assembly 100 into the latch to disengage the latch. In other embodiments, after the insert assembly has been pulled away from the skin to trigger actuation, the pin or similar member can be pulled out of the insert assembly 100. This includes a locking member 146 (e.g., see...). Figure 19 In one embodiment, locking member 146 may be held in place until the user begins to remove insert assembly 100 from the skin. Actuation may be triggered when removal of locking member 146 allows components of insert assembly 100 to displace relative to each other, such that, for example, a latch can be released. Various combinations of manual triggering arrangements may also be used. For example, button pressing or squeezing followed by twisting or vice versa may trigger actuation. Manual triggering may not occur until the skin has displaced from its resting position and / or until a certain degree of relative movement has occurred between the free and confined components of insert assembly 100. Any arrangement readily apparent to those skilled in the art can be used to facilitate this locking. For example, interlocking may prevent button displacement, twisting, squeezing, etc., until the skin has displaced or until a relative movement exceeding a threshold amplitude has occurred. Alternatively, interlocking may prevent access to a latch within insert assembly 100, preventing it from being expelled, until the skin has displaced or until a relative movement exceeding a threshold amplitude has occurred. In some embodiments, button displacement, twisting, squeezing, etc., may be possible, but interlocking renders them ineffective until the skin has been displaced or until a relative movement exceeding a threshold amplitude occurs. As those skilled in the art will understand, the insert assembly 100 embodiments described herein can be further modified to allow various types of additional manual actuation schemes.

[0116] While such a design makes triggering actuation simpler, more intuitive, and safer, it also offers other advantages. For example, when the insert assembly 100 is lifted, it can be designed to pull the skin of the base 106 of the infusion set 102 away from the underlying muscles and other body structures. Therefore, when inserted, the cannula 104 of the infusion set 102 can be more reliably positioned within the subcutaneous layer of adipose tissue. This can reduce pain during insertion, help reduce bruising, increase the potential body area for selecting infusion sites, and can lead to more predictable absorption of medications such as insulin. The skin can also be tightened to facilitate easy penetration of the insert tip 132. Because the skin is passively lifted along with the insert assembly 100, a pneumatic vacuum is not required. This allows the insert assembly 100 to be less complex and made with fewer parts. Furthermore, pneumatic seals against the skin or within the insert assembly 100 can be omitted. Since the body contours of the infusion site (which can present sealing challenges) are likely to be largely irrelevant, skin lifting can be performed more reliably. Furthermore, it may not be necessary to pinch the skin to pull it away from the underlying structure. This can help make insertion more comfortable, limit bruising, and allow for more reliable skin detachment from the underlying structure. The insert assembly 100 also ensures that the cannula 104 is inserted into the skin in a predetermined orientation. The skin can be held in place parallel to or perpendicular to a reference plane or axis that moves with the insert assembly 100 (e.g., parallel to the bottom surface 162 of the base 106 of the infusion set 102 or perpendicular to the axis of the insertion tip 132 or the insertion tip displacement path). Therefore, the angle of the insert assembly 100 or the path along which the insert assembly 100 is pulled away from the body may not change the insertion angle. The example embodiment shown here illustrates an insertion angle that is substantially perpendicular to the skin; however, by securing the skin relative to a reference plane or axis that moves with the insert assembly 100, insertion at any angle (just beyond 0° to 90°, e.g., 30°, 45°, 60°, etc.) can be similarly ensured. Another potential benefit is the reduction of psychological problems associated with triggering actuation. Because the user's depressing, twisting, squeezing, etc., of certain actuators may not be necessary, less anxiety may accumulate when anticipating triggering. The user may not know the exact moment of actuation when the insert component 100 is withdrawn. This may help limit psychological problems and potentially reduce perceived pain.

[0117] like Figure 22As shown, in box 242, the adhesive liner or backing 111 can be removed from the infusion set base 102 held within the insert assembly 100. Then, in box 246, the insert assembly 100 can be placed at the desired infusion site. This may cause the adhesive on the infusion set base 102 to adhere to the patient's skin. It may be desirable to press the insert assembly 100 against the skin to ensure the adhesive adheres firmly to the skin. In box 250, the locking member 146 can be removed from the insert assembly 100. In box 254, removal of the insert assembly 100 from the body can begin. In box 258, the skin can be pulled away from the underlying muscles and body structures by the adhesion of the adhesive. In box 258, the outer housing 116 and the retainer base 140 can also be displaced relative to the rest of the insert assembly 100. In box 262, at least one latch within the insert assembly 100 can be released. As described above, this can occur automatically or as a result of some manually triggered action. In box 266, the insertion tip 132 and the cannula assembly 114 can be driven toward the insertion site. In box 270, the cannula assembly 114 can be attached to the infusion set base 106. Additionally, in box 270, the catch can be released from the infusion set base 106. Attaching the cannula assembly 114 to the kit base 106 causes the catch to be released from the infusion set base 106. In box 274, the insertion tip retractor 134 can be driven through a stopping distance (described in further detail later in the specification). In box 278, the insertion tip retractor 134 and the insertion tip 132 can be driven away from the infusion site. In box 282, the insertion assembly 100 can be removed. With the removal of the insertion assembly 100 complete, the infusion set 102 can be fully assembled and positioned on the infusion site. Furthermore, the cannula 104 can be located subcutaneously within the skin.

[0118] Now for reference Figure 23 The figure illustrates a top view of the insert assembly 100, with first and second cutting planes superimposed on the insert assembly 100. The first cutting plane is labeled AA. The second cutting plane is labeled BB. This figure is provided for reference purposes in relation to several forthcoming figures. Some of these figures are cross-sectional views of the insert assembly 100 taken at one or the other of these planes, and illustrate the insert assembly 100 at different stages of operation. Unless otherwise stated, one of the following cross-sections of the insert assembly 100 is given as a figure with a number followed by the letter A, illustrating the cross-section of the insert assembly 100 at the location of plane AA. In the case where one of the following cross-sections of the insert assembly 100 is given as a figure with a number followed by the letter B, this figure illustrates the cross-section of the insert assembly 100 at the location of plane BB.

[0119] Now for reference Figure 24A -B shows two cross-sectional views of the insert assembly 100. The insert assembly 100 is shown precisely where it will be applied to the skin 356. Figure 24A In -B, locking member 146 (see example) Figure 21 ) and adhesive backing 111 (see example) Figure 1A The adhesive 374 is shown on the bottom surface 162 of the infusion set base 106. As shown, springs 136 and 138 can both be in an energy-storing state, which in this particular embodiment is a compressed state. In this example, spring 136 serves as an insertion drive biasing member, while spring 138 serves as an insertion tip retraction drive biasing member. Spring 136 is held in a compressed state between the insertion tip retainer 130 and the insertion tip retractor 134, and when the spring 136 is released, it drives the tip retainer 130 and the components carried thereon from an elevated state to a forward state. Spring 138 is held in a compressed state between the inner housing 120 and the tip retractor 134. Upon release, spring 138 drives the tip retractor 134 and the tip retainer 130 from a post insertion state to a retracted state.

[0120] Still referencing Figures 25 to 29 The diagram illustrates multiple views of a pointed retainer 130. The pointed retainer 130 may include a biasing member receiving compartment 290 in which a spring 136 may be disposed. The pointed retainer 130 may also include a wall 292 surrounding the biasing member receiving compartment 290. The wall 292 may include two protrusions 294 on its outer surface. In an exemplary embodiment, the two protrusions 294 are guide rails disposed opposite to each other on the pointed retainer 130. These guide rails may run along a guide 354 (see, for example...) Figure 35A B) Riding on a portion of the tip retractor 134. The protrusion 294 may extend from the tip retainer 130 to match the width of the cannula assembly 114 at the plane of the ear 204 including the diaphragm housing 108.

[0121] In various embodiments, wall 292 may also include an interruption region that creates one or more cantilever arms 296. In an exemplary embodiment, the cantilever arms 296 are disposed opposite each other on the tip retainer 130. One of the cantilever arms 296 may be longer than the other. In other embodiments, the two cantilever arms 296 may be identical mirror images (see, for example...). Figure 43CThis allows for easier assembly of the insert assembly 100. Both cantilever arms 296 can extend over the top surface 298 of the remainder of the wall 292. Each of the cantilever arms 296 may include a ridge 300 disposed at its non-supported end or terminal. A flange segment 302 may be defined by a portion of each ridge 300. At least one of the flanges 302 may extend substantially perpendicular to the cantilever arm 296. At least one of the flanges 302 may be angled relative to the cantilever arm 296 that includes it, such that the undercut region has a triangular cross-section. In an exemplary embodiment, the flange 302 on the longer of the two cantilever arms 296 is thus undercut. The tip holder 130 may also include a port 304. The port 304 may be used to supply glue or adhesive to the tip holder 130 to securely retain the insert tip 132 within the tip holder 130.

[0122] Figures 30 to 33 An alternative embodiment of the pointed retainer 130 is shown. As illustrated, the longer of the two cantilever arms 296 of the pointed retainer 130 includes a ridge 300 and a ridge 301. The ridge 301 may be located in the middle of the ridge 300, but it may also be located elsewhere. As illustrated, the ridge 300 may be double-beveled. The portion of the ridge 300 near the flange segment 302 may have a steeper bevel than the portion of the ridge 300 away from the flange segment 302. The ridge 301 may be formed on the portion of the ridge near the flange segment 302. In this example, the ridge 301 is formed as an angled extension from the portion of the ridge 300 away from the flange segment 302 to the portion of the ridge 300 adjacent to the flange segment 302. Any embodiment of the pointed retainer 130 described herein may include such a ridge 301.

[0123] like Figure 24B As best shown, the flange 302 on the longer of the cantilever arm 296 can rest on the gripper 306. The gripper 306 of the example embodiment is included on the pointed retractor 134. In the example embodiment, this suppresses the release of energy stored in the spring 136 and keeps the spring 136 in a compressed state. The gripper 306 can have an angle that cooperates with any angle of the flange 302 to securely hold the flange 302 on the gripper 306. A finger 308 extending from the base retainer 140 of the insertion assembly 100 can extend through a gap 322 adjacent to the gripper 306 (see example...). Figure 35CDisplacement of the finger portion 308 relative to the gripper 306 may cause the flange 302 to disengage from the gripper 306. Although the finger portion 308 is depicted as upright, other types of actuating protrusions may be used. Furthermore, in some embodiments, the finger portion 308 or other actuating protrusions may be included on another portion of the insert assembly 100. For example, the finger portion 308 may protrude from the inner surface of the top surface of the outer housing 116.

[0124] Still referencing Figures 34 to 35C The illustration shows multiple views of the retainer base 140 and the pointed retractor 134. As shown, the finger portion 308 of the retainer base 140 ( Figure 34 The retainer base 140 is formed as a continuous portion of the retainer base 140. An 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 are connected by an intermediate region 314 and may be concentric with each other. The intermediate region 314 may be generally flat and may serve as a skin contact portion of the insert assembly 100, which is substantially flush with the bottom surface 162 of the infusion set base 106. A finger portion 308 extends from the second ring portion 312. As shown, the finger portion 308 includes an upright section 316 and a wing portion 318.

[0125] In various embodiments, the pointed retractor 134 may include a guide 320 along which the wing 318 can slide during assembly. In some embodiments, the guide 320 may also ride along the wing 318 during at least a portion of the retraction of the pointed retractor 134. An example guide 320 is formed as two raised parallel ribs. The gripper 306 includes two supports 324 with a flange 302 of the cantilever arm 296 that can engage with the two supports 324. The supports 324 may include a gap 326 therebetween. The width of the gap 326 may be equal to or wider than the width of the wing 318. During the lifting of the insert assembly 100 from the skin 356, the wing 318 may be advanced through the gap 326. This may cause the wing 318 to abut against a ridge 300 on the cantilever arm 296 and force the cantilever arm 296 to bend inward. Once the wing 318 has advanced a certain distance, the cantilever arm 296 can deflect to the point where the flange 302 no longer engages with the gripper 306 and the spring 136 can be released. The position of the wing 318 on the finger 308 and / or the height of the finger 308 can be adjusted to change the displacement distance at which the flange 302 is released from the gripper 306. In embodiments where the ridge 300 includes the ridge 301 (see, for example...), Figures 30-33The dimensions of the ridge 301 can be designed to fit through the gap 326. Therefore, the ridge 301 can increase the total amount by which the cantilever arm 296 can be deflected by the wing 318 and provide additional assurance that the flange 302 is completely removed from the gripper 306. Consequently, the acceptable tolerance range for the various features associated with the gripper 306 and the pointed retainer 130 can be wider.

[0126] Still combined Figures 34 to 35B refer to Figure 24A -B, Spring 138 can also be held in an energy-storage state by at least one latch engagement. As shown, Pointed Retractor 134 may include a first set of arms 330 and a second set of arms 332. The first set of arms 330 may extend from the top plate 328 of Pointed Retractor 134. These arms 330 may extend substantially parallel to each other and may be arranged oppositely on Pointed Retractor 134. Additionally, the first set of arms 330 may extend laterally into the central cavity 334 of Pointed Retractor 134. In some embodiments, the first set of arms 330 may be attached to the top plate 328 of Pointed Retractor 134 at the protruding region 336 of the top plate 328. The arms 330 can thus engage within the channel formed by the guide rails 124 of the inner housing 120 to prevent rotation and to guide any displacement of Pointed Retractor 134 during actuation. Furthermore, an exposed region 336 may be included asymmetrically on the pointed retractor 134 to ensure that the pointed retractor 134 is assembled into the insert assembly 100 along a predetermined orientation. The first set of arms 330 may be cantilevered and attached to the pointed retractor 134 at a top plate and a second plate 338, which may be parallel to and extend below the top plate 328. Thus, the arms 330 may form resilient protrusions that may deflect if sufficient force is applied. The unsupported ends of the arms 330 may include curved or inclined segments 340. These segments 340 may abut against complementary profile surfaces of the deflector member 358 to facilitate and / or guide such deflection. Each of the first set of arms 330 may also have one or a pair of notches 342. In this example, each arm 330 includes a pair of notches 342 located near the unsupported ends of the arms 330.

[0127] Figure 36A cross-section of the insert assembly 100 taken through a plane extending along the length of one of the arms 330 is illustrated. As shown, each of one or more notches 342 can engage with a cooperating protrusion 344. The cooperating protrusion 344 may be included on the inner housing 120. Thus, the interaction of the notches 342 and the cooperating protrusions 344 can hold the spring 138 in a compressed state and act as a latch to prevent retraction. This can be particularly helpful during assembly, as the infusion set base 106 may not be in place, otherwise the spring 138 may be free to slack off. Furthermore, this engagement ensures that the top plate 328 of the tip retractor 134 is positioned slightly below the openings 148, 150 to allow the introduction of the locking member 146. While the notches 342 are shown, the arms 330 and the inner housing 120 can be engaged in other ways. For example, the arms 330 or the inner housing 120 may include protrusions forming flanges. The flange can engage with a grab recess in either arm 330 or another of the inner housing 120.

[0128] Now, let's focus on combining... Figure 34-35B refer to Figure 24A -B, In some embodiments, an additional latch may be included in the insert assembly 100, which helps to hold one of the springs 136, 138 in an energy-storage state. In an example embodiment, spring 138 is held in an energy-storage state by an additional latch arrangement. As shown, a second set of arms 332 of the pointed retractor 134 extends from the bottom of the wall defining the central cavity 334. The second set of arms 332 may be arranged in a relative relationship to each other and may be cantilevered. Each of the second set of arms 332 may include a ridge 346 disposed at its unsupported end. Each ridge 346 may form a flange 348 on the arm 332 including the ridge. In addition, the arm 332 may include a nodule 350 or a raised ramp, the thickness of which increases with increasing distance from the cavity 334. The nodule 350 may be disposed in the middle of the unsupported end of the arm 332 and its attachment point with the rest of the pointed retractor 134.

[0129] like Figure 24A As best shown, flange 348 can grip a portion of infusion set base 106. Specifically, flange 348 can grip an exposed portion of infusion set base 106. Base 106 may include guides, stepped features, abutments, or any other suitable protrusions to provide complementary gripping surfaces for flange 348. In some embodiments, a protrusion can grip guide 172 of infusion set base 106 (see, for example...). Figure 4ATherefore, the infusion set base 106 can be held within the insert assembly 100. The flange 348 can be angled relative to the cantilever arm 332 including the flange, such that the undercut has a triangular cross-section. For example, the portion of each flange 348 of the guide 172 (or any other gripping feature) that grips thereon can be angled cooperatively to help ensure a secure engagement. The retainer base 140 (or similar...) Figure 38A The outer housing 116 in the embodiment shown in -B may include a retaining protrusion 359 that may abut or nearly abut the arm 332 before the insert assembly 100 is actuated, and the arm 332 remains engaged with the infusion set base 106. This helps prevent any accidental triggering of the insert assembly 100.

[0130] In some embodiments, only one arm 332 may be included. In some embodiments, the arm 332 on the tip retractor 134 may not engage the infusion set base 106. The arm 332 may engage a portion of the inner housing 120 to prevent premature retraction of the tip retractor 134. The inner housing 120 may also include a latch that may abut with the guide 172 or another cooperating portion of the infusion set base 106 to hold the infusion set base 106 in place.

[0131] The insert assembly 100 may include multiple pins or alignment protrusions 352 to help ensure that the infusion set base 106 is assembled into the insert assembly 100 in the desired orientation. As shown, the pins 352 may be disposed on the inner housing 120 of the insert assembly 100. When the infusion set base 106 is held by the arm 332 of the needle retractor 134, the infusion set base 106 can be held such that the surface of the infusion set base 106 is adjacent to the pins 352. This prevents the infusion set base 106 and the needle retractor 134 holding it from shifting into the insert assembly 100 due to mechanical interference from the pins 352. Therefore, the locking of the flange 348 of the arm 332 on the infusion set base 106 also helps to keep the spring 138 in an energy-storing state. The pins 352 also ensure that the infusion set base 106 is located within the insert assembly 100 so that the adhesive 374 can be pressed against the skin 356. In this example, the retainer 352 ensures that the infusion set base 106 is substantially flush with the skin contact surface on the retaining base 140.

[0132] With the infusion set base 106 positioned in this way, it also serves as a protective barrier. Since the cannula subassembly 114 and the insertion tip 132 are located inside the insert assembly 100, the user is protected from accidental contact with the insertion tip 132 when the infusion set base 106 is in its initial holding position. This can also help prevent contact between the cannula 104 or the insertion tip 132 and contaminants. Although the gap for receiving the cannula subassembly 114 can extend throughout the entire infusion set base 106, the gap can be sized to prevent finger entry (e.g., the cross-section of the gap is smaller than the cross-section of a finger). Therefore, the infusion set base 106 can contain a barrier that blocks unintentional access to the insertion tip 132 and the cannula 104. Furthermore, since the cannula subassembly 114 is inside the insert assembly 100, any adhesive backing 111 provided on the infusion set base 106 does not need to include an interruption allowing the cannula 104 to pass through. Therefore, the gap in the infusion set base 106 for the cannula subassembly 114 can be blocked by the adhesive backing 111 until just before use. This further prevents fingers from entering and reduces the possibility of debris entering the insert assembly 100. In some examples, the adhesive 374 may also extend above the opening and can be punctured during insertion of the cannula 104 into the skin 356.

[0133] Now for reference Figure 37 , showed Figure 2 A separate view of the alternative outer housing 116 illustrated in the insert assembly 100 embodiment. As shown, instead of the retainer base 140, various features of the retainer base 140 may be included in the outer housing 116. For example, during molding operations, these features may all be integrally formed and integrally formed with each other as a single integral part. As shown, fingers 308 and wings 318 are included as part of the outer housing 116. The fingers 308 may extend from a central ring portion 313 that connects to the remainder of the outer housing 116 via a central region 314. Similarly, a deflector member 358 is included as part of the outer housing 116.

[0134] Figure 38A -B shows Figure 2 A cross-sectional view of an example embodiment of the insert assembly 100. The insert assembly 100 includes... Figure 37 The outer casing 116 is shown in the figure. Figure 38A The view in -B shows the comparison Figure 24A -B and Figure 36 This alternative embodiment of the insert assembly 100 is in the same state as the insert assembly 100 shown in the figure. Figure 38A The insert component 100 shown in -B can be used with Figure 24A -B and Figure 36The insert component 100 shown in the figure operates similarly. For the sake of brevity, the following description... Figure 24A -B and Figure 36 Various operating states of the insert component 100 shown.

[0135] Now for reference Figure 39A -B shows two cross-sectional views of the insert assembly 100. Figure 39A In step -B, the exemplary insert assembly 100 is positioned against the skin 356 at the desired infusion location and is being withdrawn by the user. As shown, adhesive 374 on the bottom surface 162 of the infusion set base 106 can adhere to the skin 356, causing the skin 356 to be pulled upwards by the insert assembly 100 as the user pulls it away from the body. When the user removes the insert assembly 100 from their body, the outer housing 116 and the retainer base 140 can be displaced with the user's hand. Other components of the insert assembly 100 are not limited to being displaced as a unit along with the outer housing 116 and the retainer base 140. These components can be retained posteriorly because the infusion set base 106 is latched into the tip retractor 134 and the tip retractor 134 is latched into the inner housing 120 and the tip retainer 130. During removal, the outer housing 116 and the retainer base 140 can be displaced relative to these components substantially along the axis of the insertion tip 132 away from the skin 356. This can cause the deflector member 358 included on the retainer base 140 to bend the arm 330 inward. It can also cause the fingers 308 on the retaining ring 140 to advance into the gap 322 (see, for example...). Figure 35C The elasticity of arm 330 can cause the entire insert assembly 100 to move as a unit for a retraction movement of at least a portion of the insert assembly 100 from the body. Once the force exerted by the elasticity of the skin exceeds a force threshold, portions of the insert assembly 100 can be displaced relative to each other.

[0136] In various embodiments, the elasticity of arm 330 can at least partially control the distance a given user's skin 356 is pulled away from the body before actuation of insert assembly 100 occurs. When skin 356 is pulled away from the body, the elasticity of skin 356 can exert a pulling force that presses arm 330 against deflector member 358. The type, quantity, and / or arrangement of adhesive 374 on infusion set base 106 can be selected to withstand this force while maintaining adhesion to and compatibility with skin 356. Once the force overcomes the elasticity of arm 330, and the components of insert assembly 100 begin to move relative to each other, finger 308 can begin to advance into gap 322. Triggering actuation can be prevented until this point. The elasticity can be selected such that insert assembly 100 can be used for a wide range of individuals with different skin 356 characteristics (e.g., elasticity), while still ensuring that skin 356 is pulled at least some minimum distance before triggering actuation. In some embodiments, the insert assembly 100 may be manufactured with different arm 330 elasticities, which may be suitable for different user groups. For example, an arm 330 with less elasticity (e.g., elderly elasticity) may be used for elderly user groups whose skin 356 tends to have less elasticity.

[0137] The steepness of the inclined segments 340 on each arm 330 can be modified to change the magnitude of the applied force before relative movement occurs. A shallower angle can be used on the inclined segments 340 where a greater force is required before relative movement occurs. A steeper angle can be used where a smaller force may be required. In some embodiments, high (e.g., adolescents), medium (e.g., adults), and low (e.g., elderly) skin elasticity ramp angles may exist. Furthermore, the thickness of the arms 330 can be varied to change their elasticity. Thinner arms can be used where less force is required, and thicker arms can be used where greater force is required. Various support features, such as buttresses, can also be included, and these support features can support the arms 330 against deflection at points near the supported ends of the arms 330. In some examples, the position of the second plate 338 can also be modified to change the length of the deflectable portions of the arms 330, making them more or less elastic. The material used to form the arms can also be selected based on its elastic properties.

[0138] The length of the finger portion 308 and the position of the wing portion 318 on the finger portion 308 can at least partially control the distance at which the user's skin 356 is pulled away from the body. These parameters can be modified to change this distance.

[0139] Referring now to 27C-D, two additional cross-sections of the example insert assembly 100 are shown. Each of the example insert assemblies 100 includes additional springs 156, 158. (The text abruptly ends here, seemingly mid-sentence.) Figure 1A-1BThese springs 156 and 158 are described. The additional springs 156 and 158 can be used to adjust the magnitude of the established force before the wing 318 triggers the insert assembly 100 to begin actuation. Springs 156 and 158 can also help remove any mechanical spillage that may exist due to tolerances of the various components of the insert assembly 100. Changing the features described in the preceding paragraphs can allow for the empirical determination of appropriate designs for various patient groups (e.g., adolescents, adults, the elderly, or those with high, moderate, or low skin elasticity). Skin swelling tests, elastomer tests, or other tests can be used to match a suitable type of insert assembly 100 to a specific patient.

[0140] Now for reference Figure 40A -B shows two cross-sectional views of the insert assembly 100. Figure 40A In step -B, the example insert assembly 100 has been further withdrawn from the skin 356. The outer housing 116 and the retainer base 140 have continued to shift away from the skin 356 relative to the remainder of the insert assembly 100. The deflector member 358 included on the retainer base 140 has continued to bend the arm 330 inward. The fingers 308 on the retainer ring 140 have advanced into the gap 322 (see example). Figure 35C This causes the wing 318 of the finger portion 308 to have driven the cantilever arm 296 of the pointed retainer 130 off the grabber 306 (see example). Figure 35C Therefore, the movement of the outer housing 116 and the retainer base 140 has advanced the insert assembly 100 to... Figure 40A -B is the insertion release point. As the cantilever arm 296 disengages from the gripper 306, the spring 136 releases its stored energy and begins to actuate the insert assembly 100.

[0141] The insertion assembly 100 can be prevented from triggering actuation until the relative displacement between the parts of the insertion assembly 100 increases to the insertion release point threshold. This ensures that the skin is lifted a certain distance before actuation of the trigger arrangement of the insertion assembly 100 can occur.

[0142] Now for reference Figure 41A -B shows two cross-sectional views of the insert assembly 100. Figure 41AIn Figure B, the example insert assembly 100 has been further withdrawn from the skin 356. As shown, the restoring action of the spring 136 can drive the tip retainer 130, the insert tip 132, and the cannula subassembly 114 towards the skin 356 along the insertion path. In the exemplary embodiment, the tip retainer 130 extends at least partially from the cavity 334 of the tip retractor 130. As shown, the insert tip 132 and the cannula 104 have just pierced the skin 356. During piercing, the skin 356 may still be in a state of being pulled away from the muscles and other underlying body structures. The cannula assembly 114 has also begun to advance towards the infusion set base 106. It should be noted that in the following figures, the spring 136 is still depicted as compressed. This is for ease of illustration. Those skilled in the art will understand that the example spring 136 will expand during the insertion movement. As also shown, the retainer base 140 of the insert assembly 100 may include a stop 364 that prevents relative movement beyond a point between the inner housing 120 and the cover formed by the outer housing 116 and the retainer base 140 (which may be connected to each other). The stop 364 may be included as part of a second ring 312 of the retainer base 140.

[0143] Now for reference Figure 42A -B shows two cross-sectional views of the insert assembly 100. As shown, the spring 136 has returned to the relaxed state and the insertion movement of the tip retainer 130, the insert tip 132, and the cannula subassembly 114 toward the skin 356 is complete. The relaxed state can be a fully relaxed state or a relatively relaxed state, wherein the spring 136 still applies some pressure to the tip retainer 130 to prevent it from wobbling. The notch 186 of the cannula subassembly 114 is shown engaging with the protrusion 182 of the infusion set base 106, thereby locking the cannula assembly 114 and completing the assembly of the infusion set 102. As shown, when the cannula assembly 114 is latched into the base 106, the ear 204 on the cannula assembly 114 can press against the nodule 350 included on the arm 332. This can cause the arm 332 to open, causing the arm 332 to disengage from the infusion set base 106. In turn, this can release the spring 138 to begin releasing stored energy. therefore, Figure 42A -B illustrates the insertion component 100 in the retracted and released state, and arm 332 can be used as a retraction prevention latch.

[0144] In some embodiments, retraction may not be automatic and / or may not be spring-biased. For example, the insertion tip 132 may be held in the advanced position and a user's removal action may manually pull the insertion tip 132 out of the cannula 104. In such embodiments, the spring 138 may be omitted. In some embodiments, disengagement of the arm 332 from the infusion set base 106 may not be automatic. Any arrangement that is obvious to those skilled in the art can be used to facilitate manual disengagement of the arm 332 from the infusion set base 106. A twisting action may be employed to release the arm 332 from the infusion set base 106, thereby allowing the insertion tip 132 to then retract automatically or be manually pulled out. In alternative embodiments, one or more buttons may be included. Displacement of one or more buttons may disengage the arm 332 from the infusion set base 106, thereby allowing the insertion tip 132 to be subsequently retracted manually or automatically from the cannula 104. Squeezing a deformable portion of the insertion assembly 100 may similarly cause the arm 332 to disengage from the infusion set base 106. As those skilled in the art will understand, the embodiment of insert assembly 100 described herein can be further modified to allow for various other manual arm 332 release schemes.

[0145] In an alternative embodiment where the infusion set base 106 is held by a portion of the inner housing 120 and the arm 332 engages with a portion of the inner housing 120, displacement of the tip retainer 130 can similarly cause release of the infusion set 102 and trigger retraction. For example, the ears 204 may collide with a grabbing feature on the inner housing 120 and cause them to displace on the inner housing 120 (e.g., unfold from the infusion set 102), thereby disengaging them from the infusion set 102. Additional ears 204 or other protruding sub-assemblies 114 may be included on the cannula sub-assembly 114 to disengage the arm 332 from the inner housing 120 (e.g., via unfolding of the arm 332) to allow retraction.

[0146] In some embodiments, a dwell period may exist during actuation of the insert assembly 100, during which retraction of the insert tip 132 has been triggered and the tip retractor 134 is displaced; however, the insert tip 132 remains substantially stationary. During this dwell period, the spring 136 may continue to apply pressure to the cannula subassembly 114 via the tip retainer 130. This prevents any possible tendency for the cannula subassembly 114 to bounce or recoil as it is advanced into the infusion set base 106 and ensures that it is securely held in the base 106. As illustrated, once the insertion movement is complete, a dwell gap 360 may exist between the stop 362 on the tip retractor 134 and the flange 302 on each cantilever arm 296 of the tip retainer 130. The spring 136 can still store energy therein and continue to press against the tip retainer 130. The dwell gap 360 on each side may be sized equally.

[0147] Now refer to another source Figure 43A -B, which depicts two cross-sectional views of the insert assembly 100, shows that the dwell gap 360 can be reduced until the stop 362 on the tip retractor 134 contacts the flange 302 of the cantilever arm 296 on the tip retainer 130. Once this occurs, the restoring action of the spring 138 can begin to displace the tip retainer 130 and the insert tip 132 attached to the tip retainer 130 together with the tip retractor 134. This displacement can retract the insert tip 132 from the cannula 104 and the infusion set 102. Figure 43C An alternative embodiment of the insert assembly 100 during this actuation phase is shown. Figure 43C In this embodiment, the cantilever arms 296 are mirror images of each other with equal length. In these embodiments, the stops 362 on the pointed retractor 134 can be at a uniform height relative to each other.

[0148] like Figure 44A As shown in Figure -B, once retraction is complete, the tip retractor 134 can be pressed against the outer housing 116 by the spring 138. For ease of illustration, as those skilled in the art will understand, the spring 138 is still depicted as compressed, but will decompress to a relaxed state during the retraction process. Like the spring 136, the relaxed state can be fully relaxed or relatively relaxed, wherein the spring 138 still applies some pressure to the tip retractor 134 to prevent it from wobbling. After retraction, the insertion tip 132 can be accommodated within the insertion assembly 100 to help prevent accidental finger pricks, etc. In the example embodiment, the insertion tip 132 is further accommodated within the insertion assembly 100 after retraction compared to its initial position. In other embodiments, the retraction position of the insertion tip 132 may vary, but it can be accommodated at least as deeply within the insertion assembly 132 as its initial starting position. The infusion set 102 can be held in place on the skin 356 while the indwelling catheter 104 is in place within the patient.

[0149] Now for reference Figures 45 to 47 In some embodiments, certain components of the insert assembly 100 may be locked in place after actuation. Alternatively, displacement of certain components in a particular direction or displacement in a particular direction beyond a predetermined distance may be prevented. This can inhibit reuse of the insert assembly 100 and help protect the user from accidental finger pricks. Some embodiments of the retainer base 140 may include one or more locking members 141. As shown, two locking members 141 are included, but other embodiments may include more or fewer (e.g., three or four). In the example embodiments, the locking members 141 are disposed opposite each other on the retainer base 140.

[0150] The exemplary locking member 141 in the example embodiment is illustrated as a cantilever locking tab. Each cantilever tab includes a ridge 143 disposed on the portion of the locking member 141 furthest from the skin contact intermediate region 314 of the retainer base 140. The ridge 143 is angled and may define a flange region 145. During the withdrawal of the insert assembly 100 from the skin 356, as the outer housing 116 and retainer base 140 are displaced relative to the inner housing 120, a portion of the inner housing 120 may contact the angled portion of the ridge 143. As shown, the inner housing 120 includes a radial flange 121 that connects the infusion set base interface section 126 of the inner housing 120 to the rail section 122 of the inner housing 120 (see [link to documentation]). Figure 1A Separate. The radial flange 121 may be part of the protrusion 143 of the contact locking member 141 of the inner housing 120. Further relative displacement may cause the locking member 141 to deflect to allow passage through the radial flange 121 of the protruding inner housing 120. As shown, in Figure 47 Once the radial flange 121 has displaced beyond the protrusion 143, the locking members 141 can elastically return to their unpressurized state. If the user presses against the inner housing 120 after actuation, the radial flange 121 may abut against the flange 145 of the locking member 141 and may not be able to displace further into the outer housing 116. Therefore, the inner housing 120 can be constrained after actuation, with this portion of the inner housing 120 maintaining a predetermined distance from the end of the insertion tip 132. This portion may contain a barrier that, after actuation, can help prevent unintentional contact between the insertion tip 132 and the user.

[0151] Now for reference Figure 48A -B indicates Figure 3Two cross-sectional views of an example insert assembly 100 are illustrated. The insert assembly 100 is shown just as it will be applied to the skin 356. The adhesive backing 111 can be removed to expose the adhesive on the infusion set base 106. As shown, springs 136 and 138 can both be in an energy-storing state, which in this particular embodiment is a compressed state. In this example, spring 136 serves as an insert drive biasing member, while spring 138 serves as an insert tip 132 retraction drive biasing member. Spring 136 is held in a compressed state between the insert tip retainer 130 and the insert tip retractor 134, and when spring 136 is released, it drives the tip retainer 130 and the components carried thereon from an elevated state to a forward state. Spring 138 is held in a compressed state between the inner housing 120 and the tip retractor 134. Upon release, spring 138 drives the tip retractor 134 and tip retainer 130 from the inserted state to the retracted state. An additional spring 158 is included in the example embodiment, but is optional. The additional spring 158 can alter the magnitude of the established force before actuation of the insert assembly 100 is triggered and can help remove any mechanical spillage that may exist due to tolerances in the various components of the insert assembly 100.

[0152] Still referencing Figure 49A-52 The diagram illustrates multiple views of the pointed retainer 130 and the retainer cap 406. The pointed retainer 130 may include a bias member receiving shelf 420 against which a spring 136 abuts. Two protrusions 422 may be included on one side of the shelf 420. In the example embodiment, the two protrusions 422 are tracks disposed opposite to each other on the pointed retainer 130. These tracks may follow a guide 354 on a portion of the pointed retractor 134 (see, for example...). Figure 53A -B) Riding. The protrusion 422 can extend from the tip retainer 130 to match the width of the cannula assembly 114 at the plane of the ear portion 204 including the diaphragm housing 108.

[0153] Wall 426 can extend upward from shelf 420. Figure 49A-CThe exemplary wall 426 shown includes interrupted regions forming one or more wall segments 428. Wall segments 428 may be crescent-shaped as shown and separated by interrupted regions formed by U-shaped recesses extending almost from the top surface 430 of the tip retainer 130 to the shelf 420. The recesses may extend at least 90-95% or more of the distance from the top surface 430 to the shelf 420. The recesses may allow deflection of the wall segments 428. The wall segments 428 may be arranged opposite each other on the tip retainer 130 and may have equal lengths. In other embodiments, the two wall segments 428 may not be exactly mirror images. Each wall segment 428 may include a ridge 432 at the end of the wall segment 428 opposite the shelf 420. The ridge 432 has a fimbrial shape and generally widens as the distance from the shelf 420 decreases. During assembly, this can facilitate the movement of the pointed retainer 130 through the arms 330, 332 of the pointed retractor 134 (see example). Figure 48A It is installed into the insertion assembly 100 from one of its extended sides. The flange segment 434 may be defined by a portion of each protrusion 432. At least one flange 434 may extend substantially perpendicular to the wall segment 428. At least one flange 434 may be angled relative to the wall segment 428 including the flange, such that the undercut region has a triangular cross-section.

[0154] Additionally, each wall segment 428 may include a first segment 436 and a second segment 438. The first segment 436 may have a smaller width than the second segment 438 and may be the area closer to the shelf 420 in these regions. The first segment 436 and the second segment 438 may be connected by an intermediate region 440. The intermediate region 440 may be angled or curved to transition between different widths of the first segment 436 and the second segment 438. A nodule 442 may be included, protruding from the intermediate segment 440 or from a portion of the first segment 436 and the second segment 438 adjacent to the intermediate segment 440. Although not shown, it may include a similar feature. Figure 26 The 304 glue or adhesive supply port.

[0155] Currently, the main reference is... Figures 50-52A protrusion 412 extending from the cap retainer 406 of the insertion assembly 100, referred herein as an expansion pin 412, may protrude into a receiving gap 444 between the wall segments 428. The expansion pin 412 may include a tapered region 446 at its end and may or may not be hollow. The tapered region 446 may abut against the inner surface 448 of the wall segment 428 when the expansion pin 412 is advanced into the tip retainer 130 beyond a certain distance, and the tapered region 446 may help guide the expansion pin 412 as it is displaced into the tip retainer 130. Further displacement of the expansion pin 412 into the tip retainer 130 may cause the wall segments 428 to elastically deflect apart or spread apart, thereby widening the tip retainer 130 to accommodate the expansion pin 412 therein. The presence of the expansion pin 412 may also result in an increased distance between the outward-facing surfaces of the nodule 442.

[0156] Currently, the main reference is... Figure 48B and Figure 53A -B, the nodule 442 can interact with another component of the insert assembly 100 and prevents the force exerted by the spring 136 on the shelf 420 from displacing the tip retainer 130 into a forward position. In the example shown, the nodule 442 is sized such that when the expansion pin 412 is in place within the tip retainer 130, the nodule 442 may not fit within the cavity 334 contained in the tip retractor 134. Because the spring 136 is held between the shelf 420 of the tip retainer 130 and the inner surface of the top plate 328 of the tip retractor 134, the nodule 442 can suppress the release of energy stored in the spring 136.

[0157] Still combined Figure 53A -B Reference Figure 48A -B, Spring 138 can also be held in an energy-storage state by at least one latch engagement. As shown, Pointed Retractor 134 may include a first set of arms 330 and a second set of arms 332. These arms 330, 332 may be substantially as described above relative to... Figure 35A As described in -B. The pointed retractor 134 in this embodiment is illustrated with a symmetrical design to allow the pointed retractor 134 to be assembled into the insert assembly 100 along multiple orientations. This may help simplify assembly. Figure 35A -B's pointed retractor 134 can also be achieved by including a gap 322 on the opposite side of the cavity 334 (see example). Figure 35C It is constructed symmetrically.

[0158] Each of one or more notches 342 or arms 330 may cooperate with a cooperating protrusion 344 on the inner housing 120 (see, for example) Figure 36The engagement of the notch 342 and the cooperating protrusion 344 allows the spring 138 to remain compressed and to function as a latch to prevent retraction. This can be particularly useful during assembly. Although the notch 342 is shown, the arm 330 and the inner housing 120 can engage in other ways as described elsewhere herein.

[0159] Now, let's focus on combining... Figure 53A -B Reference Figure 48A -B, In some embodiments, an additional latch may be included in the insert assembly 100, which helps to retain one of the springs 136, 138 in an energy-storage state. In an exemplary embodiment, spring 138 is held in an energy-storage state by engagement of an additional latch provided by the interaction of features of arm 332 with features of infusion set base 106. This latch arrangement may be similar to that described above relative to... Figure 24A As described in -B. When the infusion set base 106 is held by the arm 332 of the needle retractor 134, the infusion set base 106 can be held such that the surface of the infusion set base 106 is adjacent to the retainer 352. This prevents the infusion set base 106 and the needle retractor 134 holding the infusion set base 106 from shifting into the insert assembly 100 due to mechanical interference from the retainer 352. Therefore, the engagement of the arm 332 with the infusion set base 106 also helps to hold the spring 138 in an energy-storage state. The retainer 352 also ensures that the infusion set base 106 is located within the insert assembly 100, allowing the adhesive 374 to press against the skin 356. In this example, the retainer 352 ensures that the infusion set base 106 is substantially flush with the skin contact surface on the holding base 140. As described elsewhere in this document, with the infusion set base 106 positioned in this manner, the infusion set base 106 and / or adhesive lining 111 can also serve as a protective barrier.

[0160] Still mainly refer to Figure 48A -B, When the retaining pin 412 is removed from the pointed retainer 130, the wall section 428 can return to its non-deflected state. This reduces the distance between the nodules 442, allowing the nodules 442 to enter the cavity 334 in the pointed retractor 134. In turn, this allows the spring 136 to begin releasing energy and displace the pointed retainer 130 toward the forward position. As shown, in Figure 48A In -B, the example insert assembly 100 is configured such that the entire insert assembly 100 can move as a unit, allowing at least a portion of the insert assembly 100 to retract from the body. This may result in the skin 356 being lifted a certain distance before the retaining pin 412 begins to retract and triggers actuation. The amount by which the skin 356 is lifted, or the force applied, before the portions of the insert assembly 100 are displaced relative to each other can be as follows: Figure 39A -B was modified as described in the discussion.

[0161] In various embodiments, the flange portion 434 of the pointed retainer 130 can prevent the pointed retainer 130 from shifting beyond a certain amount. Alternatively, the flange portion 434 can be provided on the pointed retainer 130 such that a dwell gap 360 exists after the pointed retainer 130 is advanced to the forward position (e.g., see...). Figure 42B As described elsewhere in this document, the dwell gap 360 helps ensure that the cannula subassembly 114 is securely held in the base 106.

[0162] In various embodiments, when the tip retainer 130 is displaced, the cannula subassembly 114 can be coupled to the infusion set 106 as described elsewhere herein. Furthermore, the lug 204 of the cannula assembly 114 can cause the arm 332 to unfold as the tip retainer 130 displaces, causing the infusion set base 106 to release from the arm 332. This releases the spring 138 and begins retraction of the insertion tip 132. During retraction, the dwell gap 360 can decrease (if present) until the top plate 328 of the tip retractor 134 contacts the flange 434 on the tip retainer 130. Once this occurs, the restoring action of the spring 138 can begin to displace the tip retainer 130 and the insertion tip 132 attached to the tip retainer 130 together with the tip retractor 134. This displacement retracts the insertion tip 132 from the cannula 104 and the infusion set 102. Once retraction is complete, the pointed retractor 134 can be pressed against the outer housing 116 by the spring 138, and the insertion tip 132 can be housed within the insertion assembly 100 to help prevent accidental finger injuries. The infusion set 102 can be held in place on the skin 356 while the indwelling catheter 104 is in place within the patient.

[0163] Now for reference Figure 54This illustration depicts another embodiment of an insert assembly 100 including a manual trigger. The example insert assembly 100 includes a button 550 that is actuated upon displacement. The button 550 may be included as a separate part assembled into the insert assembly 100. Alternatively, and as shown, the button 550 may be integrally formed with another part of the insert assembly 100. In the example embodiment, the button 550 is formed as a continuous portion of the outer housing 116. In the example embodiment, the button 550 includes an enlarged region that may include a recess 552, which may be substantially centrally located within the enlarged region. The recess 552 may facilitate interaction with a user's finger. The button 550 may also include a cantilever beam portion 554 that connects the button 550 to the remainder of the outer housing 116. In the example embodiment, the enlarged portion of the button 550 is located at the terminal, unsupported end of the cantilever beam portion 554, but in other embodiments it may be located anywhere along the length of the cantilever beam portion 554. In an exemplary embodiment, the cantilever beam 554 extends in a direction substantially parallel to the longitudinal axis of the insert assembly 100 and toward the top of the insert assembly 100. In other embodiments, the cantilever beam portion 554 may extend in any direction. The cantilever beam portion 554 may include a curvature matching the curvature of the outer housing 116. A gap 556 may be included around the button 550 to provide clearance for displacement or deflection of the button 550 during use. During actuation, the button 550 may be at least partially displaced into the insert assembly 100 to trigger insertion.

[0164] In some embodiments, button 550 may not include cantilever beam portion 554 and may instead be a material strip defined by cutouts on both sides of the strip. An enlarged section may be positioned at or near the center of the strip. When pressure is applied to trigger insertion, the strip may deflect inward toward the interior of insert assembly 100.

[0165] Still referencing Figure 55A-C and Figure 56 It may include an interlocking device that prevents button 550 from actuating insert assembly 100 until the skin has been displaced or until a relative movement exceeding a threshold amplitude has occurred. As shown, button 550 may include a protrusion 558 on its inner surface (in... Figure 56 (As best shown in the diagram). As illustrated, the raised section 558 can be positioned opposite the recess 552 of the enlarged area of ​​the button 550. In the initial state, for example, as shown... Figure 55BAs shown, the bulge 558 may not be aligned with the skid member 560. As the insert assembly 100 is removed from the body, the skin is lifted, and a portion of the insert assembly 100 undergoes relative displacement, the bulge 558 can align with the skid 560. At this time, the portion 100 of the insert assembly can resemble... Figure 40B The arrangement is shown in the diagram. Once aligned, button 550 can be displaced to engage skid 560. Displacement of button 550 can then drive skid 560 into a protrusion 300 at the end of the cantilever arm 296 located on the tip retainer 130. As skid 560 continues to advance, protrusion 300 can be removed from the gripper 306, thereby releasing the bias member 136.

[0166] Main Reference Figures 56-59 In its initial state, the skid 560 can be positioned within a receiving gap 564 included in the inner housing 120. The skid 560 may have a curved wall 566, which, in its initial state, is substantially flush with the outer surface of the inner housing 120. As shown, the receiving gap 564 is shaped as a protrusion 558 for receiving the button 550. In an example embodiment, the protrusion 558 is cross-shaped and the receiving gap 564 mimics this shape. Until the insert assembly 100 is aligned, the walls of the inner housing 120 exhibit mechanical interference that prevents the button 550 from being pressed. Once aligned, the protrusion 558 can enter the receiving gap 564 and the skid 560. Although a cross-shaped shape is used, any other type of shape can be used. For example, a star-shaped or asterisk-type shape can be used in alternative embodiments. Figure 56 As best shown, the selected shape may include one or more inclined portions that extend substantially parallel to the longitudinal axis of the insert assembly 100. This allows for increased tolerances on the skid 560 and the ridge 558 as the insert assembly 100 is removed from the body and helps ensure smooth operation.

[0167] Main Reference Figures 59 to 60The skid 560 may include a cantilever member 568, which includes a skid ridge 570 at its unsupported end. The cantilever member 568 may be included within an actuating protrusion 576 of the skid 560. The skid ridge 570 may form a flange 572 that can grip onto a component of the insert assembly 100 to retain the skid 560 within the insert assembly 100. As shown, the top plate 328 of the pointed retractor 134 includes a bridge 574. The bridge 574 forms a lower channel aligned with a receiving gap 564 of the inner housing 120 when the insert assembly 100 is assembled. During assembly, the skid 560 can pass through the receiving gap 564, and the actuating protrusion 576 can pass through the lower channel formed by the bridge 574. The flange 572 of the cantilever member 568 can grip the surface of the bridge portion 574 to hold the skid 560 within the insert assembly 100. The skid protrusion 570 on the cantilever member 568 can be tilted to facilitate deflection of the cantilever member 568 about the bridge portion 574 during installation of the skid 560. The bridge portion 574 can also act as a guide, providing a displacement channel for the skid 560 when it is driven into the protrusion 300 of the cantilever arm 296.

[0168] Still referencing Figure 61 In some embodiments, button 550 may not be included; however, a portion of the outer housing 116 may be deformable. Figure 61 In the example shown, the outer housing 116 includes a deformable region 580 with a protrusion 558 on it. In some examples, the deformable region 580 may be coupled to (e.g., overmolded to or otherwise adhered to) the outer housing 116. In embodiments including the deformable region, once the insert assembly 100 is aligned, a user can squeeze the outer housing 116 at the deformable region 580 to drive the protrusion 558 into the skid 560 (see example...). Figure 59 (To trigger actuation)

[0169] In some embodiments, and now refer to Figure 62 The inner surface of the outer housing 116 may include a protrusion 558. The button 550 or deformable region 580 may not be included. During the retraction of the insert assembly 100 from the body, relative displacement of the components of the insert assembly 100 may automatically trigger the insert assembly 100. This relative displacement may cause the protrusion 558 to contact the skid 560 (see, for example...). Figure 59 And drive the skid 560 to the cantilever arm 296 (see example) Figure 55B 300 on the ridge (see, for example) Figure 55B Therefore, the protrusion 300 can be displaced away from the grabber 306 (see, for example, see...). Figure 55BTo release the bias member 136 (see, for example) Figure 55B The inner housing 120 may include a suitably sized channel that accommodates the bulge 558.

[0170] Now for reference Figure 63 A flowchart 450 is shown describing multiple exemplary actions that can be performed to assemble, for example... Figure 24A -B shows the insert assembly 100. In block 452, a first biasing member, such as spring 136, can be placed in the cavity 334 of the tip retractor 134. In block 454, the cannula subassembly 114 can be placed on the tip 132 attached to the tip retainer 130. In block 456, the tip retainer 130 can be placed into the cavity 334 of the tip retractor 134. In block 458, the tip retainer 130 can be latched to the position where the first biasing member is in an energy-storing state. In various examples, this can be a compressed state. In block 460, a second biasing member, such as spring 138, can be clamped between the tip retractor 134 and the inner housing 120. In block 462, the tip retractor 134 can be latched to the position where the second biasing member is in an energy-storing state. In various examples, this can be a compressed state. In block 464, a cover (which may be formed by an outer housing 116 and a retainer base 140) can be coupled together around an inner housing 120. In block 466, an infusion set base 106 can be releasably coupled to a tip retractor 134. In block 468, a locking member 146 can be mounted into the insert assembly 100. As mentioned elsewhere herein, in some embodiments, the locking member may be welded to an adhesive liner 111 that covers the adhesive on the infusion set base 106. During assembly of the components, any tracks, rails, key features, fingers, etc., contained on the components can be aligned with the cooperating features of the components in which they are placed. Latching the various components of the insert assembly 100 together simplifies the assembly of the insert assembly 100 because these components can resist any spring biases and hold themselves in the proper orientation or position. Therefore, an assembler (human or robot) can easily lock the components together and be able to release them thereafter. This allows the partially assembled parts of the insert component 100 to move around the production facility or be transported to other facilities, and simplifies any fixtures used during assembly.

[0171] Now for reference Figure 64In some examples, the insert assembly 1000 may be reusable. After actuation, certain insert assembly 1000 embodiments can be reset and used to install the next infusion set 102 (or, in some examples, an analytical sensor). Thus, the same insert assembly 1000 can be used to install multiple different infusion sets 102. For example, the container of the infusion set 102 may include a single insert assembly 1000 (or a number of insert assemblies 1000 less than the number of infusion sets 102). A single insert assembly 1000 may be designed to be used to install each infusion set 102 in the container onto a patient. Therefore, waste and costs associated with site changes can be reduced. In embodiments where the insert assembly 1000 is a multi-purpose device, the infusion set 102 may be housed in a separate kit cartridge 1002. Similarly, where the insert assembly 100 is configured to apply a sensor to a patient, the sensor may be housed in a sensor cartridge separate from the insert assembly 1000. As in other embodiments described herein, the infusion set 102 may be configured to be partially assembled within the kit cartridge 1002. The kit cartridge 1002 is... Figure 64 The cartridge 1002 is shown detached from the insert assembly 1000. The cartridge 1002 can be attached to the insert assembly 1000. Once attached, the insert assembly 1000 can be actuated to install the infusion set 102 at the desired infusion site. After actuation, the used cartridge 1002 can be detached from the insert assembly 1002 and disposed of. The insert assembly 1000 can be reset when another cartridge 1002 is attached to it for installation of another infusion set 102.

[0172] Depending on the embodiment, actuation of the insert assembly 1000 may also result in the assembly of the infusion set 102. The infusion set 102 may be configured as multiple parts (e.g., individual components, sub-assemblies, or combinations thereof) within the kit cartridge 1002. Actuation of the insert assembly 1000 may cause each part of the infusion set 102 to engage together to complete the assembly of the infusion set 102. For example, the assembly of the infusion set 102 may occur as an initial stage of actuation of the insert assembly 1000, or as part of an insertion stage that results in the introduction of the cannula 104 into the patient.

[0173] Now for reference Figures 65A to 65BAn exploded view of an exemplary kit cartridge 1002 is illustrated. As shown, the kit cartridge 1002 may include an outer housing 1004. When the kit cartridge 1002 is assembled, the outer housing 1004 may contain other components of the kit cartridge 1002. Therefore, the outer housing 1004 may also be referred to herein as a container. In this example, the outer housing 1004 is shown as a cup-shaped object and includes an open top. Depending on the embodiment, when fully assembled, the open top of the outer housing 1004 may be covered by a barrier member to completely surround the components of the kit cartridge 1002. This barrier member may be disinfectant-permeable to allow for disinfection of the kit cartridge 1002 after assembly. The barrier member may also help minimize contact between the components in the outer housing 1004 and the surrounding environment or a user.

[0174] As shown, the infusion set 102 may be included within the kit cartridge 1002 as separate first and second parts, but are joined together during actuation of the insert assembly 1000 to form the infusion set 102. The first part may include a base 106 that can be applied to a patient's skin and can be coupled to a fluid passage (e.g., via a terminal connector on the passage) that is part of or extends from an infusion pump. An adhesive backing, film, or liner 111 may be included and may be applied to an adhesive 374 included on the infusion set base 106. The infusion set base 106 may be located within a receiving compartment 1006 of the inner housing 1008 of the kit cartridge 1002. The receiving compartment 1006 may include a notch 1010 that can receive a tube retainer 184 included on the infusion set base 106. In an example embodiment, the notch 1010 can also be used to ensure that the base 106 can be mounted within the receiving compartment 1006 only in the desired orientation. As shown, the inner housing 1008 may include a recess 1012. The recess 1012 may be sized to accommodate the pull tab 410 included on the receiving adhesive liner 111. Because the recess 1012 is visible to the user, it can be used as an orientation indicator. This can help the user install the infusion set 102 in a manner consistent with their planned routing path for the infusion tubing to be coupled to the infusion set 102. An indicator showing the orientation of the infusion set 102 may be included on a portion of the insert assembly 1000. This is particularly true in embodiments where the kit cartridge 1002 can be coupled to the insert assembly 1000 only in a single orientation.

[0175] The second part of the infusion set 102 may be a sub-assembly 114 of two or more components of the infusion set 102. The second part may include, for example, a cannula 104, a diaphragm housing 108, a diaphragm 110, and a diaphragm retainer 112 (in...). Figure 1AAn exemplary cannula subassembly 114 is shown in exploded view. Any cannula assembly 114 described herein can be used. In an exemplary embodiment, the cannula 104 and the diaphragm housing 108 are shown as a single, continuous integral part. The housing with the cannula can be a molded part made of a single material, such as, for example, PTFE, Teflon, polypropylene, etc. When the kit cartridge 1002 is assembled, the insertion tip 132 can extend through the cannula assembly 114 and the cannula assembly 114 can be disposed against the tip retainer 130. In a sensor cartridge embodiment, the cannula assembly 114 and the infusion set base 106 can be replaced by a sensor assembly.

[0176] The cartridge case 1002 may also include a tip retainer 130. The tip retainer 130 may hold the insertion tip 132 thereon. The insertion tip 132 may be glued or otherwise joined to the tip retainer 130 for fixed positioning relative to the tip retainer 130. Alternatively, the insertion tip 132 may be press-fitted into the tip retainer 130, or the tip retainer 130 and the insertion tip 132 may be joined in an overmolding process. Any suitable type of tip 132 may be used. For example, the tip 132 may be a hollow or solid needle, a core needle, or other sharp member, which may be made of a metallic material such as steel.

[0177] Currently, the main reference is... Figure 66 The infusion base holder 1014 may also be included in the cartridge 1002. The infusion base holder 1014 may include a set of holder arms 1016. The holder arms 1016 may extend from the end plate 1028 of the infusion base holder 1014. The arms 1016 may be separated from the wall 1018 defining the central cavity 1020 of the infusion base holder 1014 by an interruption region included in the wall 1018. The wall 1018 may also include a set of protrusions 1030. The protrusions 1030 may be disposed opposite to each other on the wall 1018 and may be approximately 90° spaced from the arms 1016. The protrusions 1030 may include an inclined surface 1032 on the portion of each protrusion 1032 furthest from the end plate 1028. The protrusions 1030 may also define a gripping surface 1034 on the portion of the protrusion 1030 closest to the end plate 1028.

[0178] Still referencing Figure 67During the assembly of the infusion base holder 1014 into the inner housing 1008, the protrusion 1030 can travel along a corresponding channel 1036 defined in the inner housing 1008. As shown, the end point of the channel 1036 can be closed by a stop wall 1038. When the protrusion 1030 is driven into the stop wall 1038, the portion of the wall 1018 including the protrusion 1030 can be resiliently deflected inward to allow the protrusion 1030 to pass outside the stop wall 1038. The inclined surface 1032 can facilitate this deflection. Once the protrusion 1030 has passed the stop wall 1038, the portion of the wall 1018 can return to a pressure-free state. When the portion of the wall 1018 is in a pressure-free state, the latching surface 1034 of the protrusion 1030 can latch onto the stop wall 1038 of the channel 1036, thereby preventing the infusion base holder 1014 from being pushed out of the inner housing 1008. The end plate 1028 of the infusion base holder 1014 may abut an edge 1040, which prevents the infusion base holder 1014 from further displacing into the inner housing 1008. Therefore, the infusion base holder 1014 can be securely positioned within the inner housing 1008.

[0179] Again, the main reference Figure 66 A set of arms 1016 of the infusion base holder 1014 may be arranged opposite to each other and may extend cantileveredly from the end plate 1028. Each of the arms 1016 may include a ridge 1022 disposed at its unsupported end. Each ridge 1022 may form a flange 1024 on the arm 1016 including it. In addition, the arm 1016 may include a nodule 1026 or a raised ramp, the thickness of which varies with distance from the cavity 1020 (see, for example...). Figure 65A The number of lumps increases with the increase of ). The nodule 1026 may be disposed between the non-supported end of the arm 1016 and its attachment point with the rest of the infusion base holder 1014.

[0180] Now for reference Figures 68-69B And as Figure 69BAs best shown, each flange 1024 can grip a portion of the infusion set base 106. Specifically, the flange 1024 can grip the exposed portion of the infusion set base 106. The base 106 may include guides, stepped features, nodules, or any other suitable protrusions to provide complementary gripping surfaces for the flanges 1024. In some embodiments, the flanges 1024 can grip the guide 172 of the infusion set base 106. Thus, the infusion set base 106 can be held within the kit cartridge 1002. The flanges 10244 can be angled relative to the cantilever arm 1016 including these flanges, such that the undercut has a triangular cross-section. For example, the portion of each flange 1024 of the guide 172 (or any other gripping feature) gripping thereon can be angled cooperatively to help ensure a secure engagement.

[0181] In some embodiments, only one arm 1016 may be included. In some embodiments, the inner housing 1008 may also or alternatively include a latch that can engage with the guide 172 or another mating segment of the infusion set base 106 to hold the infusion set base 106 in place.

[0182] Because the infusion set base 106 is held by the arm 1016, it also serves as a protective barrier. Since the cannula subassembly 114 and the insertion tip 132 are located inside the kit cartridge 1002, the user is protected from accidental contact with the insertion tip 132 when the infusion set base 106 is in its initial holding position. This also helps prevent contact between the cannula 104 or the insertion tip 132 and contaminants. Although the gap for receiving the cannula subassembly 114 can extend throughout the entire infusion set base 106, the gap can be sized to prevent finger entry (e.g., the cross-section of the gap is smaller than the cross-section of a finger). Therefore, the infusion set base 106 can contain a barrier that blocks unintentional access to the insertion tip 132 and the cannula 104. Furthermore, because the cannula subassembly 114 is located inside the kit cartridge 1002, any adhesive backing 111 provided on the infusion set base 106 does not need to include an interruption allowing the cannula 104 to pass through. Therefore, the gaps in the infusion set base 106 for the cannula subassembly 114 can be blocked by the adhesive backing 111 until just before use. This further prevents fingers from entering and reduces the possibility of debris entering the kit cartridge 1002. The outer housing 1004 may also have a barrier to prevent the user from interacting with the insertion tip 132 and / or the cannula 104.

[0183] like Figures 69A-69B As shown, in various embodiments, the infusion base holder 1014 may include at least one guide. In an example embodiment, the infusion base holder 1014 includes a set of tip retainer guides 1042 (see...). Figure 69AThe tip retainer guide 1042 may be recessed into the cavity-facing side of the wall 1018 of the infusion base retainer 1014. The tip retainer 130 may include a wing 1044 that may ride within the tip retainer guide 1042 during displacement of the tip retainer 130 within the kit cartridge 1002. In an alternative embodiment, the tip retainer 130 may include a recess, and the wall may include a track projecting from the cavity-facing side of the wall 1018. The track may be received within the recess of the tip retainer 130, and the track guides the displacement of the tip retainer 130 during displacement within the kit cartridge 1002.

[0184] The infusion base holder 1014 may also include a set of diaphragm housing guides 1046. Diaphragm housing guides 1046 (see...) Figure 69B The cannula assembly 114 can be recessed into the cavity-facing side of the arm 1016. During movement of the cannula assembly 114 within the kit cartridge 1002, the ear 204 of the diaphragm housing 108 can ride within the diaphragm housing guide 1046. As shown, the tip retainer 130 may also include a flap 1048 aligned with the ear 204 and also located within the diaphragm housing guide 1046. When the cannula assembly 114 is latched into the base 106, the ear 204 on the cannula assembly 114 can press against the nodule 1026 included on the arm 1016. This may cause the arm 1016 to open, disengaging the arm 1016 from the infusion set base 106. In turn, this may release the now-assembled infusion set 102 from the kit cartridge 1002.

[0185] Now for reference Figures 70A-70B and Figures 71A-71BAn exploded view of two example embodiments of the insert assembly 1000 is illustrated. Insert assemblies such as the insert assembly 1000 can be coupled to the kit cartridge 1002 and subsequently used to place the infusion set 102 at the patient's infusion site and introduce the cannula 104 of the infusion set 102 into the patient's body. As mentioned elsewhere, some insert assemblies 1000 can be used to place other patient care components onto the patient's body. For example, certain insert assemblies 1000 can be operated to place a physiological monitor or analyte sensor in working relation with the patient's body. The insert assembly 1000 can be used to place a blood glucose monitor such as a continuous glucose sensor. In some embodiments, the same insert assembly 1000 can be matched with either the kit cartridge 1002 or the sensor cartridge, depending on the type of device the patient intends to place on their body. In some embodiments, the insert assembly 1000 may also be coupled to a lancet cartridge (e.g., a kit cartridge 1002 without the cannula assembly and infusion set base 106) to create a skin puncture to facilitate the collection of a body sample with an analyte test strip.

[0186] like Figures 70A-71B As shown in the exploded view, the insertion assembly 1000 may include an outer housing 116. The outer housing 116 may surround various parts of the insertion assembly 1000 and serve as a part of the insertion assembly 1000 for user gripping during operation. Figures 70A-70B In the example embodiment, the outer housing 116 has a circular cross-sectional shape, but other embodiments may have different shapes, such as any type of polygon. In some examples, shapes such as... Figures 71A-71B The rectangular or oblong cross-sectional shape shown is advantageous. This shape allows for easier fitting into a pouch, or into a smaller pouch, such as a more typical women's garment. The cross-sectional area in the example embodiment also varies as the bottom section of the outer housing 116 (the section closest to the skin during use) is wider or has a larger cross-sectional area than the top. The outer housing 116 may include various ergonomic features that facilitate gripping of the insert assembly 1000 containing it. For example, textures or finger or thumb recesses may be included on the outer surface of the outer housing 116. Alternatively or additionally, the width of a region of the outer housing 116 may be thinner than the width of the rest of the outer housing 116. This makes a firm grip on the insert assembly 1000 easier.

[0187] Example outer housing 116 may include markings, tabs, embossed sections, recessed sections, textured sections, raised areas, color coding, decals, or other markings used to indicate the position and / or orientation of the infusion set 102 within the insertion assembly 1000. It may include, for example... Figure 1AThe raised rib 118 shown. This allows the user to position the insert assembly 1000 in a desired orientation so that, once the infusion set 102 is attached to the user, the planned deployment of the infusion tubing 366 can be permitted (see, for example...). Figure 6 ).

[0188] The retaining cap 406 can be attached to the top of the insert assembly 1000 to hold various components in place within the insert assembly 1000. Figures 70A-71B In the example shown, the retainer cap 406 includes a cantilever retainer body 408 that can snap into a retaining interface 411 included on the outer housing 116 (see example...). Figure 70A Other connections are also possible, such as bayonet mounts, interference fits, snap-fit ​​fits, adhesives, glue, threads, solvent bonding, welding, etc. When joined together, the outer housing 116 and the retaining cap 406 can form a cover of the insert assembly 1000. The outer housing 116 and the retaining cap 406 together can form a first unit of the insert assembly 1000. The remaining parts of the insert assembly 1000 can be referred to as a second unit of the insert assembly 1000.

[0189] Still referencing Figures 70A-71B The insert assembly 1000 may further include an inner housing 120. When the insert assembly 1000 is assembled, the inner housing 120 may be disposed inside the outer housing 116. A first unit of the insert assembly 1000 may be displaceable relative to the inner housing 120 and other components of a second unit of the insert assembly 1000 contained within the inner housing 120. Various outer housings 116 may have at least one keying feature that constrains the inner housing 120 such that the inner housing can only be mounted within the outer housing 116 in a limited number of orientations. The cross-sectional shape may be selected to specify this constraint (see, for example...). Figures 71A-71B Alternatively, the outer housing 116 may include at least one guide rail 1090 (see, for example...). Figures 70A-70B ).exist Figures 70A-70BIn the exemplary embodiment shown, two guide rails 1090 (only one visible) directly opposite each other are included on the inward-facing surface of the outer housing 116. The guide rails 1090 extend substantially parallel to each other. The guide rails 1090 may have different widths if it is desired to restrict the inner housing 116 to a single mounting orientation. The outer surface of the inner housing 120 may include a track 1092 cooperating with the guide rails 1090. The inner housing 120 may be prevented from being moved into the outer housing 116 until the guide rails 1090 are aligned with the track 1092. The interaction 1092 of the guide rails 1090 within the track 1092 may also inhibit rotation of the inner housing 120 and the outer housing 116 relative to each other. Although the guide rails 1090 are shown on the outer housing 116 in the example, in some embodiments, the guide rails 1090 may alternatively exist on the outer surface of the inner housing 120. In such an example, the track 1092 may be located on the outer housing 116.

[0190] like Figures 70A to 70B As shown, the outer housing 116 may also include a stop protrusion 1094 on its inner surface. The stop protrusion 1094 may be a dome, pin, guide rail, or any suitable feature. The stop protrusion 1094 may restrict the travel of the inner housing 120 along the axis of the outer housing 116. In an example embodiment, the stop protrusion 1094 extends from an end of the outer housing 116 in a direction parallel to the guide rail 1090. In some examples, the retainer arm 408 of the retainer cap 406 may also serve as a stop to restrict the travel of the inner housing 120 relative to the outer housing 116.

[0191] The housing body 1060 (relative to) Figures 73-75 and Figure 77 (As described in more detail) can be used to attach to the bottom of the insert assembly 1000 to hold various components in place within the insert assembly 1000. Figures 70A-71B In the example shown, the receiving body 1060 includes a cantilever retaining arm 1096 that can snap into a retaining interface 1098 included on the inner housing 116. Other connections are also possible, such as bayonet mounts, interference fits, snap-fit ​​fits, adhesives, glues, threads, solvent bonds, welding, etc. Locking members 1112A and B may be included, which may be another component (e.g., Figures 70A-70B It is part of the retractable latch body 1102 or as a separate, independent component (see, for example) Figures 71A-71B Furthermore, locking components 1112A and B can protrude through the container body 1060.

[0192] It may also include a retractable latch body 1100 and a retraction spring retainer 1102. As will be further described later in this specification, during partial actuation of the insert assembly 1000, the retractable latch body 1100 and the retraction spring retainer 1102 may engage with each other to hold, for example, a spring 1104 (or...) Figures 71A-71B The biasing members of springs 1104A and 1108 are kept in an energy storage state. The retractable latch body 1100 can be connected and positioned on the receiving body 1060 via the interaction of the latch finger 1097 of the receiving body 1060 and the grab body 1099 on the retractable latch body 1100.

[0193] Insertion actuator 1062 may also be included in insert assembly 1000. As will be further described later in this specification, insertion actuator 1062 may have a plunger 1106 and a spring 1108 housed in a portion of insertion actuator 1062. Assembly reset body 1110 may be included. As will be further described later in this specification, reset body 1110 may act on various components of insert assembly 1000 to place the components in a ready state for actuation. When released to transition from an energy-storage state to a relaxed state, spring 1108 may displace insertion actuator 1062 to induce insertion of cannula 104 from attached kit cartridge 1002 and complete assembly of kit cartridge 1002 into infusion set 102. When spring 1104 (or Figures 71A-71B When the springs 1104A, B) are released to transition from an energy-storage state to a relaxed state, the tip 132 may also retract into the cartridge 1002. During this transition, in some embodiments, the spring 1104 may drive the retractable spring retainer 1102 within the insert assembly 1000 toward the retracted state. This can result in the insert actuator 1062 (which may be attached to the tip retainer 130, see example) Figure 73 The discussion was driven to a retraction state.

[0194] refer to Figure 72 It depicts Figures 71A-71B A cross-sectional view of the insert assembly 1000. The insert assembly 1000 is shown in a relaxed or stored state. As shown, no cartridge 1002 is attached to the insert assembly 1000. In some embodiments, an end cap may be included for storage and may be positioned above the end of the insert assembly 1000 that can be engaged with the cartridge 1002. Furthermore, in Figure 72In this diagram, all biasing members 1108, 1104A, and B are shown in a relaxed or unpressurized state. The insert assembly 1000 can be in a relaxed state between uses. Because the insert assembly 1000 may typically only be used during site changes (e.g., every three days), it can remain in a relaxed state for the majority of its service life. Therefore, biasing members 1108, 1104A, and B may only need to be in an energy-storing state or a pressurized state (compressed state in the example embodiment) for short periods. When the insert assembly 1000 is in its stored state, Figures 70A-70B The biasing members 1108 and 1104 of the insert assembly 1000 can similarly be in a substantially stress-free state.

[0195] The uncompressed storage state of bias members 1108, 1104A, B facilitates the use of various bias members 1108, 1104A, B or their materials. For example, spring relaxation and / or creep may be less critical, allowing for easier use of materials such as various polymers in the construction of bias members 1108, 1104A, B. Furthermore, when the insert assembly 1000 is stored (e.g., during transport or in stock), other components of the insert assembly 1000 may not be subjected to the continuous stress exerted by the compressed bias members of the insert assembly 1000. Therefore, any creep caused by such continuous stress can be eliminated. This, in turn, allows for greater design flexibility for other components of the insert assembly 1000. For example, a wider variety of materials can be used, or certain components can be manufactured smaller. It should be noted that in some examples, the kit cartridge 1002 (or sensor cartridge or lancet cartridge) may not include any bias members. Conversely, all biasing components can be included in the insert assembly. As a result, the components of cartridge 1002 can also be stored in a state free from sustained stress. This similarly helps to provide greater design flexibility for the components of cartridge 1002.

[0196] Now for reference Figure 73 The diagram illustrates a view of an example cartridge 1002 disassembled from an exemplary insert assembly 1000. As shown, the end plate 1028 of the infusion base holder 1014 (see, for example...) Figure 66 The top plate 1028 may include at least one mating pin 1050. In an exemplary embodiment, two mating pins 1050 are included. The mating pins 1050 may be disposed opposite to each other on the top plate 1028 and are shown in the example as being 180° apart from each other. The mating pins 1050 may include enlarged heads 1052 that are connected to the end plate 1028 via pin bodies 1054. A portion of the tip retainer 130 is in Figure 73 It is also visible in the middle. For example... Figure 74 As best shown in the detailed view, the tip retainer 130 may include a mating segment 1056. The mating segment 1056 may include a tapering region 1058 adjacent to a terminal flange 1059 forming the end of the tip retainer 130. The length dimension of the terminal flange 1059 may be longer than its width dimension. In an example embodiment, the tip flange 1059 is oblong in shape.

[0197] To attach the cartridge 1002 to the insert assembly 1000, the cartridge 1002 can be placed against a receiving body 1060 included within the insert assembly 1000. A tip driver 1062, including a port 1064 for a tip retainer 130, can be accessed through the receiving body 1060. In the initial attachment state, the mating section 1056 can be oriented in a position aligned with the port 1064, allowing the mating section 1056 to enter the port 1064. A mating pin 1050 can act as a retainer, limiting the amount of displacement of the mating section 1056 into the port 1064. In an example embodiment, the mating pin 1050 can limit the displacement of the mating section 1056 into the port 1064 such that the tapered section 1058 is aligned with the edge 1066 surrounding the port 1064. The cartridge 1002 can then be rotated from the initial attachment state to a fully attachment state. Because the tapered segment 1058 is aligned with the edge 1066, the mating segment 1056 can rotate freely. During connection, the terminal flange 1059 can sweep over the inner surface of the edge 1066 into an orientation where it no longer needs to pass through the port 1064. The top flange 1059 can be biased against the inner surface of the edge 1066 by at least one biasing member 1108 (see, for example...). Figure 77This can help suppress additional rotation of the terminal flange 1059. The mating pin 1050 can also be displaced into the mating interface, such as a retaining boot 1068 included on the receiving body 1060. The retaining boot 1068 can be formed as a "U"-shaped body protruding from the receiving body 1060. The width of the "U"-shaped body can vary in a stepped manner with increasing distance from the receiving body 1060. Adjacent to the receiving body 1060, the width can be sized to receive the head 1052 of the mating pin 1050. The width of the portion of the boot 1068 furthest from the receiving body 1060 can be sized to receive the pin body 1054 of the mating pin 1050. Thus, when the cartridge 1002 is rotated to the fully engaged state, the head 1052 of the mating pin 1050 can be suspended by a portion of the boot 1068, preventing the mating pin 1050 from translating out of the boot 1068 in a direction parallel to the longitudinal axis of the insert assembly 1000. In an alternative embodiment, a mating pin 1050 (or another mating protrusion) may be included on the receiving body 1060. A retaining boot 1068 (or another mating interface) may be included as part of the cartridge 1002.

[0198] Still referencing Figure 75 In some embodiments, rotating the cartridge 1002 to the fully engaged state can actuate the housing tab 1070 of the inner housing 1008 to disengage from the receiving slot 1072 of the outer housing 1004 (see also, for example...). Figure 69B The engagement of the housing tabs 1070. In an exemplary embodiment, each of the housing tabs 1070 includes an inclined protrusion 1074, which may be disposed on the middle portion of the housing tab 1070. Figure 67 As best shown, each housing tab 1070 can be disposed on a cantilever arm 1076. During attachment of the cartridge 1002 to the insert assembly 1000, a portion of the receiving body 1060 can interact with the housing tab 1070 and deflect the cantilever arm 1076 toward the center of the cartridge 1002. This deflection can cause the housing tab 1070 to be displaced from the receiving slot 1072 of the outer housing 1004 (in... Figure 69B(Best shown in the image) Removal. In an example embodiment, the receiving body 1060 includes a set of deflector members 1078 that protrude from the receiving body 1060. The deflector members 1078 may include a tilted portion 1080. When the cartridge 1002 is rotated to the fully engaged state, the tilted portion 1080 of the deflector member 1078 may be displaced to abut a tilted protrusion 1074 of the housing tab 1070. As further rotation occurs, the tilted protrusion 1074 may be pushed out of the displacement path of the deflector member 1078 by a bending cantilever arm 1076. This, in turn, may actuate the housing tab 1070 away from the receiving slot 1072. The outer housing 1004 can then be separated from the cartridge 1002.

[0199] Still mainly refer to Figure 73 The insert assembly 1000 may include one or more locking members 1112A, B. In an exemplary embodiment, the insert assembly 1000 includes two locking members 1112A, B that are diametrically opposed or spaced 180° apart from each other. Other embodiments may include more or fewer locking members 1112A, B. When the cartridge 1002 is attached to the insert assembly 1000 and the outer housing 1004 is removed, the locking members 1112A, B may be in a state where they protrude from the receiving body 1060. When in the protruding state, the locking members 1112A, B may be positioned between portions of the edge walls 1084 on either side of the cantilever arm 1076. This can inhibit the placement of the inner housing 1008 of the cartridge 1002 relative to the insert assembly 1000, because the edge walls 1084 can act as stop surfaces that present mechanical interference that blocks the displacement of the locking members 1112A, B. Therefore, by preventing the mating pin 1050 from rotating out of the retaining shoe 1068, the insert assembly 1000 and the inner housing 1008 can be locked together in the fully engaged direction. A sensor cartridge or lancet cartridge can be similarly attached to the insert assembly 1000.

[0200] Now for reference Figure 76 In some embodiments, cartridge 1002 (or other cartridges) may be coupled to insert assembly 1000 in the same manner, but may not have the same cross-sectional shape as insert assembly 1000. Figure 76 In the example shown, the insert component 1000 has a generally oblong cross-sectional shape, while the cartridge 1002 has a generally circular shape. In some examples, different types of cartridges may have different cross-sectional shapes, making them easily distinguishable during visual inspection. Different types of cartridges may also have different colors or different textures, surface finishes, markings, labels, etc.

[0201] Now for reference Figure 77 It depicts Figures 71A-71B Another cross-sectional view of the insert assembly 1000. The insert assembly 1000 is coupled to... Figure 77 Example kit cartridge 1002. The mating pin 1050 of kit cartridge 1002 can be held within the retaining shoe 1068 of the receiving body 1060 of insert assembly 1000. The deflector member 1078 of the receiving body 1060 has deflected the cantilever arm 1076 of the inner housing 1008. This, in turn, pushes the housing tab 1070 out of engagement with the receiving slot 1072 of the outer housing 1004. Therefore, the outer housing 1004 of kit cartridge 1002 can be decoupled from kit cartridge 1002 to expose the infusion set base 106.

[0202] Still referencing Figure 77 During the engagement of the kit cartridge 1002 with the insert assembly 1000, a portion of the kit cartridge 1002 can displace the locking members 1112A, B from a protruding state to a retracted state. For example... Figure 77 As shown, when the cartridge case 1002 abuts against the insert assembly 1000, the outer housing 1004 of the cartridge case 1002 can force the locking members 1112A and B into a retracted state. When in the retracted state, the locking members 1112A and B can allow the cartridge case 1002 to rotate.

[0203] Now for reference Figure 78 , Figure 77 The locking member 1112A of the insert assembly 1000 is shown in isolation. As shown, the locking member 1112A may include a locking protrusion 1114, which may be a portion of the locking member 1112A extending from the receiving body 1060. The locking protrusion 1114 may extend a distance from a first end 1124 of the positioning plate 1116 at a generally perpendicular angle to the positioning plate 1116. The positioning plate 1116 may include one or more apertures 1118, 1120 that allow the positioning plate 1116 to slide on a portion of another component of the insert assembly 1000 to hold the positioning plate 1116 in a predetermined position within the insert assembly 1000. The positioning plate 1116 may slide on a portion of the retracted latch body 1100, for example as... Figure 77 As shown. The second end 1126 of the positioning plate 1116, which is opposite to the attachment point of the locking protrusion 1114, can be rounded.

[0204] As shown, the positioning plate 1116 may include a ridge 1122, which may be disposed on the side of the positioning plate 1116. Other components of the insert assembly 1000 may also include ridges along their side edges (see, for example...). Figure 71A(Exploded view in -B). These ridges 1122 can be configured as reinforcements that increase the rigidity of locking members 1112A, B and any other components including these ridges 1122. In some embodiments, the ridges 1122 can also help guide or position other components as they shift within the insert assembly 1000.

[0205] like Figure 77 As shown, locking members 1112A, B can be biased toward the protruding state. In this example, locking members 1112A, B are positioned between the respective biasing members 1104A, B and the face of the retracted latch body 1100. When they lock members 1112A, B are driven to the retracted state, the rounded end 1126 of each locking member 1112A, B can allow the locking members 1112A, B to pivot. The orifices 1118, 1120 can also be sized to allow this pivoting. When the locking members 1112A, B pivot, they can apply pressure to their associated biasing members 1104A, B. Therefore, when the outer housing 1004 of the cartridge 1002 is dislodged, the locking members 1112A, B can automatically shift back to the protruding state because the biasing members 1104A, B return to their unpressured state (see, for example...). Figure 80 For example, this can lock the inner housing 1008 of the kit cartridge 1002 into place on the insert assembly 1000.

[0206] Now for reference Figure 79 In some alternative embodiments (see, for example) Figures 70A-70B In this assembly, locking members 1112A and B can be integrated into another component. As shown, locking members 1112A and B are formed as protrusions extending from an arcuate member 1128, which can be, for example, cantilevered to the retractable latch body 1100. When assembling the insert assembly 1000 including such locking members 1112A and B, as... Figure 73 As shown, locking members 1112A and B can extend from the receiving body 1060. When locking members 1112A and B are displaced to the retracted state, the cantilevered bow-shaped member 1128 can be elastically deflected. For example, when the outer housing 1004 is removed, the cantilevered bow-shaped member 1128 can elastically return to its unpressurized state. This can cause the locking members 1112A and B to return to the protruding state and lock the inner housing 1008 into place on the insert assembly 1000.

[0207] Now for reference Figure 80 Remove the adhesive backing 111 by pulling the pull tab 410 (see, for example) Figure 65AAfterward, the cartridge 1002 can be placed against the skin 356. The insert assembly 1000 can then be actuated to a ready state. Since the storage state of the example insert assembly 1000 is that all bias members 1104A, B, 1108 are in a relaxed or unpressurized state, the insert assembly 1000 can be actuated through a setting phase to place the insert assembly 1000 into a ready state. During the setting phase, the bias members 1104A, B, 1108 of the insert assembly 1000 can be transformed (e.g., compressed) into a compressed state. To achieve this, the user can press the first unit of the insert assembly 1000 (e.g., the outer housing 116 and the retainer cap 406) against the rest of the insert assembly 1000 (or the second unit of the insert assembly 1000) and the skin 356. In addition to actuating the insert assembly 1000 to a ready state, pressure applied by the user helps ensure that the adhesive 374 on the infusion set base 106 adheres firmly to the skin 356. Although Figure 80 It is illustrated Figures 71A-71B The insert component 1000 shown is... Figures 70A-70B The example insert assembly 1000 can also advance through the setting phase by pressing its outer housing 116 and retainer cap 406. The insert assembly 1000 can be considered to have advanced through the setting phase, and the insert assembly 1000 enters the ready state once the first unit of the insert assembly 1000 has moved at least a threshold distance to the ready position. Once the setting phase has been reached, and as described in more detail elsewhere herein, the retainer can engage with a latch to hold the bias members 1104A, B, 1108 in a compressed state.

[0208] Now for reference Figure 81 In the example embodiment, when the user moves the outer housing 116 toward the skin 356, the biasing members 1108, 1104A, B (or Figures 70A-70BThe bias member 1104 shown in the example can be compressed. As shown, the retainer cap 406 may include a set of pins 1130. The pins 1130 may surround the cylinder 1132 of the reset body 1110 of the insert assembly 1000. When the outer housing 116 is displaced, the pins 1130 may be driven to contact the flange 1134 of the reset body 1110. In the example embodiment, the flange 1134 is located in the central region of the cylinder 1132 and extends substantially perpendicular to the cylinder 1132. Further displacement of the outer housing 116 may cause the pins 1130 to push against the flange 1134, causing the reset body 1110 to move together with the outer housing 116. This may cause the cylinder 1132 to advance along the plunger 1106, such that an increased amount of the plunger 1106 is disposed within the bore of the cylinder 1132. When the biasing member 1108 is gripped between the end of the cylinder 1132 and the flange 1136 of the plunger 1106, the advance of the cylinder 1132 on the plunger 1106 may compress the biasing member 1108.

[0209] As the reset body 1110 is displaced, the biasing components 1104A, B (or Figures 70A-70B The biasing member 1104 in the example shown can also be compressed. In the example embodiment, the retraction spring retainer 1102 can be coupled to the reset body 1110, such that the reset body 1110 and the retraction spring bracket 1102 are displaced together as a single unit. To illustrate this, the exemplary reset body 1110 and the retraction spring retainer 1102 are... Figure 82 It is depicted as being connected to and independent of the rest of the insert assembly 1000. (Reference) Figure 81 and Figure 82In an example embodiment, the retraction spring retainer 1102 includes a set of retainer arms 1138. The retainer arms 1138 may be cantilevered to a base 1140 of the retraction spring retainer 1102, which is illustrated as a planar body in the example embodiment. Each retainer arm 1138 may include a protrusion 1142 disposed at its non-supported end or terminal. A flange segment 1144 may be defined by a portion of each protrusion 1142. The flange 1134 of the reset body may include a channel 1146 through which the protrusions 1142 may be displaced to engage the reset body 1110 and the retainer arm 1138 via a snap-fit ​​engagement. The protrusions 1142 may include an inclined portion to facilitate deflection of the retainer arms 1138 when the reset body 1110 and the retraction spring retainer 1102 are engaged with each other. When joined together, the bottom surface of flange 1134 can abut against at least one step 1148 included on each retaining arm 1138. The width of retaining arm 1138 can vary at step 1148. The portion of retaining arm 1138 near base 1140 can be wider than the width of channel 1146 relative to step 1148. Therefore, flange 1136 can be gripped between flange 1144 and step 1148 of each retaining arm 1138 and is substantially immobile relative to flange 1144 and step 1148. With reset body 1110 and retraction spring retainer 1102 joined together, they can be displaced as a unit.

[0210] Main Reference Figure 81 Bias members 1104A and B can be engaged between the retraction spring retainer 1102 and the retracted latch body 1100. One end of the bias members 1104A and B can contact the retraction spring retainer 1102, while the other end can contact the locking members 1112A and B. In an exemplary embodiment, the bias members 1104A and B are disposed around a guide protrusion 1150 included on the retracted latch body 1100. The guide protrusion 1150 can thus serve as a locator protrusion for positioning the bias members 1104A and B within the insert assembly 1000. The retraction spring retainer 1102 and the insert driver 1062 may include a guide hole 1152 through which the guide protrusion 1150 can extend. When a user pushes down on the outer housing 116, the retraction spring retainer 1102 can be displaced along the guide protrusion 1150 toward the retracted latch body 1100. Since the biasing members 1104A and B are held between the retraction spring retainer 1102 and the retracted latch body 1100, the advancement of the retraction spring retainer 1102 may cause the biasing members 1104A and B to be compressed.

[0211] Now for reference Figures 83-84In some embodiments, an additional guide protrusion 1150 may be included, or the guide protrusion 1150 may be included on another part of the insert assembly 1000. Figure 84 It is illustrated Figures 70A-70B A three-quarter section view of an example internal housing 120 of the insert assembly 1000 shown (along...) Figure 83 (Lines 84-84 are cut off). As shown, the inner housing 120 may include four guide protrusions 1150 (one of which is cut off) extending from the top of the inner housing 120. In an alternative embodiment, the guide protrusions 1150 may be spaced apart from each other at a uniform angle, but the spacing and number of the guide protrusions 1150 may vary. The retraction spring retainer 1102 and the insertion actuator 1062 may have cooperating guide holes 1152 (see Figures 70A-70B) and may be displaced along the guide protrusions 1150.

[0212] Now for reference Figure 85 As the outer housing 116 of the insert assembly 1000 continues to shift and the biasing members 1104A, B, 1108 continue to compress, the base 1140 of the retractable spring retainer 1102 can contact the latch arm 1190 of the retractable latch body 1100. As shown, the latch arm 1190 cantilevered from the base 1192 of the retractable latch body 1100. Each latch arm 1190 may include a first portion 1194 near the base 1192. When not under pressure, the first portion 1194 extends substantially perpendicularly and parallel to each other from the base 1192. Each latch arm 1190 may also include a second portion 1196 away from the base 1192, which may be angled relative to the first portion 1194. In this example, the second portion 1194 is tilted such that the distance between the latch arms 1190 increases with the distance from the base 1192. A latching element 1198 may be included where the second portion 1194 meets the first portion 1192 of each latch arm 1190. When the retraction spring retainer 1102 is driven to contact the second portion 1194 of each latch arm 1190, the latch arms 1190 can separate from each other, as... Figure 85 As shown.

[0213] Now for reference Figures 86-88 It depicts the state of readiness. Figures 70A-70B and Figures 71A-71BA view of an example insert assembly 1000. Once the contraction spring retainer 1102 has been displaced beneath the second portion 1194 of each latch arm 1190, the latch arms 1190 can elastically return from their deployed state. When the latch arms 1190 return to their uncompressed state, the gripper 1198 can extend from the base 1140 of the contraction spring retainer 1102. Thus, with the bias members 1104A, B, 1108 compressed, the gripper 1198 can hold the retractor spring retainer 1102 in place. The insert assembly 1000 can then be prepared to be actuated to drive the infusion set 102 to be installed at the selected infusion site on the patient. Figures 86-88 It can be assumed that the outer housing 116 and the retainer cap 406 are in the ready position.

[0214] Now for reference Figure 89 and Figure 90 A cross-sectional view of the example insert assembly 1000 is shown. Figure 89 ) and a detailed view of its indicated area ( Figure 90 When the outer housing 116 of the exemplary insert assembly 1000 is pressed against the skin 356 during the setting phase (see, for example...), Figure 81 When the release finger 1154 extends from the retainer cap 406, it can deflect about the guide wedge 1156 included on the inner housing 120. Each release finger 1154 can be cantilevered to the base 1174 of the retainer cap 406. At the unsupported end 1162 of each release finger 1154, a paddle 1164 with a protrusion 1166 can be included. The width of the paddle 1164 can be greater than the width of the remainder of the release finger 1154. In some embodiments, the width can be 2-3 times the width of the remainder of the release finger 1154 (e.g., 2.15-2.30 or 2.25 times in some examples). The paddle 1164 can be arranged such that the central region of the paddle 1164 is connected to the remainder of the associated release finger 1154. Thus, the paddle 1164 can include two uniformly sized portions (only one in... Figure 89 (As can be seen in the cross-section), the two uniformly sized portions are located on the side of the release finger portion 1154.

[0215] Each paddle 1164 may include an inner surface 1168 near the longitudinal axis or midplane of the insert assembly 1000 and an outer surface 1170 on the side of the paddle 1164 opposite to the inner surface 1168. A protrusion 1166 may be provided on the outer surface 1170 of each paddle 1164. The protrusion 1166 may be located at the center of each paddle 1164 such that the protrusion 1166 can be displaced during actuation without contacting the guide wedge 1156. The outer surface 1170 of each paddle 1164 may include an outer ramp portion 1172 on the flank portion of the paddle 1164. A lateral ramp portion 1172 may be included on the portion of the paddle 1164 furthest from the base portion 1174 of the retainer cap 406. The lateral ramp portion 1172 may be inclined toward the inner surface 1168 as the distance from the base portion 1174 of the retainer cap 406 increases. The inner surface 1168 of the paddle-shaped body 1164 may also include a central ramp portion 1176 on the flank portion of the paddle-shaped body 1164. The central ramp portion 1176 may be included on the portion of the paddle-shaped body 1164 furthest from the base portion 1174 of the retainer cap 406. As the distance from the base portion 1174 of the retainer cap 406 decreases, the central ramp portion 1176 may be inclined toward the outer surface 1170.

[0216] Still referencing Figure 91 In an exemplary embodiment, the guide wedge 1156 extends from the sidewall 1160 of the channel 1158 through the top of the inner housing 120 (in Figure 91 (Shown separately). Guide wedges 1156 are included in pairs. Each pair of guide wedges 1156 extends from opposite sidewalls 1160 of the channel toward each other. Guide wedges 1156 include a top surface 1180 that slopes toward the mid-plane of the insert assembly 1000 as the distance from the top of the inner housing 120 increases. Guide wedges 1156 also include a bottom surface 1182 parallel to the top surface 1180. The ends of the top surface 1180 and the bottom surface 1182 furthest from the top of the inner housing 120 may be rounded or chamfered to form points (e.g., ...). Figures 89 to 91 (As shown). When the outer housing 116 is displaced toward the body during the setting phase, the release fingers 1154 and paddles 1164 can be displaced along the displacement path extended by the guide wedges 1156. During this displacement, the outer ramp portion 1172 of the paddle 1164 of each release finger 1154 can contact the top surface 1180 of the pair of guide wedges 1156. Further displacement can cause the outer ramp portion 1172 to slide along the top surface 1180 of the guide wedges 1156. This can produce a deflection of the associated release fingers 1154 and the protrusions 1166 of the paddles 1164 toward the midplane of the insert assembly 1000 (see, for example). Figure 81The movement of the paddle 1164. When this displacement occurs, the protrusion 1166 of the paddle 1164 can pass through the gap between the associated pair of guide wedges 1156. Once the paddle 1164 has been displaced below the guide wedges 1156, the release finger 1154 can freely and elastically return to its undeflected state (see, for example...). Figure 85 ).

[0217] As will be described in more detail later in the specification, the outer housing 116 may be displaced relative to the inner outer housing 120 in the opposite direction to launch the insert assembly 1000. When this occurs, the intermediate ramp portion 1176 of the paddle-shaped portion 1164 of each release finger 1154 may contact the bottom surface or underside 1182 of the associated guide wedge 1156. Further displacement may cause the intermediate ramp portion 1176 to slide along the underside 1182 of the guide wedge 1156. This may result in deflection of the release finger 1154 and movement of the protrusion 1166 of the paddle-shaped portion 1164 away from the midplane of the insert assembly 1000. When the outer housing 116 is displaced, the protrusion 1166 of the paddle-shaped portion 1164 may pass through the gap between the associated pair of guide wedges 1156.

[0218] When the release finger 1154 deflects away from the mid-plane of the insert assembly 1000, the protrusion 1166 can deflect toward the cantilever arm 1184 on the insert driver 1062. The arm 1184 may form resilient protrusions that can deflect if sufficient force is applied. The unsupported end of the arm 1184 may include a bent or angled section. A notch or a pair of notches 1188 may also be present on each cantilever arm 1184. In this example, each arm 1184 includes a pair of notches 1188 located near the unsupported end of the arm 1184. The notches 1188 may resemble, for example... Figure 36 The notches 342 shown are arranged as shown. Each of one or more notches 1188 can engage with a cooperating protrusion 1200. The cooperating protrusion 1200 can be included on the inner housing 120 and can protrude from the sidewall 1160 of the channel 1158 through the top of the inner housing 120. The interaction of the notches 1188 and the cooperating protrusions 1200 can hold the biasing member 1108 in a compressed state and serve as an insertion prevention latch or an insertion drive latch.

[0219] As the release finger 1154 deflects toward the arm 1184, further displacement of the outer housing 116 away from the skin 356 may cause the protrusion 1166 on the paddle 1164 to collide with the protrusion 1202 on the cantilever arm 1184. This may drive the notch 1188 of the cantilever arm 1184 away from the cooperating protrusion 1200 of the inner housing 120. Thus, once the first unit of the insert assembly 1000 (e.g., the outer housing 116 and the retainer cap 406) has been pulled away from the remainder of the insert assembly 1000 (the second unit of the insert assembly 1000) beyond a threshold distance (which can be measured from the ready position), the insert actuator 1062 can be driven out of the insert actuator latch. This releases the spring 1108 to its unpressurized state and moves the insert actuator 1062 toward the skin 356. When the spring transitions from its compressed state to its relaxed state, the insert actuator 1062 can move from its retracted state to an extended position, in which at least a portion of the insert actuator 1062 protrudes from the insert assembly 1000 and enters the cartridge 1002. Figure 91 As shown in the diagram, a ridge 1201 that prevents displacement of the cantilever arm 1184 may be included in the middle of each cooperating protrusion 1200. This helps ensure that the cantilever arm 1184 can be released from the cooperating protrusion 1200 only when the user wants it.

[0220] Now for reference Figure 92 It depicts Figures 70A-70B The cross-section of the insert component 1000 shown. In some embodiments, and as... Figure 92 As shown, the release finger 1154 can be disposed inside the cantilever arm 1184 of the insertion driver 1062 (see example...). Figures 71A-71B In such embodiments, the outer side (relative to the mid-plane) of the insert assembly 1000 can be moved toward the mid-plane of the insert assembly 1000 in order to be removed from their respective cooperating protrusions 1200 of the inner housing 120. In such embodiments, the retaining post 1130 included on the retaining cap 406 may include an enlarged section 1131. The enlarged section 1131 may prevent the cantilever arm 1184 from being expelled until the insert assembly 1000 has been withdrawn from the skin 356 by more than a certain amount.

[0221] Also refer to Figure 94 , Figure 93 A detailed view of the indicator area shows that the release finger 1154 may have a paddle 1164, which is configured to cause the release finger 1154 to move along a path relative to the... Figures 89-91The directions described are opposite to the deflection. Each paddle 1164 may include an inner surface 1168 near the longitudinal axis or midplane of the insert assembly 1000 and an outer surface 1170 on the side of the paddle 1164 opposite to the inner surface 1168. A protrusion 1166 may be provided on the inner surface 1170 of each paddle 1164. The protrusion 1166 may be provided at the center of each paddle 1164 such that the protrusion 1166 can be displaced during actuation without contacting the guide wedge 1156. The outer surface 1170 of each paddle 1164 may include an outer ramp portion 1172 on the flank portion of the paddle 1164. At the base 1174 of the paddle 1164 closest to the retainer cap 406 (see, for example, Figure 93 The paddle 1164 may include an outer ramp portion 1172. As the distance from the base portion 1174 of the retainer cap 406 decreases, the lateral ramp portion 1172 may tilt toward the inner surface 1168. The inner surface 1168 of the paddle 1164 may also include an inner ramp portion 1176 on the side wing portion of the paddle 1164. The inner ramp portion 1176 may be included on the portion of the paddle 1164 furthest from the base portion 1174 of the retainer cap 406. As the distance from the base portion 1174 of the retainer cap 406 increases, the inner ramp portion 1176 may tilt toward the outer surface 1170.

[0222] When the outer housing 116 is pressed against the skin 356 during the setting phase, the intermediate tilting portion 1176 can deflect the blade body 1164 of the release finger 1154 outward around the guide wedge 1158. As the insert assembly 1000 rises from the skin 356 to trigger insertion, the lateral tilting portion 1172 can deflect the release finger 1154 inward around the deflector wedge 1158 and toward the cantilever arm 1184. As the release finger 1154 deflects toward the arm 1184, further displacement of the outer housing 116 away from the skin 356 may cause the protrusion 1166 on the paddle 1164 to collide with the protrusion 1202 on the cantilever arm 1184. This can drive the notch 1188 (as described above) of the cantilever arm 1184 out of the cooperating protrusion 1200 (as described above) of the inner housing 120. This allows the spring 1108 to transition to its unpressurized state and moves the insertion driver 1062 toward the skin 356.

[0223] like Figure 95As shown, actuation of the insert assembly 1000 can be triggered when the insert assembly 1000 is lifted from the skin 356 for removal from the patient. Actuation may not require further pressing, twisting, squeezing, etc., by the user on triggers, buttons, housing sleeves, or other parts of the insert assembly 1000; however, actuation can still be under the user's control. In alternative embodiments, and as discussed elsewhere herein, actuation of the insert assembly 1000 can be triggered by discrete manual triggering actions. Triggering occurs automatically when the insert assembly 1000 is withdrawn from the skin 356; relative movement of one or more free parts of the insert assembly 1000 relative to one or more restraining parts can trigger actuation. As described above, actuation can be triggered, for example, by shifting or removing the latch and releasing one or more biasing members to initiate actuation. Thus, one or more triggers within the insert assembly 1000 can be actuated as a result of the removal of the insert assembly 1000 from the body. From the user's perspective, this insert assembly 1000 can be simply placed on the skin 356 and then removed to perform placement of the infusion set 102. This may be advantageous for several reasons detailed elsewhere in the instruction manual.

[0224] Figure 95 It is illustrated Figures 71A to 71B The example insert assembly 1000 is attached to the kit cartridge 1002 and when the insert assembly 1000 is being removed from the skin 356. As shown, adhesive 374 on the infusion set base 106 can adhere to the skin 356, causing the skin 356 to be pulled upward as the insert assembly 1000 and the kit cartridge 1002 are removed. When the user removes the insert assembly 1000 from their body, the outer housing 116 and the retainer cap 406 can be displaced as a unit along with the user's hand. Figures 70A-70B The same applies to the outer housing 116 and retainer cap 406 of the example insert assembly 1000 shown. Other components of the example insert assembly 1000 and the kit cartridge 1002 can be displaced as a unit together with the outer housing 116 and retainer cap 406 without constraint. These components can form a second unit that can be retained rearward and cannot be displaced relative to the skin patch 356 attached to the adhesive 374.

[0225] During the removal of the insert assembly 1000 and the cartridge case 1002, the outer housing 116 and the retainer cap 406 can be displaced substantially along the axis of the insert tip 132 away from the skin 356. This displacement relative to other components can cause the release finger 1154 to deflect toward the cantilever arm 1184 of the insert actuator 1062, as described above. The elasticity of the release finger 1154 may cause the entire insert assembly 1000 and the cartridge case 1002 to move together so that at least a portion of the insert assembly 1000 is withdrawn from the skin 356. During this portion of the removal action of the insert assembly 1000, the skin 356 can be raised away from the underlying body structure. Once the force exerted by the skin elasticity exceeds a force threshold and the release finger 1154 is fully deflected around the deflector wedge 1158, portions of the insert assembly 1000 can again be displaced relative to each other.

[0226] Now for reference Figure 96 As the outer housing 116 and retainer cap 406 continue to shift relative to the insert assembly 1000 and the remainder of the cartridge 1002, the cantilever arm 1184 of the insert driver 1062 can be driven out from the associated cooperating protrusion 1200 of the inner housing 120. (As stated above regarding...) Figures 89-91 or Figures 92-94 As described, this may be caused by the collision of the protrusion 1166 of the paddle 1164 on the release finger 1154 with the protrusion 1202 at the unsupported end of the cantilever arm 1184.

[0227] Now for reference Figure 97 This allows the biasing member 1108 between the reset body 1110 and the plunger 1106 to transition to its uncompressed state. As the biasing member 1108 transitions to its relaxed state, the plunger 1106 and the insertion driver 1062 can be pushed toward the skin 356. When the tip retainer 130 is coupled to the port 1064 of the insertion driver 1062, the tip retainer 130 and the cannula subassembly 114 connected to it can also be ejected toward the skin 356 along the insertion path. Figure 97 As shown, it is illustrated for illustrative purposes. Figures 71A-71BThe insert assembly 1000, insert tip 132, and cannula 104 have just pierced the skin 356. During piercing, the skin 356 may still be in a state of being pulled away from muscles and other underlying body structures. The cannula subassembly 114 has also begun to advance toward the infusion set base 106. As also shown, the retainer cap 406 of the insert assembly 100 may include one or more stop arms 1204 that prevent relative movement beyond a certain point between the inner housing 120 and the cover formed by the outer housing 116 and the retainer cap 406. The stop arms 1204 may grip a portion of the top of the inner housing 120 to prevent further relative displacement. The stop arms 1204 may engage at the beginning or in progress of the insertion of the cannula 104. Therefore, additional lifting of the skin 356 may occur during the insertion movement of the cannula 104.

[0228] In some embodiments, a biasing member may be included such that the stop arm 1204 must compress the biasing member before the cantilever arm 1184 of the insertion driver 1062 is expelled from the cooperating protrusion 1200. This can help to further elevate the skin 356 before insertion is triggered. In some embodiments, the portion of the inner housing 120 that contacts the stop arm 1204 may be elastically cantilevered in the path of the stop arm 1204. Thus, when the insert assembly 1000 is withdrawn, the cantilevered portion of the inner housing 120 may be deflected by the stop arm 1204 before the cantilever arm 1184 is expelled from the cooperating protrusion 1200. The elasticity of these cantilevered portions can be selected to ensure that the skin is elevated by at least a certain amount. In other embodiments, springs (e.g., compression springs, leaf springs, etc.) may be placed in the path of the stop arm 1204. These springs may need to be compressed via displacement of the stop arm 1204 before the cantilever arm is released. Alternatively, a spring can be selected such that at least the desired amount of skin lifting occurs before the cantilever arm 1184 is released from the cooperating protrusion 1200.

[0229] Now for reference Figure 98 Another cross-sectional view of the example insert assembly 1000 and the cartridge 1002 is shown. As illustrated, the spring 1108 has returned to the relaxed state and the insertion movement of the tip retainer 130, the insert tip 132, and the cannula subassembly 114 toward the skin 356 is complete. The relaxed state can be a fully relaxed state or a relatively relaxed state, wherein the spring 1108 still applies some pressure to the tip retainer 130 to prevent it from wobbling. Similar to Figure 42BAs shown, the notch 184 of the cannula assembly 114 can engage with the protrusion 182 of the infusion set base 106, thereby locking the cannula assembly 114 into place and completing the assembly of the infusion set 102. As illustrated, when the cannula assembly 114 is latched into the base 106, the lug 204 on the cannula assembly 114 can press against the nodule 1026 included on the retainer arm 1016. This may cause the retainer arm 1016 to open, thereby causing the retainer arm 1016 to disengage from the infusion set base 106. Therefore, the assembled infusion set 102 can be installed at the infusion site and released from the cartridge 1002.

[0230] For example Figure 98 As shown, when the now-assembled infusion set 102 is released, the insertion actuator 1062 may collide with the latch arm 1190 of the retracted latch body 1100. This collision may cause the latch arm 1190 to open, thereby preventing the contraction spring retainer 1102 from engaging with the catch 1198 of the latch arm 1190. Therefore, Figure 98 The illustration shows the insertion component 1000 in the retracted and released state. Figures 70A-70B Example insert component 1000 in Figures 99A-99B The image shows the retracted and released state.

[0231] Now for reference Figure 100 As the retraction spring retainer 1102 is released from the catch 1198, the biasing members 1104A, B (or those used for...) Figures 70A-70B The biasing members 1104 of the insert assembly 1000 can be switched to their unpressurized state, driving the retraction spring retainer 1102 toward the retainer cap 406 of the outer housing 116. Since a portion of the insert driver 1062 is located between the retraction spring retainer 1102 and the retainer cap 406, the insert driver 1062 can also be displaced along with the retraction spring retainer 1102 when the biasing members 1104A, B are relaxed. Since the tip retainer 130 is coupled to the insert driver 1062, the displacement of the insert driver 1062 may cause the insert tip 132 to be removed from the skin 356 and retracted into the kit cartridge 1002.

[0232] In some alternative embodiments, the retraction of the insertion tip 132 may not be automatic and / or may not be spring-biased. For example, the insertion tip 132 may be held in the advanced position and the user's removal action may manually pull the insertion tip 132 out of the cannula 104. In such embodiments, the biasing members 1104A, B may be omitted. In some embodiments, a button press or similar interaction may be required to trigger the spring-biased retraction of the insertion tip 132.

[0233] Now for reference Figure 101The outer housing 1004 is shown as being detachable from the remainder of the used cartridge 1002 mounted on the insert assembly 1000. Once the infusion set 102 is installed at the desired infusion site, the outer housing 1004 can be removed and accommodated using a tool for removing and receiving the used cartridge 1002. As shown, the cantilever arm 1076 of the inner housing 1008 may be recessed relative to the outer surface 1082 of the inner housing 1008. Recessed edge walls 1084 may be present on each side of the cantilever arm 1076. The outer housing 1004 may include a set of stops 1086 that may engage within a recess formed in the inner housing 1008. After the infusion set 102 is inserted, the outer housing 1004 may slide on the inner housing 1008, and the used cartridge 1002 may be rotated to a disengaged state. The stop 1086 can abut against the recessed edge wall 1084 and secure the inner housing 1008 and outer housing 1004 to rotate cooperatively. See also... Figure 73 This allows the inclined protrusion 1074 of the housing tab 1070 to disengage from its abutment with the deflector member 1078 of the receiving body 1060. Due to the elasticity of the cantilever arm 1076, the housing tab 1070 can return to engagement with the receiver slot 1072 in the outer housing 1004. The insert assembly 1000 can then be removed from the used kit cartridge 1002.

[0234] After use, the outer housing 1004 can be sealed with the remaining parts of the used cartridge 1002. This ensures that the used insert tip 132 is enclosed within the cartridge 1002. Therefore, the point of insertion tip 132 is inaccessible to the user. The engagement of the housing tab 1070 with the receiver slot 1072 locks the insert tip 132 within the used cartridge 1002. In some embodiments, the infusion set 102 can be placed on the infusion site using one hand via the insert assembly 1000. Therefore, after removing the outer housing 1004, when applying the infusion set 102 with the insert assembly 1000, the user can be encouraged to hold the outer housing 1004 in their free hand. The user can then remove the used cartridge 1002 by reattaching the outer housing 1004 to the inner housing 1008 and separating the cartridge 1002 from the insert 1000. Occupying the user's hands during this process can help limit the chance of the user accidentally touching the insertion tip 132.

[0235] Now for reference Figures 102-106 An example tube connector 368 for assembling tube connector 368 is illustrated. Figure 102-103B ) and fixing device 480 ( Figures 104-105 The fixing device 480 can help to secure the tip 482 and the infusion tubing 366 (see, for example). Figure 6 The tip 482 is assembled into the tube connector 368. The retaining device 480 ensures that the tip 482 is positioned with an exposed portion 484 of a specified length. In various embodiments, this helps to ensure that when the tube connector 368 is coupled to the infusion set 102 (see, for example...), the tip 482 is positioned into the tube connector 368. Figure 6 When the tip 482 extends into the diaphragm 110 to the desired distance (see, for example, see...), the tip 482 extends into the diaphragm 110 to the desired distance (see...). Figure 5B For example, the length of the exposed portion 484 can be sized to extend into the fluid introduction volume of the cannulation subassembly 114 as described elsewhere herein.

[0236] In this example, tip 482 is depicted as having a lancet tip, but other types of tips can be used. For example, in some embodiments, tip 482 with a rear bevel can be used. Exemplary tip 482 (see Figure 103B The device includes a primary grinding region 487, which is at an angle (e.g., between 10-20°, such as 15.5°) relative to the longitudinal axis of the tip 482. A set of secondary grinding sections 489 are also included and form the point 485 of the tip 482.

[0237] Furthermore, the retaining device 480 ensures that the tip 482 enters a predetermined rotational orientation. This can be achieved using magnetic force. Therefore, the end 486 of the tip 482 of the tubing connector 368 can be uniformly oriented across the tubing connector 368. This may be desirable for a variety of reasons. For example, during the typical service life of the infusion set 102, the tubing connector 368 may be disconnected and reconnected multiple times. When the end 486 is tilted, there may be a tendency for the tip 482 to deviate from the insertion axis when the tubing connector 368 is advanced to engage with the infusion set base 106. This tendency may be amplified by repeated connection and disconnection. By ensuring that the end 486 is always oriented in a specific direction, any deflection of the tip 482 can occur in a predictable direction, and the diaphragm 110 can be designed to accommodate such deflection. This allows the diaphragm 110 to be made smaller in sections where deflection of the tip 482 is not expected to occur. The diaphragm 110 can be manufactured smaller in terms of space or height and with less material. In addition, the diaphragm recess 196 (see, for example) Figure 5BThe fluid introduction volume formed can be made smaller. This will minimize any stagnant volume in the infusion set 102 and the amount of drug or medication consumed to fill that volume. This rotational alignment of the tip 482 allows for the use of a wider variety of beveled ends 486. Since the ends 486 are completely surrounded by the diaphragm 110 material after connection, any possibility of blockage can also be minimized. Alternatively, it allows for a more forgiving connection between the infusion set 102 and the tubing connector 368. As a result, the acceptable tolerance range for various features of the infusion set 102 and the tubing connector 368 can be wider. Similarly, the guide 172 forming the tubing connector 368 (see, for example) can be reduced. Figure 6 The amount of material required for the 372 side protrusions.

[0238] like Figure 106 As best shown, the mounting device 480 may include a docking station 490 for the tubing connector 368. The docking station 490 may mimic the mating interface of the infusion set base 106 (see, for example...). Figure 6 It may include, for example, a guide 172' and a connector receiver 170'. Thus, the tube connector 368 can engage with and be held within the fixture 480. The docking station 490 can also position the tube connector 368 at a desired location and orientation on the fixture 480.

[0239] The fixing device 480 may include an adhesive port 510 (in) Figure 105 (best shown in the diagram), the adhesive port 510 allows glue, epoxy resin, or adhesive to be introduced into the tube connector 368 so that the tip 482 can be retained in the tube connector 368 once it is properly positioned. In some embodiments, a UV-curable adhesive may be used.

[0240] Now for reference Figures 107-108 Two cross-sectional views of the pipe connector 368 installed on dock 490 are shown. Figure 107 In the diagram, tip 482 is shown mounted into tube connector 368. Tip 482 is positioned within tube connector 368 and rotated to time such that point 485 of tip 482 is in a specific position, which is the 12 o'clock position in the example embodiment. In an exemplary embodiment, when tube connector 368 is connected to point 485 of end 486 of tip 482, point 485 of end 486 of tip 482 is positioned substantially in line with and perpendicular to the axis of the cavity 202 of the cannula 104 of infusion set 102. Primary abrasive portion 487 and secondary abrasive portion 489 on end 486 are also in a downward-facing position.

[0241] As shown, the fixing device 480 includes a first body 498 and a second body 500. The bodies 498 and 500 can be joined together by any suitable method, including joining, welding, adhesives, fasteners, etc. In this example, a screw 502 is used to connect the first body 498 and the second body 500. The second body 500 can fit within a cavity or slot 504 in the first body 498, which can be used to position the second body 500 relative to the first body 498. As shown, the second body 500 may include a beveled surface 506. The beveled surface 506 may have an angle relative to the axis of the tip 482, which is substantially equal to the angle of one of the grinding portions 487 and 489 on the tip 482. In this example, the angle is approximately 15.5°, which is the angle of the primary grinding portion 487 of the tip 482. The beveled surface 506 may include a portion aligned with the tip receiving hole 508 of the first body 498. This portion can serve as a support surface for the primary grinding portion 487 of the tip 482. The second body 500 can be constructed from a rigid non-metallic material.

[0242] As shown, the fixing device 480 may include a first magnet 492 and a second magnet 494. The first magnet 492 may be larger than the second magnet 494. The dimension of each edge of the second magnet 494 may be half the dimension of each side of the first magnet 492. In some embodiments, the first magnet 492 may be a 1 / 8in x 1 / 8in x 1 / 2in NdFeB magnet. The second magnet 494 may be a 1 / 16in x 1 / 16in x 1 / 4in NdFeB magnet. In alternative embodiments, an electromagnet, for example equivalent to the permanent magnet just described, may be used. The first magnet 492 and the second magnet 494 may be located in a channel 496 included in the fixing device 480. The channel 496 for the second magnet 494 may be at an angle relative to the channel 496 of the first magnet 492. In an example embodiment, this angle is approximately 15.5°. This angle may reflect the angle of one of the grinding portions 487, 489 of the tip 482. This angle can be the same as the angle of the inclined surface 506 of the second body 500. The first magnet 492 can be oriented such that each of its magnetic poles is closest to the opposing magnetic pole of the second magnet 494. The ends of the magnets 492 and 494 are recessed rearward from the support surface portion of the inclined surface 506. In an exemplary embodiment, the ends of the magnets 492 and 494 are recessed by approximately 0.060 inches.

[0243] When the tip 482 is introduced into the tube connector 368, the magnetic field generated by magnets 492, 494 can rotate and guide the tip 482 into the desired rotational orientation. The magnetic field can also pull the tip 482 into contact with the beveled surfa...

Claims

1. An insert assembly, comprising: The first unit includes a deflector component and a trigger actuation protrusion; and A second unit, which is housed within the first unit, and the second unit comprises: The body includes a cavity and a resilient arm aligned with the deflector component; A pointed retainer having an insertion point on the pointed retainer, the pointed retainer being at least partially disposed in the cavity; A biasing member, which is held in an energy-storage state by a trigger; and An insert kit base, the insert kit base comprising an adhesive and releasably coupled to the body; When the adhesive is applied to the skin and the insert assembly is removed from the user, in the first phase of actuation, the first and second units move together to pull the skin away from the user until the force exerted by the elasticity of the skin overcomes the elasticity of the arm by pressing the arm into the deflector. In the second phase of actuation, the trigger is displaced and the energy stored in the bias member is released to push the tip retainer toward the skin.

2. An insert assembly, comprising: A cover, the cover including a skin contact surface surrounding an opening in the cover; A pointed retainer, the pointed retainer including an inserting pointed tip; The cannula assembly is supported by the insertion tip, and both the insertion tip and the cannula of the cannula assembly have a skin-penetrating end disposed above the skin contact surface; An infusion set base is disposed within the opening of the cover and has a bottom surface substantially flush with the skin contact surface. The infusion set base includes a cannula assembly receiving gap, which is sized to receive the cannula assembly and prevent fingers from entering. as well as An insertion biasing member is provided, wherein the tip retainer is configured to be displaced by the transition of the insertion biasing member from an insertion energy storage state to a relaxed state, so as to drive the insertion tip and the cannula at least partially outside the cover and to connect the cannula subassembly to the infusion set base.

3. An insert assembly, comprising: Cover section; A pointed retainer having an insertion point and a cantilever arm, the insertion point being coupled to the pointed retainer, and the cantilever arm having a protrusion defining a flange; A pointed retractor having at least partially accommodating a cavity containing a pointed retainer and having a stop configured to engage the flange, the pointed retractor further having a gripping member configured to engage the flange and hold an insertion spring in an biased state. A cannula assembly, the cannula assembly being carried by the insertion tip; and An infusion set base is releasably coupled to the tip retractor and, while being releasably coupled to the tip retractor, holds the contraction spring in an biased state. The insertion spring is configured to drive the tip retainer along the insertion path when the flange disengages from the gripper, the infusion set base disengages from the tip retractor, the cannula subassembly is connected to the infusion set base, and when the tip retainer is turned to the end of the insertion path, the flange is separated from the stop by a stopping distance, and the retraction spring is configured to move the tip retractor and the tip retainer together into the cover after the tip retractor has passed the stopping distance and engaged the stop with the flange.

4. An insert assembly, comprising: A first unit, the first unit including a skin contact surface surrounding the opening; and A second unit, which is housed within the first unit, and the second unit comprises: An infusion set base, the infusion set base being disposed within the opening and having a bottom surface, the bottom surface being substantially flush with the skin contact surface and at least partially covered with adhesive; Spring-biased insertion assembly; A cannula subassembly, the cannula subassembly being carried by the insertion tip of the insertion assembly; The spring-biased insertion assembly and the cannula subassembly are configured to be driven into the skin, and the cannula subassembly is configured to be connected to the infusion set base by an insertion spring, the insertion spring being configured to release from an energy-storage state when the insertion assembly is withdrawn, after the skin has been pulled upward by the adhesive beyond a certain distance.

5. An insert assembly, comprising: The first unit includes: An infusion set base, wherein the bottom surface of the infusion set base includes an adhesive; An insertion tip drive assembly, releasably coupled to the infusion set base and including an insertion tip, a drive spring, an elastic member, and a latching arrangement configured to hold the drive spring in an energy-storage state in an engaged state; and The infusion set base is disposed within the opening of the cover; In the first stage, when the adhesive is in an adhesive relationship with the skin, the displacement of the insert assembly away from the body pulls the skin away from the underlying structure, and in the second stage, the force exerted by the elasticity of the skin overcomes the elasticity of the elastic member, displacing the cover relative to the first unit and disengaging the latch arrangement. The drive spring is arranged to remove the insert tip from the cover when transitioning to a relaxed state.

6. An insert assembly for placing an infusion set at an infusion site on the body, the insert assembly comprising: The cover portion has an actuating protrusion; and A first unit, located within the cover, is movable relative to the cover. The first unit includes: An infusion set base, the infusion set base having an adhesive; Tip retainer, the tip retainer including an insert tip, The body includes a cavity in which a drive spring and the pointed retainer are at least partially disposed, the pointed retainer being movable from a raised state to a forward state by the drive spring; and A drive spring release latch arrangement is provided, wherein the actuating protrusion is configured such that, after the relative displacement between the cover and the first unit exceeds a threshold, the actuating protrusion disengages the drive spring release latch arrangement. The adhesive is configured such that when the cover is pulled away from the body and the relative displacement between the cover and the first unit increases, the adhesive anchors the first unit to the body.

7. A method for placing an infusion set on a user's body, the method comprising: The infusion set base, which will be releasably attached to the inserter assembly, will be adhered to the body; Pull the insert assembly away from the body; When the insert assembly is pulled away from the body, the skin is lifted from the underlying structure of the body via the adhesion of the infusion set; After the skin has been lifted at least a certain distance, the trigger actuator is moved into the trigger of the insert assembly; as well as The drive inserts the tip through the skin.

8. A method of placing an infusion set on a user's body, the method comprising: The infusion set base, which will be releasably attached to the inserter assembly, will be adhered to the body; Pull the insert assembly away from the body; When the insert assembly is pulled away from the body, the skin is displaced from its resting position via the adhesion of the infusion set; The actuation trigger is disabled until the skin has shifted to the point where the elasticity of the skin applies a force exceeding a threshold to the infusion set base; The trigger actuator is moved into the trigger of the insert assembly; as well as The drive inserts the tip through the skin.

9. An insert assembly comprising: The first unit includes a cover portion; and The second unit, the second unit includes: Infusion set base with adhesive; A pointed retainer, the pointed retainer including an inserting pointed tip; Triggers; and The body includes a cavity in which a drive spring and the pointed retainer are arranged at least partially, and when the trigger is actuated from a first state to a second state, the pointed retainer can be moved from an elevated state to a forward state by the drive spring. The adhesive is configured to anchor the second unit to the body while pulling the cover away from the body, and the trigger is prevented from actuating until the relative displacement between the cover and the second unit reaches a threshold.

10. An insert assembly comprising: Part One; The second part, wherein the first part is capable of being shifted relative to the second part; Insert a driver, which is included in the second part; An insertion bias member, included in the second portion, is configured such that when the insertion bias member is in a compressed state, the insertion bias member pushes the insertion driver from a retracted state to an extended state. A retainer, which is included in the second part; A first latch, which is included in the second part; and An insertion driver latch is included in the second portion, and the insertion driver is releasably engaged with the insertion driver latch. The displacement of the first portion toward the second portion and into the ready position applies stress to the insertion bias member and engages the retainer with the first latch to hold the insertion bias member in the compressed state, and the displacement of the first portion away from the ready position by more than a threshold distance drives the insertion driver out of the insertion driver latch, thereby releasing the insertion bias member from the compressed state.

11. A method for placing an infusion set, the method comprising: Connect the infusion set cartridge to the insert assembly; A portion of the infusion set, contained within the infusion set cartridge, is adhered to the infusion site; By shifting the first portion of the insert assembly toward the second portion of the insert assembly, the insertion bias member of the insert assembly is locked in a compressed state; The insertion biasing member is released from the compressed state by moving the first portion of the insert assembly away from the second portion of the insert assembly; Push the insertion tip of the insertion driver, which connects to the infusion set cartridge, toward the infusion site; as well as Release the infusion set from the infusion set cartridge.

12. A tubing connector for fluidly connecting a section of infusion tubing to the cannula of an infusion set, the tubing connector comprising: A flow hub having a channel passing through it, a section of infusion tubing connected to a first end of the channel, and a tip connected to the opposite second end of the channel, the tip's inner cavity being in fluid communication with the flow cavity; A pair of alignment channels, one of which is recessed into a first side of the flow hub, and the other of which is recessed into an opposite second side of the flow hub, the alignment channel including a variable width section near the second end of the channel and a constant width section; and A pair of cantilever connector fingers, wherein a first connector finger of the pair is connected to a first side via a first tube connector body portion, and a second connector finger of the pair is connected to an opposite second side via a second tube connector body portion, each connector finger including a latching protrusion; and At least one pointed side projection extends from the hub parallel to the axis of the pointed tip.

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