Infusion set and inserter assembly systems and methods

An inserter assembly comprising:

• a first unit including a deflector member;
• and
• a second unit housed within the first unit and comprising:
• a body including a cavity and an arm having a resiliency, the arm aligned with the deflector member;
• a sharp holder having at least one insertion sharp thereon at least partially disposed in the cavity;
• a bias member for driving the sharp holder to an insertion position and held in an energy storing state by a trigger;
• and
• a medical device base including an adhesive, the base releasably coupled to the body;
• and
• wherein the first and second unit are configured to move together and tug skin away from a user when the adhesive is stuck to skin until a force exerted by elasticity of the skin overcomes the resiliency of the arm by pressing the arm into the deflector in a first stage of actuation, and in a second stage of actuation, the first unit is configured to displace into the trigger.

An inserter assembly for placing a device at an administration site of a patient comprising:

• a casing having an actuation projection;
• and
• a first unit at least partially within the casing moveable relative to the casing comprising:
• a device base having an adhesive;
• a sharp holder including an insertion sharp;
• a drive spring configured to propel the sharp holder from a raised state to a forward state;
• and
• a drive spring release latch configured to be transitioned, by the actuation projection, from an engaged state to a disengaged state after a magnitude of displacement of the casing relative to the first unit exceeds a threshold;
• and
• wherein the adhesive is configured to anchor the first unit against the patient while the casing is pulled away from the patient and the magnitude of displacement increases and wherein a resilient member is configured to abut a portion of the casing to inhibit displacement of the casing relative to the first unit until a force threshold is exceeded.

An inserter assembly comprising:

• a first unit including a triggering body;
• a second unit including an actuation assembly having a trigger;
• and
• a device base releasably coupled to the second unit and having an adhesive thereon for anchoring the base to a patch of skin;
• and
• wherein the first unit is configured to displace in a direction away from the patch of skin while the second unit is configured to be restricted from displacing relative to the patch of skin when the adhesive is engaged with the patch of skin and the triggering body is configured to actuate the trigger with relative motion between the first and second units and wherein the second unit further comprises a member configured to abut a portion of the first unit and inhibit relative motion of the first unit and second unit until a threshold force is applied to deflect the member.

An inserter assembly comprising:

• a first unit comprising a casing;
• and
• a second unit comprising:
• a patient care assembly base having an adhesive;
• a sharp holder including at least one insertion sharp;
• a trigger;
• and
• a drive spring arranged to displace the sharp holder from a raised state to a forward state upon actuation of the trigger;
• and
• wherein the adhesive is configured to anchor the second unit against skin of a patient the casing is pulled away from the patient and the trigger is configured to remain in an unactuated state until a magnitude of displacement of the casing away from the second unit reaches a threshold and the second unit further comprises a member in a temporary interfering relationship with a portion of the casing which inhibits relative displacement of the casing and second unit until a force threshold is exceeded.

An inserter assembly comprising:

• a first unit comprising a casing;
• and
• a second unit comprising:
• a patient care assembly including a first portion having an adhesive and a second portion having at least one indwelling portion for transcutaneous placement into a patient;
• a sharp holder including at least one insertion sharp;
• a trigger;
• and
• a drive spring arranged to displace the sharp holder from a raised state to a forward state upon actuation of the trigger;
• and
• wherein the adhesive is configured to anchor the second unit against skin while the casing is pulled away from a patient and wherein the trigger is configured to transition to an actuated state when the casing has been pulled, relative to the second unit, to a triggering position and wherein the second unit further comprises a resilient member configured to abut a portion of the casing to inhibit relative displacement of the casing and the second unit until a force threshold is exceeded.

An inserter for placing an infusion set at an infusion site comprising:

• a first portion including a triggering body;
• an infusion set base having an adhesive thereon configured to anchor the base to a patch of skin;
• and
• a second portion including an insertion assembly with a trigger, the base releasably coupled to the second portion thereby constraining the second portion from displacing relative to the patch of skin when the base is anchored to the skin by the adhesive;
• and
• wherein the first portion is displaceable in a direction away from the second portion from an initial position to a triggering position, the triggering body actuating the trigger as the first portion is displaced to the triggering position and wherein the second portion further comprises a member configured to abut a portion of the first portion to inhibit relative motion of the first portion and second portion until a force threshold is exceeded.

An inserter assembly comprising:

• a first portion including triggering body;
• an infusion set base having an adhesive thereon for anchoring the infusion set base to a patch of skin;
• and
• a second portion including an actuation assembly with a trigger, the infusion set base releasably coupled to the second portion, the second portion constrained from displacing relative to the patch of skin when the infusion set base is coupled to the second portion and the infusion set base is anchored to the skin by the adhesive;
• and
• wherein the first portion is configured to displace with respect to second portion from an initial position to a triggering position once a threshold force in a direction away from the infusion set base is applied to the first portion, the triggering body configured to actuate the trigger as the first portion is displaced toward the triggering position.

An inserter assembly comprising:

• a first unit;
• a second unit, there being a temporary interference between the first and second units which inhibits relative displacement of the first and second units until more than a threshold force is applied to pull apart the first and second unit;
• a patient care assembly having an adhesive on a portion thereof for adhering the portion to a patch of skin;
• and
• an insertion actuation assembly including a trigger;
• and
• wherein the trigger is configured to be actuated once a magnitude of relative displacement separating the first and second unit exceeds a displacement threshold and wherein the threshold force is selected to ensure that the patch of skin is lifted from underlying anatomy when the adhesive is in an adhering relationship with the patch of skin and the first unit is displaced in a direction away from the patch of skin.

An inserter comprising:

• a first unit;
• a second unit releasably engaged with the first unit and configured to displace in tandem with the first unit until more than a threshold force is applied to pull apart the first and second unit;
• a patient care assembly;
• an adhesive configured to lift a patch of skin from underlying anatomy when the adhesive is in an adhering relationship with the patch of skin and the inserter is displaced away from the patient;
• and
• an insertion actuation assembly.

An inserter assembly comprising:

• a first unit;
• a second unit in a releasable engagement with the first unit which inhibits relative displacement of the first and second units until more than a threshold disengaging force is applied to pull the first and second units apart;
• an insertion actuation assembly including a trigger configured to be actuated by a portion of the first unit once a magnitude of relative displacement of the first and second units exceeds a displacement threshold;
• and
• a patient care assembly having a base coupled to the second unit and bearing an adhesive, withdrawal of the first unit away from the patch of skin when the adhesive is adhered to the patch of skin generating the threshold disengaging force and lifting the patch of skin from underlying anatomy.

An inserter assembly for transcutaneously placing a cannula comprising:

• a casing;
• an infusion set including the cannula;
• a spring loaded sharp bearing body;
• an adhesive configured to adhere to a patch of skin at an infusion site and lift the skin from underlying anatomy when the casing is displaced in a direction away from the infusion site;
• and
• a trigger actuatable between an untriggered state and a triggered state, the trigger configured to remain in the untriggered state at least until a force pulling the adhesive in a direction toward the infusion site reaches a threshold, the trigger inhibiting displacement of the spring loaded sharp bearing body when in the untriggered state.

An inserter comprising:

• a casing;
• a sharp holder bearing at least one insertion sharp;
• a medical device including a base and including an assembly carried by the sharp holder with at least one indwelling portion for placement into a transcutaneous destination of a patient;
• an adhesive configured to adhere to a patch of skin and lift the skin from underlying anatomy when the casing is displaced in a direction away from the skin;
• a trigger configured to remain in an untriggered state at least until a force pulling on the adhesive in a direction toward the transcutaneous destination reaches a threshold;
• and
• a bias member configured to urge the sharp holder to a forward position when the trigger is in a released state.