Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: A fluid connector, including a fluid path portion having an integral cannula extending in a first direction from a interior surface, and a latching portion secured to the fluid path portion and having a pair of displaceable arms. Each arm includes a connector latch disposed at a first cantilevered end of the arm, and an activation lever disposed at an opposite cantilevered end of the arm and extending in a second direction, not parallel to the first direction. A portion of the activation lever includes a first lateral tactile feature aligned substantially parallel to the first direction to prevent forward slippage of the fluid connector from a user's grasp in the second direction, and a portion of the activation lever includes a lateral tactile feature aligned substantially parallel to the second direction to prevent slippage of the fluid connector from a user's grasp in the first direction.

Abstract: An insulin delivery device (10) includes a cannula (40) for delivering insulin to a patient at an infusion site, a pump assembly (30), and a valve (36) for controlling the flow of insulin. A removable leak detector unit (28) is coupled to the delivery device for sensing and detecting leakage of insulin at the infusion site. The leak detector unit (28) has electrodes (56) positioned for contacting the insulin leaking from the infusion site, a sensing electrical circuit (54) and a power source (58) for operating the leak detector unit. The removable leak detector unit (28) has an electrical contact (62) for mating with an electrical contact (64) of the delivery device for electrically and operatively connecting the leak detector unit (28) to the delivery device. The leak detector unit (28) sends a signal to the pump assembly (30) and/or valve (36) to stop the flow of insulin when leakage is detected at the infusion site.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

Abstract: An infusion set system includes a base and a fluid connector removably coupleable thereto. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Abstract: An infusion set configured to be secured to a skin surface for targeting a desired depth to deliver content to an upper skin surface, comprising a hub and a needle configured to travel during insertion as urged by a motion, wherein said needle is configured to assume a first angle relative to said skin surface in a free state, and wherein said needle is configured to return toward said first angle relative to said skin surface upon release of said motion, wherein said motion is at an angle relative to said skin surface that is different from said first angle of said needle.

Abstract: An infusion set is disclosed that includes an inserter including an inserter housing having at least one flexible arm for holding an infusion set in a single axial position prior to insertion of at least a portion of a cannula of the infusion set, the inserter housing having a surface for contacting the patient's skin. The inserter also includes a movable plunger disposed within the inserter housing for releasing the infusion set from the inserter housing, impacting the infusion set, and imparting momentum to the infusion set to insert the cannula into the patient's skin. The inserter additionally includes a biasing element biasing the plunger toward the activated position.

Abstract: An infusion set system includes a base and a fluid connector removably coupleable thereto. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Abstract: An infusion set system includes a base and a fluid connector removably coupleable thereto. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Abstract: A needle assembly includes a needle and a needle shield device. The needle shield device includes an inner shield connectable to at least one a base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.

Abstract: An insulin delivery device (10) includes a cannula (40) for delivering insulin to a patient at an infusion site, a pump assembly (30), and a valve (36) for controlling the flow of insulin. A removable leak detector unit (28) is coupled to the delivery device for sensing and detecting leakage of insulin at the infusion site. The leak detector unit (28) has electrodes (56) positioned for contacting the insulin leaking from the infusion site, a sensing electrical circuit (54) and a power source (58) for operating the leak detector unit. The removable leak detector unit (28) has an electrical contact (62) for mating with an electrical contact (64) of the delivery device for electrically and operatively connecting the leak detector unit (28) to the delivery device. The leak detector unit (28) sends a signal to the pump assembly (30) and/or valve (36) to stop the flow of insulin when leakage is detected at the infusion site.

Abstract: A fluid connector for use with an infusion set. The fluid connector includes a housing having a cannula integral with and extending distally from a proximal interior surface of the housing. A proximal exterior surface of the housing has a flattened portion with a raised tactile feature centered about a longitudinal axis of the cannula to aid a user in connecting the fluid connector with an infusion set base.

Abstract: An infusion set system includes a base and a fluid connector removably coupleable thereto. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Abstract: An infusion set is disclosed that includes an inserter including an inserter housing having at least one flexible arm for holding an infusion set in a single axial position prior to insertion of at least a portion of a cannula of the infusion set, the inserter housing having a surface for contacting the patient's skin. The inserter also includes a movable plunger disposed within the inserter housing for releasing the infusion set from the inserter housing, impacting the infusion set, and imparting momentum to the infusion set to insert the cannula into the patient's skin. The inserter additionally includes a biasing element biasing the plunger toward the activated position.

Abstract: An infusion set is disclosed that includes an inserter including an inserter housing having at least one flexible arm for holding an infusion set in a single axial position prior to insertion of at least a portion of a cannula of the infusion set, the inserter housing having a surface for contacting the patient's skin. The inserter also includes a movable plunger disposed within the inserter housing for releasing the infusion set from the inserter housing, impacting the infusion set, and imparting momentum to the infusion set to insert the cannula into the patient's skin. The inserter additionally includes a biasing element biasing the plunger toward the activated position.

Abstract: An infusion set system includes a base and a fluid connector removably coupleable thereto. The fluid connector includes a fluid path portion and at least one connector latch displaceably connected to the fluid path portion and displaceable to a latching position in which at least a portion of the connector latch extends into the fluid path portion, which includes a cannula extending from a top interior surface thereof, and a plurality of internal sidewalls corresponding to at least two of a plurality of flat side surfaces of at least one of a base section and a base latch, thereby facilitating connection between the base and the fluid connector in a plurality of discrete rotational connecting positions. When the fluid connector is locked to the base, the at least one connector latch engages a base latching portion of the base and restricts proximal displacement of the fluid connector.

Abstract: An infusion set has a partially integrated ballistic inserter that can insert a needle at a controlled rate of speed to a depth to deliver content to the upper 3 mm of skin surface, and a skin-securing adhesive layer to secure the skin surface at the insertion site such that the inserter that can insert a needle with a reduced risk of tenting of the skin surface. A removable turnkey or pushable handle can be provided to release a driving spring of the ballistic inserter to insert a needle at a controlled rate of speed, of 3.3 ft/sec. (1.0 m/sec.) up to and including those greater than 10 ft/sec. (3.0 m/sec.), then release from the set for disposal. The infusion set can further include an extendable interface ring that retracts when the inserter is removed from the infusion set.

Abstract: A needle assembly includes a needle and a needle shield device. The needle shield device includes an inner shield connectable to at least one a base and a fluid connector connectable to the base, and an outer shield fixedly connected to the opposing end the needle and displaceable relative to the inner shield between a first position, in which the sharpened end of the needle is exposed outside the inner shield, and a second position, in which the sharpened end of the needle is shielded by the inner shield. Interaction between portions of the inner and outer shields during or after proximal displacement of the outer shield from the first position to the second position automatically releases or permits release of the inner shield from connection to the at least one of the base and the fluid connector.