A wearable infusion pump assembly. The wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set. The fluid delivery system includes a controller, a pump assembly for extracting a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the external infusion set, the pump assembly comprising a pump plunger, the pump plunger having distance of travel, the distance of travel having a starting position and an ending position, at least one optical sensor assembly for sensing the starting position and ending position of the pump plunger distance of travel and sending sensor output to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, wherein the controller receives the sensor output and determines the total displacement of the pump plunger.

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.

A wearable infusion pump assembly. The wearable infusion pump assembly includes a reservoir for receiving an infusible fluid and a fluid delivery system configured to deliver the infusible fluid from the reservoir to an external infusion set. The fluid delivery system includes a controller, a pump assembly for extracting a quantity of infusible fluid from the reservoir and providing the quantity of infusible fluid to the external infusion set, the pump assembly comprising a pump plunger, the pump plunger having distance of travel, the distance of travel having a starting position and an ending position, at least one optical sensor assembly for sensing the starting position and ending position of the pump plunger distance of travel and sending sensor output to the controller, and a first valve assembly configured to selectively isolate the pump assembly from the reservoir, wherein the controller receives the sensor output and determines the total displacement of the pump plunger.

A method for site assessments of a catheter insertion site and/or dressing includes: scanning the catheter insertion site and/or dressing with an image capture device and/or sensor; selecting a patient baseline site location and skin tone; recording a baseline condition using a computing device; determining a site assessment rate using a computing device; prompting a clinician to make a site assessment of the catheter insertion site and/or dressing using a computing device; and recording site assessment information in an electronic medical record using a computing device.

A system for providing the collection of advanced, improved, and novel new components and elements in a single package to simplify assembly and use of the infusion set by the user, including one or more of an exemplary pushbutton-type inserter, squeeze-type inserter, contact-type inserter, skin pinching-type inserter, folding retraction-type inserter, and/or multistage-type inserter (700) having at least one reusable stage, an exemplary set (350) having an adhesion means with two or more user-selectable degrees of adhesion strength, a self-sealing tube connection means, a lens feature to view a site beneath the set, exemplary tube management and connection elements (450), insulin supply (475), adhesion concealment means (500), finger loops on the inserter and site preparation wipes or sprays (550) which can be provided as part of the inserter. The system can further include an exemplary package (12) which can hold a number of sets that can be easily released and retrieved from the tray by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

A needle insertor for a medicament delivery device is presented having a driver having a first part movably arranged within the case and a second part connected to the base, a needle assembly movably held by the first part in the case, a rotator arranged in the case and configured to engage the first part for moving the driver, an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator, a movable stop arranged on the base and configured to interact with the rotator for preventing the rotator from rotating. The first part has a first position where the needle assembly is held inside the case, a second position where the needle portion is positioned outside the case after being moved to pass through the injection site end, and a third position where the needle portion is positioned inside the case.

In one embodiment, an infusion set and sensor assembly delivered within a subject is disclosed. The assembly includes a cannula that is terminated at a cannula opening. The assembly further includes a sharp that is at least partially within the hollow of the cannula. A sensor having a proximal end and a distal end is also included in the assembly. The proximal end of the sensor is held in a fixed location while the distal end is retained with a portion of the cannula. The sensor further includes sensor slack, wherein transitioning the sharp from a first position to a second position simultaneously inserts the cannula and sensor to a desired insertion depth within a subject via a single point of insertion.

A system for providing the collection of advanced, improved, and novel new components and elements in a single package to simplify assembly and use of the infusion set by the user, including one or more of an exemplary pushbutton-type inserter, squeeze-type inserter, contact-type inserter, skin pinching-type inserter, folding retraction-type inserter, and/or multistage-type inserter (700) having at least one reusable stage, an exemplary set (350) having an adhesion means with two or more user-selectable degrees of adhesion strength, a self-sealing tube connection means, a lens feature to view a site beneath the set, exemplary tube management and connection elements (450), insulin supply (475), adhesion concealment means (500), finger loops on the inserter and site preparation wipes or sprays (550) which can be provided as part of the inserter. The system can further include an exemplary package (12) which can hold a number of sets that can be easily released and retrieved from the tray by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

A portable electronic fluid dispensing system can provide pre-filled, pre-primed IV bag assemblies comprising therapeutic fluids. The same fluid line and connector in the IV bag assembly can be used to fill the IV bag as is used to withdraw fluid from the IV bag and infuse such fluid into the patient. The connection points along the IV assembly, such as the connection between the IV bag and a drip chamber, or between an IV bag and tubing, or between a drip chamber and tubing, or between tubing and a closeable, resealable connector, can each be resistant to disconnection by a user. The healthcare practitioner at the patient care site is not required to attach any of these components to each other, and the healthcare practitioner at the patient care site is not required to introduce a spike into a spike port on the IV bag.

Presented herein are methods, systems, and apparatus for administering an antibody treatment via an infusion device, e.g., a rapid infusion device, e.g., for the treatment of a disease or condition that requires one or more infusions of monoclonal and/or polyclonal antibodies.