A drug-delivery device is provided including a drug reservoir configured to contain a fluid drug, a needle cartridge comprising a plurality of needle assemblies, a drive member, a pump, one or more springs, a loading button and a dosing button. The device is configured to use work done by the user in actuating the loading button to load the one or more springs. When the user actuates the dosing button after actuating the loading button, the device is configured to (i) release the one or more loaded springs to operate the drive member to drive a needle assembly that is in operational alignment with the drive member from a retracted position to an injection position, (ii) drive the pump to pump fluid drug from the drug reservoir through the driven needle assembly, and (iii) retract the driven needle assembly from the injection position to the retracted position.

A drug-delivery device is provided including a drug reservoir configured to contain a fluid drug, a needle cartridge comprising a plurality of needle assemblies, a drive member, a pump, one or more springs, a loading button and a dosing button. The device is configured to use work done by the user in actuating the loading button to load the one or more springs. When the user actuates the dosing button after actuating the loading button, the device is configured to (i) release the one or more loaded springs to operate the drive member to drive a needle assembly that is in operational alignment with the drive member from a retracted position to an injection position, (ii) drive the pump to pump fluid drug from the drug reservoir through the driven needle assembly, and (iii) retract the driven needle assembly from the injection position to the retracted position.

Infusion systems, infusion devices, and related operating methods are provided. An exemplary method of operating an infusion device involves obtaining one or more measurement values of a physiological condition in the body of a user during an initial monitoring period and determining a fasting reference value for a metric based on the one or more measurement values. After the initial monitoring period, the method continues by obtaining an updated measurement value during a fasting period, determining a current value for the metric based at least in part on the updated measurement value, and generating a notification in response to a deviation between the current value and the fasting reference value exceeding a threshold indicative of insertion site loss or other loss of effectiveness.

A sensor patch, system, and method for detecting a fluid leaked from a target site of a subject are provided. The sensor patch (100) includes a first detecting unit (127), a second detecting unit (128), and a patch body (110). The first detecting unit (127) includes a first pair of sensors (120A) respectively having a first end (121A) configured to be placed approximating the target site, while the second detecting unit (128) includes a second pair of sensors (120B) respectively having a first end (121B) configured to be placed away from the target site. Each sensor includes a conductive wire (125) and an insulating sheath (126) encapsulating the conductive wire (125) in a manner that a portion of the first end (121A, 121B) of the conductive wire (125) is exposed yet without directly contacting the subject's skin. The patch body (110) has an adhesive surface (104) for securing the first and second detecting units (127, 128) to the subject. The sensor patch enhances the detection specificity.

An infusion state detection system includes: a pump unit configured to deliver a liquid in an infusion line; a pressure detector configured to detect a pressure in the infusion line; and a determination processing unit configured to: when the pressure detected by the pressure detector is at a predetermined value or above, stop driving of the pump unit for a stop period, and determine an infusion state on the basis of a value of the pressure detected by the pressure detector during the stop period.

An infusion state detection system includes: a pump unit configured to deliver a liquid in an infusion line; a pressure detector configured to detect a pressure in the infusion line; and a determination processing unit configured to: when the pressure detected by the pressure detector is at a predetermined value or above, stop driving of the pump unit for a stop period, and determine an infusion state on the basis of a value of the pressure detected by the pressure detector during the stop period.

A valve assembly including a housing having a base and an outer shell, which forms a proximal cavity and a distal cavity joined by a canal; an inner housing configured for longitudinal movement within the distal cavity; a seal positioned within the distal cavity that together with the longitudinal movement of the inner housing regulates the flow of fluid through the valve assembly; and one or more selected from the group consisting of the base notched with one or more notches and the inner housing having one or more through slots aligned to permit access to the one or more notches, the seal being a reversibly deformable sealing pin, and a torque limiter mechanism configured to resist the longitudinal movement of the inner housing distally until a sufficient radial force is applied.

A valve assembly including a housing having a base and an outer shell, which forms a proximal cavity and a distal cavity joined by a canal; an inner housing configured for longitudinal movement within the distal cavity; a seal positioned within the distal cavity that together with the longitudinal movement of the inner housing regulates the flow of fluid through the valve assembly; and one or more selected from the group consisting of the base notched with one or more notches and the inner housing having one or more through slots aligned to permit access to the one or more notches, the seal being a reversibly deformable sealing pin, and a torque limiter mechanism configured to resist the longitudinal movement of the inner housing distally until a sufficient radial force is applied.

An infusion pump system is disclosed. The infusion pump system includes an infusion pump and a controller device in wireless communication with the infusion pump, wherein the controller including instructions for controlling the infusion pump, wherein the instructions may be synchronized with a secure web portal.

A device, system and method are provided for controlling the rate of infusion of fluids during infusion therapy using non-electric infusion devices. Rotation of a flow regulator dial causes an orifice connected to the inlet to modify its position relative to a particular one or more orifices or groove portions, the characteristics of which provide a certain flow rate characteristic. The flow regulator allows for the infusion pump to infuse at a rate that may be varied during use by the user. Additionally, the flow regulator is made from a material selected to operate under a wide range of pressures, from 5-40 PSI, making the flow regulator compatible with pressurized devices, such as, a non-electric pump.