A fluid extravasation detection device detects the subcutaneous extravasation of fluid from a vein containing an intravenous (IV) catheter. The device includes one or more first temperature sensors for positioning on skin near an entry point of the IV catheter into the vein, and one or more second temperature sensors for positioning on skin near a tip of the subcutaneously located IV catheter. The first and second temperature sensors are operably connected to an electronic thermometer that compares the temperature difference between a first temperature and a second temperature. The first temperature is determined based on temperature detected by at least one of the one or more first temperature sensors. The second temperature is determined based on temperature detected by at least one of the one or more second temperature sensors. An alarm is activated if the difference between the first and second temperatures changes more than a predetermined amount.

An extension set may include a tube having an outer surface. An instrument, such as a tubing or a probe, may be disposed within the tube and may include a proximal end and a distal end. A translation handle may be coupled to the outer surface of the tube and may move along the outer surface between a proximal position and a distal position to translate the distal end of the instrument between a retracted position and an advanced position. In the advanced position, the distal end of the instrument may extend beyond the distal end of the tube and into a catheter assembly and/or vasculature of a patient.

A hollow puncture needle includes: a needle body portion; a needle distal end portion that extends from the needle body portion in a distal direction and that includes a blade surface that is inclined with respect to an axis of the puncture needle; and an ultrasonic wave reflecting structure including at least one reflecting portion having a concave or hole shape that opens on an inner peripheral surface of the needle distal end portion. An inner surface of the reflecting portion includes a pair of inclined surfaces that face each other, wherein a distance between the inclined surfaces becomes smaller in a direction towards an outer peripheral surface side of the needle distal end portion. The inclined surfaces is parallel to the axis of the puncture needle.

Peripheral intravenous (IV) waveform analysis (PIVA) systems and methods for determining an intravascular volume status of a living subject and monitoring an IV line functionality of a peripheral IV device are provided. The PIVA system includes a peripheral IV device and a processing device. The peripheral IV device includes a peripheral IV catheter inserted into a vein of the living subject, and a fluid controlling device to control fluid flow from a fluid source to the peripheral IV catheter. The processing device receives peripheral venous signals from the peripheral IV device, performs a spectral analysis on the peripheral venous signals to obtain a peripheral venous pressure frequency spectrum; and performs a statistical analysis on amplitudes of peaks of the peripheral venous pressure frequency spectrum to determine an intravascular volume status of the living subject and/or an IV line functionality of the peripheral IV catheter in real time.

In one embodiment, an integrated cannula and sensor assembly is disclosed. The integrated cannula and sensor assembly includes a cannula with a proximal end and a distal end. The cannula also has a body and a tip. The body includes a channel and a body distal that is defined between the proximal end and the distal end. The tip is defined between the body distal and the distal end. The assembly further includes a sensor assembly that is located within the channel, wherein the tip further includes an undercut configured to retain the sensor assembly.

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 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 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.

Systems and methods for automatic flow termination for fluid delivery, including a housing configured for coupling a fluid delivery tube to a needle configured for subcutaneous delivery of fluid within a tissue of a patient and a spring-loaded activation mechanism having a first orientation corresponding to a condition where the housing is disposed substantially adjacent to the tissue and the needle lodged within the tissue and a second orientation corresponding to a condition where the housing is disposed away from the tissue or the needle being dislodged from the tissue. A flow termination mechanism is coupled to the activation mechanism and having an open configuration allowing flow from the fluid delivery tube to the needle when the activation mechanism is in the first orientation and a closed configuration substantially terminating flow from the fluid delivery tube to the needle when the activation mechanism is in the second orientation.

Devices and methods are provided for automatic vascular access. An automatic vessel cannulation device, mechanical or electronic, has a sensor configured to detect a physiologic parameter of a needle tip, and a blunting device advancing member released in response to the sensor. The sensor may measure pressure or any other physiological parameter. A processor is configured to analyze data sent by the sensor and is pre-set to identify parameters unique to arteries, veins, or other body cavities or organs. A method may include comparing a physiologic parameter with pre-determined parameters to deploy a blunting element if the physiologic parameter is within a range of the pre-determined parameters. An expandable sheath may be included. A device can be provided having a motor controlling the cannulation device orientation to scan tissue with the tip of the needle by moving the cannulation device through the ultrasound transducer.