Abstract: Methods of quantitating extra-cellular vesicle surface markers are provided. Aspects of the methods include comparing: a mean fluorescence intensity of a surface marker of interest (surface marker MFI) of a labeled extra-cellular vesicle (EV) sample with a calibration plot obtained from a liposome calibration composition to quantitate the surface marker on extra-cellular vesicles of the EV sample. Also provided are compositions that find use in practicing embodiments of the invention.

Abstract: Vented syringes are described herein. A vented syringe includes a syringe body and a plunger body. The syringe body defines a syringe cavity. The plunger body is at least partially disposed within the syringe cavity. The plunger body includes an air intake channel defined within the plunger body. The vented syringe further includes a plunger seal that is sealingly engaged with the syringe cavity to cooperatively define a syringe volume. The vented syringe further includes a one-way valve in fluid communication with the air intake channel and the syringe volume, wherein the one-way valve is configured to prevent fluid flow from the syringe volume to the air intake channel and permit fluid flow from the air intake channel to the syringe volume.

Abstract: Fluid applicators with precise volume dispensing control for dispensing fluids such as a disinfectant in a controlled manner. Such fluid applicators may include a barrel including a sidewall having an inside surface defining a chamber for retaining a fluid, an end press, a push rod disposed within the chamber, the push rod having a push button and a piercing tip, a cap attached to a port via a hinge to cover a hydrophobic filter disposed on the sidewall of the chamber, a one-way valve disposed on the outlet on a distal end of the barrel, a disinfectant disposed within the chamber; a housing having a base and an open proximal end; and a fluid applicator sponge disposed in the base of the housing. An alternate fluid may include a deformable end press, a plurality of volume scale markings on an outer surface of the barrel, a push rod, a one-way valve and applicator sponge.

Abstract: A sealed fluid transfer device comprised of tubing, a proximal fitting, and a distal needle assembly is provided. The needle assembly includes a needle hub secured to a needle cannula. A cantilevered actuator arm extends outwardly from the needle hub having an actuator button at its free end. The needle assembly is disposed in a barrel and can move from a distal position, where the needle is exposed, to a proximal position, where the needle is shielded. The barrel includes a septum which seals the barrel. A spring is disposed in the barrel for propelling the needle assembly to the proximal position. The barrel includes an aperture that receives the actuator button for locking the spring in a compressed condition. Depression of the actuator button enables the spring to propel the needle assembly into its proximal position. A safety mechanism prevents inadvertent depression of the actuator button.

Abstract: A disinfection cap or device for disinfecting medical connectors. The cap includes a visual indicator that changes color after sufficient scrubbing effort and time have been expended by a clinician to disinfect the medical device, giving positive visual feedback to the treating clinician. An external housing of the cap includes a disinfection medium, such as a disinfectant sponge that is coupled to a rotating collar. The housing is oriented so that the sponge contacts the medical device to be cleaned. Collar rotation in turn rotates the disinfectant sponge against the VAD, providing scrubbing action. A visualization chamber within the cap contains two isolated fluids of distinct colors. As the collar is rotated it mixes the two isolated fluids, changing color of the resultant mixture. When the visualization chamber shows the new, mixed third color, the medical device is disinfected.

Abstract: A disinfection device for disinfecting a female medical connector. The device includes an inner housing having an absorbent material that includes a disinfectant or antimicrobial agent that receives the connector. The device also includes an outer housing having an outer wall that receives the inner housing wherein the inner housing is rotatable within the outer housing. An indicator is located between the outer wall and a transparent collar that includes at least one rib. The indicator includes a first visual indicator and a second visual indicator concealed by the first visual indicator. The inner housing includes a boss element that extends through the outer wall and indicator and is attached to the collar. Rotation of the collar causes rotation of the absorbent material and causes the rib to remove sufficient portions of the indicator to expose the second visual indicator to provide visual indication that the connector is disinfected.

Abstract: A dual chamber syringe facilitates selective drug mixing, dosing, and administration through catheters or other vascular accessing devices (VADs), as well as pre- or post-administration flushing of catheters with a single syringe instrument. A syringe barrel incorporates an outlet, such as a Luer connector, variable-volume, primary and secondary, concentrically oriented, fluid chambers, with nested respective plungers, plunger rods capable of selective translation within the barrel interior along a common axis, and plunger stoppers. A selectively resealable valve disposed within the barrel interior, selectively isolates the secondary fluid chamber from fluid communication with the primary fluid chamber and/or the outlet of the syringe barrel. In some embodiments, the valve is a one-way valve.

Abstract: A dual chamber syringe facilitates selective drug mixing, dosing, and administration through catheters or other vascular accessing devices (VADs), as well as pre- or post-administration flushing of catheters with a single syringe instrument. A syringe barrel incorporates an outlet, such as a Luer connector, variable-volume, axially tandem primary and secondary fluid chambers, with nested respective plungers, plunger rods capable of selective translation within the barrel interior along a common axis, and plunger stoppers. The secondary fluid chamber is incorporated within the primary plunger. A selectively resealable valve disposed within the barrel interior, selectively isolates the secondary fluid chamber from fluid communication with the primary fluid chamber and/or the outlet of the syringe barrel. In some embodiments, the valve is a duckbill-type valve or an umbrella valve. In some embodiments, the syringe is prepackaged with flushing solution in the secondary fluid chamber.

Abstract: An injection pen, comprising a housing, a lead screw axially moveable in the housing, a dose set member for dose setting and dose correcting, threadably connected to the housing and having a first mating feature, a setback member having a second mating feature for engaging the first mating feature, a clicker that generates an audible or tactile indication during operation, the clicker being operatively connected to the dose set member, and a push button operatively connected to the setback member to cause the second mating feature to engage the first mating feature during an injection, the push button receiving the clicker, wherein the first mating feature is disengaged from the second mating feature during dose setting and dose correcting and engaged with the second mating feature during an injection.

Abstract: A dual chamber syringe facilitates selective drug mixing, dosing, and administration through catheters or other vascular accessing devices (VADs), as well as pre- or post-administration flushing of catheters with a single syringe instrument. A syringe barrel incorporates an outlet, such as a Luer connector, variable-volume, primary and secondary fluid chambers, with nested respective plungers, with plunger rods capable of selective translation within the barrel interior along a common axis, and plunger stoppers. An externally accessible, selectively resealable, manual valve disposed within the barrel interior, selectively isolates the secondary fluid chamber from fluid communication with the primary fluid chamber and/or the outlet of the syringe barrel. Selective manipulation of the valve facilitates aspiration into or discharge from either of the chambers separately or jointly. In some embodiments, the syringe is prepackaged with flushing solution in the secondary fluid chamber.

Abstract: A safety lock syringe assembly comprising a barrel including a distal end and a proximal end, one or more lugs extending outwardly from an outer surface of the barrel, and a needle extending from the distal end, and a sleeve having threads that engage the one or more lugs, the sleeve includes a sleeve locking mechanism, wherein the sleeve threadably rotates in a first direction to a first position that exposes the needle, the sleeve threadably rotates in a second direction to a second position that shields the needle, and the sleeve threadably rotates in the second direction to a third position that engages the one or more lugs to the sleeve locking mechanism to irreversibly lock the shield to the barrel.

Abstract: Dried reagent strainers, such as cell strainers are provided. Aspects of the strainers include a body having an opening with a filter positioned in the opening, where the filter includes a dried reagent composition. Aspects of the invention further include methods of making and using the strainers, as well as kits containing the strainers.

Abstract: Provided is a medical device assembly for detection of medical device components and/or mating thereof. The medical device assembly may include a first medical device component having at least one first resonant structure, which may have a first resonant frequency spectrum. A second medical device component may have at least one second resonant structure, which may have a second resonant frequency spectrum different than the first resonant frequency spectrum. Upon mating of the first medical device component to the second medical device component, the first resonant structure(s) and the second resonant structure(s) may combine to have a third resonant frequency spectrum, which may be different than the first resonant frequency spectrum and the second resonant frequency spectrum. A system and method are also disclosed.

Abstract: A system for accessing a patient's vascular system may have a tube with a wall that defines an exterior surface and lumen with a proximal end and a distal end, and a guidewire that is deployable, by sliding distally, from a retracted position in which the guidewire resides in the lumen, to a deployed position in which the guidewire extends beyond the distal end. The system may further have a retraction mechanism that can be actuated to retract the guidewire from the deployed position to the retracted position, or a protective shield that can be actuated to extend distally from the distal end of the tube to cover the guidewire in the deployed position.

Abstract: Integrated light interrogation modules are provided. In embodiments, the subject integrated light interrogation modules include a flow cell having a light-accessible flow channel for transporting particles in a flow stream, a focusing optical assembly integrated with the flow cell, and a connector for operably attaching a fiber optic light conveyor to the focusing optical assembly, where the focusing optical assembly is projects excitation wavelength light from the fiber optic light conveyor onto a focal spot of the flow cell when the fiber optic light conveyor is operably attached to the connector. In certain embodiments, focusing optical assemblies also include a connector for operably attaching a fiber optic light collection element for collecting fluorescent light emitted by the particles transported through the flow cell. Flow cytometers, methods and kits for practicing the invention are also provided.

Abstract: An intravenous catheter system may include a catheter adapter, which may be integrated. The intravenous catheter system may also include a housing coupled to a proximal end of the catheter adapter, an introducer needle having a proximal end, a distal tip, and a needle lumen extending between the proximal end of the introducer needle and the distal tip, a guidewire disposed within the housing and the needle lumen, and a guidewire advancement element. The housing may include a proximal end, a distal end, and a slot. A proximal end of the introducer needle may be secured within the housing. The guidewire advancement element may extend through the slot and be moveable along the slot in a distal direction to move the guidewire from a retracted position to an advanced position, in which the guidewire may extend beyond the distal tip.

Abstract: Compositions, methods and kits are disclosed for high-sensitivity single molecule digital counting by the stochastic labeling of a collection of identical molecules by attachment of a diverse set of labels. Each copy of a molecule randomly chooses from a non-depleting reservoir of diverse labels. Detection may be by a variety of methods including hybridization based or sequencing. Molecules that would otherwise be identical in information content can be labeled to create a separately detectable product that is unique or approximately unique in a collection. This stochastic transformation relaxes the problem of counting molecules from one of locating and identifying identical molecules to a series of binary digital questions detecting whether preprogrammed labels are present. The methods may be used, for example, to estimate the number of separate molecules of a given type or types within a sample.