Abstract: Disclosed is a plunger piston for use in a syringe and especially in a micro-dosing syringe pump application. The plunger piston comprises a front face opposite a rear face and at least one annular groove positioned between the front face and the rear face. The plunger piston includes a plurality of channels extending from the front face into the groove, the channels providing communication between the front face and the groove. An O-ring is received in the groove and the channels serve to equalize pressures around a first side of the O-ring to improve sealing performance and micro-dosing accuracy of a syringe or a micro-dosing syringe pump utilizing the plunger piston.

Abstract: A dose control and overrun protection mechanism is provided for use in fluid delivery devices such as wearable infusion pumps and medication delivery pens. The mechanism comprises oppositely rotating spur gears with surface features that guide a pin on a plate rotating along a desired arc path (e.g., less than 180 degrees) in alternating directions per delivery cycle of a predetermined dose amount. The surface features are configured to controllably rotate one of the spur gears and output a selected amount or rotation to another component in the power train of a fluid delivery device regardless of direction of actuator input and regardless of whether the actuator rotates beyond the arc path.

Abstract: A rotary pump for a fluid metering system is provided. The rotary pump reciprocates, and is reversed by a signal from a limit switch that is deflected by an actuator arm on a rotating sleeve of the pump system.

Abstract: An integrated vascular access device can include strain relief features to minimize the likelihood of the extension tubing becoming kinked during use. These strain relief features can be configured at both ends of the extension tubing to minimize the likelihood of kinking at the interfaces to the catheter adapter and luer adapter. To provide strain relief at the catheter adapter end of the extension tubing, an interface formed of a flexible material can be aligned with an extension of the catheter adapter into which the extension tubing inserts. The interface can be integrated into a stabilization platform or formed separately from a stabilization platform. To provide strain relief at the luer adapter end of the extension tubing, a flexible spacer can be coupled to a distal end of the adapter and have a distal portion that is positioned around the extension tube.

Abstract: An infusion set includes a base (221) and a flexible catheter (242) movable from a first catheter position disposed substantially entirely within the base (221) to a second catheter position in which a free end of the catheter (242) is disposed externally of the base (221). An introducer needle (234) is located within the catheter (242) and is movable between a first introducer needle position disposed substantially entirely within the base (221) and a second introducer needle position in which a free end of the introducer needle (234) is disposed externally of the bases (221). A spring (281) is activated to move the catheter (242) from the first to the second catheter position and the introducer needle (234) from the first to the second introducer needle position to facilitate insertion of the catheter (242).

Abstract: A syringe adapter includes a housing having a first end and a second end with the first end configured to be secured to a first container, a cannula having a first end and a second end with the second end positioned within the housing, and a collet having a first end and a second end with at least a portion of the collet received within the housing. The collet includes a body defining a passageway, a seal member received by the passageway, and an arcuate, resilient locking member connected to the body of the collet. The collet is movable from a first position where the locking member is open to receive a mating connector to a second position where radially outward movement of the locking member is restricted.

Abstract: A safety needle device for connection to a medical connector, including threaded connections. The safety needle comprises a collar configured to interdigitate with a conventional needle hub, the collar having attachment points for a hinged cap, the hinged cap being in a two-piece configuration. In further embodiments, the safety needle device comprises a removable hard needle cover configured to cover needle cannula and a distal portion of a needle hub. The hard needle enclosure further comprises a cap configured to interdigitate with the needle cover and cover a proximal portion of the needle hub. The cap and at least a portion of the needle cover are covered by a removable sleeve which holds the cap and the needle cover together. Even further embodiments comprise a needle hub, a needle cover, an adapter and a cap, the adapter configured to attach to a conventional needle cap.

Abstract: A catheter assembly may include a catheter adapter. A body of the catheter adapter may include a distal end, a proximal end, and a first lumen extending through the distal end and the proximal end. The catheter adapter may include a side port, which may extend outwardly from the body. The side port may include a second lumen, which may be perpendicular to the first lumen. The catheter assembly may include a catheter extending distally from the distal end of the body. The catheter assembly may include a valve disposed within the first lumen. The valve may include an outer surface that is cylindrical and may seal the first lumen from the second lumen. The catheter assembly may include a divider disposed with the second lumen. The divider may divide the second lumen into a plurality of openings and may increase a burst value of the valve.

Abstract: A cannula insertion device is disclosed. The device includes a needle carriage, a rail device on which the needle carriage is slidable, a yoke having a channel, a linkage connected to the needle carriage and extending into the channel, a torsion spring with one end connected to the linkage, and locking device for locking the torsion spring in tension and maintaining the needle carriage and the linkage in a locked position prior to activation. Upon release of the locking device, the tension of the torsion spring is released, which causes the linkage to move in the channel and slide the needle carriage along the rail device. A catheter carriage may also be provided for actuation by the linkage.

Abstract: A needle actuator assembly for a drug delivery system includes a housing, a needle having retracted and extended positions, a needle actuator body received within the housing and configured to move from a pre-use position where the needle is in the retracted position to a use position where the needle is in the extended position and to a post-use position where the needle is in the retracted position, with the needle actuator having a button contact surface, and an actuator button received by the housing.

Abstract: Devices, systems, and methods are described including an invasive medical device with a magnetic region. The magnetic region can include a discontinuity in the magnetic region providing a diameter transition, a plurality of spaced magnetic regions can be provided or the magnetic regions can be encoded with data. Systems and methods are described that include ways to read the data.

Abstract: A system and method is provided for detecting fluid low-volume and occlusion in a device using force sensing resistor (FSR) sensor. One or more force sensing resistors are positioned in communication with a fluid channel at one or more of a pump intake and pump outlet to detect pressure in the fluid channel. The pressure is detected through communication with the force sensing resistor and indicates an irregular system condition including but not limited to, fluid low-volume level and occlusion. Also provided are a fluid flow sensor (e.g., FSR or MEMS sensor) disposed relative to an embedded fluid channel in the base of a wearable medicine delivery pump.

Abstract: A catheter assembly may include a catheter hub and a catheter tube, which may extend distally from the catheter hub. The catheter assembly may include a push tab and one or more ribs extending outwardly from an upper portion of the catheter hub. The ribs may be shorter in height than the push tab and proximal to the push tab. A needle assembly may include a needle hub, an introducer needle extending distally from the needle hub and through the catheter tube, and a grip coupled to the needle hub. The grip may include a face disposed outwardly from the push tab and the ribs. A grip of a user may contact the push tab, the ribs, and the face to reduce rotation between the catheter hub and the needle hub in response to distal advancement of the catheter hub.

Abstract: A silicone septum having a surface coating. The coated silicone septum may be incorporated in an intravenous catheter assembly. The coating reduces static charge among a plurality of vibrating silicone septa during manufacture of the intravenous catheter assembly. The surface coating includes a coating agent selected from a bicarbonate salt and a siloxane polyalkyleneoxide copolymer. The bicarbonate salt may be an alkali metal bicarbonate. The siloxane polyalkyleneoxide copolymer may include copolymer groups selected from ethyleneoxide, octamethylcyclotetrasiloxane, and mixtures thereof. The silicon septum may be coated by contacting an exterior surface of the silicone septum with a coating solution of a solvent and the coating agent for at least 5 minutes. The coating agent has a concentration in the solvent greater than 1 wt. %. Excess coating solution is removed from the exterior surface of the silicone septum. The exterior surface is dried to remove the solvent, forming the surface coating.

Abstract: A smart vial adapter is capable of measuring the dose of a drug that is withdrawn from a vial, measuring the time of a dose capture event, monitoring the vial temperature, measuring the amount of motion or perturbation the vial is subjected to, capturing various other parameters that can provide additional insights associated with the drug or the amount of the dose being drawn from the vial, and communicating the recorded information to a companion application on a computer, smartphone or other device. Related methods are also disclosed and claimed.

Abstract: A one-piece catheter (30) and manufacturing method therefor are disclosed. The catheter (30) includes a catheter tube (33) and an adapter (31). The catheter catheter tube (33) includes a tip (331) at one end and an end portion (332) at another other end. The adapter (31) can be configured for receiving a septum (402). The adapter (31) includes a narrow opening. The end portion (332) of the catheter tube (33) is connected to the adapter (31) at the narrow opening for fluid communication between the catheter tube (33) and the adapter (31). The catheter tube (33) and adapter (31) are formed as a one-piece element that is preferably injection molded in a single-shot process. Additional elements, such as one or more retention tabs (313) for attaching to a base can be formed on the catheter (30). The one-piece catheter (30) can be made by a single-shot injection molding process. Additional structures, such as a base can be attached to the catheter (30) by a second-shot injection molding process.

Abstract: Sensors are disclosed that detect whether a cannula is properly inserted to its full depth in a subject's skin. The sensors may be used with a blood glucose monitor, or with a continuous insulin infusion pump, infusion set, or other system involving intermittent or continuous testing and/or drug delivery.

Abstract: A specimen collection container having a separation chamber includes a first chamber, a second chamber, and a valve located between the first chamber and the second chamber. In an open position, the valve permits fluid communication between the first chamber and the second chamber. In a closed position, the valve maintains fluid isolation between the first chamber and the second chamber. A fluid stream passes from the first chamber to the second chamber through the valve permitting a predetermined volume of fluid to pass from the first chamber to the second chamber. When the predetermined volume of fluid passes to the second chamber, the valve transitions from the open position to the closed position so that additional fluid of the fluid stream received by the first chamber is maintained in the first chamber in fluid isolation from the predetermined volume of fluid contained in the second chamber.

Abstract: Flow cytometers including light collection modules are provided. In embodiments, the subject flow cytometers include a light source for irradiating a particle passing through a flow cell at an interrogation point, an objective lens for focusing particle-modulated light, and a light collection module for collecting objective lens focused light. In some embodiments, the light collection module includes a fiber optic light conveyor and a refractive optical element positioned between the objective lens and the fiber optic light conveyor. In such embodiments, the refractive optical element is configured to direct the objective lens focused light onto the surface of the fiber optic light conveyor by refracting the objective lens focused light such that it propagates along a single optical axis. Methods for using the flow cytometers are also provided.