Abstract: A needle assembly for medical or surgical use is disclosed, such as for hemodialysis. A representative needle assembly comprises an outer needle assembly and an integral needle tip protector. A representative outer needle assembly comprises: an outer needle comprising: a first lumen; a first aperture with a sharp needle tip at a first distal end of the outer needle; and a second aperture arranged opposite the first aperture. In another embodiment, the outer needle has a longitudinal slot and the integral needle tip protector includes a sliding connector which is slidable in the longitudinal slot. The integral needle tip protector is arranged within the first lumen and moveable between a retracted configuration and an extended configuration, and comprises: a needle tip cover arranged to shield the sharp needle tip in the extended configuration, the needle tip cover having a smooth or beveled distal surface forming a blunt tip.

Abstract: In another example, a bioresorbable implant for use in a nasal region includes one or more bioresorbable polymers, and a pharmaceutical composition coupled to the one or more bioresorbable polymers. A release rate of the pharmaceutical composition is related to a degradation rate of the one or more bioresorbable polymers.

Abstract: An example catheter includes a handle assembly having a control member, an elongate body, a pull wire, and at least one radiopaque marker. The elongate body defines a lumen configured to receive a medical electrical lead including at least one electrode array. The elongate body includes a proximal portion coupled to the handle assembly and a distal portion that includes an articulating segment and a preformed curve segment. The at least one radiopaque marker is positioned on the distal portion. The pull wire extends from the control member and is anchored to the elongate body distal to the articulating segment such that actuation of the control member controllably bends the articulating segment in a first curve in a first geometric plane. The preformed curve segment defines a second curve in a second geometric plane different from the first geometric plane.

Abstract: The present specification relates to a plunger configured to transmit a force from an energy source to a piston of a primary container, the plunger comprising a plunger rod configured to be subjected to the force from the energy source, the plunger rod having an inner surface forming a cavity, wherein a support element adapted to constrain the energy source within the cavity protrudes radially inwards from the inner surface into the cavity.

Abstract: The present disclosure relates to a drug delivery device, comprising a housing adapted to receive a medicament container, a plunger and a plunger release mechanism, the plunger release mechanism comprising a first plunger boss arranged on the plunger, a profiled slot arranged on the housing and adapted to be engaged by the first plunger boss so as to inhibit movement of the plunger in a distal direction, wherein the plunger is rotatable about a longitudinal axis to release the first plunger boss from the profiled slot so as to allow movement of the plunger in the distal direction, a sleeve coupled to the housing to permit movement of the sleeve relative to the housing, wherein a sleeve ramp is arranged on the sleeve, the sleeve ramp adapted to engage a rib or boss on the plunger to rotate the plunger to release the first plunger boss from the profiled slot when the sleeve is moved in a proximal direction.

Abstract: Fluid communication devices and supporting structures may be provided for use with intraosseous devices. Apparatus and methods may also be provided to communicate fluids with an intraosseous device.

Abstract: A pump device includes a pump driver comprising a first diaphragm and a second diaphragm, the first and second diaphragms each comprising a middle portion bounded by an outer portion, the first and second diaphragms being spatially separated from each other at the respective outer portions, and coupled together at the respective middle portions. The pump also includes a fluid passageway and a pump chamber fluidly connected to the fluid passageway, wherein the pump chamber comprises a moveable wall coupled to the pump driver at the middle portions of the first and second diaphragms such that a fluid movement between the pump chamber and the fluid passageway is induced by movement of the middle portions. An input device is configured to obtain a target flow rate. A controller is configured to operate the pump driver and a flow regulator based on signals received from a flow detector.

Abstract: An injector device includes a housing and a cartridge having a reservoir for medicament. The injector device further includes a needle unit comprising a needle, and an actuator. The needle unit is movably mounted to the housing and, prior to use of the injector device the reservoir, is sealed from the needle. The actuator is configured to move the needle unit 5 into engagement with the cartridge such that the needle is moved into fluid communication with the reservoir. A thread is arranged to cause rotation of the needle unit as the needle unit moves into engagement with the cartridge.

Abstract: This disclosure includes intraluminal tubes comprising: an elongated tube (e.g., having a proximal portion, a distal portion configured to be disposed inside of an internal cavity of a patient, and a sidewall defining a lumen extending from the proximal portion to the distal portion, the distal portion defining one or more openings in fluid communication with the lumen) and a plurality of deployable tines, each coupled to the tube and disposed outside the sidewall of the distal portion, where each tine is movable from a collapsed state to a deployed state in which a portion of the tine extends laterally away from the distal portion of the tube. In some of the present intraluminal tubes, the sidewall of the distal portion defines a plurality of longitudinal grooves, and each tine is disposed in a different one of the grooves when the tines are in the collapsed state.

Abstract: Aortic occlusion and embolic protection devices include radially expandable and collapsible proximal and distal end portions, such as annular self-expanding stents or frames, that are configured to radially expand within an aorta to secure the device within the aorta. The devices can also include a catheter extending axially between the distal end portion and the proximal end portion and a porous covering, or filter, positioned around the catheter and between the proximal end portion and the distal end portion and configured to filter emboli from blood flowing into upper-body arteries. The device can further include a one-way valve positioned at or adjacent to the distal end portion of the device and configured to restrict retrograde blood flow through the device toward the heart.

Abstract: In some embodiments, a catheter system may include a catheter adapter having a distal end, a proximal end, and a lumen extending there between. In some embodiments, the catheter system may also include a catheter extending distally from the distal end of the catheter adapter, an extension tube, and a connector coupled to a proximal end of the extension tube. In some embodiments, a distal end of the extension tube may be coupled to the proximal end of the catheter adapter. In some embodiments, the connector, the extension tube, the lumen, and the catheter may form a straight pathway for delivery of an instrument to the catheter system. In some embodiments, an extension set for a catheter assembly may include the extension tube, the connector coupled to the proximal end of the extension tube, and another connector coupled to the distal end of the extension tube.

Abstract: A medical device for fixing a catheter to a patient is disclosed. It includes a base having a planar main development, a first face configured to be glued to a patient's skin, a second face, opposite to the first face, adapted to receive a catheter according to an axis of insertion of the catheter, and at least two pegs which rise substantially perpendicular to the second face. Each peg has a stem which rises from the second face and has a cross section suitable to freely pass through a through hole of a fin of a catheter. The peg also has an enlarged free terminal end having a cross section greater than the cross section of the stem so that it cannot freely pass through the through hole. The enlarged terminal end is able to pass through the through hole only by elastically widening the through hole.

Abstract: A catheter insertion device is provided for positioning and inserting a catheter, particularly a midline catheter into a patient. The insertion device includes an actuator assembly movable with respect to a housing for deploying the catheter over a needle. A step-wise movement of the actuator advances a catheter assembly, including the catheter, in stages over the introducer needle. An indexing finger of the catheter assembly engages the actuator body during distal advancement of the actuator, and deflects as the actuator is moved proximally. The device further includes a lockout device such as a button, collar, slider, or tab, which allows movement of the catheter relative to the needle but prevents advancement of the catheter to the first stage of the step-wise movement.

Abstract: A catheter system may include a catheter adapter, a catheter extending distally from the distal end of the catheter adapter, and a needle hub coupled to the catheter adapter. The needle hub may be transparent, and a needle may be secured within the needle hub. The catheter system may also include a flow control plug coupled to the proximal end of the needle hub. In some embodiments, a flashback pathway may be disposed between an outer surface of the flow control plug and an inner surface of the needle hub. In some embodiments, the catheter system may include an inner barrel and an outer barrel, and the inner barrel and the needle hub may be configured to move proximally within the outer barrel to retract the needle. The flashback pathway may be disposed between an outer surface of the needle hub and an inner surface of the inner barrel.

Abstract: An apparatus, assembly and method for controlling release of a drug from a drug-eluting balloon during delivery of a drug-eluting balloon to a situs within a body. More particularly, the present invention relates to a diametrically expandable sleeve having a first non-diametrically unexpanded state in which drug retained on or in a drug-eluting balloon is protected from release by a sleeve and a second diametrically expanded state in which drug retained on or in the drug-eluting balloon is exposed for focal release in the body by diametric expansion of the sleeve, exposing openings in the sleeve during diametric expansion and closing the openings in the sleeve when the sleeve is in its diametrically unexpanded state.

Abstract: Methods and devices for trans-jugular carotid access are disclosed. Methods within the scope of this disclosure include methods of trans-jugular carotid access originating in the leg of a patient or other location remote to the jugular vein and carotid artery and methods originating at the neck of a patient. Devices used in connection with the disclosed methods may comprise access catheters, lumens, and stylets.

Abstract: Embodiments of the present disclosure provide a method and apparatus for securing a medical device. An exemplary apparatus includes a body having an inner portion and an edge portion, the edge portion defining a terminal end of the body, the body defining at least one surface spanning the inner portion and the edge portion. The apparatus further includes at least one wing fixedly coupled to the edge portion of the body, the at least one wing defining at least one hole extending through the at least one wing. The apparatus still further includes at least one channel disposed on the at least one surface of the body, the at least one channel having a first terminal end at the edge portion of the body, wherein the at least one channel comprises at least one curve.

Abstract: In some embodiments an apparatus for providing access for a medical procedure in a patient's body cavity includes a stem configured for insertion through an opening in a body cavity wall. The stem has a bore and a cap is disposed at a proximal end thereof and includes an entry port in communication with the bore which receives an instrument to be inserted into the body cavity. An inflatable annular seal is disposed on the stem proximate the cap and a conduit extends through the cap providing pressurized gas at a first outlet in fluid communication with the body cavity providing insufflation pressure. A second outlet of the conduit is in fluid communication the seal, which when disposed inside the body cavity proximate the wall and inflated by pressurized gas, bears on an inner surface of the wall urging the cap into contact with an outer surface of the wall while sealing the opening.

Abstract: In various examples, a medical device is configured to be at least partially insertable within a patient. The medical device includes a first elongate member including a sidewall surrounding and defining a lumen extending through the first elongate member between a first proximal end and a first distal end. A second elongate member is sized and shaped to fit within the lumen of the first elongate member. A coil is disposed within the sidewall of the first elongate member, wherein the coil is configured to sense a position of the second elongate member with respect to the coil. In some examples, the first elongate member includes a catheter, and the second elongate member includes a guidewire.

Abstract: 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.