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: 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: 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: 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: A method for preparing a pre-filled multi-chamber injection system includes providing an injection system body, the injection system body defining an open proximal end, a body interior, and an open distal end. The method also includes introducing a first substance into a distal end of the body interior. The method further includes disposing a distal stopper member in the body interior, the distal stopper member and the injection system body defining proximal and distal chambers in the body interior. Moreover, the method includes introducing a second substance into the body interior. In addition, the method includes disposing a proximal stopper member in the body interior. The method also includes inserting an elongate member at least partially into the body interior, the elongate member having a plurality of flow channels for fluidly coupling the proximal and distal chambers. The method further includes coupling a plunger member to the proximal stopper member.

Abstract: Syringe assemblies comprising a first cap and a second cap to ensure sterilization of the fluid path without the need for external packaging are described. Also described are methods of sterilizing the fluid path of a syringe assembly.

Abstract: A container adapter for a medical delivery device is disclosed. The medical delivery device has a container seat for holding a container, a dosage chamber, a dosing mechanism and a lock mechanism adapted to prevent operation of the dosing mechanism when no container is held in the container seat and to allow operation of the dosing mechanism when the container is held in the container seat. The container adapter includes an adapter container seat arranged to hold a container, a joint structure arranged to be detachably positioned in the container seat of the medical delivery device and to connect the adapter container seat to the dosing mechanism, and an unlock member adapted to activate the lock mechanism. A delivery assembly and a method of delivering a liquid to a patient from different containers is also disclosed.

Abstract: An apparatus comprising a catheter tube; a hub having a distal section joined to the catheter tube and a proximal section defining a housing; at least one port connected to the hub by a fluid passage through a passageway; a needle extending through the hub and the catheter tube, wherein the needle has opposite proximal and distal ends, the distal end forming a needle tip; a needle hub attached to the proximal end of the needle; a needle guard slidably arranged on the needle, wherein the needle guard is movably retained in the housing of the hub when the needle extends through the hub and the catheter tube, wherein the needle guard is removable from the hub once the needle tip is received in the needle guard upon withdrawal of the needle from the catheter tube; and wherein the hub is made of two parts each having distal and proximal end sections.

Abstract: A guide catheter extension, having a push member having a proximal end and a distal end; a tube frame coupled to the distal end of the push member, the tube frame defining a lumen having a diameter sufficient to receive an interventional vascular device therethrough; and an inflatable element coupled to the tube frame, wherein the inflatable element is expandable into the lumen.

Abstract: The infusion pump for stem cells includes a liquor storage device and an infusion pipe. The inner wall of the liquor storage sac of the liquor storage device and inner walls of the infusion pipe are provided with an anionic protective film to prevent stem cells from adhering to the infusion pump by mutual repulsion between anions. The infusion method includes checking an infusion pump for integrity, losing a liquor stop clamp, injecting a mixed liquor of stem cells and medicine, covering a protective cap, opening the liquor stop clamp, closing the liquor stop clamp for use, connecting an external cone joint with a venous cannula, and then opening the liquor stop clamp. The method also includes steadily placing the liquor storage sac on a horizontal plane using an auxiliary placing device, and after infusion ends, closing the liquor stop clamp, and disconnecting the external cone joint.

Abstract: The present specification relates to a subassembly for a drug delivery device, the subassembly comprising: a housing adapted to contain a drug container with a needle, a cap, and a spacer, wherein the housing has an inner surface forming a cavity configured to retain the drug container, wherein the cap is configured to be releasably connected to the housing, and wherein the spacer is arranged between the cap and the housing.

Abstract: A needle shield remover for a medicament delivery device is presented that has a metal tubular body, a proximal part, a distal part, and a substantially circular cross-section, where the tubular body is arranged with a slot extending from a distal end of the body, at least half the length of the body, towards a proximal end, such that at least the distal part of the body may flex radially outwards to exert a radially inwardly directed clamping force on a needle shield accommodated by the body.

Abstract: A valve assembly for a drug delivery device includes a valve housing having a first side and a second side positioned opposite from the first side, a cannula having a first end and a second end positioned opposite the first end, a pierce plate having a body and a piercing member extending from the body, with the body defining a coiled elongate member, and a valve boot connected to the valve housing and defining an interior space. The valve boot is configured to move from a pre-use position where the first end of the cannula and the piercing member of the pierce plate are received within the interior space to a use position where the piercing member of the pierce plate and the first end of the cannula extend outside of the valve boot and the interior space.

Abstract: The disclosure relates to a drug delivery device including: a housing configured to contain a drug container with a needle, a needle shroud that is telescopically connected to the housing, and a cap that is configured to be releasably connected to the housing before use of the device. At least one of the cap and the needle shroud is adapted to unreleasably lock the cap onto the housing after reapplying the cap onto the housing after the drug delivery device is used.

Abstract: A needle guard grip device may include a body extending from a first end to a second end along a central longitudinal axis of the body. The body may include a plurality of ribs extending perpendicularly to the central longitudinal axis. The plurality of ribs may include a first set of longitudinally spaced ribs disposed on a first side of the central longitudinal axis, and a second set of longitudinally spaced ribs disposed on a second side of the central longitudinal axis that is opposite of the first side. Moving along the central longitudinal axis, ribs of the first set of longitudinally spaced ribs may alternate with ribs of the second set of longitudinally spaced ribs.

Abstract: A method for performing a medical procedure requiring effective, reliable and foolproof delivery of controlled amounts of a medical grade gas to a patient includes providing a compressed gas cylinder having a weight with medical grade gas sealed therein of at least twelve grams and not greater than fifty grams. The method also includes connecting the compressed gas cylinder to an integrated compressed gas unit including a regulator valve assembly positioned between an outlet port and an inlet port, wherein the regulator valve assembly includes a press button actuator and regulator adjustment dial. A flow control system is secured to the compressed gas unit and the medical grade gas is delivered in precisely controlled amounts by actuating the compressed gas unit and operating the flow control system to deliver the medical grade gas to vasculature of the patient.

Abstract: A device for removing a protective shield such as a needle shield is disclosed. The device includes a cup shaped body with a sidewall, a distal bottom wall and a proximal opening. The protective shield is insertable into the cup shaped body through its proximal opening. Fingers are disposed opposite each other in openings in the sidewall. The fingers are flexibly coupled with the sidewall at a proximal end of the finger and can be resiliently biased inwardly to engage the protective shield. Each finger includes at least one projection for engaging the protective shield. The fingers may also include a distal engagement surface for engaging a lip on the protective shield.

Abstract: Tissue access devices and methods of using the same are disclosed. The devices can have a sensor configured to occlude a flow path by deflecting a membrane into the flow path when the devices become dislodged from tissue. The sensor can be configured to partially or fully occlude the flow path. The sensor can have a spring. The spring can be biased to move the sensor from a sensor first configuration to a sensor second configuration when a force applied by the sensor first surface against a non-sensor surface changes from a first force to a second force less than the first force. The membrane can be deflected into the flow path when the sensor is in the sensor second configuration.

Abstract: A venous access device includes a hub and a bifurcated cannula. The hub includes a bifurcated connecting arm, a blood sampling arm connected to the bifurcated connecting arm, a fluid transfer arm connected to the bifurcated connecting arm, a blood sampling channel and a fluid transfer channel. The blood sampling channel passes through the blood sampling arm and the bifurcated connecting arm. The fluid transfer channel passes through the fluid transfer arm and the bifurcated connecting arm. The bifurcated cannula is coupled to the bifurcated connecting arm and includes a blood sampling lumen having a blood sampling port, a fluid transfer lumen having a fluid transfer port, and a dividing member separating the blood sampling lumen from the fluid transfer lumen. The blood sampling port is 2 mm to 20 mm proximal from the fluid transfer port. The blood sampling channel is fluidly connected to the blood sampling lumen, and the fluid transfer channel is fluidly connected to the fluid transfer lumen.

Abstract: An inserter assembly comprising a first unit including a skin contacting face which surrounds an opening and a second unit housed within the first unit. The second unit comprises an infusion set base disposed within the opening and having a bottom face which is substantially level with the skin contacting face and covered at least partially with adhesive and further comprising a spring biased insertion assembly. The second unit further comprising a cannula sub assembly carried by an insertion sharp of the insertion assembly. The spring biased insertion assembly and a cannula of the cannula sub assembly are driven into skin and the cannula sub assembly is coupled into the infusion set base by an insertion spring which is released from an energy storing state after the skin has been tugged upward beyond a certain distance by the adhesive as the inserter assembly is withdrawn from the body.