Abstract: A breast pump device for pumping breast milk is disclosed. The breast pump device may include a breast shield for receiving a breast, a collection container for receiving breast milk, a tubing connecting the breast shield to the collection container, and a pump connected to the collection container, configured to draw breast milk from the breast shield, through the tubing, and into the collection container. The breast shield may include a channel extending from an interior portion of the breast shield located near a nipple of the breast to an exterior portion of the breast shield. The various components of the breast pump device may be made out of antimicrobial materials. One or more sensors and/or computing devices may be incorporated to measure the amount of milk produced, monitor temperature of the milk, and provide alerts regarding pumping schedules.

Abstract: A device for delivering a beneficial agent is provided and generally includes a cassette, a pump, and a delivery tube. The pump includes a pump housing containing a pump assembly having a fluid drive component. The pump housing has a receiving region disposed proximate the fluid drive component and further includes a rear closure portion. The rear closure portion includes a membrane disposed between the receiving region and the fluid drive component. The cassette includes a cassette housing, which has a cassette body region defining a fluid reservoir chamber therein. The cassette further includes a cassette base region having a boundary configured to be received by the receiving region.

Abstract: An article 100 comprising at least one microneedle 160 is provided. The article comprises a first side 112 and a second side 114 opposite the first side. The first side comprises a central cavity portion 120 and a platform portion 130, with at least one microneedle extending therefrom, wherein the platform portion is not coplanar with the central cavity portion. The platform portion substantially surrounds the central cavity portion. The at least one microneedle 160 comprises a body comprising an outer surface 163; a base segment 166 having a base and a first shape; a tip segment 168 having a tip 164 and a second shape, wherein the second shape is distinct from the first shape; a transition plane 167 that delineates the base segment and the tip segment; and a central axis.

Abstract: The present specification discloses a solution delivery device having a container component and a plug component configured for selective engagement with the container component. The container component has an internal cavity including an elongated mixing channel containing a first constituent, and the plug component provides an internal flow path configured for introduction of a second constituent into the mixing channel for mixing with the first constituent. The plug component may be inserted within the container component partially in a first operational mode and fully in a second operational mode. The first constituent may be a drug and the second constituent a diluent, such that the drug may be lyophilized with the device in the first operational mode and reconstituted with the device in the second operational mode. Multiple devices may be employed in tandem for the co-delivery of multiple constituents. The device may be included in a kit or installed within an injector.

Abstract: In one aspect, a peritoneal dialysis (PD) machine can be used to detect a heater bag filled with dialysate. The PD machine has a heater tray that includes a temperature sensor and also has a processor that determines a status of the heater bag based on data received from the temperature sensor. For example, the status may be presence of the heater bag on the heater tray and/or correct positioning of the heater bag on the heater tray.

Abstract: An implantable venous device includes a catheter including a passage; a locking nut including a channel for receipt of the catheter and an annular convex end; an injection seat including a base, a peripheral wall, and a mounting member projecting out of the wall; a connecting tube projecting out of the mounting member and including a bulged central portion and an annular curved outward end with the locking nut secured onto the bulged central portion; a base member including a groove; a housing including a top opening, a clamping portion on a periphery of the top opening, and a passageway through a bottom edge for receipt of the base member with the injection seat fastened in the housing, and with the locking nut in the groove; and an implant member in the top opening and including a peripheral flange urged downward by the clamping portion.

Abstract: A therapeutic system in an exemplary embodiment comprises a fluid delivery device having a fluid reservoir, an outlet port with a lumen for outputting fluid from the reservoir, a pump for pumping the fluid through the lumen and a controller for controlling the therapeutic system. The therapeutic system may also comprise an adaptor for an infusion set, the adaptor having a plug operable for attaching to the outlet port, and wherein the adaptor has an adaptor septum operable for being pierced by the lumen when attached to the outlet port. The therapeutic system comprises an infusion set recognition system, wherein the controller is operable to query the infusion set recognition system for infusion set data, wherein the infusion set data comprises an infusion set type, wherein the controller is operable to operate the pump to provide a basal dosage of the fluid if the infusion set type is not recognized.

Abstract: A needle tip assembly for a pre-loaded syringe or a pen needle injection device, wherein the needle tip assembly comprises a needle mounted to a needle support. A body is sized and configured to receive therein the needle support and the needle. The body comprises a front portion, a rear portion, and an overall axial length that is greater than an axial length of the needle. Prior to the needle tip assembly being in an installed condition on the pre-loaded syringe or the pen needle injection device, each of the front portion covers a first puncturing end of the needle and the rear portion covers a second puncturing end of the needle. Prior to removal from the pre-loaded syringe or the pen needle injection device, the body is at least axially movably relative to the needle support to a position the front portion covers the first puncturing end.

Abstract: A catheter for treatment of sinusitis capable of causing a space in a further rear (distal side) of a posterior nasal aperture to communicate with external air is provided. The catheter comprises an anterior nasal aperture balloon 33, an anterior nasal aperture balloon air supply lumen 39b for inflating the anterior nasal aperture balloon 33, a posterior nasal aperture balloon 13, a posterior nasal aperture balloon air supply lumen 19b for inflating the posterior nasal aperture balloon 13, and a drainage lumen 39a having an opening 41 between the anterior nasal aperture balloon 33 and the posterior nasal aperture balloon 13, in which an external air communication lumen 19a having an opening 21 on a distal side from the posterior nasal aperture balloon 13 is further provided.

Abstract: The priming configuration comprises a piston rod (1), a bung (2), which is provided to be driven by the piston rod, and a movable element (5), which is engaged with the piston rod. The movable element is arranged to be movable in a predefined direction (10) with respect to the piston rod by a user of the drug delivery device. A movement of the movable element in the predefined direction advances the piston rod in a further direction (11), providing a priming of the drug delivery device before use. The predefined direction may especially be transverse to the further direction, and the further direction may especially be directed from the piston rod towards the bung (2). A gap (12) or clearance between the piston rod (1) and the bung (2) can thus be removed, and the stiction of the bung (2) to the cartridge (3) can be reduced.

Abstract: Device for delivering a beneficial agent includes a cassette including a cassette housing with a fluid reservoir and a cassette base region. The device also includes a delivery tube. The device also includes a pump including a pump housing containing a pump assembly having a fluid drive component. The pump housing has a receiving region to receive the cassette base region. The fluid drive component is proximate the receiving region. A lock member is coupled to the pump housing and movable between an open position and a closed position. The cassette is capable of being inserted into and removed from the receiving region when the lock member is in the open position, and the cassette is secured to the pump with the cassette base region within the receiving region and the delivery tube in operative engagement with the fluid drive component when the lock member is in the closed position.

Abstract: Catheter includes an outer shaft member having a proximal section and a distal outer member. The outer shaft has an inflation lumen defined therethrough. A balloon is in fluid communication with the inflation lumen and has a proximal balloon shaft, a proximal cone portion, a working length, a distal cone portion, and a distal balloon shaft. Catheter also includes a monolithic inner tubular member extending from the outer shaft proximal section through the distal outer member and through the balloon to form a tip. The distal balloon shaft has an inner diameter and comprises a distal seal portion coupled to the inner tubular member and a proximal portion free of attachment to the inner tubular member. The length of the proximal portion of the distal balloon shaft is at least about two times the inner diameter of the distal balloon shaft. Methods of making a catheter are also provided.

Abstract: A tube management system has a tube receiving element, a base element, and attachment elements extending from the base element. The tube receiving element is provided with a gripping element that functions to prevent tube migration. The attachment elements are provided within openings for receiving a device which is used to secure the tube management system to a patient.

Abstract: An elongate catheter tip may be coupled to an elongate catheter body adjacent a distal end of the catheter body. To couple a catheter tip to a catheter body, a proximal portion of the catheter tip may (1) be disposed between a first elongate member and an second elongate member and (2) be subsequently fused to the second elongate member and the first elongate member. The resulting catheter and catheter tip may, among other functions, facilitate the measurement of differences in fluid pressure and/or facilitate the delivery of fluid or medical devices during a medical procedure.

Abstract: An improved handle for a steerable catheter apparatus steerably manipulated by steering wires or rods, and including an elongated housing having one end thereof adapted for attachment to the proximal end of the steerable catheter; a steering actuator carried by the housing and including an elongated lever pivotally affixed to the housing and rotatable about an axis transverse to both the length of the housing and the length of the lever and further having an end thereof attached to the steering wires or rods of the catheter to cause deformation of at least a portion of the catheter; and a locking mechanism carried by the lever for selectively locking the steering actuator in place relative to the housing during at least a portion of the time of use of the catheter apparatus.

Abstract: An in-situ material delivery device for handheld, stereotactic table or MRI stage use may comprise a work element configured to selectively open and close at least one articulable beak configured to penetrate tissue to a target delivery site, or follow a central lumen of another device or other guiding modality, and then to deliver selected materials. Such a device may deliver a variety of materials such as markers, radio-active pellets, medications, other devices, and other materials of solid, liquid or gaseous form to a target site, and materials of similar nature may also be captured and removed from a target site. A single tube with or without coatings or an inner sheath and an outer sheath which may be co-axially disposed relative to a work element may be configured to actuate a beak or beaks and internal delivery mechanisms simultaneously. One embodiment of this device may be applicable to field use or one time use.

Abstract: A medical connector can include a body having a fluid path with an inlet port, an outlet port, a luer portion, and a post extending through a fluid path. An arm having a latch member is coupled to the body to engage a ridge or thread on an exterior surface of a reciprocal connector. The arm may also include an extension. When the connector is in an open position, the latch member restricts retraction of the reciprocal connector from the outlet port. A seal is coupled to the body and includes a flap extending across the outlet port or a bellows to compress along an axis. In a closed position, the post restricts flow through the luer portion. In an open position, the post permits flow through the luer portion.

Abstract: Flexible manifolds configured for use in a wearable artificial kidney are provided and can include an array of manifold plates defining one or more flow path and which are adapted to receive dialysis components including cleaning columns and dialyzers. Wearable artificial kidneys are also provided. For example, a wearable artificial kidney can include a flexible manifold, a first flow path, a second flow path, a third flow path, a first cleaning column, a first dialyzer, a second dialyzer, a second cleaning column, and at least one pump. Systems for performing dialysis are further provided. The systems can include a wearable artificial kidney and manifold inlet and outlet lines for connecting the peritoneum of a dialysis patient to the wearable artificial kidney. Methods for performing dialysis utilizing the flexible manifolds, wearable artificial kidneys, and systems containing the same, are also provided.

Abstract: Deflectable apparatus and methods for performing a procedure within a patient's body using such apparatus are provided. Generally, the apparatus includes an elongate tubular member including a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, a deflectable distal portion including first and second lumens spaced apart from one another on generally opposite sides of the longitudinal axis, and a handle coupled to the proximal end of the tubular member. A pull wire includes a loop disposed within the handle and first and second segments extending from the loop and slidably received in the first and second lumens, respectively, and coupled to the distal end. An actuator is provided on the handle for applying tension to either the first or the second segment to cause a distal portion of the tubular member to deflect, e.g., in opposite directions.

Abstract: A system for administering a medicament includes a plurality of capsules, a capsule dispenser, and a capsule activator. Each of the capsules includes a reservoir containing a medicament and an outlet in communication with the reservoir through which the medicament exits the capsule. The capsule dispenser releasably contains the ingestible capsules and is adapted to dispense the capsules to a user in accordance with a predetermined schedule. The capsule activator activates the dispensed capsules prior to administration to the user.