Abstract: A reusable safety syringe training device is provided. The device comprises a syringe contained within a syringe protective member. The syringe protective member is movable vertically within an outer protective sheath from a first position to a second position and back to the first position. In the first position, the device is in an injection-ready position with the needle exposed and the syringe protective member in a locked vertical position with respect to the outer protective sheath. In the second position, the device is in a post-injection position such that the syringe protective member is no longer vertically locked with respect to the outer protective sheath and has moved vertically upward thereby rendering the needle within the outer protective sheath. The plunger carries a release flange sufficient to engage release latches that otherwise retain the syringe protective member in the first position.

Abstract: A balloon catheter adapted for use with a guidewire includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends. An insert located within the interior compartment of the balloon includes at least a radiopaque portion separate from the shaft. Related methods are also disclosed.

Abstract: A catheter insertion device includes a housing, a needle, a guide wire, and a catheter disposed coaxially over the needle. The needle has a proximal end in the housing and a distal end extending from a distal end of the housing in an insertion position. The guide wire has a distal portion disposed in a lumen of the needle in a withdrawn position. The guide wire may include a safety tip having a non-coiled configuration in the withdrawn position and a coiled configuration in an advanced position. The catheter insertion device may include a sliding member attached to the guide wire, wherein movement of the sliding member translates the guide wire from the withdrawn position to the advanced position.

Abstract: A device for secluding a body vessel may include a distal balloon, a proximal balloon, an aspiration port positioned adjacent to the distal balloon, an injection port positioned adjacent to the proximal balloon, and a lumen assembly. The lumen assembly may comprise a central lumen, a distal balloon lumen operably coupled to the distal balloon, a proximal balloon lumen operably coupled to the proximal balloon, an aspiration port lumen operably coupled to the aspiration port, and an injection port lumen operably coupled to the injection port. The distal balloon and the proximal balloon may define a treatment chamber therebetween, and the aspiration port and the injection port may be positioned within the treatment chamber on the lumen assembly.

Abstract: Medicament delivery device comprising a movable guard (10) being movable between a proximal and a distal position and a locking mechanism (15) having a lever (16), the lever (16) restricting movement of an actuation locking member (24) until the movable guard is positioned in a distal position and the lever (16) restricting movement of the guard (10) in a proximal position after actuation of the device.

Abstract: The present invention relates to a method and corresponding apparatus for just in time mixing of a solid or powdered formulation and its subsequent delivery to a biological body. In some embodiments, a powdered formulation is maintained in a first chamber of a plurality of chambers. A plurality of electromagnetic actuators are in communication with the plurality of chambers. The actuators, when activated, generate a pressure within at least the first chamber. The pressure results in mixing of the powdered formulation and a diluent in time for delivering into the biological body.

Abstract: Provided is a warming device which can efficiently warm a blood product and inhibit a liquid in a warming flow path from exceeding an upper limit temperature thereof when liquid delivery of the blood product is stopped. The warming device includes the warming flow path in which the blood product flows and a heat plate which is in contact with the warming flow path to supply heat to the warming flow path. On the heat plate, a heater in a predetermined pattern corresponding to the warming flow path is disposed. The heater is disposed such that an amount of heat generation toward the warming flow path decreases in stages from an upstream side toward a downstream side in the warming flow path and that a decrease rate of the amount of heat generation at each of the stages decreases from the upstream side toward the downstream side.

Abstract: A needle hub (10) includes a core mounting structure (27), a first panel (28) and a second panel (29) connected to the core mounting structure (27) with an opening formed between the first panel (28) and the second panel (29), an introducer needle (72) fixedly attached to the core mounting structure (27) for insertion into a patient, and an actuation lever (16, 18) cantilevered longitudinally at a central portion thereof from the core mounting structure (27) and having an actuation button (12, 14) disposed at a proximal free end and a latch (24, 26) disposed at a distal free end.

Abstract: Systems and methods for treating a medical condition such as worsening heart failure (WHF) are described. A medical system may sense one or more physiological signals, and generate from the sensed physiological signals a signal metric trend indicating a progression of heart failure. A detector may detect a physiological event leading to WHF. A therapy control circuit may generate a therapy titration protocol using the generated signal metric trend. The therapy titration protocol includes a temporal profile of therapy dosage relative to a target dosage. The therapy control circuit may adjust the target dosage based on patient response. Therapies may be administered by a clinician or automatically delivered to the patient according to the therapy titration protocol.

Abstract: A method of providing and/or injecting octreotide acetate to a subject in need thereof includes storing the octreotide acetate in a cartridge of a multi-use multi-dose injector provided with a variable dose setter and actuator. The injector includes a needle configured for subcutaneous administration of the octreotide acetate, the octreotide acetate having a concentration of 2,500 ?g/mL. The method further includes providing, on the injector, a plurality of indicia only at prescribed doses of 50 ?g, 100 ?g, 150 ?g and 200 ?g settable via the dose setter without indicia between said prescribed doses; and permitting setting of a dose of the octreotide acetate by rotation of the variable dose setter, wherein the injector is configured to provide at least one audible feedback during the rotation.

Abstract: An infusion pump including a fluid chamber having an outlet valve and a piezo-stack actuator including a stack of piezo-electric layers. The infusion pump also includes a linear actuator to measure displacement of the piezo-stack actuator during operation. An electronic processor is programmed to operate the outlet valve and the piezo-stack actuator to pump fluid through the fluid chamber at a programmed flow rate.

Abstract: Peritoneal dialysis, such as automated peritoneal dialysis (“APD”) is provided with any one or more or all of the following sensing or feedback features: impedance sensing to detect peritonitis, temperature sensing to detect peritonitis, bio-MEMS sensing to detect peritonitis, and glucose control for diabetes patients, wherein each sensing or feedback feature analyzes patient effluent fluid or fluid dwelling within a patient's peritoneal cavity.

Abstract: An apparatus is provided for detecting mating of a cap with a fluid delivery device having a housing, a receptacle, and a sensor. The housing is configured to carry an insulin delivery device having a reservoir of the fluid. The receptacle is provided by the housing having a coupling with a locking recess configured to receive a cap with a sprung locking arm. The pressure sensor is carried by the receptacle proximate the coupling and configured to detect engagement force of the sprung locking arm with the receptacle when mated with the housing. A method is also provided.

Abstract: A flexible implantable contraceptive disc device is disclosed which can be inserted inside the female body, such as inside the uterus, is disclosed. The disc device can be bent and inserted into a laparoscopy tube, which allows it to be delivered to an appropriate location inside a female subject. The disc device has three layers, a central core silicon reservoir containing an active ingredient, such as a contraceptive progesterone, which is sandwiched and encased by upper and lower porous silicon casings. The casings are porous to the contraceptive, allowing controlled release over a prolonged period of time. The lower casing has a series of micro-hooks around a circumference, allowing the disc device to be attached to a desired tissue by rotating the disc device such that the hooks engage with the desired tissue. Such a device is easier to insert, and to remove, than a rod-like rigid plastic T-shape IUDs which are considerably larger, also and more expensive to manufacture.

Abstract: In some embodiments, a device may include an intraventricular access device and an infusion device. The intraventricular access device may include more than one catheter and a container. In some embodiments, the catheter may include an aspiration lumen and an infusion lumen. A distal end of the intraventricular portion of the catheter may be positionable, during use, in a subject's brain fluid. In some embodiments, the container may be coupled to a proximal end of the aspiration lumen. The proximal end of the aspiration lumen may be in fluid communication with the container. In some embodiments, the container may include a barrier positioned between a proximal opening of the aspiration lumen and at least a portion of the infusion lumen adjacent to and/or associated with the container. The barrier may inhibit penetration of a surgical instrument.

Abstract: Disclosed is an angioplasty balloon catheter and method of use, said angioplasty balloon catheter includes an elongated tip end with physical characteristics nearly identical to a standard angiographic diagnostic catheter. The elongated tip end extends approximately between 2 cm to 75 cm beyond a distal end of a balloon, depending upon embodiments. The tip of the elongated tip end may be angled or straight depending upon embodiments and may or may not have a plurality of side holes in addition to an end hole depending on embodiments. The elongated tip end permits the angioplasty balloon catheter to tract more easily across tortuous or markedly angulated segments of a dialysis graft or fistula, minimizing complications that can result with currently available devices. If angulated, the elongated tip end also enables a user to selectively catheterize an artery without needing a separate diagnostic catheter to do so, and enable tracking and cornering across sharply angulated vessel segments.

Abstract: A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

Abstract: A device and method for directing an agent that is magnetic or magnetizable having a magnetic configuration in which a first magnet has a first magnetization that is opposite to a second magnetization of the second magnet. The first magnet and the second magnet define a minimal convex set and the push node is outside the convex set. The first magnetic field and the second magnetic create a combined field and a pushing force.

Abstract: Medical device assemblies having a connection mechanism for securely connecting a hub to fluid storage containers in a luer slip relationship are described. An exemplary medical device includes a hub forming a cavity, a second indicating element disposed within the cavity that engages the hub. Additional features of the medical device include a second indicating element contoured to form a line contact with the hub. In a specific configuration, the hub includes a first indicating element attached to the hub and extending proximally into the cavity having a protrusion. In a more specific configuration, the medical device includes a fluid storage container that has an indication system for visually indicating optimal fluid-tight engagement of the hub and the fluid storage container.

Abstract: A catheter can include a catheter main body and a sheath that covers the catheter main body and can move along the longitudinal axis with respect to the catheter main body. An operating unit can be disposed at a proximal end portion of the sheath and can move the sheath and the catheter main body with respect to one another. The catheter main body can include a slit on an outer peripheral surface of a distal end portion and can extend along the longitudinal axis from a slit distal end to a slit proximal end side. An outside diameter of the distal end portion of the catheter main body is larger than an inside diameter of a distal end portion of the sheath when the distal end portion of the catheter main body is housed in the sheath.