Abstract: An over-the-wire rapid-exchange catheter having a guidewire channel and a rupturable membrane along one side of the guidewire channel. The catheter is exchanged by withdrawing the catheter from a guiding catheter, while stripping the operative catheter from the guidewire by tearing the guidewire through the rupturable membrane. The guidewire channel provides a sealing surface for a releasable seal on the guiding catheter, avoiding the gripping of the guidewire. A replacement catheter can be threaded onto the guidewire, and the end of the guidewire can puncture the rupturable membrane at a selected location to establish a guidewire channel at the distal end of the catheter.

Abstract: The protected needle assembly employs a retractable sheath which can be moved from an extended protected position over a hollow needle to a retracted position exposing the hollow needle. A projection carried on the sheath is disposed in a guide slot having a circumferentially directed portion for receiving the projection. In addition, a spring or resilient sleeve is provided between the movable sheath and the housing to not only bias the sheath longitudinally of the hollow needle but also in a circumferential manner. In order to release the sheath, the needle assembly is brought into contact with a patient's skin or a septum and twisted. Thereafter, an axial force on the needle assembly causes the sheath to be retracted while the hollow needle penetrates through the skin or septum. Other embodiments are provided wherein a blunt needle can be moved within a hollow needle from an extended position protecting the hollow needle and a retracted position permitting exposure of the hollow needle.

Abstract: An over-the-wire rapid-exchange catheter having a distal guidewire channel and a proximal guidewire channel. The catheter is exchanged by withdrawing the catheter from a guiding catheter until the guidewire can be removed from the proximal guidewire channel and then further withdrawn in the conventional fashion. The proximal guidewire channel provides a sealing surface for a releasable seal on the guiding catheter, avoiding the gripping of the guidewire.

Abstract: An antegrade/retrograde cardioplegia valve, system and method are provided. The valve includes conduits for entry of blood and cardioplegic solution, for pressure sensing, and for delivery of blood and cardioplegic solution to the aortic root by means of an aortic root cannula for antegrade infusion or to the coronary sinus by means of a coronary sinus cannula for retrograde infusion. Within the valve a cylindrical sliding member slides axially within an inner cylindrical chamber for selection of retrograde or antegrade infusion. An independent conduit communicates with the coronary sinus cannula for continuous coronary sinus pressure monitoring. A method and system incorporating the valve are also provided.

Abstract: An iontophoretic agent delivery device having a simplified structure and ease of manufacture. The device utilizes an electrical pathway comprising a source of electrical energy and an output means. The electrical pathway is disposed upon one of the two sides of a flexible, non-conductive substrate (e.g., a film). The output means of the pathway are connected directly or indirectly, e.g., by means of an electrically conductive adhesive tape, to the remaining components of the device such as current distribution members, lead wires, or electrodes. In this arrangement, the circuit is inverted from that of conventional devices. Economical, reel-to-reel methods of manufacturing a one-sided iontophoretic circuit apparatus of the invention are disclosed.

Abstract: A catheter (1, 18) is essentially rigid in cross-section in the peripheral region, and has at least two lumina (3, 4, 19, 20), which are mutually separated by a wall (2, 21) which can be expanded and/or deformed in the transverse plane. The flow cross-sections of the lumina change owing to the deformation of the separating wall (2, 21), depending on the prevailing differential pressure. If drugs are introduced through the lumina one after another, then there is used, in the lumen, an over pressure in relation to the other lumen or lumina, which causes a deformation of the separating wall (2, 21), and hence a reduction in the resistance to flow. The catheter (24) can, therefore, be given a smaller cross-section than that of the prior art multi-lumen catheters (32, 33, 34), resulting in easier manipulation by the doctor and less risk for the patient.

Abstract: Methods and devices for the diagnosis, evaluation and treatment of coronary artery disease (CAD) by means of a closed-loop drug delivery system that delivers an exercise simulating agent, including novel exercise simulating agents which elicit both acute and adaptive cardiovascular responses similar to those elicited by aerobic activity are provided. The acute responses to the exercise simulating agent are used to diagnose and evaluate CAD in lieu of the acute responses to aerobic exercise. Due to their adaptive responses these compounds may be used to treat CAD in lieu of the adaptive responses caused by aerobic exercise training or to treat other conditions where the adaptive responses caused by aerobic exercise are desirable.

Abstract: An improved syringe apparatus for use with interchangeable, disposable medicinal ampoules is provided with an advantageous mechanism for facilitated, one-handed operation in the ejection of a spent ampoule. The improved construction also includes a needle ejector projection for one-handed ejection of the used, disposable needle assembly. An improved cap apparatus for covering the needle assembly is also provided.

Abstract: A surgical cannula includes a first valve seal for preventing insufflation gas from escaping from a patient's abdomen when an instrument is inserted or removed through the cannula. The valve seal has a V-shaped cross section and includes two opposing lips which face each other across a slit. Each lip has an internal and external edge separated by an intermediate section. The front surface of the first seal is relatively flat and has a width X. The preferred distance between the internal and external edges is preferably one-half X. This permits the internal edges to absorb the shock and damage from the introduction of a sharp instrument such as a trocar into the cannula without destroying the sealing capability of the external edges. A spring-loaded tubular member is located within the cannula housing and a reducer subassembly and is normally biased away from the interior surface of the first seal.

Abstract: Catheters manufactured by extrusion are described along with methods and devices for their manufacture. Catheters are manufactured according to the invention by simultaneously conveying a plurality of streams of different materials to a molding nozzle and merging the streams together to form a catheter. An apparatus for the manufacture of such catheters includes means for opening and closing the flow of materials in a controlled manner to thereby vary the composition within the finished extrusion profile. The finished extrusion profile is provided as a catheter containing at least one wall section having bands of different materials extending longitudinally along the length of the catheter.

Abstract: Safety device for taking samples and performing infusions which comprises: a grip end provided with a coupling for connection to a fluid supply duct; a delivery end for a container for collecting fluid; a double-tip needle in which the tip proximal with respect to the supply duct is directed toward the grip end and the distal end is directed toward the delivery end; a needle support engaging an intermediate portion of the needle and movable from an inactive position to an active position toward the grip end in order to cause the proximal tip of the needle to penetrate the supply duct; elastic return means for said support; and an element for abutment at the delivery end for acting as a locator for a collection container, which moves with respect to the needle between a retracted needle protection position and a protruding position for insertion on the needle in order to expose its distal tip and simultaneously insert it in the collection container.

Abstract: A cartridge assembly for holding a lyophilized product, forming a disposable portion of a pen injector includes a cylindrical glass cartridge adapted to receive the product, a closure cap, a cartridge case, and a plunger mechanism. The closure cap is adapted to retain an elastomeric disc seal during lyophilization and includes diametrically opposed ledges. The closure cap and seal are adapted to cover a neck portion of the ampule, the neck portion having on its end a radially extending circumferential flange. The ledges of the closure cap and the flange of the neck portion allow the closure cap to remain open during lyophilization, oxygen purge and nitrogen overlay. An oval-shaped indentation formed on the inside of the closure cap aids in snapping the closure cap about the flange without crimping to retain the closure cap underneath the flange.

Abstract: A device for holding an IV tube in a pumping apparatus and for selectively occluding the tube when the door of the pumping apparatus is opened, to prevent free flow of fluid in the tube. The device consists of a base member to which the IV tube is attached or through which it passes, and a slide clamp which slides relative to the base member and relative to the tube. The IV tube is passed through an elongated aperture in the slide clamp, and the slide clamp is slidingly mounted on the base member. The aperture in the slide clamp has a relatively open hole at one end, through which the tube passes when the slide clamp is in one position, allowing fluid to flow through the tube. The aperture also has a relatively constricted slot at the other end, through which the tube passes when the slide clamp is in a second position, preventing fluid flow through the tube.

Abstract: The drainage catheter comprises a basic tubular body having a distal end, a proximal end, a pressure channel in the tubular body and a discharge channel in the tubular body, the distal end having a bending of the pressure channel to communicate with the discharge channel. A nozzle ejector formation is provided in the distal end of the catheter after the bend in the pressure channel and having an orifice facing proximally into the discharge channel. The distal end further has an inlet opening disposed adjacent the orifice of the nozzle ejector formation. The basic tubular body has, at the proximal end, a pressure inlet to the pressure channel and a discharge outlet from the discharge channel.

Abstract: An improved syringe apparatus for use with interchangeable, disposable medicinal ampoules is provided with an advantageous mechanism for facilitated, one-handed operation in the ejection of a spent ampoule. The improved construction also includes a needle ejector projection for one-handed ejection of the used, disposable needle assembly. An improved cap apparatus for covering the needle assembly is also provided.

Abstract: An apparatus for assisting blood circulation includes an inflow tube which can be inserted into the right atrium from a peripheral blood vessel or which can be inserted into the left atrium from a peripheral blood vessel through the right atrium and the foramen ovale of the interarterial septum. An outflow tube is inserted into the aorta or into the carotid artery from a peripheral blood vessel to deliver the blood to the aorta or to the carotid artery. The outlet tube has an outlet for blood on the side of a upstream part of the tube and a blood pump which can take in the blood from the inflow tube and send out the blood to the outflow tube. When the former inflow tube is used, it also comprises an oxygen gas exchanger which exchanges carbon dioxide in the blood for oxygen. The apparatus can be very easily applied to the patient without thoracotomy to assist the circulation of blood.

Abstract: An electrotransport drug delivery device (1) including a reusable component (2), a disposable component (4), and a removable liner (8) temporarily separating the mating surfaces of the components (2,4) during alignment and assembly of the components (2,4). At least one of the components (2,4) has an adhesive mating surface (11) facing the removable liner (8). Also disclosed are a disposable assembly (4) for an electrotransport device (1) and a method for assembling reusable and disposable components (2,4), the components (2,4) of the electrotranport device assembly (1) are adhesively mated.

Abstract: A fluid delivery system including a vial having an opening for containing a dry medicament, a container having an opening for containing a solution, upper and lower, pierceable plugs for hermetically sealing the openings of the vial and the container, respectively, a capsule having upper and lower ends, and a sliding member slidably disposed in the capsule and having a double-pointed cannula providing with upper and lower needles. The container is slidably inserted into the capsule from the upper open end of the capsule and the vial can be detachably and fixedly connected to the lower open end of the capsule. When container is pushed downward, the lower needle of the cannula is firstly pierced and inserted into the plug of the vial so that the cannula is communicated with the medicament vial and then the upper needle of the cannula is pierced and inserted into the plug of the container so that the vial and the container are communicated to each other through the cannula.

Abstract: A container for housing body fluids. The container comprises a body defined by flexible walls having an interior for housing the body fluid. An elongated tube extends from the body for housing a fluid to be added to the body fluid. The tube includes means for allowing selective fluid flow from the interior of the tube to the interior of the body allowing the fluid to be added to the body fluid. Additionally, the means for allowing selective fluid flow allows the body fluid to be expressed from the body of the container into the elongated tube. The present invention also provides a method for storing and treating blood.

Abstract: A rectangular hypodermic syringe with a needle that can not be re-used once a nonlinear needle has been moved to a needle protecting retracted position includes a rectangular cylinder; a rectangular plunger for displacing the fluid within the cylinder; a rectangular needle guard, having an interior chamber, demountably attached to the rectangular cylinder; an elongate needle assembly, having a nonlinear needle, slidably mounted within the interior chamber of said needle guard; and means for fluidly coupling said cylinder to said needle when the needle assembly is in the extended position and for fluidly separating the cylinder from the needle when the needle assembly is in the retracted position. Lock means locks the needle assembly in the needle exposing extended position. Release means unlocks the needle assembly allowing a coil spring to move the needle assembly to the needle protecting retracted position.