Abstract: A needle point protection sheath comprises a protector tube having a bore for receiving a hollow needle plus a needle hub within the bore. The protector tube has a closure cap at one end thereof and has a retention member at the other end to engage an end of the hub, to prevent the hub from passing out of the other tube end. The cap may carry a sleeve having a needle-pierceable wall at its inner end, or a mass of resilient material which is capable of being penetrated by the needle as the cap is closed, to seal the needle tip and thus prevent the spilling of blood residue when a blood collection needle is being enclosed for protection.

Abstract: An ultrasonic dissection and coagulation system for surgical use is provided. The system includes an ultrasonic instrument, a control module, and a pedal actuator. The ultrasonic actuator has a housing and an elongated body portion extending from the housing. An ultrasonic transducer supported within the housing is operatively connected to a cutting blade by a vibration coupler. The vibration coupler conducts high frequency vibration from the ultrasonic transducer to the cutting blade. The cutting blade has a cutting surface which is angled with respect to the longitudinal axis of the elongated body portion and, thus, with respect to the axis of vibration. A clamp member having a tissue contact surface is positioned adjacent to the blade member and is movable from an open position in which the tissue contact surface is spaced form the cutting surface to a clamped position in which the tissue contact surface is in close juxtaposed alignment with the cutting surface to clamp tissue therebetween.

Abstract: The invention concerns a process and a device for the combined conveyance and volume measuring of liquids. The conveyance is performed by imparting an overpressure or, respectively, a negative pressure to the liquid by means of a pressurized or depressurized gas cushion. A piston movable in a cylinder which is connected with a receiver containing the liquid exerts either a constant overpressure upon a gas cushion above the liquid to drive the liquid through a line connected with the receiver, or it exerts a constant negative pressure upon the gas cushion to draw the liquid from the line into the receiver. The transported volumes of the liquid are determined by the volumina covered by the piston in the course of its displacements in the cylinder.

Abstract: A balloon dilatation catheter is provided which has a stiff proximal cannula made of a material such as metal hypotubing. The distal end of the catheter includes an inflatable medical device balloon, an inflation lumen and a guidewire lumen. A coiled transition assembly is positioned between the proximal cannula and the distal end section. This coiled transition assembly has a tightly wound coil within a tube and provides for a flexible transition between the two components of diverse stiffness, namely the proximal cannula and the flexible distal end portion. The dilatation catheter typically has an easily or rapidly exchangeable feature and is used in conjunction with a guiding catheter. During a procedure when the catheters are within the vascular system, the coiled transition section of the dilatation catheter readily follows tightly curved portions of the inserted guiding catheterby.

Abstract: A retracting needle syringe includes a barrel having a chamber, an open proximal end and an open distal end. A plunger is slidably positioned in fluid-tight engagement with an inside surface of the barrel. The plunger has an elongated cavity in its distal end and a cover element sealing the cavity. A needle assembly at the distal end of the barrel includes a needle cannula having an inner hub having an open proximal end and a distal end connected to the needle cannula so that the lumen of the cannula is in fluid communication with the chamber. A flange on the inner hub is connected to a proximal end of an outer hub so that the needle cannula projects distally outwardly from a distal end of the outer hub. A spring is contained between the inner hub and the outer hub. A circular release element is movably connected to a proximal end of the flange.

Abstract: A breakaway intravenous needle device, including a syringe and needle assembly, and a disposal apparatus for removing, retaining and discarding needles attached to the intravenous needle device. The breakaway syringe comprises a syringe barrel which extends from a proximal barrel end to a distal barrel end. A nozzle extends distally from the distal barrel end and includes a weakened portion. Bending of the syringe barrel relative to the nozzle distal end causes the syringe to break along the weakened portion. When coupled with a needle hub and needle assembly and used with the disposal apparatus of the present invention, the syringe and attached needle assembly are held stationary within an aperture disposed on the disposal apparatus. The syringe barrel may then be moved laterally or otherwise bent relative to the needle hub to break the syringe along the weakened portion of the nozzle.

Abstract: The syringe includes a barrel, a plunger, and an adapter for mounting the needle in the distal end of the barrel. The adapter includes a protrusion projecting away from the needle end and into the barrel defining an annular space between the barrel and the protrusion. The plunger and protrusion have complementary surfaces whereby the plunger may grip the adapter for removal of the adapter into the interior of the barrel after use. These complementary surfaces afford initial resistance to further axial movement of the plunger toward the adapter, signalling the user that further axial pressure will permanently lock the plunger and adapter to one another whereby, upon application of full axial pressure on the plunger, the complementary surfaces of the plunger and adapter permanently lock to one another to enable joint unitary movement of the plunger and adapter together with the needle carried by the adapter into the barrel.

Abstract: A catheter balloon for use in dilation procedures, such as angioplasty, has multiple pleats formed therein, preferably six such pleats, that may be folded, or wrapped, circumferentially around the catheter to provide a minimized outer diameter when the balloon is deflated. The balloon pleats form six wings in the balloon and each of the balloon wings has a length such that it overlaps a portion of an adjoining wing and each wing extends about one-quarter of the circumference of the catheter shaft. A device for forming such folds in a balloon includes a forming chamber and a plurality of forming elements radially disposed around the balloon.

Abstract: A guard for a medical cartridge, such as a pre-filled syringe, includes a body having an open proximal end communicating with a cavity for receiving the cartridge, and a shield slidably attached to the body. The body has a semi-rigid cantilever member on its distal end from which a stop tab, having a sloped distal edge and a blunt proximal edge, extends. The shield includes an elongate opening for receiving the stop tab, thereby allowing the shield to slide between unguarded and guarded positions for exposing and covering a needle, respectively. During assembly of the shield and body, the stop tab slidably engages an assembly tab on the shield, deflecting the cantilever member inward while the stop tab passes under the shield, the sloped distal edge of the stop tab minimizing damage to the stop tab or shield. In the guarded position, the blunt proximal edge of the stop tab engages a proximal wall of the elongate opening to prevent further distal movement beyond the guarded position.

Abstract: The present invention is directed to a vaginal insert for delivering an agent to a urogenital tract in a patient. The patient has a vagina, and the vagina has a vaginal wall. The vaginal insert comprises a base member sized to fit within the vagina, the base member defines a chamber and a port in fluid communication with the chamber. A membrane is operatively connected to the base member. The membrane defines a reservoir and a pore. The reservoir is in fluid communication with the port. The membrane is sized so that the vaginal wall will exert pressure against the membrane when fluid is in the reservoir, thereby forcing some of the fluid to flow through the pore and to tissue of the urogenital tract.

Abstract: A system and method for generating a gas-supersaturated fluid and delivering the fluid at high delivery pressures to thereby prevent bubble nucleation is disclosed. The system comprises a housing for containing a removable fluid assembly for housing a fluid to be gas-supersaturated and a drive assembly for delivering the fluid to a delivery site. The housing assembly comprises a cylinder and a piston which may be advanced along the inner surface of the cylinder to pressurize and to deliver the fluid. To generate a gas-supersaturated fluid, the housing assembly is removed from the system housing, filled with a fluid, and gas is introduced at or slightly above the desired gas partial pressure into the cylinder.

Abstract: A dilatation catheter includes an inflation balloon having a variable diameter inflation profile. The balloon has a first inflation profile, in which it exhibits a substantially cylindrical central working profile. The first inflation profile of the balloon is achieved by inflating the balloon to a first inflation pressure. The balloon has a second inflation profile which is achieved by increasing the inflation pressure to a second, higher pressure. In the second inflation profile, a proximal segment and a distal segment of the balloon have a first inflated diameter and a central focal segment, separating the proximal and distal segments, has a second inflated diameter, such that the second inflated diameter is greater than the first inflated diameter. Methods of using the catheter are also disclosed.

Abstract: A prefillable syringe includes an elongate barrel having an open distal end and a proximal end with at least one chamber formed therebetween for receiving a substance sensitive to pH shift, such as water for injection. The barrel is made of a low extractable ion glass preferably having a low concentration of sodium of less than 8% and preferably around 4% or less.

Abstract: Method and apparatus associated with safe retraction of medical needles after use. Embodiments are disclosed for self-retracting needle systems for both blood draw, syringe and catheter insertion systems. Invention manufacture requires only a minimal number and complexity of parts such that a projected manufacturing cost is potentially low enough to permit the apparatus to be cost competitive with contemporary non-self retracting needle systems. Methods for making and assembling each of the disclosed the embodiments is also disclosed. One blood draw embodiment can be made with as few as three molded parts. Energy-storing, needle-retracting mechanisms comprise elastic tubing and vacuum generating piston parts. In an elastic tubing embodiment, selective, constrictive control of stretched tubing volumes effectively inhibits regurgitant flow from the needle. In all embodiments, needle retraction is a single handed operation permitting a technician's other hand to be used in wound care.

Abstract: A system and method for surface tissue ablation on the patient's outer skin, such as the epidermis or the underlying dermis. An electrosurgical probe (130) comprises a shaft (132) having an array of active electrodes (136) on its distal tip and a connector (134) at its proximal end for coupling the electrode array to a high frequency power supply. An electrically conducting liquid is directed along a fluid flow path (142) past a return electrode surface (138) to the target site to provide a current flow path between the target site and the return electrode. High frequency voltage is then applied to the active and return electrodes so that an electric current flows from the active electrode, through a layer of vapor formed at the tip of the electrode, and to the return electrode through the current flow path provided by the electrically conducting liquid.

Abstract: A tracheostomy tube assembly has an outer catheter and an inner cannula that is insertable into and removable from the outer catheter. The inner cannula has two elongate regions along its length of different flexibility. The main body of the cannula may be relatively stiff and a narrow region along its length be of a more flexible material, such as extruded to form the entire thickness of the wall of the cannula, so that the cannula is preferentially flexible in the plane of the center line of the narrow region to permit the cannula to be inserted, without kinking or buckling, into the outer catheter.

Abstract: The plunger systems for use in an injector-actuated syringe of the present invention include a dynamic wedge seal which improves the sealing engagement between the plunger cover and syringe barrel, and flexible capture members extending from the rear surface of the plunger which permit the engagement and disengagement of the plunger from the injector drive means at any plunger position within the syringe. Further, the plunger systems include a contrast saving tip which expells the injection liquid from the syringe tip.

Abstract: The present invention is an injection port assembly for subcutaneous delivery of medication. A single molded body has a soft cannula extending downward from a generally flat bottom surface and a self-sealing septum mounted at the center of a top surface which is generally of a concave shape sloping downward towards its outer perimeter at which point the single body is very thin. The single body also has a tubular extension which is directed outward parallel to the skin's surface. A metal needle which penetrates through the septum and through the lumen of the soft cannula is used for inserting the cannula through the skin. Once the soft cannula is placed subcutaneously, the needle is removed and an adhesive tape is placed over the single body and onto the skin beyond the body's outer perimeter.

Abstract: An iontophoretic drug delivery device includes a controller normally being in an off or low power consumption state, and a patch including electrodes, a reservoir containing an ionizable drug for transcutaneous delivery to a patient and a return reservoir. The patch is removably and electrically connectable to the controller, and delivers the drug to patient when the patch is on the patient's skin and when the controller is switched from the off or low power consumption state to an operational state. This occurs when the patch is inserted into the controller. This feature preserves the battery of the controller. Upon patch insertion, the controller periodically changes from a non-current delivery state to a current delivery state for the predetermined period of time to deliver a pulse of current to the inserted patch. A current sensor within the controller measures the current delivered to the patch.

Abstract: A low profile wire perfusion catheter is disclosed for use in percutaneous transluminal coronary angioplasty. The catheter includes a wire configured to be inserted into a blood vessel. The wire is hollow and defines an axial lumen therein. An inflation balloon is attached directly to the wire and is configured to expand radially outward in response to inflation thereof. Inflow and outflow perfusion ports extend through the wire and communicate with the lumen to allow perfusion of blood across the balloon when the balloon is inflated within a blood vessel. Because the balloon is attached directly to the wire, the catheter has an advantageously low cross-sectional area.