Abstract: A fixed wire balloon catheter for use in angioplasty includes an elongated flexible thin walled metal tube which carries an inflatable balloon at its distal end. A metal core member of smaller outer diameter meter than the metal tube is attached to the distal end of the tube to provide support for and guiding of the balloon section. The proximal end of the balloon is connected either to the distal end of the metal tube or to an intermediate waist tube, with the core extending distally from the metal tube through the balloon. The distal end of the balloon is secured to the core. A vent arrangement is provided to purge the catheter of gases prior to use.

Abstract: A technique for ablation and removal of plaque deposits from the arterial, venous, vascular graft or other tissue wall of a patient. Ablation is accomplished by directing a high pressure jet of sterile saline solution at the plaque deposit. The high pressure jet is located at the distal end of a catheter which is advanced through the vascular system to the site of the plaque deposit. Removal of the debris is via an evacuation lumen within the catheter.The arterial wall is protected from damage by the catheter design which directs the high pressure jet towards a portion of the distal end of the catheter which serves as a target. The distal end of the catheter is placed such that the plaque or other deposit to be ablated is positioned between the high pressure jet and the target.An optional ultrasonic transducer array located adjacent the high pressure jet and the evacuation lumen permits the attending physician to monitor the procedure.

Abstract: A transdermal medication system wherein said medication is selectively dispensed on-demand from multiple reservoirs within a disposable patch so as to vary the drug choice and the drug concentration, and thereby the regimen and release rate. In a preferred embodiment electric resistance heating activates multiple heat-shrink polymer reservoirs into an absorbent layer for transdermal passage. An embodiment of the invention dispenses a heated moisturizing fluid to facilitate transdermal transfer. In another embodiment, depletion indication is provided.

Abstract: An electrically powered iontophoretic delivery device is provided. The device utilizes electrodes composed of a preferably hydrophobic polymeric matrix. The matrix contains about 10 to 50 vol % of a material capable of absorbing a liquid solvent, typically water, to provide a plurality of ion conducting pathways through the matrix. The matrix also contains about 5 to 40 vol % of a chemical species which is able to undergo either oxidation or reduction during operation of the device. Preferably, the solvent absorbing material is a hydrophilic polymer such as polyvinylpyrrolidone. For the anodic electrode, the chemical species should be able to undergo oxidation and is preferably either silver or zinc. For the cathodic electrode, the chemical species should be able to undergo reduction and is preferably silver chloride or a reducible metal.

Abstract: This invention relates to the prevention and treatment of thrombi using pminogen activators, including t-PA, urokinases, and streptokinases, in conjunction with intermittent (pulsed mode) ultrasound. A preferred modality interposes liquid-containing interface between the skin of the patient and the transducer of the ultrasound generator.

Abstract: A dry-state iontophoretic drug delivery device (10, 20) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a passageway (21, 22) is provided through the backing layer (13) and the electrode layer (11, 12) of both the donor electrode assembly (8) and the counter electrode assembly (9). Water or other liquid can be introduced through these passageways (21, 22) in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10). In another embodiment of the device (20), the drug and electrolyte reservoirs (15, 16) are initially separated from their respective electrodes (11, 12). After the reservoirs (15, 16) are hydrated, they are placed in electrical contact with their respective electrodes (11, 12). By joining the reservoir (15, 16) to the electrode (11, 12) after hydration occurs, delamination problems are reduced.

Abstract: Methods, formulations, and a system for improved iontophoretic administration of a drug, by, preferably, topical administration of a formulation containing an active vasodilator, rubefacient, or counterirritant agent such as capsaicin on the skin at the electrode site, or, iontophoretic administration of a vasodilator formulation or alpha blocker prior to iontophoretic administration of the drug.

Abstract: A needless injection device includes an initiator valve controlling flow of compressed gas into a reservoir. A poppet valve connecting to the reservoir has a gas pressure regulation end to regulate flow from the initiator valve into the reservoir. A clamp piston is driven forward by gas pressure from the reservoir and causes jaws to clamp onto a plunger extending into an ampule. The poppet valve opens when reservoir pressure reaches the cracking pressure of the poppet valve. Gas from the reservoir rushes through the popper valve into a drive chamber and forces a drive piston, containing the clamp piston and jaws, forward causing the plunger to slide into the ampule. A jet of injectant sprays out of the nozzle of the ampule and penetrates through the patient's skin.

Abstract: An ultrasound catheter (10) for removing obstructions from tubular anatomic structures such as blood vessels, said catheter comprising an elongate flexible catheter body (20) having an ultrasound transmission member or wire (24) extending longitudinally therethrough. A distal head (26) is formed on the distal end member of the ultrasound transmission member or wire (24) and is affixed to the catheter body (20). The ultrasound transmission member or wire may be formed of any material capable of transmitting ultrasonic energy including various superelastic metal alloys such as nickel titanium metal alloys. The distal portion of the ultrasound transmission member or wire (24) may be of reduced diameter to provide enhanced flexibility and/or amplification of the ultrasonic energy through the distal portion of the ultrasound transmission member or wire. A proximal end member connector (12) may be provided with a sonic connector to effectively couple the catheter (10) to the ultrasound transducer (14).

Abstract: An elongate ultrasound transmission member having regions of differing cross-sectional dimension or diameter. A sleeve, sheath or other damping member may be positioned around a portion of the ultrasound transmission member to dampen or limit transverse side-to-side movement of such portion of the member. The ultrasound transmission member may be incorporated into a flexible catheter body to form an ultrasound delivering medical catheter.

Abstract: An electrical circuit (21) for an electrotransport agent delivery device (10), and a method for making same, is provided. The circuit (21) generally includes a plurality of electrically conductive circuit traces (71-77) deposited on a substrate (42). One or more electrical circuit components (61-63), such as batteries, resistors, capacitors and/or transistors, is mounted on the substrate (42) and are electrically connected to the circuit traces (71-77), using an electrically conductive adhesive. The circuit traces (71-77) and the adhesive contain an electrically conductive filler which renders the traces and the adhesive electrically conductive. Preferably, the electrically conductive filler is a material which is relatively non-toxic, such as silver, carbon and/or graphite. The electrical circuit components (61-63) may be connected to the circuit traces (71-77) using automated component attachment procedures.

Abstract: The present invention describes a catheter suitable for introduction into a tubular tissue for dissolving blockages in such tissue. The catheter is particularly useful for removing thrombi within blood vessels. In accordance with the preferred embodiments, a combination of vibrating motion and injection of a lysing agent is utilized to break up blockages in vessels. The vessels may be veins, arteries, ducts, intestines, or any lumen within the body that may become blocked from the material that flows through it. As a particular example, dissolution of vascular thrombi is facilitated by advancing a catheter through the occluded vessel, the catheter causing a vibrating, stirring action in and around the thrombus usually in combination with the dispensing of a thrombolytic agent such as urokinase into the thrombus. The catheter has an inflatable or expandable member near the distal tip which, when inflated or expanded, prevents the passage of dislodged thrombus around the catheter.

Abstract: Disclosed is apparatus for administration of a drug in active form, which includes means defining a prodrug reaction zone including an immobilized enzyme for modifying chemically a prodrug to a physiologically compatible, physiologically active drug form, means in communication with the reaction zone for establishing parenteral access to the body of a patient, and means for transporting a prodrug through the reaction zone at a rate sufficient to convert the prodrug to the active drug form and then into the body of a patient.

Abstract: An inflatable percutaneous oxygenator has an inflatable balloon suitable for insertion into a blood vessel. Oxygen is circulated through a number of gas-permeable passageways (such as hollow gas-permeable fibers) adjacent to the balloon surface to permit diffusion of oxygen and carbon dioxide between the blood vessel and the passageways. Pulsatile flow can be used to increase the rate of cross-diffusion of gases. A pump is used to alternately expand and contract the balloon. This causes movement of the passageways within the blood vessel to minimize streaming or channeling of the blood flow around the oxygenator, maximizes turbulence in the bloodstream, and therefore maximizes diffusion of gases. In one alternative embodiment, the balloon is made of a gas-permeable material and is inflated with oxygen to supplement cross-diffusion of gases with the bloodstream.

Abstract: An electrophoretic/electro-osmotic transdermal drug delivery system for passing at least one drug, or therapeutic compound, through the skin membrane of a patient by way of a drug reservoir or gel for delivery to the systemic blood of a patient in selected, periodic pulsations. The system can be varied to accommodate various types of therapeutic compounds having varied characteristics and purposes. The system includes a current oscillator that applies periodic electrical variations to the system in order to trigger rhythmical variations of the potential and resistance of the skin membrane so as to cause oscillatory electro-osmotic streaming of the liquid with the therapeutic compound across the skin membrane in synchronization with the oscillator to the systemic blood of the patient in response to the rhythmical variations.

Abstract: A medical probe device comprises a catheter having a stylet guide housing with one or more stylet ports in a side wall thereof and a stylet guide for directing a flexible stylet outward through the stylet port and through intervening tissue at a preselected, adjustable angle to a target tissue. The total catheter assembly includes a stylet guide lumen communicating with the stylet port and a stylet positioned in said stylet guide lumen for longitudinal movement from the port through intervening tissue to a target tissue. The stylet can be an electrical conductor enclosed within a non-conductive layer, the electrical conductor being a radiofrequency electrode. Preferably, the non-conductive layer is a sleeve which is axially moveable on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue. The stylet can also be a microwave antenna. The stylet can also be a hollow tube for delivering treatment fluid to the target tissue.

Abstract: An ultrasound catheter device for transmitting ultrasound into a mammalian body comprising an elongate catheter body having at least one lumen extending longitudinally therethrough. Also extending longitudinally through the lumen are at least two ultrasound transmission members, each of which have a proximal end coupleable to an external ultrasound source and a distal end which terminates near the distal end of the catheter.

Abstract: A pump assembly (20) employs electrochemistry to selectively control the delivery rate of a dispensing fluid (21) from a dispensing reservoir (24) by selectively controlling the flow rate of a driving fluid (19) from a driving reservoir (23) to a receiving reservoir (33). A partition (25), separating the driving reservoir from the receiving fluid reservoir, includes at least one aperture (28) which is opened or closed depending upon an electrical signal from a remote programming unit. Flow into the receiving reservoir deflects a barrier member to expel dispensing fluid from the dispensing reservoir. The dispensing fluid flow rate can be programmed to provide an appropriate steady or varying flow rate; user-initiated pulses of dispensing fluid can also be provided. A method of controlled infusion of an infusate employing electrochemistry is also provided.

Abstract: A catheter device insertable into a body lumen and incorporating combined ultrasound ablation and endoscopic visualization apparatus. The catheter device generally comprises an elongate catheter body including an ultrasound transmission member extending longitudinally therethrough having a proximal end connectable to an ultrasound transducer such that ultrasonic energy will pass through the ultrasound transmission member to the distal end thereof. Also extending longitudinally through the catheter body is a light transmission member having a proximal end connectable to a light source such that light will pass through the light transmission member to the distal end thereof, and an optical image transmission member having a proximal end connectable to an external image viewing apparatus such that an optical image will pass through the optical image transmission member from the distal end thereof to the external image viewing apparatus.

Abstract: A medical probe device comprises a catheter having a stylet guide housing with one or more stylet ports in a side wall thereof and guide means for directing a flexible stylet outward through the stylet port and through intervening tissue at a preselected, adjustable angle to a target tissue. The total catheter assembly includes a stylet guide lumen communicating with the stylet port and a stylet positioned in said stylet guide lumen for longitudinal movement from the port through intervening tissue to a target tissue. The style can be an electrical conductor enclosed within a non-conductive layer, the electrical conductor being a radiofrequency electrode. Preferably, the non-conductive layer is a sleeve which is axially moveable on the electrical conductor to expose a selected portion of the electrical conductor surface in the target tissue. The stylet can also be a microwave antenna. The stylet can also be a hollow tube for delivering treatment fluid to the target tissue.