Abstract: A medical device comprising an organic polymer substrate material having a coating thereon, the coating comprising an interpenetrating network of two different hydrogel polymers, one of which is a polyurethane/polyurea hydrogel polymer, the polyurethane/polyurea hydrogel polymer being linked to the substrate material by covalent urea linkages.

Abstract: Generally, the present invention provides a device for insertion into a body of a subject being treated to deliver localized x-ray radiation, and a method for use of such a device. The device includes an anode and a cathode, disposed within a vacuum housing. The device further includes a balloon coupled to and circumferentially surrounding the vacuum housing, and a fluid loop for circulating a cooling fluid proximate to the vacuum housing. A method for delivering localized x-ray radiation to an interior passage of a body is also described, including the steps of positioning an x-ray device at the passage to be treated and applying a high voltage to the x-ray producing unit to produce localized x-ray radiation.

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract: A device and method for treatment of cancerous tissue from a body conduit involves insertion into the body conduit of a probe including an energy-emitting element for delivering ionizing energy. The body conduit is dilated to decrease a distance between at least a portion of the body conduit and the cancerous tissue. Ionizing energy is delivered from the energy-emitting element to selectively injure the cancerous tissue, with dilation of the body conduit minimizing the radiation dose delivered to the body conduit for a given radiation dose delivered to the cancerous tissue.

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract: Systems and methods for treating thrombosis by driving the drugs or lytic agents through the thrombus by pressure, are disclosed. The system preferably comprises a guide catheter with an occlusion balloon for isolating the region proximal to the thrombus, a guide wire with an occlusion balloon for isolating the region distal to the thrombus and an infusion catheter for delivering drugs or other agents into the region distal to the thrombus under pressure. A lumen of the guide catheter is preferably provided to evacuate material proximal to the thrombus, decreasing the pressure in the proximal to the thrombus. The lumen can be coupled to a thrombus filter to remove thrombolytic material from the drug or lytic agent evacuated from the proximal region. The filtered drug or lytic agent can then be redelivered into the distal region. Recycling of the drug or lytic agent in this manner decreases the costs of the procedure.

Abstract: Slippery, hydrophilic coating compositions of a polyurethane/urea prepolymer adduct intermediate commingled with at least one dissimilar hydrogel polymer precursor, and materials composed of a polymeric plastic or rubber substrate or a metallic substrate with a slippery hydrogel coating of a polyurethane/urea prepolymer adduct intermediate and at least one dissimilar hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device.

Abstract: Generally, the present invention provides a device for insertion into a body and delivery of x-ray radiation, and a method for fabricating such a device. The device includes a connector, the vacuum housing, an anode and a cathode having a granular surface and being composed of a material that allows it to act as a getter. The cathode may also contain diamond material in one embodiment.

Abstract: A dilatation balloon (20,98) is fabricated according to a process that yields high hoop strength and uniformity in balloon wall thickness. A length of tubing (34) is axially elongated and radially expanded in a form (36) to provide the requisite biaxial orientation and strength. Then, an excimer laser (46,66,84) is used to remove the polymeric material by photo-chemical ablation, virtually without thermal effects. Dilatation balloon walls are thinned primarily along tapered sections (26,28) between proximal and distal balloon stems (30,32) and a medial working section (24) of the balloon. Material removal, particularly near the balloon stems, enables tighter wrapping of the balloon for a reduced delivery profile, and reduces rigidity near the stems for better maneuverability of the catheter in tortuous passageways. The balloon tapered sections are reduced to a wall thickness substantially equal to that of the medial section. Alternatively, an array of grooves (96) is formed in each tapered section.

Abstract: An infusion guide wire of superelastic nickel titanium is disclosed comprising a lumen extending longitudinally through the wire and a distal portion with a smaller outer diameter than a proximal portion. One or more intermediate portions of intermediate outer diameters can be provided, as well. An occlusion balloon can be attached to the distal portion, and inflated through the lumen. Alternatively, or in conjunction with the occlusion balloon, drugs or other agents can be delivered through the lumen.

Abstract: A dilation-drug delivery catheter comprises a dilation portion for dilating a stenosis and a drug delivery portion for delivering antithrombolytic, antiproliferative, or any other type of medication, to the dilation site. The drug delivery portion of the catheter is located within the dilation portion, which can be retracted to reveal the drug delivery portion, after dilation. Occlusion balloons are preferably provided on the drug delivery portion to isolate the dilation site during drug delivery.

Abstract: A dilatation balloon is fabricated according to a process that yields high hoop strength and uniformity in balloon wall thickness. A length of tubing is axially elongated and radially expanded in a form to provide the requisite biaxial orientation and strength. Then, an excimer laser is used to remove the polymeric material by photo-chemical ablation, virtually without thermal effects. Dilatation balloon walls are thinned primarily along tapered sections between proximal and distal balloon stems and a medial working section of the balloon. Material removal, particularly near the balloon stems, enables tighter wrapping of the balloon for a reduced delivery profile, and reduces rigidity near the stems for better maneuverability of the catheter in tortuous passageways. The balloon tapered sections are reduced to a wall thickness substantially equal to that of the medial section. Alternatively, an array of grooves is formed in each tapered section.

Abstract: A catheter for delivering drugs or other agents is disclosed particularly suited for delivering drugs proximate the walls of a vessel or lumen, such as an artery or vein. The catheter comprises a shaft with a distal portion comprising at least one and preferably a plurality of delivery members. When deployed, the delivery members flare from the catheter shaft at an acute or obtuse angle. At least a portion of the delivery members are within a restraining member such as a sleeve or thread, for example, to maintain the delivery member within the diameter of the shaft prior to deployment. Delivery lumens provide drugs to ports in the delivery members for delivery out of the catheter. The delivery members preferably bear against the wall of the vessel when deployed, to deliver the drug or other agent proximate the walls of the blood vessel, where blood flow is slow. In another embodiment the delivery members comprise a first tapered portion, a second longitudinal portion and a plurality of drug delivery ports.

Abstract: A process for preparing coating compositions of a commingled hydrogel of a polyurethane-polyurea polymer hydrogel and a poly(N-vinylpyrrolidone) polymer hydrogel; a process for making materials composed of a polymeric plastic or rubber substrate or a metallic substrate, with a coating of the commingled hydrogel thereon; and a process for making medical devices with a coating of the commingled hydrogel thereon, are disclosed. The coating compositions tenaciously adhere to the substrate materials and medical devices to which they are applied due to bonding of a tie coat to a reactive substrate surface and due to the commingling of the two hydrogel components. The coating compositions and coated materials and medical devices are non-toxic and biocompatible, making them ideally suited for use in applications such as for catheters, catheter balloons and stents.

Abstract: A process for preparing coating compositions of a commingled hydrogel of a polyurethane-polyurea polymer hydrogel and at least one other polymer hydrogel of a polymer different from polyurethane-polyurea; a process for making materials composed of a polymeric plastic or rubber substrate or a metallic substrate, with a coating of the commingled hydrogel thereon; and a process for making medical devices with a coating of the commingled hydrogel thereon, are disclosed. The coating compositions tenaciously adhere to the substrate materials and medical devices to which they are applied due to bonding of a tie coat to a reactive substrate surface and due to the commingling of the two hydrogel components. The coating compositions and coated materials and medical devices are non-toxic and biocompatible, making them ideally suited for use in applications such as for catheters, catheter balloons and stents.

Abstract: This invention relates to a drug delivery device having a hollow tube which is configured to serve as a guide wire for intraluminal procedures. The distal portion of the tube has at least one opening which has a diameter suitable for the infusion of a drug formulation therethrough. The tube is preferably formed from a superelastic material such as nickel-titanium alloy. This invention also relates to various methods of using this drug delivery device in thrombolytic and other intraluminal procedures.

Abstract: An apparatus includes a flexible tubular member containing a shape-memory tube formed to include a lumen extending along the central axis of the tubular member. A liner sleeve extends through the lumen of the shape-memory tube and lies inside the tubular member. A control system selectively heats the shape-memory tube to its activated state causing the shape-memory tube to move toward a predetermined shape if it is different than its present configuration. Whether the shape-memory tube moves or not, it will increase significantly in stiffness, both axial and bending to help retain, hold, or wedge the apparatus in place in a selected body cavity while catheters or other objects are passed through a lumen in the liner sleeve.

Abstract: Catheters for drug delivery or for both dilatation and drug delivery are provided with a guide wire lumen terminating within the catheter shaft and having an opening through the catheter shaft to enable a guide wire to exit the catheter shaft substantially distal to the proximal end of the catheter. In one embodiment, drug delivery ports are provided between occlusion balloons. In another embodiment, a dilatation balloon is also provided between the occlusion balloons. In another embodiment, a double layered balloon is provided to simultaneously dilatate the stenosis and deliver medication to the site. Alternatively, a balloon can be provided which only delivers medication.