Abstract: A thrombolysis catheter system having a fixed length infusion zone is disclosed. The invention contemplates apparatus, method and kit aspects. The apparatus, which has the capability to track a guidewire, uses a multilumen catheter to deliver radially thrombolytic agent to an infusion zone defined by one or more balloon means. In one aspect, with an occluder means, a primary lumen of the catheter is used both for catheter placement and delivery of fluid. The method discloses utilization of radiopaque indicia to place the catheter in proximity to the occlusion or diseased tissue to be treated. The kit includes a catheter of the invention in conjunction with a steerable guidewire and a tip occluder wire, either or both of the tip occluder wire and the guidewire having an enlargement on their distal tip which cooperates with a reduced diameter portion of the catheter lumen.

Abstract: An indwelling urinary catheter comprises a two-ply (or equivalent) air-inflatable anchoring balloon means in which an outer ply or skin thickness thereof, is not bonded to the inner ply over one or more small areal segments each measured at the intersection of the two plys radially located from the axis of symmetry of a central catheter body. Instead, when inflated, each areal segment expands mostly in a sidewise looking direction over a minimum radial arc relative to a central catheter body, to form one or more elongated lobes that are larger than and hence stabilize the catheter body relative to the entry port of the user's bladder but leaving rigid collar regions located between adjacent segments so as to not interfere with the formation of large drainage ports therethrough.

Abstract: Methods and devices for treating vulnerable plaque deposits within a blood vessel, having an inner surface and one or more plaque deposits containing a core material are disclosed. A device in accordance with an exemplary embodiment of the present invention includes an elongate shaft having a proximal end and a distal end, a balloon disposed about the elongate shaft for engaging one or more plaque deposits and extracting the core material therefrom, a first venturi section disposed proximally of the balloon, and a second venturi section disposed distally of the balloon.

Abstract: A central venous catheter includes coolant supply and return lumens which communicate coolant to and from first and second heat exchange membranes arranged along the distal segment of the catheter. The coolant in the heat exchange membranes removes heat from the patient. Additional lumens are provided for conventional central venous catheter uses.

Abstract: An intravenous catheter system (apparatus and method) for controlling patient temperature includes a generally tubular elongated body having lumens for circulating a heat exchange fluid in a plurality of heat exchange elements provided at spaced intervals along the length of the elongated body. The heat exchange elements preferably comprise inflatable balloons. Heat exchange occurs between the fluid in the balloons and blood in the blood vessel. Each balloon preferably is sized such that, when inflated, each balloon blocks no more than approximately 30% to 75% of the blood vessel in which it is intubated. The catheter preferably has two to four balloons, each of which may have a different shape. The catheter also preferably has three to five infusion lumens for providing access to the patient's blood at different locations in the patient's bloodstream.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes an inner shaft longitudinally movable within an outer shaft, each shaft having at least one balloon and at least one lumen formed therein. The catheter prevents leaking through a biological membrane by sealing the catheter tip passageway through the biological membrane with inflatable balloons on either side of the biological membrane. Further, the inflated balloons secure the position of the catheter relative to the biological membrane and the biological space targeted for therapy or diagnosis.

Abstract: A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes inflatable balloons which when inflated in a target segment of a biological space, create closed agent delivery pockets for the delivery or collection of agents from a defined space.

Abstract: Methods of treating the prostate include administering a thermal ablation therapy and inhibiting the obstruction or closure of the prostatic urethral opening by forming a biodegradable stent in situ in the subject such that the stent attaches to the walls of the prostatic urethra. A related method of treating BPH includes thermally treating or ablating localized tissue in the prostate with a treatment catheter and inserting flowable stent material via the treatment catheter into the prostate (either before, during, or after the thermal treatment), forming the flowable stent material so that it defines a stent that remains in position after removal of the treatment catheter to inhibit the closure of the urinary passage. Associated stents and catheters are included.

Abstract: An apparatus for treating an occlusive region of a blood vessel includes a catheter including a first lumen extending from an end port to a first side port, and a second lumen extending from a proximal end of the catheter to a second side port. A balloon is mounted on the catheter between the first and second side ports. During use, a guidewire is placed into an occlusive region, and the guidewire is backloaded through the first and second lumens. The catheter is advanced over the guidewire, and the balloon is expanded to isolate the occlusive region. The guidewire is removed, and an agitator is advanced through the second lumen. After the agitator is agitated to dislodge occlusive material from the occlusive region, the agitator is removed, and the loose occlusive material is aspirated via the second side port.

Abstract: Compositions, methods, kits, and apparatus are provided for delivering a macromolecular assembly such as a plasmid, virus vector, or other gene vector, to an extravascular tissue such as muscle tissue. The composition comprises the macromolecular assembly and a vascular permeability-enhancing agent. In another embodiment, the composition further comprises a vasodilating agent. The method of the invention comprises proving a vascular permeability-enhancing agent to a blood vessel and providing a macromolecular assembly to the vessel. An oxygenator useful for providing oxygen to a fluid extracorporeally prior to providing the fluid to a blood vessel of a mammal is included in the invention. Kits, apparatus, and methods for using the catheters described herein for isolating cardiac circulation, diverting caval blood flow from the right atrium, and for other purposes, are also described.

Abstract: A system and methods are described for performing catheter based procedures on high risk patients that mitigate the risk to the patient and extend the acceptable time window for response when emergencies or complications arise. The system is useful for stopped heart catheter procedures or as a safety backup in beating heart catheter procedures and is compatible with concurrent or sequential surgical interventions. The system combines a therapeutic or diagnostic catheter subsystem with a selective aortic perfusion and cardiopulmonary bypass subsystem. The catheter subsystem may include catheters for angioplasty, stent delivery, atherectomy, valvuloplasty or other diagnostic or therapeutic procedures.

Abstract: Described is a closed chest intravascular catheter system for a simultaneous biventricular approach to (1) intravascular cardiopulmonary surgery; (2) acute or prolonged mechanical circulatory support. The catheter system includes a left heart catheter and a right heart catheter with flow control members that segment the circulatory system into subcirculations of cardiopulmonary support. The left heart catheter has an elongated shaft with a first flow control member positioned at the entry site into a peripheral artery, a second flow control member positioned in the proximal descending aorta, a third flow control member positioned in the ascending aorta, and a fourth flow control member positioned within the left ventricle.

Abstract: Clot disruption and dissolution are achieved using a catheter having both an agitator and the ability to deliver a thrombolytic agent. The catheter is introduced to a target region with a blood vessel and the agitator manipulated to engage and disrupt a region of clot therein. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.

Abstract: A catheter provided with an elongated tube having channels for the guiding of a radioactive element and for the passage of a guide wire for the catheter as well as fluid under pressure, in which the elongated tube is provided near its distal end on its outer circumference with a recanalization balloon and activatable centering means arranged therein. A by-pass can also be arranged through the recanalization balloon.

Abstract: A method for treating loosely formed, friable or fragile lesions in a patient's blood vessel. A catheter having a pair of sealing mechanisms is advanced such that the sealing mechanisms are positioned distal to and proximal to the lesion. The sealing mechanisms are activated to seal the vessel on either side of the lesion. A medication is then delivered through the catheter to the sealed area of the vessel. The medication interacts with the lesion in order to partially or completely solidify it. Once the lesion is solidified, the catheter is removed and the lesion can be treated with a conventional intravascular device.

Abstract: Methods and apparatus for creating and delivering a medical agent into an isolated vein segment, the isolated vein segment not having any communicating vein branches, the apparatus comprising a catheter having at least expandable vein occlusion devices to engage and expand the inside wall of a vein, thereby blocking the interior of the vein and preventing fluid located in the isolated segment from flowing between the occlusion devices and the wall of the vein at a pressure within the isolated vein segment of at least 100, and preferably 200, millimeters of mercury, the catheter including one or more lumens for directing a fluid into the isolated vein segment at a pressure of at least 100 millimeters of mercury.

Abstract: A thrombolysis catheter system having a fixed length infusion zone is disclosed. The invention contemplates apparatus, method and kit aspects. The apparatus, which has the capability to track a guidewire, uses a multilumen catheter to deliver radially thrombolytic agent to an infusion zone defined by one or more balloon means. In one aspect, with an occluder means, a primary lumen of the catheter is used both for catheter placement and delivery of fluid. The method discloses utilization of radiopaque indicia to place the catheter in proximity to the occlusion or diseased tissue to be treated. The kit includes a catheter of the invention in conjunction with a steerable guidewire and a tip occluder wire, either or both of the tip occluder wire and the guidewire having an enlargement on their distal tip which cooperates with a reduced diameter portion of the catheter lumen.

Abstract: The emboli protection system provides one or more inflatable blocking balloons for isolation of a section of a blood vessel to prevent migration of emboli from the section during an interventional procedure, and fluid infusion and evacuation ports for flushing emboli from the isolated section. One embodiment provides for a distal blocking balloon catheter, over which an interventional device can be introduced, and a proximal blocking balloon catheter to be introduced over the interventional device for isolating a portion of a blood vessel to be treated. The blocking balloons can be perforated to provide the infusion ports, and thrombolytic inflation fluid may be used to break down and dissolve thrombus and plaque in the isolated portion of the blood vessel.

Abstract: Methods and apparatus are provided for treating congestive heart by actively or passively enhancing perfusion to the renal arteries. A first embodiment comprises a specially configured balloon catheter and extracorporeal pump, wherein the pump operates in a “once-through” fashion or alternating volume displacement mode. In another embodiment the catheter includes a pair of balloons to isolate a region of the aorta, and a third balloon that directs flow into the renal arteries. In still further embodiments, a stent or cuff having a constricted region is deployed in or around the aorta, respectively, to create a backpressure upstream of the stent or cuff. Methods of enhancing renal perfusion also are provided.

Abstract: A novel process for paving or sealing the interior surface of a tissue lumen by entering the interior of the tissue lumen and applying a polymer to the interior surface of the tissue lumen. This is accomplished using a catheter which delivers the polymer to the tissue lumen and causes it to conform to the interior surface of lumen. The polymer can be delivered to the lumen as a monomer or prepolymer solution, or as an at least partially preformed layer on an expansible member.

Abstract: The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit dose composition comprising 0.2 &mgr;g/kg to 48 &mgr;g/kg of an FGF-2 of SEQ ID NO: 2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. In another aspect, the present invention is directed to a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of a human patient in need of treatment for coronary artery disease a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. The single unit dose composition of the present invention provides an angiogenic effect in a human CAD patient that lasts six months before re-treatment is required. In another aspect, the present invention is directed to a method of administration which optimizes patient's safety.

Abstract: Methods and apparatus are provided for improved administration of brachytherapy in the treatment of prostate disease. More particularly, a prostate visualization device is provided comprising a disk-shaped bladder neck balloon that sealing engages and defines an enclosed space within a proximal region of a patient's bladder. The device is preferably coupled to a catheter for injection of echo-contrast agent into the enclosed space to facilitate imaging of the patient's bladder/prostate junction with an ultrasound system. The device may alternatively be radiopaque. Apparatus for selectively stiffening the catheter is also provided.

Abstract: An intravascular drug delivery balloon catheter incorporating a highly compliant balloon having a plurality of infusion holes. The highly compliant balloon elastically expands at a low inflation pressure (e.g., less than 1.0 ATM), and preferably has a compliance of 2.0 mm/ATM or more at pressures less than 2.0 ATM. A pressure relief valve may be incorporated into the catheter to avoid over pressurization. The infusion holes may be open when the balloon is deflated and may enlarge when the balloon is inflated. The balloon may define a single lobe or two inflatable lobes with the infusion holes disposed therebetween.

Abstract: A catheter for delivering a medical agent to tissue external to a body passage through which the catheter is inserted. The catheter includes a tissue piercing member, e.g., a needle having a rectangular cross-section that is asymmetrically flexible, such that the member is substantially more flexible about a first cross-sectional axis than about a second cross-sectional axis. The tissue piercing member is thus readily deflected about one axis, away from the catheter and into the tissue, while minimizing buckling of the tissue piercing member about the other axis. The catheter can include a balloon located proximal to and on the same side as the piercing member, and a second balloon located distal to and on the opposite side as the piercing member. When inflated, the balloons cause the portion of the catheter between the balloons to flex and bend, facilitating penetration of the tissue by the tissue piercing member.

Abstract: A multi-catheter emboli containment system is disclosed which is adapted to provide at least one pair of optimized paths for irrigation and aspiration fluid flow. Through careful design of the cross-sectional area of these paths, the present system is able to be compactly utilized in even the smaller size blood vessels. The catheter system itself is provided with occlusive devices to form an emboli containment chamber in which irrigation and aspiration occur. The catheter system of the present invention provides an improved emboli containment and removal system which can be utilized in a wide range of vessel diameters. The system is easy to use and can quickly and efficiently evacuate the containment chamber.

Abstract: The invention provides a method and system for treatment of body strictures to restore luminal diameter to within a normal diameter range, in which the stricture is dilated to stretch its lumen to a desired diameter, collagen is exuded near to existing tissue of the stricture so as to be absorbed by that tissue or adhere to that tissue, making a collagen-enhanced tissue structure, and energy is emitted to affect the collagen-enhanced tissue, such as by ablation or by hardening. Ablation and hardening may be repeated so as to create a set of layers of hardened collagen in the form of a supporting frame, preferably having a hollow cylindrical shape. Dilation of the stricture is achieved by expanding one or more balloons, or by the pressure of exuded collagen, until the stricture is larger than a normal diameter range. When energy is emitted into the collagen, the stricture contracts back to the normal diameter range, either by ablation of excess tissue or by plating of the stricture wall.

Abstract: The instant invention provides an apparatus, a kit and a method for treating a tumor in an extremity of a patient.

Abstract: An arterial perfusion cannula and method for achieving cardiopulmonary bypass during heart surgery. The arterial perfusion cannula is inserted peripherally into a preselected arterial vessel and advanced within the vessel and positioned in the ascending aorta cephalid of the junction of the coronary arteries with the aortic root. The arterial cannula has an arterial return lumen for returning oxygenated blood from to the patient from a cardiopulmonary bypass system. The arterial perfusion cannula further has a cardioplegia/venting lumen for the passage of cardioplegia solution to arrest the heart or for the evacuation of blood from the aortic root. An expandable occlusion member is provided for internal occlusion of the ascending aorta between the coronary arteries and the brachiocephalic artery.

Abstract: An arterial perfusion cannula and method for achieving cardiopulmonary bypass during heart surgery. The arterial perfusion cannula is inserted peripherally into a preselected arterial vessel and advanced within the vessel and positioned in the ascending aorta cephalid of the junction of the coronary arteries with the aortic root. The arterial cannula has an arterial return lumen for returning oxygenated blood from to the patient from a cardiopulmonary bypass system. The arterial perfusion cannula further has a cardioplegia/venting lumen for the passage of cardioplegia solution to arrest the heart or for the evacuation of blood from the aortic root. An expandable occlusion member is provided for internal occlusion of the ascending aorta between the coronary arteries and the brachiocephalic artery.

Abstract: A method and apparatus for pressurizing the right atrium or right ventricle of a beating heart during surgery to assist cardiac function. The apparatus has an intake tube for insertion in the inferior or superior vena cava, a return tube for insertion in the right atrium or right ventricle, and a pump (e.g., a peristaltic pump). In operation, blood is pumped from the vena cava into an intake port of the intake tube, from the intake tube through the pump to the return tube, and from the return tube to the right atrium or right ventricle. Optionally, a balloon mounted around the intake tube's distal end is inflated to center the intake port in the vena cava and provide a pressure bulkhead. The pump preferably pumps blood in one direction from an input port to an output port.

Abstract: A balloon catheter for isolating and treating an aneurysm in a vessel. The catheter including one or more inflatable balloons for defining an isolated volume within the vessel and for preventing any blood flow from coming into contact with the interior walls of the vessel outside the isolated volume. The catheter further including a lumen for injecting into the isolated volume a crosslinking agent, such as glutaraldehyde, for toughening the aneurysmal vessel wall.

Abstract: Percutaneous repair of cardiovascular anomalies via the introduction of a photoactivated biopolymer introduced to the affected site via a catheter system.

Abstract: A system for controlling patient temperature uses a central venous line catheter having axially spaced distal and proximal heat exchange balloons. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the balloons. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Abstract: A suprapubic drainage catheter (10) for draining the bladder and maintaining the patency of the urethra of a patient following a radical prostatectomy. The catheter includes an elongated member (11) having a drainage passage(12) extending longitudinally therein and a plurality of drainage ports (21) in a drainage portion (14) thereof for providing external access for the drainage passage in the bladder of the patient. First and second retention balloons (17, 18) are connected with the elongated member and positioned distally and proximally of the drainage ports, respectively. The elongated member also includes first and second inflation passages (26, 27) for individual and independent inflation and deflation of the retention balloons. One-way connector valves (32, 33) are positioned at the proximal end of the catheter for controlling inflation and deflation of the balloons via the inflation passages.

Abstract: A catheter system and method of performing posterior epicardial revascularization and intracardiac surgery on a beating heart. Several catheter systems are provided to achieve a left ventricular isolation and a right ventricular isolation as required to facilitate surgery according to the methods of the present invention. Myocardial infusion is provided in either antegrade or retrograde flow to insure the myocardium meets its oxygen demand.

Abstract: Apparatus and methods are provided for delivering oxygenated blood to a patient undergoing cardiac surgery using a perfusion catheter having a distal end carrying first and second sealing members. When the perfusion catheter is inserted through an arteriotomy site, the first and second sealing members are disposed to engage opposite surfaces of a thickness of a vessel to apply pressure against the opposite surfaces of the thickness to seal blood perfused into the vessel from leaking through the arteriotomy site. Apparatus for placing the perfusion catheter, and methods of using the apparatus also are provided.

Abstract: A kit and method for causing tissue death within a tissue site is disclosed. The kit includes a media with a light activated drug activatable upon exposure to a particular level of ultrasound energy. The kit also includes a catheter with a lumen coupled with a media delivery port through which the light activated drug can be locally delivered to the tissue site. The ultrasound transducer is configured to transmit the level of ultrasound energy which activates the light activated drug with sufficient power that the ultrasound energy can penetrate the tissue site.