Abstract: A catheter apparatus captures thromboembolic material in the arterial and venous circulation. The apparatus includes an inner hollow tube and an outer hollow tube in sliding engagement with the inner hollow tube. A radially expandable segment, such as an inflatable balloon, is attached near the distal end of the catheter. One end portion of the balloon is attached to the inner tube and the other end portion is attached to the outer tube. When the catheter is advanced through a vessel to be treated, the balloon is deflated and the outer tube is slidably advanced to a storage position so that the balloon compactly surrounds the catheter. When the catheter is in place within the vessel, the outer tube is slidably advanced to a treatment position and the balloon is inflated. As the vessel is treated, the inflated balloon captures and contains thromboembolic particles that may be released, and the particles are suctioned out of the patient through apertures located in the outer hollow tube proximal to the balloon.

Abstract: A catheter including an injection port at or near the distal end thereof and a mechanism for causing the injection port to move between a first position and a second position. In the first position the injection port is substantially aligned with a central axis of the catheter. Upon activation of the mechanism, the injection port moves between the first position and the second position perpendicular to the central axis of the catheter. The mechanism also causes the injection port to move away from the central axis of the catheter and into a wall of the vasculature.

Abstract: A self-deploying catheter assembly comprises an anchoring device mounted to a tube. A distal end of the anchoring device is held in a fixed position by a releasable suture while a proximal end is freely movable between a proximal position and a distal position defined by a stop on the tube. During insertion into a body cavity, the anchor automatically maintains a low-profile state with the ends spaced apart. Once fully inserted, the anchor self converts into a high-profile state when the tube is slightly withdrawn, bringing the ends closer together. The suture is disengaged to release the distal end of the anchor in order to facilitate a low-profile state for withdrawal of the assembly.

Abstract: Apparatus and methods for perfusing ischemic myocardium are provided using a tubular member having an end region adapted to be disposed in a portion of a patient's venous vasculature. The end region includes a lumen and a valve in communication with the lumen that controls pressure within an occluded portion of the vasculature by venting excess blood at a location proximal of a point of occlusion of the vasculature via the valve. An occlusion element optionally may be provided in the end region that retains the tubular member within the patient's venous vasculature and occludes the flow of blow around the lumen.

Abstract: A balloon catheter and method of use for inflating the balloon more effectively, particularly during stent deployment. The balloon catheter includes a catheter shaft and a balloon, wherein the proximal end of the balloon is connected to the distal end of the shaft. A tip is disposed in the interior of the balloon, with the proximal end of the tip extending from the distal end of the catheter shaft and the distal end of the tip connected to the distal end of the balloon. The tip includes a fluid path to facilitate the passage of inflation fluid from the inflation lumen to the interior of the balloon, and the tip may further include a guide wire lumen extending therethrough. The fluid path may be configured to inflate the balloon uniformly or to initially inflate the distal end of the balloon such that a stent loaded on the balloon will not have a tendency migrate distally during deployment.

Abstract: A balloon catheter having a perfusion lumen communicating with a blood vessel, and a magnetically driven impeller disposed in the perfusion lumen to increase blood flow through the catheter and the arteries.

Abstract: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Abstract: This invention is a single, multichannel catheter useful for extracorporeal circulation of blood to a patient undergoing cardiovascular treatments or surgery. The catheter has three independent channels and an expandable balloon at one end of the catheter. The first channel is the largest and is of a size that allows for delivery of blood to a patient in an amount sufficient to maintain the patient's metabolism and perfusion throughout the treatment or surgery. A second channel, smaller than the first. is integrated into the wall of the first channel. and is suitable for delivering a biologically active fluid (e.g., for cardioplegia) to the heart and/or venting the left heart. A third channel, also smaller than the first, is integrated into the wall of the first channel, and suitable for delivering a fluid to the balloon for its expansion when positioned in the ascending aorta to occlude the flow of blood to the heart. Preferably, the first channel accounts for at least about 70% of the total channel volume.

Abstract: An autoinflating catheter and balloon assembly having an autoregulating structure to prevent overinflation of the balloon as a result of variable fluid flow rates through the catheter lumen. A tight-fitting elastomeric balloon is provided on the distal end of the catheter body, and the assembly is constructed so that at least a portion of the fluid flow through the lumen is directed to the balloon to inflate it. As the balloon is inflated, more and more of the fluid flow through the catheter is discharged from the catheter, thereby preventing overinflation of the balloon.

Abstract: A catheter for intravascular corporeal cooling comprises an elongated tubular member having at least one lumen extending therethrough for providing cooled blood, an inflatable annular balloon positioned on the outer surface of the elongated tubular member, and a pressure reliever positioned in the external wall of the elongated tubular member and proximal to the annular inflatable balloon, wherein when the pressure of blood within a lumen reaches a predetermined value, the pressure reliever opens to permit fluid to be released from the elongated tubular member. In other embodiments of the invention the catheter may have two or more inflatable annular balloons that are separately inflatable and/or the catheter has an insulative outer annular member.

Abstract: An aortic occlusion catheter has a blood return lumen for returning oxygenated blood to a patient and an occluding member for occluding the patient's ascending aorta. The blood return lumen has openings on both sides of the occluding member for infusing oxygenated blood on both sides of the occluding member.

Abstract: A method of fabricating a catheter shaft having one or more guidewire ports is disclosed. A method in accordance with the present invention includes the steps of cutting the wall of a first shaft portion to create an opening defined by the wall of the first shaft portion, inserting the proximal end of an inner member through the opening defined by the wall of the first shaft portion, inserting the distal end of the inner member into the lumen of a second shaft portion, inserting the bonding end the second shaft portion into a lumen defined by first shaft portion, and bonding the bonding portion of the first shaft portion to the bonding portion of the second shaft portion.

Abstract: A method and apparatus for retroperfusing cerebral venous vasculature with autologous venous blood through a percutaneous entry site which incorporates a double-lumen catheter, a self-inflating pressure-regulated balloon mounted on the catheter and a perfusion outflow region either distal to the balloon for direct perfusion into the superior sagittal sinus, or proximal to the balloon for perfusion into the transverse sinus near the junction of the superior sagittal sinus.

Abstract: The diamter of &bgr;-titanium alloy wire is reduced by cold wire-drawing and the &bgr;-titanium alloy wire is subjected to heat treatment. The heat treatment comprises the first aging process for precipitation strengthening and the second aging process for removing processing strain. &bgr;-titanium alloy wire is heat-treated under the supply of tension at the second aging process.

Abstract: A catheter system includes a catheter having a proximal end, a distal end, and a lumen extending therein. An administering portion is disposed at the distal end of the catheter and is configured to administer a bolus of liquid in response to positive pressure in a distal portion of the lumen. The catheter system of the present invention has a dead space of less 0.32 cc and preferably less than 0.15 cc in which residual therapeutic agents remain after delivery. The present invention also includes a method of administering a liquid to a treatment site. The distal end of the catheter is transluminally positioned proximate the treatment site. The catheter is charged by placing a bolus of the liquid in the lumen A positive pressure is created to drive the bolus to the administering tip to express the bolus from the distal end of the catheter.

Abstract: A Balloon dilation catheter comprising an elongated tubular shaft and an inner tube defining inflation and guide wire lumens. A dilation balloon is mounted on the distal end of the tubular shaft and communicates with the inflation lumen. The guide wire lumen extends through the balloon. A stiffening wire is positioned within the tubular shaft and has a proximal end secured in the proximal portion of the catheter. The distal end of the stiffening wire is anchored within the inner tube in an area adjacent the guide wire entrance port. The stiffening wire maximizes strength to the proximal portion of the catheter while maintaining flexibility in the distal end of the catheter as well as the balloon.

Abstract: A balloon catheter for use with a guidewire is disclosed. The catheter has a body with a balloon located thereon, preferably at the distal end. A lumen within the catheter body communicates with the interior of the balloon which can be inflated by known methods with saline solution. A series of sleeve members of predetermined lengths and sizes are coupled to and positioned along the length of the catheter body. One or more of the sleeve members can span the length of the balloon. Each sleeve member has a passageway and both an exit and entry port so that the guidewire can pass therethrough. Instead of a balloon, the catheter can include a device member that forms a chamber which can store medicine until discharged at the desired site within the blood vessel. Apertures or pores on the catheter body allow for the perfusion of blood or the delivery of medicine to the site of the blood vessel. A method of operation is also disclosed.

Abstract: A catheter for intravascular corporeal cooling comprises an elongated tubular member having at least one lumen extending therethrough for providing cooled blood, an inflatable annular balloon positioned on the outer surface of the elongated tubular member, and a pressure reliever positioned in the external wall of the elongated tubular member and proximal to the annular inflatable balloon, wherein when the pressure of blood within a lumen reaches a predetermined value, the pressure reliever opens to permit fluid to be released from the elongated tubular member. In other embodiments of the invention the catheter may have two or more inflatable annular balloons that are separately inflatable and/or the catheter has an insulative outer annular member.

Abstract: Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port. Also disclosed herein is an inflation adaptor for moving the sealer portion within the catheter to establish or close the fluid pathway between the inflation port and the inflatable balloon.

Abstract: Disclosed herein is a compliant catheter balloon with an improved elastic response and reduced longitudinal expansion, and a method of forming the same. The balloon comprises a SEBS block copolymer, which is longitudinally pre-stretched during the balloon manufacture process. In order to control the working length of a balloon on a catheter, at least one adhesive stop is provided on the catheter which prevents adhesive from wicking into the working length of the balloon. Preferably, a pair of thermoset tubings with an outer diameter size close to the size of the inner diameter of the balloon are inserted on the distal portion of the catheter. After the proper placement of the balloon, the adhesive is applied at the balloon's proximal and distal ends. As the adhesive wicks to the balloon, the thermoset tubings will eventually stop the adhesive to prevent further wicking of adhesive into the balloon's working length.

Abstract: Catheter devices and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter devices include at least a first, second and third lumen, where: (a) the first lumen is used for delivery of an acidic dissolution solution to the vascular site; (b) the second lumen is used for delivery of a buffer solution to the vascular site; and (c) the third lumen is used for removal of fluid from the vascular site. In many preferred embodiments, the first, second and third lumens are coaxial. In practicing the subject methods, the vascular site is flushed simultaneously with an acidic dissolution fluid and a buffer solution, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the acidic dissolution fluid and the remainder of the vascular site is not contacted with fluid having a pH that is lower than about 4.

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 balloon catheter for use with a guidewire is disclosed. The catheter has a body with a balloon located thereon, preferably at the distal end. A lumen within the catheter body communicates with the interior of the balloon which can be inflated by known methods with saline solution. A series of sleeve members of predetermined lengths and sizes are coupled to and positioned along the length of the catheter body. One or more of the sleeve members can span the length of the balloon. Each sleeve member has a passageway and both an exit and entry port so that the guidewire can pass therethrough. Instead of a balloon, the catheter can include a device member that forms a chamber which can store medicine until discharged at the desired site within the blood vessel. Apertures or pores on the catheter body allow for the perfusion of blood or the delivery of medicine to the site of the blood vessel. A method of operation is also disclosed.

Abstract: A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The system includes an emboli-capturing catheter which is capable of occluding a blood vessel distal to or at an interventional procedure site, perfusing the blood to enable blood to flow past the occlusion, and filtering the blood to capture embolic material which may be released into the blood during a therapeutic interventional procedure. The emboli-capturing catheter includes an expandable member which is capable of being expanded distal to or at the area of treatment at the interventional procedure site for occluding the blood vessel.

Abstract: An expandable lumen cannula which includes an elongate tube having a proximal end, a distal end, an intermediate flexible region, and a lumen therebetween. The cannula further includes a balloon occluder mounted on the distal end of the tube. The intermediate flexible region of the tube further includes an elongate generally cylindrical balloon disposed circumferentially about the flexible region which, upon inflation, expands the luminal diameter of the intermediate region. First and second inflation ports are in fluid communication with the balloon occluder and the cylindrical balloon. The cannula may optionally include a cardioplegia port disposed within the distal region of the tube, proximal the balloon occluder and distal the generally cylindrical balloon.

Abstract: The present invention relates to a device for actively supporting the flow of body fluids, comprising an artificial flow guide system (10) with an operational area into which a pump (1) is embedded in such a way that it can transport blood from at least one inlet opening (3) situated in the guide system to at least one outlet opening (4) situated in the guide system; a flexible feed hose (5) connected to the flow guide system; an energy or force transmission line (6) which is guided through the interior of the flexible feed hose and which, when the device is in the operational state, transmits energy or force substantially continuously to the pump from a drive unit for the extracorporeal generation of this energy or force.

Abstract: Disclosed herein is a catheter for use in an emboli containment system. In one embodiment, the catheter has a tubular body with a metallic braid construction. Two lumen extend through the tubular body, the lumen being in a side-by-side configuration. One of the lumen functions as an inflation lumen, and is in fluid communication with an inflatable balloon mounted on the distal end of the catheter. The second lumen is adapted to receive other therapeutic catheters which comprise the emboli containment system.

Abstract: A balloon catheter for medical applications has a balloon 11 in a tip region facing the patient having a structured outer surface 12. The structured outer surface 12 is formed by wave troughs and wave crests which are not connected to each other. The structured outer surface 12 of a balloon 11 can cling to adjacent surfaces. The balloon catheter is introduced via a left-ventricular cardiotomy in the tip region and inserted into the aorta ascendens. The balloon 11 occludes the aorta ascendens. The balloon allows cardioplegia to be performed and relieves the heart through suctioning-off. Particular applications for the balloon catheter include by calcification of the aorta ascendens, for effecting LIMA/RIMA-anastomoses, and when effecting venovenostomies.

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: An improved perfusion system for a dilatation catheter includes inlet openings disposed at an acute angle with the normal direction of vascular flow.

Abstract: A device for occlusion of a body passageway and subsequent perfusion of the body passageway with arterial return blood, cardioplegia and other fluid is disclosed. The device of the present invention is an expandable cannula comprising a flexible, expandable tubular elongate body having a first diameter and a second diameter, wherein the expandable cannula is inserted having a first diameter and then expanded to a second diameter to provide perfusion flow to the body passageway through at least one arterial return aperture provided on the distal end of the expandable tubular elongate body in fluid communication with a perfusion lumen provided within the cannula. The device may be further provided with one or more additional lumens for providing additional functions to the vessel lumen and may also include an expandable occluding member fixed at the distal end of the cannula for isolating the surgical area from the rest of the arterial system.