Abstract: The present invention provides an improved core wire for use in a medical catheter. In one aspect, the invention provides a core wire with a shapeable tip and method of manufacturing the same. A core wire previously made superelastic is subject to additional processing to remove its superelasticity thereby allowing the material to be shapeable to aid in advancing the core wire through a blood vessel or other body cavities. In another aspect of the present invention, a method is provided for securing the core wire to the distal end of an elongated catheter tubular body. The tubular body is mechanically crimped onto the core wire to secure the core wire in place. This crimping method has been found to increase the strength of the bond between the core wire and the catheter tube so that greater pull force is required to break the core wire off from the catheter.

Abstract: Exchange catheters which allow for the removal of a standard guidewire and replacement with a guidewire or catheter bearing an occlusive device during percutaneous transluminal angioplasty or related procedures. The elongate catheters have at least one lumen, and are preferably provided with a slit approximately 3-20 mm in length at the distal end of the lumen to allow the catheter to expand to accommodate the passage of the occlusive device while still maintaining a low profile. The catheters can also be used to provide aspiration and/or delivery of fluid.

Abstract: The present invention provides a protective sheath assembly which combines the function of an introducer, the function of a protective sheath and the function of a sealing valve in an integrated assembly. The protective sheath assembly of the present invention preferably comprises a protective sheath, a strain-relief tubing, and a connecting member or a hub. These parts are mounted, removably or permanently, into an integral device. The protective sheath assembly can also be used in combination with an introducer such as a needle introducer. The protective sheath has a proximal end, a distal end, and an elongated hollow body defining a lumen along the longitudinal direction of the protective sheath. A hub is provided to secure the proximal end of the protective sheath to an introducer. The lumen of the protective sheath serves to accommodate and protect a balloon catheter, as well as seal around the catheter.

Abstract: Aspiration catheters and methods for the treatment of an occlusion in a blood vessel. These catheters and methods are especially useful in the removal of occlusions from saphenous vein grafts, the coronary and carotid arteries, arteries above the aortic arch and even smaller vessels. The catheters of the present invention are provided in either over-the-wire or in single operator form. Radiopaque markers are preferably incorporated into distal ends of the catheters, and visual markers are incorporated into the proximal end of the catheters, to facilitate their positioning within the body. The catheters are provided with varying flexibility along the length of the shaft, such that they are soft and flexible enough to be navigated through the vasculature of a patient without causing damage, but are stiff enough to sustain the axial push required to position the catheter properly and to sustain the aspiration pressures.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel in which an occlusive device is first delivered and activated at a site distal to the occlusion to at least partially occlude the vessel. A therapy catheter is then introduced to treat the occlusion and a debris removal device is delivered to aspirate debris from the vessel. The present invention eliminates the need for a separate irrigation catheter and irrigation fluid which allows the procedure to be performed quickly and efficiently, and is especially useful in the removal of occlusion from saphenous vein grafts, the coronary and carotid arteries, arteries above the aortic arch and vessels of similar size and pressure.

Abstract: The present invention provides an apparatus for performing angioplasty or vascular intervention procedures. The apparatus of the present invention comprises a catheter apparatus comprised of a superelastic hollow guidewire, a balloon member and a flexible tip. The superelastic hollow guidewire of the invention is preferably a hypotube of nitinol alloy. The use of nitinol alloy as hollow guidewire provides a catheter apparatus having high flexibility and torqueability as well as small cross sectional diameter.

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: 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 present invention provides a protective sheath assembly which combines the function of an introducer, the function of a protective sheath and the function of a sealing valve in an integrated assembly. The protective sheath assembly of the present invention preferably comprises a protective sheath, a strain-relief tubing, and a connecting member or a hub. These parts are mounted, removably or permanently, into an integral device. The protective sheath assembly can also be used in combination with an introducer such as a needle introducer. The protective sheath has a proximal end, a distal end, and an elongated hollow body defining a lumen along the longitudinal direction of the protective sheath. A hub is provided to secure the proximal end of the protective sheath to an introducer. The lumen of the protective sheath serves to accommodate and protect a balloon catheter, as well as seal around the catheter.

Abstract: A stent positioning apparatus and method are provided for the attachment of a stent to a balloon to be used in the treatment of stenosis, such as coronary angioplasty. In one preferred embodiment, a first generally cylindrical member has a radially deformable wall defining a channel within which the stent and balloon assembly are inserted. A second generally cylindrical member has an opening sufficient to receive the first member with the assembly therein. The second member is then slid longitudinally over the deformable wall of the first member causing nonuniform depressions to be formed in the inner diameter of the stent, thus crimping the stent onto the balloon. Thus, the stent is attached to the balloon without damage and without risk of the stent falling off the balloon prematurely.

Abstract: A multi-catheter emboli containment system is disclosed in which a treatment chamber within a blood vessel is formed by at least two occlusion balloons on opposite sides of a stenotic lesion, thereby preventing emboli migration during the treatment procedure. Irrigation and aspiration are provided to remove emboli and debris from the chamber. The irrigation and aspiration can be provided through separate catheters, or, the catheters used to create the chamber, together with the catheter used to provide therapy to the stenosis can be used. The catheters are all sized so as to be concentric, slidably disposed with respect to one another, and able to be delivered into blood vessels less than 25 mm in diameter or even smaller.

Abstract: A catheter assembly for treatment of a stenosis in a lumen in a blood-carrying vessel comprising a first flexible elongate tubular member having proximal and distal extremities. A first inflatable balloon is coaxially mounted on the distal extremity of the first flexible elongate tubular member and has a main lumen and an aspiration lumen exiting through the distal extremity. A second flexible elongate tubular member has proximal and distal extremities and has a second inflatable balloon coaxially mounted on the distal extremity and has a blood perfusion lumen extending therethrough. The second flexible elongate tubular member is slidably mounted in the main lumen of the first flexible elongate tubular member. The first balloon is positioned so that it is adjacent to but proximal of the stenosis and is thereafter inflated to create a first occlusion in the lumen in the vessel. A negative pressure is created in the lumen in the vessel distal of the first balloon through the aspiration lumen.