Abstract: Aspiration catheters suitable for use in the treatment of an occlusion in a blood vessel are disclosed. These catheters 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 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: Apparatus for sealing a puncture communicating with a blood vessel includes an introducer sheath, an occlusion member with a balloon thereon, a retraction assembly, and a syringe assembly including sealing material therein. During use, the introducer sheath is introduced into the puncture. With the balloon in a collapsed state, the occlusion member is introduced through the introducer sheath until the balloon is disposed within the vessel. The introducer sheath is coupled to the retraction assembly, the balloon is expanded, and the occlusion member is partially withdrawn to seal the puncture. A sealing compound is delivered from the syringe assembly through the introducer sheath into the puncture, the syringe assembly triggering the retraction assembly, whereupon the introducer sheath is automatically withdrawn at least partially from the puncture, delivering the sealing compound along the puncture.

Abstract: Apparatus for sealing a puncture includes an elongate occlusion member having a balloon attached to distal ends of telescoping inner and outer members. A housing on the proximal end of the outer member includes a piston coupled to the inner member and slidable within a chamber communicating with a fluid reservoir. A switch on the housing is actuated to direct fluid from the reservoir through the outer member into the balloon to expand the balloon and into the chamber to move the piston and pull the inner member, shortening the balloon as it expands. During use, the distal end of the occlusion member is introduced into a puncture communicating with a vessel until the collapsed balloon is disposed within the vessel. The balloon is expanded, and a tensioner is connected to the housing to apply a proximal force holding the balloon against the vessel wall to seal the puncture.

Abstract: Apparatus for sealing a puncture communicating with a blood vessel includes a pair of syringe barrels having sealing components therein, and a plunger assembly biased to slide within the barrels from proximal to distal positions for injecting the components through outlets of the barrels. An auto-injector assembly is coupled to the plunger apparatus, and includes a spring mechanism locked in an inactive condition and an actuator activatable to release the spring mechanism, whereupon the spring mechanism automatically advances the plunger assembly towards the distal position to inject the components from the barrels. A valve coupled to the outlets and movable from a first position for mixing and/or reconstituting the sealing components from vials, a second position where the outlets communicate with a delivery line for delivering the sealing components into a puncture, and a third position for closing the outlets.

Abstract: An apparatus for sealing a puncture communicating with a blood vessel includes an inner member slidable within an outer member, and a balloon coupled to distal ends of the inner and outer members. A proximal end of the outer member includes a port for delivering fluid into the balloon, and a cylinder that communicates with the port. A piston coupled to the inner member is slidable and biased to move distally within the cylinder. The apparatus is introduced into the puncture until the collapsed balloon is disposed within the vessel. Fluid is introduced into the port, moving the inner member proximally to shorten the balloon as it expands. The balloon is withdrawn to seal the puncture, and a hydrogel is introduced into the puncture. Fluid is removed via the port, moving the inner member distally to extend the balloon as it collapses, and the apparatus is withdrawn from the puncture.

Abstract: A low profile catheter valve comprises 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: An inflation adaptor is provided to move a wire within a hollow tubular body, the movement of the wire enabling actuation of an expandable member at the distal end of the hollow tubular body. The expandable member can be a balloon, filter or similar device. The adaptor generally includes a clamping mechanism which clamps the hollow tubular body and wire within the adaptor, and also includes a drive mechanism for moving the wire within the hollow tubular body. An actuator, such as a rotatable knob, is provided to operate both the clamping mechanism and the drive mechanism. The adaptor may also include a fluid delivery and expansion system within a housing when the expandable member is a balloon, wherein movement of the actuator delivers a predetermined amount to the balloon while still operating the clamping mechanism and the drive mechanism.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire.

Abstract: A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire.

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: 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: A method for the treatment of a stenosis or an occlusion in a blood vessel is disclosed in which a main catheter is first delivered to a site proximal to the occlusion. The main catheter may include an occlusive device at its distal end. An inner catheter or elongate member (e.g., a guidewire) having an occlusive device at its distal end is delivered to the site of the occlusion, and the occlusive device is activated at a site distal to the occlusion. A therapy catheter is then introduced to treat the occlusion. Next, a catheter is delivered just proximal to the occlusive device, and this catheter is used to aspirate and/or irrigate the area removing particles and debris. The aspiration and irrigation steps are preferably repeated until the particles and debris are removed. Perfusion may be performed by using a perfusion-filter distal of the lesion to be treated or a hypotube which extends beyond the occlusive device attached to the guidewire.

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: A balloon catheter having improved flexibility in and about its distal end is provided. The flexibility of the catheter is determined in part by improving the properties of a wire or catheter located within the area where the balloon is mounted. In one aspect of the present invention, connecting wires extend through the balloon from the distal end of a catheter body to the proximal end of a core wire. The core wire extends distally away from the connecting wires and the catheter body. In another aspect of the present invention, a core wire is provided having a proximal end extending within the balloon into the catheter tubular body but is not mounted therein. This allows the proximal end of the core wire to “float” within the tubular body, such that when the catheter is advanced through the vasculature of a patient, the core wire may move longitudinally within the tubular body.

Abstract: Various methods and apparatus are provided for aspirating emboli and other particles from the vasculature of a patient, particularly within saphenous vein grafts, coronary arteries, carotid arteries and similar vessels. One embodiment of an aspiration catheter is particularly well suited for delivery over a guidewire. Preferably, the guidewire is hollow and carries a distal occlusive device, and has a low profile to facilitate passage into small vessels. The aspiration catheter comprises an elongate body having a guidewire lumen positioned within an aspiration lumen, thereby providing a low profile catheter having a round cross-sectional shape. The aspiration lumen has an angled aspiration mouth which improves evacuation efficiency, and facilitates aspiration of larger particles within vessels. The angle of the aspiration mouth prevents suction between the mouth and the occlusive device, thereby reducing forced movement of the occlusive device while it is deployed during aspiration procedures.

Abstract: A guide wire apparatus for prevention of distal atheroembolization during percutaneous catheter intervention procedures, such as angioplasty or stent deployment. An expandable protection element, such as a self-expanding or self-collapsing filter or occluder, is mountable adjacent the distal end of a core wire, which can guide a therapeutic catheter. Relative displacement of the ends of the protection element causes transformation of the protection element between a closed configuration and an expanded configuration that spans the vessel to be treated. An operator rod, which may be a hollow rod or an interventional catheter, may be slidably disposed over the core wire to engage with and either push or pull the proximal end of the protection element to cause transformation thereof.

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: 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: 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: 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.