Abstract: An embolic protection system for treating a lesion in a blood vessel is provided. The embolic protection system includes a guide catheter, an evacuation sheath, a guidewire, and an infusion catheter. The guide catheter has a guidewire lumen. The evacuation sheath has an evacuation lumen and a sealing surface and is configured to move within the lumen of the guide catheter. The guidewire is configured to move within the lumen of the guide catheter and the evacuation lumen. The infusion catheter has an infusion lumen, at least one infusion port, and a guidewire lumen configured to accept the guidewire, the infusion catheter guidewire lumen being shorter than the guide catheter guidewire lumen. Furthermore, the infusion catheter is configured to move within the lumen of the guide catheter and the evacuation lumen over the guidewire. The system may further comprise a dilation catheter having a dilation balloon and a guidewire lumen.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Prior to advancing a device across a stenosis to be treated, normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped. While blood flow is stopped, the stenosis is treated.

Abstract: A method of treating a constricted sinus passageway of a patient includes traversing the canine fossa region of the patient so as to form a passageway in the sinus cavity. A cannula is positioned in the passageway. A visualization tool such as an endoscope is passed through a lumen or channel in the cannula to aid in visualization of the anatomical site of interest. A balloon dilation catheter is then deployed through or along the cannula so as to place the balloon within or across the constricted anatomical space (e.g., ostium). The balloon is then expanded so as to expand at least a portion of the constricted anatomical space. Alternative embodiments include the use of an optional guide wire and incorporating a endoscope lumen through the balloon dilation catheter.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated.

Abstract: A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Abstract: An endovascular graft system used to repair aneurysms in arteries which bifurcate such as the aorta which bifurcates at the aortoiliac junction. The graft system includes two legs, each defining a lumen. Each leg comprises an aortic stent, a graft component and an iliac stent. The graft component is affixed at one end to the aortic stent and at the other end to the iliac stent. Each leg of the graft system is preferably a mirror image of the other with the exception of the aortic stents. The graft component of each leg includes a means for allowing in situ adjustment of the length of the leg to accommodate the different sizes required for different patients.

Abstract: A wire control catheter for aligning and guiding a guide wire through a lesion in a vessel is provided. The wire control catheter includes a shaft having a guide wire lumen and a control wire lumen. A control wire passes through the control wire lumen and is used in combination with an articulation structure to deflect or curve a distal tip portion of the catheter. The distal catheter shaft may include a centering device for centering the catheter within the vessel. The distal catheter shaft also may include a pre-dilation balloon for dilating the lesion prior to performing angioplasty or other treatment on the lesion. Additionally, a sliding sheath catheter may be used to provide additional support to the guide wire. The sliding sheath catheter is sized to fit within the guide wire lumen of the control catheter and to allow the guide wire to pass through it.

Abstract: Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated.

Abstract: A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Abstract: A method for endoluminally treating a pathological defect is disclosed using grafts having a shape memory alloy disposed along their length. The method comprises the steps of introducing first and second grafts through respective first and second access sites on a first side of a pathological defect; advancing the grafts within delivery sheaths until each extends across the defect and is positioned within a common body passageway on a second side of the pathological defect; releasing the grafts from their respective delivery sheaths with the grafts opening in response to action of the shape memory alloy; and joining or attaching the grafts together within the common body passageway.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Prior to advancing a device across a stenosis to be treated, normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped. While blood flow is stopped, the stenosis is treated.

Abstract: A prosthetic graft for use with a graft system is used to repair the treatment of aortic aneurysms which extend into at least one common iliac artery and do not have a suitable region for seating a stent or other attachment device. The graft is designed to be used in combination with a graft system having legs extending into the common iliac arteries and provides the graft system with a place to securely seat its iliac legs without blocking the internal iliac artery.

Abstract: A prosthetic graft for use with a graft system is used to repair the treatment of aortic aneurysms which extend into at least one common iliac artery and do not have a suitable region for seating a stent or other attachment device. The graft is designed to be used in combination with a graft system having legs extending into the common iliac arteries and provides the graft system with a place to securely seat its iliac legs without blocking the internal iliac artery.

Abstract: A parent vessel lies adjacent heart tissue, and a restriction in the parent vessel is bypassed. A first region of the parent vessel on a first side of the restriction is accessed and an aperture is formed therein. A lumen is formed through the heart tissue, and the lumen communicates with the parent vessel through the first aperture. A second aperture is formed in a second region of the parent vessel on a second side of the restriction. The lumen through the heart tissue communicates with the parent vessel through the first and second apertures, thus bypassing the restriction.

Abstract: An endovascular graft system used to repair aneurysms in arteries which bifurcate such as the aorta which bifurcates at the aortoiliac junction. The graft system includes two legs, each defining a lumen. Each leg comprises an aortic stent, a graft component and an iliac stent. The graft component is affixed at one end to the aortic stent and at the other end to the iliac stent. Each leg of the graft system is preferably a mirror image of the other with the exception of the aortic stents. The graft component of each leg includes a means for allowing in situ adjustment of the length of the leg to accommodate the different sizes required for different patients.

Abstract: According to the invention, a novelly improved ablation device includes releasably joinable drive and catheter assemblies. The drive assembly includes a tachometer assembly and a regulator for monitoring and controlling ablating burr speed. A bifurcated drive shaft includes a coiled distal portion and a tubular proximal portion for facilitating force transfer from the proximal portion to the distal portion. A dilating member is provided in addition to an ablating burr on the catheter assembly. The catheter tube may have multiple independent lumens having axes of elongation offset parallelly in the tube. Additionally, the ablating burr may be operatively connected to the catheter tube by drive gears or releasable threads. A radiopaque member is included on the distal end of the catheter tube, thereby rendering it visible to an observer. Novel, improved methods of ablating intravascular deposits are also provided.

Abstract: An over-the-wire balloon dilatation catheter of the short guide wire lumen type has a stainless steel hypotube catheter shaft section, a distal plastic shaft section attached to the hypotube and a balloon connected to the distal plastic shaft section. A relatively short guide wire lumen extends throughout the length of the balloon. The distal shaft section includes a reinforcing and kink-resistant transition member extending throughout the length of the distal shaft section. The transition member allows the proximal guide wire lumen aperture to be placed distally from the distal end of the hypotube. This configuration permits the length of the guide wire lumen to be minimized.

Abstract: An intravascular balloon catheter including a dilation balloon is provided. The intravascular balloon catheter includes a shaft assembly including a proximal end, a distal end, and an inflation lumen extending longitudinally therethrough. The dilation balloon is operably coupled proximate the distal end of the shaft assembly, such that an interior chamber of the dilation balloon is in fluid communication with the inflation lumen. In one aspect of the invention, a core wire is disposed within the inflation lumen of the shaft assembly. In another aspect of the invention, a tubular member extends longitudinally over the exterior of the dilation balloon for receiving a guidewire.