Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. A method of treating a lesion within a blood vessel, includes providing an evacuation sheath assembly having a multi-lumen tube with proximal and distal ends, first and second lumens therebetween, and at least one sealing surface mounted on the distal end of the multi-lumen tube. The evacuation sheath assembly is advanced to a region of interest within a blood vessel. The sealing surface is deployed upstream of the region of interest to occlude antegrade flow adjacent to the lesion to be treated. A dilation catheter is advanced through the multi-lumen tube such that the dilation balloon is positioned across the lesion and the lesion is dilated. Suction is applied to induce retrograde blood flow to carry dislodged embolic material into a lumen of the evacuation sheath assembly.

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: 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: 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 preferably also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end fixedly connected to the left atrial anchor and a portion, proximal to the first end, passing through the right atrial anchor. Preferably, the elongate member is flexible.

Abstract: Embodiments of the invention relate to a method and apparatus for coating a medical device. In one embodiment, the method for preparing a substantially uniform coated medical device includes (1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive; (2) loading a metering dispenser with the coating solution; (3) rotating the medical device about the longitudinal axis of the device and/or moving the medical device along the longitudinal or transverse axis of the device; (4) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and (5) evaporating the solvent, forming a substantially uniform coating layer on the medical device.

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: 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 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 may also include a pre-dilation balloon for dilating the lesion prior to performing angioplasty or other treatment on the lesion. A method of treatment of a blood vessel includes inserting a guide wire into the blood vessel and advancing a control wire over the guide wire until the distal tip of the catheter is near the occlusion in the blood vessel. The tip of the catheter then is deflected via a control wire and an articulation structure. The guide wire is then advanced across the occlusion.

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: 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 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 preferably also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end fixedly connected to the left atrial anchor and a portion, proximal to the first end, passing through the right atrial anchor. Preferably, the elongate member is flexible.

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: 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.