Abstract: A method of treating a constricted sinus passageway in a frontal sinus of a patient includes forming an artificial passageway into the frontal sinus of the patient with a tool. An elongate member having an inflation member thereon is inserted through the passageway. The inflation member is positioned with the constricted sinus passageway and the inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

Abstract: An endoscope includes a substantially rigid shaft having a distal end and a proximal portion, the shaft having a first lumen and a second lumen separate from the first lumen, the second lumen containing one or more objective lenses disposed at the distal end thereof. A housing is mounted on the proximal portion of the shaft, the housing including an eyepiece mount and a light input port. An image fiber bundle is disposed in the second lumen, the image fiber bundle extending proximally from adjacent the one or more objective lenses to the eyepiece mount. An illumination fiber bundle is disposed in the second lumen, the illumination fiber bundle extending proximally from the distal end of the shaft to the light input port.

Abstract: A method of remodeling the uncinate process associated with a paranasal sinus includes positioning at least one shim member in the infundibulum, the shim member deforming the uncinate process and widening at least a portion of the infundibulum. The infundibulum space may be dilated with a dilating member. Dilation may occur prior to delivery of the at least one shim. The dilation member may be delivered into the sinus cavity via an access passageway formed in the canine fossa.

Abstract: A balloon catheter for treating a constricted sinus passageway of a patient includes an elongate flexible shaft defining a lumen therein, the elongate flexible shaft having a proximal end and distal region. The elongate flexible shaft may include a kink-resistant coil in the distal region. A hub is affixed to the proximal end of the elongate flexible shaft, the hub including a port in communication with the lumen. An expandable member is disposed on the distal region of the elongate flexible shaft, wherein an interior portion of the expandable member is in communication with the lumen.

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, e.g., a coronary artery, includes advancing a sheath into the blood vessel, the sheath having a lumen extending to a port at a distal end of the sheath and further having an occlusive member within a distal region of the sheath. The occlusive member is then positioned within the blood vessel proximal to the lesion. Subsequently, the occlusive member is deployed, thereby stopping antegrade flow across the lesion. A contrast agent can then be infused through a port in the sheath. A dilation balloon is then advanced across the lesion. Suction is then applied to the lumen to induce retrograde flow across the lesion after dilating the lesion.

Abstract: A method of remodeling the uncinate process associated with a paranasal sinus includes positioning at least one shim member in the infundibulum, the shim member deforming the uncinate process and widening at least a portion of the infundibulum. The infundibulum space may be dilated with a dilating member. Dilation may occur prior to delivery of the at least one shim. The dilation member may be delivered into the sinus cavity via an access passageway formed in the canine fossa.

Abstract: An embolic protection system and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The embolic protection system includes a guide catheter, a multi-lumen tube having a sealing surface on the distal end and an interventional device. A method of treating a blood vessel includes providing a guide catheter and a multi-lumen elongate member having proximal and distal ends, evacuation and inflation lumens extending therebetween and a sealing surface on the distal end. The elongate member is advanced through the guide catheter into a blood vessel that supplies blood to the heart proximal a lesion. The sealing surface is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow. An interventional device is advanced through the evacuation lumen to treat the lesion.

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 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. 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 method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject's sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage 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. 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 steerable guide wire includes a core wire having a proximal end and a distal end. A braided filament is affixed to the distal end of the core wire. An outer coil surrounds at least a portion of the core wire and the braided filament. A proximal end of the braided filament is secured to a distal end of the coil. By locating the braided filament in the distal tip portion of the guide wire, a guide wire is provided that is highly flexible, has a high degree of tensile integrity, and is highly steerable, even in tortuous vasculature. Filter and balloon catheters having braided filaments at the distal end are also described.

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 method for treating a natural drainage passageway in a subject includes forming a cannulated artificial passageway into a subject's sinus cavity through the canine fossa region with a piercing member, the piercing member containing a hollow cannula thereon, the cannula comprising an elongate flexible member having a lumen passing therethrough. The piercing member is removed so as to leave the cannula in place. A balloon dilation catheter is then advanced within the lumen of the cannula so as to place the dilation balloon at least partially across the natural drainage passage in the sinus cavity. The dilation balloon is dilated so as to at least partially expand the natural drainage passageway.

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. An elongate member is inserted through the passageway, the elongate member having an inflation member such as a balloon disposed thereon. The inflation member is positioned within the constricted passageway. The inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

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: A method of treating diseased ethmoid sinuses in a patient with a therapeutic agent includes providing an injection device comprising an elongate member having a proximal end, a distal tip or end, and a lumen extending between the distal tip and the proximal end, the proximal end being operatively coupled to a source of the therapeutic agent. The distal tip of the injection device is inserted at least partially within an interior portion of an ethmoid air cell. The therapeutic agent is then injected into the interior portion of the ethmoid air cell using the injection device, the therapeutic agent being delivered via the lumen in the elongate member.