Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: Method and apparatus for deploying a medical device in a vessel. The apparatus includes a cannula and a medical device, for example a blood filter. The cannula has a lumen that extends from a proximal end to a distal end, and a port on the outer surface of the cannula. The port has a passage extending distally. In use, the distal end of the cannula is inserted into a vessel. The medical device is inserted into the port. The medical device is advanced through the passage into the blood vessel. The medical device is deployed within the vessel. Finally, the medical device is removed from the vessel.

Abstract: An ablation catheter system for capturing and removing necrotic tissue and thrombi generated during an ablative procedure is disclosed. The catheter typically includes an elongate member, a filtration assembly disposed within the distal region, and an ablation instrument at the distal end. Alternatively, the ablation instrument is carried on the distal end of an ablation catheter, which is disposed within a lumen of the catheter system. The catheter may further include an aspiration port and lumen. Methods of using the devices in preventing distal embolization during ablative procedures are disclosed.

Abstract: A cardioplegia occluder and methods of using the device during cardiac surgery are disclosed. The system typically includes a substantially rigid cannula with an occluder mounted on the distal region of the cannula that expands upon activation to occlude the aorta downstream of an infusion port which delivers cardioplegia solution to arrest the heart. Systems including cutting blades, blade guards, flanges, radiopaque markers and occluder aligners are also disclosed. In use, the distal end of the cannula is inserted through an incision into the aorta, the occluder is expanded and cardioplegia solution is infused upstream of the aorta to arrest the heart. The infusion port can alternately be used to aspirate cardioplegia or embolic debris or other unwanted material from the aorta.

Abstract: An intravascular thermography device comprising an elongate catheter having a distal guidewire port, a proximal guidewire port at a location closer to the distal end of the catheter than the proximal end, and a guidewire lumen. An expansion frame is attached to the catheter. The expansion frame is operable to expand, and has at least one temperature sensor. A capture sheath is slideably disposed about the expansion frame and operable from the proximal end of the catheter to release the expansion frame when the capture sheath is removed from the expansion frame. The capture sheath has a passage in a distal region of the capture sheath, the passage being shaped to align with the proximal guidewire port of the catheter. A registry mechanism is provided to maintain circumferential alignment between the proximal guidewire port and the passage in the distal region of the capture sheath. Methods of use are also disclosed.

Abstract: An intravascular thermography device comprising an elongate catheter having a proximal end, a distal end, a distal guidewire port in a distal region of the catheter, a proximal guidewire port at a location closer to the distal end of the catheter than the proximal end, and a lumen is described. The lumen extends between the proximal guidewire port and the distal guidewire port and is adapted to receive a guidewire. An expansion frame is attached to the catheter at a location distal to the proximal guidewire port. The expansion frame is operable between a contracted condition and an expanded condition, and has at least one temperature sensor. Methods of use are also described.

Abstract: Modular systems comprising a cannula and at least one access port adjacent to a distal end of the cannula provide insertion of one or more therapeutic or diagnostic devices into a vessel or cardiac tissue through a single incision site. Other embodiments include a vessel introducer or multi-port introducer. The devices can be operated in combination or independently. The systems can be employed to provide multiple therapies, including blood perfusion, filtration, aspiration, vessel occlusion, atherectomy, and endoscopic devices. Methods of using the system for vessel cannulation are also disclosed herein.

Abstract: A balloon occlusion device for aspirating embolic material from a blood vessel, such as from the aorta during cardiac surgery. The device includes an arterial cannula having a proximal end adapted to receive blood from a bypass-oxygenator machine, a distal end adapted to enter an artery, and a blood flow lumen extending between the proximal end and an outlet on the distal end. The cannula has an aspiration port proximate to the outlet, which communicates with an aspiration lumen. The cannula also includes an inflatable balloon attached to the cannula between the outlet and the aspiration port and capable of assuming an inflated condition for occluding a blood vessel. To use the device, the distal end of the cannula is introduced into a blood vessel, such as the aorta, the outlet is oriented downstream for delivering blood, and the balloon is inflated to occlude the vessel.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: An ablation catheter system for capturing and removing necrotic tissue and thrombi generated during an ablative procedure is disclosed. The catheter typically includes an elongate member, a filtration assembly disposed within the distal region, and an ablation instrument at the distal end. Alternatively, the ablation instrument is carried on the distal end of an ablation catheter, which is disposed within a lumen of the catheter system. The catheter may further include an aspiration port and lumen. Methods of using the devices in preventing distal embolization during ablative procedures are disclosed.

Abstract: A modular blood filter apparatus and methods of use. The modular filter apparatus includes an adjustable frame capable of assuming enlarged and contracted conditions and a frame sizing mechanism associated with the frame. Certain embodiments include a filter cartridge to protect the adjustable filter device therein. The cartridge may be removably introduced into a blood vessel, and the adjustable filter device may be deployed through the device into the vessel. The adjustable frame may be self-adjusting or externally adjusted to fit the vessel and to capture embolic material in the filter. The frame may be collapsed to the contracted condition, and may be removed from the vessel.

Abstract: A medical device comprising a tubular member having a proximal end, a distal end, and a lumen extending therebetween. An adjustable filter is provided having a frame and a mesh disposed about the frame. The frame is generally circular when deployed and has a first point, a first arc extending 180° from the first point to a second point on the circular frame that is opposite the first point, and a second arc extending 180° from the first point to the second point. The filter is deployed by advancing the frame distally through the tubular member with the second point leading and the first point trailing.

Abstract: The invention provides a nested tubing cannula which comprises outer and inner elongate tubular members, both having a proximal end, a distal end, and a lumen therebetween. The inner tubular member is sealed at its distal end and is nested substantially coaxially within the lumen of the outer tubular member, so that the gap between the inner and the outer tubular member defines a second lumen whereas the first lumen is the lumen of the inner tubular member. A tubular sleeve is disposed coaxially between the inner and outer tubular members. A balloon is mounted on a distal region of the outer tubular member and is in communication with the first lumen. The cannula further comprises a port proximal or distal the balloon occluder and is in communication with the second lumen. Methods for making the devices herein are disclosed.

Abstract: An improved catheter capable of detecting metabolic activity within vascular anomalies is disclosed. The apparatus of the present invention includes a catheter having a distal end and a proximal end, an expandable body located at the distal end of the catheter, the expandable body comprising one or more expandable body arms, and at least one sensor integrally formed on each of the expandable body arms. The at least one sensor may include a variety of sensors, including ultrasonic sensors, flow sensors, thermal sensors, thermocouples, blood temperature sensors, electrical contact sensors, conductivity sensors, and infrared sensors.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: A balloon arterial cannula and methods for filtering blood. The devices generally include a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, a means to actuate the structure, and a balloon occluder which typically includes a flexible material enclosing a chamber. The methods generally include the steps of introducing a mesh into a blood vessel to capture embolic material, adjusting the mesh, if necessary, during the course of filtration, inflating the balloon occluder to occlude the vessel upstream of the mesh, and thereafter deflating the balloon occluder and removing the mesh and the captured foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Abstract: An apparatus suitable for filtering emboli in an open surgical procedure. The apparatus comprises an elongated member having a distal region and a support hoop attached to the distal region. A blood permeable sac is affixed to the support hoop so that the support hoop forms a distally-facing mouth of the blood permeable sac. A guidewire is slideably attached to the elongated member. A delivery sheath is provided having a cavity for accepting the elongated member, support hoop and blood permeable sac, and a lumen extending through the cavity to permit the guidewire to pass therethrough. Methods of use are also described.

Abstract: A method for open surgery using a flexible elongate member having a filter on a distal region thereof. The flexible elongate member is introduced into a peripheral artery. The flexible elongate member is advanced to a site within the aorta upstream of a branch vessel from the aorta. The filter is deployed. The aorta is manipulated by diret access. The filter is removed from the aorta. Embolic material is generated and filtered before the flexible elongate member is removed from the aorta.

Abstract: A bendable shape-retaining cannula and methods of use. The bendable shape-retaining cannula comprises a tubular member having a proximal region, a distal region adapted to enter a blood vessel or heart chamber, a lumen therebetween, and a flexible region positioned proximal the distal region. A suture flange may be disposed about the cannula distal the flexible region. The flexible region can be bent and retains its bent configuration until a positive force is applied.

Abstract: Devices and methods for filtering blood. The devices generally comprise a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta, a structure adapted to open and close the mesh within the blood vessel, and a means to actuate the structure. The methods generally include the steps of introducing a mesh into a blood vessel to entrap embolic material, and removing the mesh and the entrapped foreign matter from the blood vessel.