Abstract: Methods and apparatus for removing emboli during an endarterectomy procedure are provided. The present invention provides a proximal catheter disposed proximal to a stenosis and a distal catheter disposed distal to the stenosis. Each catheter may selectively communicate with a venous return catheter via a manifold having a setting controlled by a physician. Blood flows into an aspiration lumen of the distal catheter and is reperfused into a remote vein via the venous return catheter. Additionally, emboli generated during the procedure are removed via an aspiration lumen of the proximal catheter, and filtered blood then is reperfused into the remote vein.

Abstract: Methods and apparatus are provided for removing emboli generated during a surgical procedure comprising a catheter having proximal and distal ends, a lumen extending therethrough, an occlusive member affixed to the distal end, and at least one blood intake port disposed in a lateral surface of the catheter. The occlusive member preferably is disposed in a treatment vessel, and the blood intake port, when uncovered, permits a portion of the antegrade flow from a host vessel to be diverted into the lumen of the catheter. A pressure differential caused by the blood intake from the host vessel establishes a venturi-effect suitable for manipulating flow in the treatment vessel. The flow characteristics may be manipulated via the intake port to direct emboli into the lumen of the catheter for subsequent removal.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding a branch artery to prevent reversal of flow during carotid artery stenting, the apparatus comprising a retrieval sheath configured to reduce the risk of potentially dangerous interaction with the stent during retrieval.

Abstract: A device and method for inflating and deflating a balloon, used to protect the cerebrum against emboli, during carotid stenting, is provided wherein the device comprises a balloon carried on a guide wire and wherein inflation can be accomplished without the need of a port on the guide wire, so that coaxial systems may be applied over the guide wire. The device comprises a guide wire having an interior lumen and a balloon that communicates with the lumen. A core segment is inserted into the open end of the guide wire, and serves as a piston to inflate the balloon after saline is introduced into the lumen. A locking mechanism is provided to retain the core segment in position during the procedure. Coaxial systems, such as balloon catheters and stent delivery systems, can be applied over the guide wire without deflating the guide wire balloon.

Abstract: Apparatus for occluding a vessel and enhancing blood flow within a catheter are provided, wherein a catheter comprises a multi-section self-expanding wire weave forming a radially expandable body and an occlusive distal section, covered with an elastomeric polymeric coating, and disposed within an outer sheath. Methods of using the apparatus of the present invention to remove emboli also are provided.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery during carotid stenting, the apparatus further comprising a wedge or capsule configured to reduce the risk of potentially dangerous interaction with the stent during retrieval.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. A blood filter and/or flow control valve may be included in-line with the tubing to filter emboli from blood reperfused into the patient and to control the degree of flow reversal.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

Abstract: A protective device against embolization is provided for use in angioplasty of the carotid artery comprising a guide catheter that forms a lumen, and a tubular member axially movable in the lumen and having a distal end expandable against the walls of the artery. The distal end includes a drainage port with non-folding edges that communicates through the tubular member with an outlet port having an hemostatic valve and an access port that enables the introduction of a guide wire and angioplasty balloon. When deployed in the carotid artery, the distal end occludes antegrade flow through the vessel and induces retrograde flow that carries emboli through the drainage port and out of the body.

Abstract: A method of performing an operation including angioplasty of the internal carotid artery includes blocking blood flow in the internal carotid artery, performing the angioplasty while the blood flow is blocked in the internal carotid artery, and reversing flow in the internal carotid artery after the angioplasty has been performed to wash material loosened during the angioplasty out of the internal carotid artery. Normal flow in the internal carotid artery is restored after the loosened material is washed out of the internal carotid artery.

Abstract: A method of performing an operation including angioplasty of the internal carotid artery which includes blocking blood flow in the internal carotid artery, performing the angioplasty while the blood flow is blocked in the internal carotid artery, and reversing flow in the internal carotid artery after the angioplasty has been performed to wash material loosened during the angioplasty out of the internal carotid artery. Normal flow in the internal carotid artery is restored after the loosened material is washed out of the internal carotid artery.

Abstract: An atherectomy device is provided wherein a catheter has a cutting region including plurality of slotted tubular members interconnected by flexible segments. Each slotted tubular member includes cutting edges that sever occlusive material from the interior of a vessel when the cutting region is rotated. The flexible segments may be formed by cutting windows in a tapered hollow tubular member, or may comprise bellows-shaped tubes or helical coils, or may comprise one or more tubular segments and may include a lumen that allows suction to be drawn through the device, or to permit the delivery of contrast agents, dyes, fluids or drugs to the operative site. A guide catheter also may be provided for positioning the cutting region of the atherectomy device at the operative site.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure using a catheter having an occlusion element disposed on its distal end, a suction device, and an aspiration lumen communicating therebetween. The occlusion element is configured to be placed proximal of a stenosis and deployed to occlude antegrade flow, so that flow is reversed in the vessel when the suction device is selectively activated. The aspiration lumen is sized so that an interventional device, such as an angioplasty catheter, may be readily advanced therethrough to the site of a stenosis. The suction device may be activated intermittently at key stages of the procedure to provide reverse flow through the vessel, and the catheter may include bypass holes for limiting suction levels and/or providing intermittent antegrade flow.

Abstract: An atherectomy device is provided wherein a catheter has a cutting region including plurality of slotted tubular members interconnected by flexible segments. Each slotted tubular member includes cutting edges that sever occlusive material from the interior of a vessel when the cutting region is rotated. The flexible segments may be formed by cutting windows in a tapered hollow tubular member, or may comprise bellows-shaped tubes or helical coils, and may be coated with a flexible material allowing suction to be drawn through the device, or to permit the delivery of contrast agents, dyes, fluids or drugs to the operative site. A guide catheter also may be provided for positioning the cutting region of the atherectomy device at the operative site.