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 sheath 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 medical guidewire system including an inner member having an outer diameter and an outer member having an inner diameter, the inner diameter being larger than the outer diameter. The inner and outer members are relatively slidable to adjust a stiffness of the guidewire system. The lumen of the outer member forms a gap for fluid flow therethrough. A connector has a first end portion connected to the outer member, a second end portion connected to the inner member and a fluid infusion channel communicating with the gap for injection of fluid through the gap to exit a distal portion of the outer member.

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 sheath 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 method of adjusting the stiffness and size of a guidewire without full withdrawal of the guidewire from a patient's vascular system comprising providing a guidewire system comprising an inner member having a first outer diameter and a first stiffness, an outer member having a third larger diameter and a third stiffness, and a stiffener positioned between the inner and outer members and having a second outer diameter larger than the first diameter and smaller than the third diameter. The method includes selectively changing the relative positions of the members to alter the pushability and stiffness of the guidewire system.

Abstract: A medical guidewire system comprising a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter larger than the second outer diameter of the second member. The second member has a longitudinal extending opening to receive the first member for sliding movement with respect to the first member and the third outer member has a longitudinally extending opening to receive the second member for sliding movement with respect to the first and second member. The first member has a first stiffness, the third member has a third stiffness greater than the first stiffness, and the second member is movable to stiffen the guidewire system.

Abstract: A method of adjusting the stiffness and size of a guidewire without full withdrawal of the guidewire from a patient's vascular system comprising providing a guidewire system comprising an inner member having a first outer diameter and a first stiffness, an outer member having a third larger diameter and a third stiffness, and a stiffener positioned between the inner and outer members and having a second outer diameter larger than the first diameter and smaller than the third diameter. The method includes selectively changing the relative positions of the members to alter the pushability and stiffness of the guidewire system.

Abstract: A medical guidewire system comprising a first inner member having a first outer diameter, a second intermediate member having a second outer diameter larger than the first outer diameter, and a third outer member having a third diameter larger than the second outer diameter of the second member. The second member has a longitudinal extending opening to receive the first member for sliding movement with respect to the first member and the third outer member has a longitudinally extending opening to receive the second member for sliding movement with respect to the first and second member. The first member has a first stiffness, the third member has a third stiffness greater than the first stiffness, and the second member is movable to stiffen the guidewire system.

Abstract: A method for deployment of a multi-part endoluminal device includes deploying a first portion of the device sequentially from its distal end to its proximal end, then deploying a second portion of the device sequentially from its proximal end to its distal end so that its distal end overlaps the first portion proximal end. The system for deploying the endoluminal device includes a first introducer loaded with a first endoluminal device and adapted to deploy the first device sequentially from the distal end to the proximal end, and a second introducer loaded with a second endoluminal device and adapted to anchor the second endoluminal device proximal end while deploying the second endoluminal device sequentially from the proximal end to the distal end.

Abstract: Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in either the common carotid artery (CCA) or both the vertebral artery (VA) and the CCA on the hemisphere of the cerebral occlusion. Blood flow in the opposing carotid and/or vertebral arteries may be inhibited. Retrograde or antegrade flow may be provided through either catheter independently to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter(s).

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: Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in the common carotid artery of the hemisphere of the cerebral occlusion. Retrograde flow may be provided through the catheter to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter.

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 sheath 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: Apparatus and methods for treatment of stroke are provided. In a preferred embodiment, the present invention disposes at least one catheter having a distal occlusive member in either the common carotid artery (CCA) or both the vertebral artery (VA) and the CCA on the hemisphere of the cerebral occlusion. Blood flow in the opposing carotid and/or vertebral arteries may be inhibited. Retrograde or antegrade flow may be provided through either catheter independently to effectively control cerebral flow characteristics. Under such controlled flow conditions, a thrombectomy device may be used to treat the occlusion, and any emboli generated are directed into the catheter(s).

Abstract: An arterial graft device and a process for positioning the same, wherein the device provides a first part positioned by conventional techniques within the artery, and a second part which is positioned and fixed on the first part by a segment which is provided on the first part so as to prevent a catheter guidewire—whereby the second part is positioned in place—from deviating and damaging arterial walls.

Abstract: An introducer for implanting a prosthesis in a junction of a main lumen and a branch lumen. The prosthesis comprises a trunk to be implanted within the main lumen and at least one arm to be implanted within the branch lumen. The introducer comprises an outer sheath, an axial guide wire and at least one peripheral guide wire slideable within the outer sheath, and a nose cone at a distal end of the sheath. The nose cone has an axial conduit for receiving the axial guide wire and at least one peripheral channel for guiding the peripheral guide wire and guiding it into the branch lumen. A unitary branched prosthesis having at least one radial arm may be deployed using this introducer. Methods for deploying a unitary or modular branched prosthesis at a junction in a lumen use the introducer of this invention.

Abstract: A stent graft device has an upper main tubular portion dividing into two tubular limbs and is adapted for location in an aorta having an aneurysm. The stent graft device is well suited for an aorta having a restricted section having an inner diameter smaller than the sum of the inner diameters of the iliac arteries, which branch from the aorta. The diameters of the two tubular limbs are sufficiently small to allow for both tubular limbs to be deployed side-by-side in a fully expanded state within the restricted section without being constrained by the aorta inner surface. The limbs also have distal end portions having diameters larger than the diameters of limbs at the area near the restricted section for being retained within the iliac arteries.

Abstract: An endo-vascular fastener applicator is provided for endo-luminal fastening a prosthetic to a vessel with a fastener. The applicator includes a tubular body that is configured for positioning within a vessel; an expandable portion disposed adjacent distal end of the tubular body, and deployed to support a prosthetic in contact with an inner surface of a vessel; and a drive assembly for advancing a fastener into the prosthetic. The applicator may include a control assembly; and a delivery tube that is disposed for movement within the tubular body, and which defines a channel for movement of the drive assembly therewithin. The delivery tube may include an applicator head having an injection mount that is disposed for movement relative to the prosthetic. A method for endo-luminal repairing a damaged portion of a vessel is also disclosed.

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.