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: Methods and devices for surgical repair of an aortic aneurysm are described. The devices comprise an elongate member having one or more expandable filters or membranes mounted at a distal end. In certain embodiments, the devices also include aspiration and flushing capability to assist in removal of embolic debris. In use, the filter is inserted and expanded downstream of an aortic aneurysm. The aneurysm is repaired and the filter captures emboli dislodged during the repair. The filter is then collapsed and removed from the aorta.

Abstract: A method for carotid endarterectomy. A blood filter is positioned within a carotid artery downstream of an atheromatous plaque. The filter is expanded. The carotid artery is clamped upstream and downstream of the atheromatous plaque while the filter is expanded. An endarterectomy procedure is performed on the region of the carotid artery having the atheromatous plaque. The carotid artery is unclamped while the filter is expanded. In certain cases a shunt is positioned in a region of the carotid artery having the atheromatous plaque and secured to the shunt by clamping, the shunt comprising a tubular member having a proximal opening, a distal opening, and a lumen therebetween.

Abstract: An introducer system having an elongate shaft with proximal and distal ends. A flexible sleeve is mounted on the distal end of the shaft and is adapted to circumferentially cover the outer surface of a distal end of a cannula when the shaft is positioned within a lumen of the cannula. The introducer system has dilation capabilities which facilitates insertion of a medical device into a vessel or organ. Methods of using the devices herein are also disclosed.

Abstract: A cannula is described that includes a diverter mechanism in the form of a diffusion surface deployable from within the lumen of the cannula and retractable from the lumen of the cannula. The diffusion surface may take the form of a planar surface, a curved surface, a membrane mounted on a wire ring, or a conical sleeve, or any other suitable shape. In use, the cannula is inserted in a vessel, the diffusion surface is deployed in the lumen of the cannula beyond the distal end of the cannula, and blood flow is passed through the cannula and against the diffusion surface. Alternative devices and methods are also described.

Abstract: An introducer system having an elongate shaft with proximal and distal ends. A flexible sleeve is mounted on the distal end of the shaft and is adapted to circumferentially cover the outer surface of a distal end of a cannula when the shaft is positioned within a lumen of the cannula. The introducer system has dilation capabilities which facilitates insertion of a medical device into a vessel or organ. Methods of using the devices herein are also disclosed.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: A catheter comprising a flexible elongate tubular member having a lumen communicating with a proximal end and a distal port at a distal end. A chamber, filled with gas or fluid less dense than blood, is mounted at the distal end. Methods of using the aspiration catheter for removing embolic air or gaseous bubbles within a body cavity are also disclosed.

Abstract: A shunt and method of use for maintaining distal blood flow during an arteriotomy procedure is disclosed. The shunt includes a first tubular member having a proximal end, a distal end, and a lumen therebetween. The proximal end has an opening in communication with the lumen, and the proximal opening is adapted to receive blood from a first region of an artery. The distal end has an opening in communication with the lumen, and the distal opening is adapted to release blood into a second region of the artery. The shunt includes a second tubular member having a proximal end, a distal end, and a lumen therebetween which either merges and communicates at its distal end with the lumen of the first tubular member, or rides separate and parallel to it.

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 cannula is described that includes a diverter mechanism in the form of a blast plate deployable from within the lumen of the cannula and retractable from the lumen of the cannula. The blast plate may take the form of a planar surface, a curved surface, a membrane mounted on a wire ring, or a conical sleeve, or any other suitable shape. In use, the cannula is inserted in a vessel, the blast plate is deployed in the lumen of the cannula beyond the distal end of the cannula, and blood flow is passed through the cannula and against the blast plate. Alternative devices and methods are also described.

Abstract: Described are devices and methods for diverting emboli away from the carotid arteries in the aorta. The devices are aortic diverters that generally comprise a hollow tube with a substantially cylindrical or conical wall, which is impermeable to emboli and which has open ends that allow blood to enter one end, flow through the tube and exit the other end. Additionally, snowshoe aortic diverters, which are planar rather than cylindrical are also shown. The methods of the invention generally include the steps of providing an aortic diverter carried by an intravascular catheter, introducing the intravascular catheter into the vascular system, advancing the intravascular catheter into the aortic arch to the region of the carotid arteries, and deploying the aortic diverter.

Abstract: An expansion mechanism that includes an elongate instrument and a plurality of struts arranged around the elongate instrument provides radial expansion of a medical device. Each strut has a first end pivotally connected to the elongate instrument and a second strut that expands radially outward. Each strut further carries a flexible line which has a proximal end and a distal end. The distal end of each line passes beyond the second end of the strut which carries it and is attached to the strut immediately adjacent the strut which carries it. Methods of using such an expansion mechanism are also disclosed, particularly to provide deployment of medical devices within a patient's blood vascular system.

Abstract: An expansion frame system for deploying medical devices in a patient's body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Abstract: A filter comprising a porous material is arranged in a generally conical shape having an expandable base and a vertex. An elongate member having a proximal end and a distal end is attached to the expandable base of the porous material at a first circumferential location of the expandable base and extends perpendicularly from a central axis of the filter. An aspiration tube, for removing embolic material under vacuum, communicates with an area at the first circumferential location of the expandable base. Methods of using the filter and occluding devices for protecting a patient from embolization during cardiovascular procedures are described.

Abstract: A cannula is described that includes a diverter mechanism in the form of a blast plate deployable from within the lumen of the cannula and retractable from the lumen of the cannula. The blast plate may take the form of a planar surface, a curved surface, a membrane mounted on a wire ring, or a conical sleeve, or any other suitable shape. In use, the cannula is inserted in a vessel, the blast plate is deployed in the lumen of the cannula beyond the distal end of the cannula, and blood flow is passed through the cannula and against the blast plate. Alternative devices and methods are also described.

Abstract: A catheter comprising a flexible elongate tubular member having a lumen communicating with a proximal end and a distal port at a distal end. A chamber, filled with gas or fluid less dense than blood, is mounted at the distal end. Methods of using the aspiration catheter for removing embolic air or gaseous bubbles within a body cavity are also disclosed.

Abstract: An atrial isolator comprising two tubular members, two lumens, drainage ports, and expandable occluders. The expandable occluders are adapted to engage an opening of the superior vena cava into the right atrium or the inferior vena cava and right tricuspid valve into the right atrium. The second tubular member is inserted into the lumen of the first tubular member to provide a displacement between the first expandable occluder and the second expandable occluder which is adjustable. A cardioplegia port is located between the two expandable occluders and in communication with a cardioplegic lumen. Methods of using such an atrial isolator are also disclosed, particularly to provide circulatory isolation of the heart and coronary blood vessels, and cardioplegia delivery.

Abstract: A shunt and method of use for maintaining distal blood flow during an arteriotomy procedure is disclosed. The shunt includes first and second tubular members having proximal ports, distal ports, and lumens therebetween. The distal port of the second tubular member is adapted for releasable attachment to the proximal port of the first tubular member. A second lumen merges and communicates at its distal end with the lumen of the first tubular member and includes a hemostatic valve attached to its proximal end. In using the apparatus for performing open endarterectomy, a filter device is inserted into the vessel and deployed downstream the region of interest in the internal carotid artery. The distal end of the shunt is advanced over the filter device and secured onto the artery. The proximal end of the shunt is inserted upstream the region of interest, typically in the common carotid artery.