Abstract: The present invention is directed to a blood aspiration system that is configured to enable various types of aspiration through a working lumen of a catheter. The blood aspiration system facilitates natural aspiration by providing a circuit between a patient's arterial and venous vasculature, and also comprises a manually actuated pump configured to selectively vary rates of aspiration in the working lumen. The blood aspiration system further comprises an external port that allows suction-assisted aspiration or infusion through the working lumen, and further comprises a detachable filter that removes emboli prior to reperfusing blood into a patient's venous vasculature.

Abstract: Embolic protection and plaque removal apparatus and methods are provided wherein an aspiration device aspirates, filters and reperfuses blood using a closed fluid circuit having a bi-directional working lumen. The plaque removal device includes a plurality of self-expanding cutting elements that form cage that self-centers within the blood vessel to reduce the risk of trauma to the vessel lining.

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: The present invention is directed to a proximal catheter assembly that is configured to facilitate natural or suction-assisted aspiration through a catheter lumen. The proximal catheter assembly comprises a relief valve configured to regulate the level of suction-assisted aspiration provided through the working lumen of the catheter. When the level of suction-assisted aspiration exceeds a predetermined threshold, the relief valve opens to allow fluid to be drawn from tubing coupled to the proximal catheter assembly, thereby mitigating the relatively high levels of aspiration imposed upon the working lumen and the patient's vessel.

Abstract: Apparatus and methods for treating cerebral occlusions are provided, including a thrombectomy device having at least one deployable element. The deployable element is advanced through the occlusion in a contracted state, then self-deploys distal of the occlusion or, alternatively, may be deployed to a wide range of configurations using a physician-actuated deployment knob. The thrombectomy device then may be retracted to cause the deployable element to snare the occlusion, and/or rotated circumferentially to cause the fibrin strands of the occlusion to be wrapped around the deployable element.

Abstract: Apparatus and methods for treating cerebral occlusions are provided, comprising a thrombectomy device having at least one deployable element. The deployable element is advanced through the occlusion in a contracted state, then self-deploys distal of the occlusion or, alternatively, may be deployed to a wide range of configurations using a physician-actuated deployment knob. The thrombectomy device then may be retracted to cause the deployable element to snare the occlusion, and/or rotated circumferentially to cause the fibrin strands of the occlusion to be wrapped around the deployable element.

Abstract: The present invention is directed to a proximal catheter assembly configured to facilitate natural or suction-assisted aspiration through a catheter lumen. The proximal catheter assembly comprises a multi-function valve configured to perform functions associated with conventional check valves and relief valves. The valve is configured to regulate the direction of fluid flow, and further configured to regulate the rate of suction-assisted aspiration provided through the lumen of the catheter. When the rate of suction-assisted aspiration exceeds a predetermined threshold, the valve opens to allow fluid to be drawn from tubing coupled to the proximal catheter assembly, thereby mitigating excessively high rates of aspiration imposed upon the patient's vessel.

Abstract: An implantable vascular prosthesis having improved flexibility is provided comprising a helical body portion having a reduced delivery configuration and an expanded deployed configuration, the helical body portion comprising a plurality of cells interconnected by hinge points that enhances flexibility of the vascular prosthesis and provides at least partial nesting of adjacent turns of the helical body portion in the reduced delivery configuration.

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: The present invention is directed to a delivery system for delivering a vascular prosthesis within a vessel, the vascular prosthesis having a contracted delivery configuration and a deployed configuration. The delivery system comprises a loader tube having a lumen preloaded with a delivery wire carrying a vascular prosthesis in the contracted delivery configuration. A separately inserted sheath includes a lumen configured to accept the vascular prosthesis, while retaining it in the contracted delivery configuration. The delivery wire is used to translate the vascular prosthesis to a distal end of the sheath for deployment in a vessel.

Abstract: The present invention is directed to a proximal catheter assembly that is configured to facilitate aspiration through a catheter lumen. The proximal catheter assembly enables natural aspiration to be achieved within the catheter lumen, for example, using an arterial-venous shunt, and further enables suction-assisted aspiration or infusion to be applied through the catheter lumen. This allows a physician to provide a substantially continuous level of retrograde flow within a vessel during a medical procedure without damaging the vessel wall, while providing the option of suction-assisted aspiration, when necessary, to further influence the level of aspiration within the vessel.

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 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: An emboli filtration apparatus is provided comprising a guide wire having a filter element captured thereon, so that the guide wire is free to rotate and translate while the filter element remains stationary. The apparatus allows for movement and rotation of the guide wire as devices are advanced over it to treat occlusive disease, substantially without dislodging the filter element. In a preferred embodiment, the guide wire comprises a proximal stop configured to reposition the filter element during a medical procedure without having to remove or insert additional interventional devices.

Abstract: The present invention is directed to an implantable vascular prosthesis configured for use in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, and allowing for the controlled delivery of therapeutic agents to a vessel wall. The prosthesis comprises a helical proximal section coupled to a distal anchoring section having a generally zig-zag or cell-like configuration. The prosthesis is configured to conform to a vessel wall without substantially remodeling the vessel, and further is configured to be precisely deployed in a vessel without shifting during deployment. The prosthesis also has a substantially small delivery profile compared to other known stents, while having an increased surface area to enhance delivery of therapeutic agents.

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: 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: 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: The present invention is directed to a catheter that is configured to self-regulate aspiration rates through a working lumen of the catheter. The catheter comprises a compliant member in communication with the working lumen that is configured to transition from an open position to a closed position when a predetermined aspiration threshold is exceeded. In the closed position, the compliant member is temporarily drawn inward to at least partially occlude flow through the working lumen, thereby mitigating the rate of aspiration imposed upon a patient's vessel. When the rate of aspiration is reduced below the threshold level, the compliant member returns to the open position.

Abstract: The present invention is directed to apparatus and methods for treating a vascular occlusion by providing an infusion catheter having an atraumatic tip and at least one delivery port configured to infuse fluid into the occlusion. The fluid that is infused dilutes the occlusion and reduces adhesion of the occlusion to an intima of the vessel wall, thereby causing the occlusion to dislodge. Emboli generated in the process are directed into an emboli removal catheter for removal.