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.

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: 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: 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: Methods and apparatus are provided for brachytherapy treatment of prostate disease for use in conjunction with needles containing a plurality of radioactive seeds. The apparatus comprises a housing and plunger assembly operable by a single clinician. The plunger is coupled to the housing, so that when the apparatus is actuated the needle is retracted against the plunger and the plurality of radioactive seeds is ejected.

Abstract: Methods and apparatus are provided for temporarily excluding an aneurysm or an arterio-venous fistula from a flow path by transluminally disposing a hollow balloon catheter structure within the aneurysm so that its proximal and distal ends extend past the aneurysm while maintaining continuity of the flow path, and then injecting a synthetic molding material or a biological hardening agent into the aneurysm cavity to cause solidification of the volume within the cavity. Once the material within the excluded aneurysm has solidified, the balloon catheter structure is deflated and removed, so that the hardened mass forms a new lining for the organ or vessel, and relieves the weakened tissue of the aneurysm or fistula from further flow-induced stress.

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: 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: Methods and apparatus are provided for improved brachytherapy treatment of prostate disease. The apparatus provides for angular reorientation of a needle template with respect to an ultrasound probe during brachytherapy administration. Angular reorientation is expected to beneficially overcome anatomical constraints, such as skeletal structures, that may limit a medical practitioner's ability to deliver radioactive brachytherapy seeds into a prostate in proper alignment.

Abstract: Apparatus and methods for manufacturing a guidewire having a plurality of radiopaque markers are disclosed. In a preferred embodiment, the present invention provides a guidewire having a tapered distal section comprising a plurality of gold markers that are deposited on the guidewire at predetermined intervals, so that the outer surface of the guidewire is substantially smooth. The gold markers provide a fluoroscopic reference for positioning the guidewire and enable accurate sizing of vessel features, such as the length of a lesion.

Abstract: Methods and apparatus are provided for brachytherapy treatment of prostate disease for use in conjunction with needles containing a plurality of radioactive seeds. The apparatus comprises a housing and plunger assembly operable by a single clinician. The plunger is coupled to the housing, so that when the apparatus is actuated the needle is retracted against the plunger and the plurality of radioactive seeds is ejected.

Abstract: Several embodiments of an intravascular hemostasis device are disclosed which in one embodiment generally comprises at least a first elongated tubular member having a proximal end portion and a distal end portion, and a flexible, deformable sealing member coupled to the distal end portion of the elongated tubular member which has at least a first pre-formed expanded state, the sealing member being at least partially radially compressible to at least a first compressed state for insertion of the sealing member into an opening in a blood vessel, the sealing member being radially expandable from its compressed state to its expanded state after the sealing member is inserted into the opening in the vessel in which the sealing member is adapted to seal against an inner wall of the blood vessel around the opening.

Abstract: Methods and apparatus are provided for improved administration of brachytherapy in the treatment of prostate disease. More particularly, a prostate visualization device is provided comprising a catheter coupled to at least one deployable member at the distal end of the catheter. The deployable member is preferably manufactured from a shape memory alloy having a petal-shaped configuration suitable for engaging and defining the proximal region of a patient's bladder. The deployable member may comprise tubing filled with air or other radiopaque agents to facilitate ultrasonic imaging of the deployable members near the bladder/prostate junction.

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: 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 are provided for temporarily excluding an aneurysm or an arterio-venous fistula from a flow path by transluminally disposing a hollow balloon catheter structure within the aneurysm so that its proximal and distal ends extend past the aneurysm while maintaining continuity of the flow path, and then injecting a synthetic molding material or a biological hardening agent into the aneurysm cavity to cause solidification of the volume within the cavity. Once the material within the excluded aneurysm has solidified, the balloon catheter structure is deflated and removed, so that the hardened mass forms a new lining for the organ or vessel, and relieves the weakened tissue of the aneurysm or fistula from further flow-induced stress.

Abstract: A prosthesis is provided for treating aneurysms, occlusive disease of vessels and body organs, and arterio-venous fistulas, occurring in single and bifurcated lumens. The prosthesis comprises an expandable coiled sheet portion having a biocompatible graft, either a sheet or tube, affixed thereto along part or all of the circumference of the coiled sheet portion. The prosthesis has a small delivery profile, making it suitable for use in a variety of body vessels. Methods of making and deploying the prosthesis in single and bifurcated lumens are also provided.

Abstract: Apparatus and methods for depositing radioactive seeds into a patient's prostate are provided that include impedance measuring circuitry for detecting whether the distal end of an elongated needle extends into a patient's bladder. The elongated needle includes two conductive traces and a lumen adapted to receive a column of radioactive seeds and spacers. The impedance measuring circuitry is coupled to the conductive traces of the elongated needle and provides a display indicative of the monitored impedance.

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.