Abstract: A system for removing matter from a partially or totally occluded stent includes a cutter that is urged radially outward toward the inner surface of the stent. Preferably, the cutter has a hardness that is less than or equal to the hardness of the material used to make the stent. Aspiration may be provided to remove portions of the occluding material from the vessel.

Abstract: A hemostasis valve which provides a fluid tight seal at all times to prevent back-bleeding, and offers relatively low friction when devices are inserted therein. The hemostasis valve may either be an integral part of a tubular device (e.g., sheath, catheter, or the like) or releasable from the tubular device (e.g., Y-adapter or the like). In one embodiment, the hemostasis valve is biased to a closed position in response to distal pressure to prevent back-bleeding. The hemostasis valve is also biased to an open position in response to proximal force or pressure to reduce friction when devices are inserted therein. For example, the hemostasis valve may comprise a plurality of leaflets or flaps. In another embodiment, the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein.

Abstract: A system for removing matter from a partially or totally occluded stent includes a cutter that is urged radially outward toward the inner surface of the stent. Preferably, the cutter has a hardness that is less than or equal to the hardness of the material used to make the stent. Aspiration may be provided to remove portions of the occluding material from the vessel.

Abstract: An atherectomy device having the ability to create variably sized lumens in a vessel. An ablation burr rotated by a drive shaft is routed through a control shaft having a bend in its distal end. The control shaft is in turn routed through a surrounding guide catheter. By extending or retracting the bend of the control shaft into the distal end of the guide catheter, the lateral displacement of the ablation burr is varied. A lumen in a vessel is created by rotating the control shaft within the surrounding guide catheter. In addition, the atherectomy device may include an integrated imaging sensor contained within a separate lumen of the catheter surrounding the drive shaft. The imaging sensor provides images of the interior of the vessel wall to determine if an occlusion has been removed by operation of the ablation burr. The catheter may include a self-expanding stent at its distal end to force the ablation burr against a vessel wall in order to create various sized lumens in a patient's vasculature.

Abstract: Devices and methods for creating a series of percutaneous myocardial revascularization (PMR) channels in the heart. One method includes forming a pattern of channels in the myocardium leading from healthy tissue to hibernating tissue. Suitable channel patterns include lines and arrays. One method includes anchoring a radiopaque marker to a position in the ventricle wall, then using fluoroscopy repeatedly to guide positioning of a cutting tip in the formation of multiple channels. Another method uses radiopaque material injected into each channel formed, as a marker. Yet another method utilizes an anchorable, rotatable cutting probe for channel formation about an anchor member, where the cutting probe can vary in radial distance from the anchor. Still another method utilizes a multiple wire radio frequency burning probe, for formation of multiple channels simultaneously. Still another method utilizes liquid nitrogen to cause localized tissue death.

Abstract: Devices and methods for creating a series of percutaneous myocardial revascularization (PMR) channels in the heart. One method includes forming a pattern of channels in the myocardium leading from healthy tissue to hibernating tissue. Suitable channel patterns include lines and arrays. One method includes anchoring a radiopaque marker to a position in the ventricle wall, then using fluoroscopy repeatedly to guide positioning of a cutting tip in the formation of multiple channels. Another method uses radiopaque material injected into each channel formed, as a marker. Yet another method utilizes an anchorable, rotatable cutting probe for channel formation about an anchor member, where the cutting probe can vary in radial distance from the anchor. Still another method utilizes a multiple wire radio frequency burning probe, for formation of multiple channels simultaneously. Still another method utilizes liquid nitrogen to cause localized tissue death.

Abstract: Devices and methods for percutaneous translumenal minimally invasive coronary surgery, particularly bypass surgery involving the following basic steps: determining a proper location for treatment, navigating a suitable device to the treatment site, creating an extravascular opening and pathway, guiding and/or monitoring the progress of creating the opening and pathway, and maintaining the extravascular opening and pathway. One or more extravascular openings and/or pathways may be created to define a fluid path or bypass around the vascular restriction. For example, an intravascular catheter for creating an extravascular opening in a vessel wall includes an elongate shaft adapted for intravascular navigation, an anchoring mechanism disposed on the distal end of the shaft, and a tissue penetrating member having a proximal end slidably disposed in the shaft and a distal end including a tissue penetrating mechanism.

Abstract: A system for removing matter from a partially or totally occluded stent includes a cutter that is urged radially outward toward the inner surface of the stent. Preferably, the cutter has a hardness that is less than or equal to the hardness of the material used to make the stent. Aspiration may be provided to remove portions of the occluding material from the vessel.

Abstract: The present invention pertains generally to the field of cryo balloon therapy and the use of cryo balloon therapy catheters to generate cold-induced lesions. The present invention includes a cryo balloon therapy apparatus, comprising a catheter having a proximal and a distal end, a cooling member disposed at the distal end of the catheter, a pull cord coupled to the cooling member, and a sheath that couples the pull cord and the catheter. A method for causing cold-induced necrosis is also disclosed.

Abstract: A bypass system for bypassing a restriction in a parent vessel of a mammal to provide blood flow past the restriction. The bypass system couples a restricted artery to a venous vessel distal of a restriction to provide blood flow through the artery distal of the restriction. Blood flow is provided to a distal portion of the artery through an adjacent venous vessel so that blood can be provided to distal portions of the restricted artery.

Abstract: A hemostasis valve which provides a fluid tight seal at all times to prevent back-bleeding, and offers relatively low friction when devices are inserted therein. The hemostasis valve may either be an integral part of a tubular device (e.g., sheath, catheter, or the like) or releasable from the tubular device (e.g., Y-adapter or the like). In one embodiment, the hemostasis valve is biased to a closed position in response to distal pressure to prevent back-bleeding. The hemostasis valve is also biased to an open position in response to proximal force or pressure to reduce friction when devices are inserted therein. For example, the hemostasis valve may comprise a plurality of leaflets or flaps. In another embodiment, the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein.

Abstract: Methods and devices for separating plaque from vessel walls using everting membranes. Everting tubes disposed on catheters are used in one embodiment of the invention to separate plaque from blood vessel walls. One embodiment of the invention utilizes a single everting membrane including a fixed portion, a leading edge, and an advancing portion. The everting tube can have an interior which can be pressurized to propel the everting tube distal edge distally onward, so as to separate the plaque from the vessel inner wall. One device has double everting membranes fixedly attached to a tubular member and having facing advancing membrane portions which may be proximally fixed relative to one another, but are preferably both free to travel distally. The outermost tube can be laid down over the vessel inner wall and the innermost tube laid down over the plaque, with the advancing surfaces of each everting membrane facing each other.

Abstract: In order to bypass a restriction in a parent vessel, a first site in a branch vessel branching from the aorta is accessed intraluminally. An occlusion is formed at the first site, and the aperture is formed in the branching vessel, intraluminally, proximal of the first site. An aperture is formed in the parent vessel distal of the restriction, and a lumen is formed which communicates between the branching vessel proximal of the occlusion, and the parent vessel distal of the restriction.

Abstract: A method and apparatus for creating a lumen through a total vascular occlusion. A directional cutter is advanced ahead of a number of proximal electrodes that engage a vessel wall. Blood in the vessel between the directional cutter and the proximal electrodes is removed by sealing the vessel with an occluding balloon and pumping a bio-compatible gas into the vessel to displace the blood. A signal source is applied to the directional cutter and used to measure the impedance between the directional cutter and each of the proximal electrodes. If the cutter engages a vessel wall, the impedance between the cutter and the proximal electrode decreases. A physician monitors the impedance to know when the vessel wall is engaged and turns the direction of the cutter away from the vessel wall such that the cutter continues creating a lumen within the occluding material.

Abstract: In order to bypass a restriction in a parent vessel, a first site in a branch vessel branching from the aorta is accessed intraluminally. An occlusion is formed at the first site, and the aperture is formed in the branching vessel, intraluminally, proximal of the first site. An aperture is formed in the parent vessel distal of the restriction, and a lumen is formed which communicates between the branching vessel proximal of the occlusion, and the parent vessel distal of the restriction.

Abstract: An in vivo source of mechanical energy is provided in close proximity to its load. In the disclosed embodiments, the mechanical energy source is a miniaturized motor (“micromotor”) and the load is a miniaturized perfusion pump located at the distal end of a transluminal catheter. The motor is powerful enough to provide the electrical energy needed by the perfusion pump to fluid, and yet small enough to fit inside a body vessel. A position sensor may be provided for automatically controlling the motor's driving current so that it is corresponds to the applied load. An embodiment of the perfusion pump is also provided in which an external energy source is used. Another embodiment is provided wherein a balloon/pump/miniaturized-motor configuration is provided on a distal end of a catheter.

Abstract: A cryoplasty catheter and method for preventing or slowing reclosure of a lesion following angioplasty. The cryoplasty catheter includes a shaft having proximal and distal ends and a dilatation balloon disposed at the distal end. An intake lumen and exhaust lumen are defined by the shaft to deliver coolant to the balloon and to exhaust or drain coolant from the balloon. The method in accordance with the present invention includes cooling a lesion to aid in remodeling the lesion through dilatation and/or freezing a portion of the lesion adjacent the dilatation balloon to kill cells within the lesion to prevent or retard restenosis.

Abstract: Devices and methods for increasing the volume of blood pumped by a heart muscle are disclosed. A therapeutic catheter in accordance with the present invention may comprise an elongate shaft having a proximal end, a distal end, and a lumen extending through at least a portion thereof. The therapeutic catheter may further include a cutter having a cutter lumen fixed to the distal end of the elongate shaft, and a mooring shaft slidingly disposed within the lumen of the elongate shaft. A method in accordance with the present invention may include the steps of engaging a muscle of a donor site with a portion of the mooring shaft, penetrating the muscle of the donor site with the cutter to form a muscle tendril, withdrawing the muscle tendril from the muscle of the donee site, positioning the distal end of the therapeutic catheter proximate a pit defined by the tissue of a donee site, inserting the muscle tendril into the tissue of the donee site, and disengaging the mooring shaft from the muscle tendril.

Abstract: A cryoplasty catheter and method for preventing or slowing reclosure of a lesion following angioplasty. The cryoplasty catheter includes a shaft having proximal and distal ends and a dilatation balloon disposed at the distal end. An intake lumen and exhaust lumen are defined by the shaft to deliver coolant to the balloon and to exhaust or drain coolant from the balloon. The method in accordance with the present invention includes cooling a lesion to aid in remodeling the lesion through dilatation and/or freezing a portion of the lesion adjacent the dilatation balloon to kill cells within the lesion to prevent or retard restenosis.

Abstract: A percutaneous system for bypassing a restriction in an artery of a mammal having an aorta includes providing a graft having a body portion with a first end, a second end and a lumen therebetween. First and second expandable stents are provided at the first and second ends of the graft, respectively. Apertures are formed in the artery, distal of the restriction, and in the aorta and the graft is inserted between the apertures. At least a portion of the first stent is inserted through the aperture in the artery and the stent is deployed to connect the first end of the graft within the artery. The second stent is positioned such that a first expandable portion is outside the aorta and a second expandable portion is within the aorta. The first and second expandable portions of the second stent are expanded to have outer diameters at least as large as the aperture in the aorta to anchor the first end of the graft in the aorta such that the lumen in the graft communicates with the aorta and the artery.