Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: An apparatus is provided that operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The -apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: A stent includes a first flaring portion including first and second sets of cells that flare outwardly when the stent is expanded from a contracted to a flared condition, and a second main portion connected to the first flaring portion. During use, the stent is introduced into a main vessel in the contracted condition and positioned with the first portion adjacent an ostium. The first portion is flared, causing first struts of the first set of cells to move from an axial towards a radial and partial circumferential orientation and causing second struts of the second set of cells to move from an axial towards a radial orientation. The second portion resists expansion when the first portion is flared. The stent is expanded further such that the second portion expands within the branch body lumen, and the first and second struts move towards a more circumferential orientation.

Abstract: Enhanced dual purpose systems enable dilating of at least a lesion within a blood vessel and providing an anti-proliferative medicament in a non-attached form directly into the lumen of the vessel. Likewise provided is the ability to stop blood flow to prevent wash-out of the medicament during dwell time within the body lumen, and the ability to remove the medicament after the dwell time of the device to prevent unwanted exposure of the same within the body.

Abstract: Generally described here are systems and methods for controlling bleeding. The systems generally comprise a blood control catheter having an expandable member, an intra-vessel support delivery device, and an intra-vessel support releasably attached to the intra-vessel support delivery device. The system may also include a guidewire. In some variations, the guidewire may be moveable between a tracking configuration and a delivery configuration.

Abstract: Apparatus and methods are provided for removing obstructive material within a body lumen. The apparatus includes a macerator device deployable from a sheath that includes an expandable cage carried by a shaft and within a constraint tube. The shaft is movable relative to the constraint tube for deploying and expanding the cage within a body lumen such that an open end of the cage is oriented towards obstructive material. The cage is advanced to capture the material or the material is directed into the cage using an expandable member expanded beyond the material and retracted to direct the material into the cage. The cage is withdrawn into the constraint tube to compress the cage radially inwardly. Materials extending through apertures in the cage are sheared off by a sharpened edge of the constraint tube. The smaller, sheared off particles are then aspirated from the body lumen through the sheath.

Abstract: Apparatus and methods are provided for removing obstructive material within a body lumen. The apparatus includes a macerator device deployable from a sheath that includes an expandable cage carried by a shaft and within a constraint tube. The shaft is movable relative to the constraint tube for deploying and expanding the cage within a body lumen such that an open end of the cage is oriented towards obstructive material. The cage is advanced to capture the material or the material is directed into the cage using an expandable member expanded beyond the material and retracted to direct the material into the cage. The cage is withdrawn into the constraint tube to compress the cage radially inwardly. Material extending through apertures in the cage are sheared off by a sharpened edge of the constraint tube. The smaller, sheared off particles are then aspirated from the body lumen through the sheath.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: Apparatus and methods are provided for delivering fluid into a body lumen during a medical procedure. A distal end of an apparatus may be introduced into a body lumen, and a valve on the distal end may be opened to deliver fluid through a first lumen into the body lumen, e.g., contrast and/or other diagnostic or therapeutic agents. The valve may be closed, and a procedure may be performed within the body lumen, e.g., using a treatment element carried on the distal end. For example, the treatment element may include a balloon that may be inflated when fluid is delivered through the first lumen with the valve closed. Optionally, a prosthesis, energy source, drug platform, and the like may be carried by the balloon for treating the body lumen. In various embodiments, the valve may be located proximal or distal to the treatment element.

Abstract: Apparatus and methods for aspirating emboli from a vascular filter or stent within a patient's circulatory system are provided. A filter sac of the vascular filter permits blood flow and captures emboli from the flow. The aspiration device removes emboli from within or proximal to the vascular filter or stent to reduce the risk to the ischemia during retrieval of the vascular filter and during a treatment procedure. Retrieval of the vascular filter may be accomplished using either the aspiration catheter or a separate retrieval catheter.

Abstract: Apparatus are provided for accessing and/or removing material from a body lumen. The apparatus includes a tubular sheath including a shaft having a proximal end and an expandable distal end that is expandable between a collapsed configuration and an expanded, tapered configuration. In one embodiment, the expandable member include inner and outer membranes attached together and to the shaft. Optionally, the inner membrane may include a reinforcement layer and/or the outer membrane may have a longer chord length than the inner membrane, to enhance the expandable member expanding such that a distal opening is defined by the expandable member having s a relatively large diameter tapering proximally to a lumen of the shaft. Optionally, the apparatus may include a dilator and/or one or more treatment devices receivable in the lumen of the shaft.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: Apparatus and methods are provided for treating a lesion within a body lumen using a catheter including a balloon on its distal end and an abrasive distal tip extending distally beyond the balloon. The distal tip may terminate in a sharpened tip for penetrating occlusive material, e.g., a beveled tip, and includes abrasive material on an outer surface thereof, e.g., abrasive grit, cutting elements, and the like, for abrading occlusive material adjacent the distal tip. The abrasive material may be arranged in a predetermined pattern, e.g., an axial, circumferential, or helical pattern, to facilitate abrading occlusive material. The distal tip may have a substantially uniform diameter or tapered shape along its length.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending therebetween, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

Abstract: Apparatus and methods are provided for treating a lesion within a body lumen using a catheter including a balloon on its distal end that includes a plurality of raised structures that extend outwardly from the balloon membrane. In one embodiment, the raised structures are provided in pairs that are spaced apart from one another about the circumference of the balloon, and each pair includes two raised structures that are spaced relatively closely together compared to the distance the two raised structures are spaced apart from adjacent pairs. Optionally, the membrane between the two raised structures of each pair may be relatively thinner than the membrane between spaced apart pairs such that the distance between the raised structures in each pair increases as the balloon is expanded within a lesion.

Abstract: An apparatus for capturing material within a body lumen includes a shaft carrying an expandable basket device on a distal end thereof. The basket device includes a distal basket carried and a proximal basket carried on the shaft such that the proximal basket is proximal to and spaced apart from the distal basket. Each basket includes an open end communicating with an interior of the respective basket and oriented towards one another. In one embodiment, a tubular middle portion extends between the baskets. In another embodiment, the distal basket includes an actuator coupled to the distal basket open end such that movement of the baskets towards one another causes the actuator to direct the distal basket open end inwardly to allow the open end to be received within the proximal basket to facilitate removal of the apparatus after capturing material within the baskets.

Abstract: Apparatus and methods are provided for removing obstructive material within a body lumen. The apparatus includes a macerator device deployable from a sheath that includes an expandable cage carried by a shaft and within a constraint tube. The shaft is movable relative to the constraint tube for deploying and expanding the cage within a body lumen such that an open end of the cage is oriented towards obstructive material. The cage is advanced to capture the material or the material is directed into the cage using an expandable member expanded beyond the material and retracted to direct the material into the cage. The cage is withdrawn into the constraint tube to compress the cage radially inwardly. Material extending through apertures in the cage are sheared off by a sharpened edge of the constraint tube. The smaller, sheared off particles are then aspirated from the body lumen through the sheath.

Abstract: An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including a proximal end, a distal end, a lumen extending therebetween, and a balloon on the distal end having an interior communicating with the lumen. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The apparatus also includes an actuator for axially compressing the balloon, and a helical member extends between ends of the balloon interior that expands the balloon from a contracted condition to an expanded helical shape when the actuator is activated.

Abstract: An apparatus is provided for removing material within a body lumen that includes a catheter including a proximal end, a distal end for introduction into a body lumen, and an aspiration lumen extending therebetween; a guide member extending from the distal end and terminating in a distal tip, the guide member comprising a track adjacent a track lumen extending from the distal tip into the aspiration lumen; and an obstruction clearing device deployable from the guide member and retractable along the track. In addition or alternatively, the apparatus includes a cutting head reciprocable within the aspiration lumen adjacent the distal end for macerating material being aspirated into the aspiration lumen.