Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: An apparatus is provided for scoring a treatment location in a vessel. A catheter includes an expandable element or inflatable balloon for achieving dilatation. A scoring element includes an elongated scoring wire having at least one ring for selective positioning over the inflatable balloon, which may then be inflated to provide scoring function in both a longitudinal and transverse direction. A plurality of the rings may be provided, and may be adapted for use with a variety of different sizes or lengths of balloons. Related methods are also disclosed.

Abstract: A blood filter extraction system for extracting a blood filter from within a blood vessel. The system includes an extraction wire, or plurality of such wires, positioned within an elongated tubular member. A plurality of extraction wires coupled to the distal end of the extraction member each include a hook for engaging filter members. Alternatively, the extraction wires may be one or more wires configured in a helical shape which engage filter members when the extraction member is rotated. The system may also include an elongated tubular member with the distal end having a conical shape. To extract a filter, the extraction wires are then pushed out of the tubular member and into the filter members. The extraction member is then withdrawn or rotated so the wires engage and draw in the filter members, after which the catheter is pushed over the conical portion of the tubular member.

Abstract: A thrombi removal catheter includes a sheath having a distal axial opening at a distal end in fluid communication with a lumen, and a lateral opening that extends through a side wall to the lumen. The lateral opening is proximally spaced from the distal end. An elongate member is disposed in the lumen of the sheath and is configured for longitudinal movement relative to the sheath. The elongate member has a proximal position and a distal position relative to the sheath. When the elongate member is in the proximal position, the distal axial opening of the sheath is closed by a distal blocker element of the elongate member and the lateral opening of the sheath is open, and when the elongate member is in the distal position, the lateral opening of the sheath is closed by the proximal blocker element and the distal axial opening of the sheath is open.

Abstract: An endovascular implant for forming a fistula includes a body including a wall forming a lumen having a distal opening and a proximal opening. An anchor is coupled to a distal end of the body adjacent the distal opening. The anchor may include a first anchor extending from a first side of a distal end of the body, and a second, separate anchor may extending from a second side of the distal end of the body. A retriever may be coupled to a proximal end of the body adjacent the proximal opening.

Abstract: An orbital atherectomy system includes a handheld driver having a motor. An elongate flexible driveshaft has a proximal end portion and a distal end portion. The proximal end portion is drivably coupled to the motor. The distal end portion defines a rotational axis. An abrasive element is fixedly disposed on the distal end portion of the elongate flexible driveshaft. The abrasive element includes a first flat side, a second flat side, a leading tapered end portion having a leading end, and a trailing tapered end portion having a trailing end. The first flat side and the second flat side are on opposite sides of the rotational axis.

Abstract: Devices and methods for performing a transseptal puncture procedure using a device which includes either an untapered or tapered blunt end cannula disposed in an introducer carrying a sharp guidewire disposed longitudinally through the lumen of the blunt cannula, and a blunt end dilator wherein the guidewire is flexible and has an atraumatic shape at its tip. The cannula gives the more flexible introducer a defined shape and steerabilty allowing an ordinarily skilled physician to easily access a selected location on the septal wall of the heart for transseptal puncture and introducer placement thereacross without employing an exposed sharp end needle during the procedure.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: Disclosed herein is a vessel shaping device configured to reshape a vessel along a single axis and regulate a blood flow therethrough. The vessel reshaping device generally consists of a frame that can transition to an expanded configuration and can temporarily reshape a vessel, e.g. the inferior vena cava (“IVC”), in a single axis extending perpendicular to a longitudinal axis. The greater the expansion of the reshaping device, the greater the reduction in cross-sectional area and the greater the reduction in flow through the vessel. Modifying a blood flow to the heart as such can improve the symptoms of hypervolemia, leading to increased diuretic efficiency and improve symptoms of congestive heart failure.

Abstract: A fistula formation device includes a first engagement member and a second engagement member. The first engagement member is configured to be positioned within a first vessel. The first engagement member includes a plate defining a first opening therethrough. The second engagement member is configured to be positioned within a second vessel. The second engagement member includes a base plate having a second opening extending therethrough, and one or more retention members extending from the base plate around the second opening, wherein the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: A method of preparing a filter for delivery into a body vessel. The filter includes a hub disposed along a longitudinal axis and a plurality of anchor members extending from the hub. Each anchor member includes either a cranial extension or a caudal extension at a distal end thereof. At least one anchor member distal end may be spaced from the hub at each of a first, second, and third distance along the longitudinal axis. The filter also includes a plurality of locator members extending from the hub, the locator members alternatingly interposed between the anchor members.

Abstract: An intraluminal prosthesis includes a stent architecture having a series of stent elements repeating along a circumferential axis. One series of stent elements includes v-shaped stent elements having at least four different orientations, and V-shaped stent elements connecting adjacent v-shaped stent elements. One series of stent elements includes R-shaped stent elements having at least four different orientations, and U-shaped stent elements having at least two different orientations, the U-shaped stent elements connecting adjacent R-shaped stent elements. Adjacent series of stent elements can be connected by connectors. Portions of the stent elements may narrow in width along a length thereof. The stent architecture may include radiopaque element receiving members. The stent architecture may be formed by machining a metal or polymer tube. The intraluminal prosthesis may include one or more graft layers.

Abstract: A removable blood clot filter includes a number of locator members and anchor members disposed radially and extending angularly downward from a hub. The locator members include a number of linear portions having distinct axes configured to place a tip portion approximately parallel to the walls of a blood vessel when implanted to apply sufficient force to the vessel walls to position the filter near the vessel centerline. The anchor members each include a hook configured to penetrate the vessel wall to prevent longitudinal movement due to blood flow. The hooks may have a cross section sized to allow for a larger radius of curvature under strain so that the filter can be removed without damaging the vessel wall.

Abstract: An endovascular apparatus takes the form of an expandable tubular body having a retriever, which may include a pair of interconnected hooks. The retriever may be formed from a single piece of material forming the tubular body, and in the case of a pair of hooks thus has a thickness corresponding to approximately twice the wall thickness of the tubular body. The innermost radial portion of the hooks may be offset from a central axis of a lumen formed by the tubular body, which facilitates free insertion of a balloon or the like for purposes of expanding the tubular body. Related methods of manufacturing an endovascular apparatus with a retriever are also described herein.

Abstract: A blood filter delivery system for delivering a filter into a vein includes an introducer and a push rod with a spline member disposed along the push rod. The spline member has a main body, and first and second boss portions spaced apart along the longitudinal axis to provide a gap for retaining anchor member of the filter during delivery via the introducer.

Abstract: In one aspect, a system for endovascular treatment of a blood vessel includes a control unit, an ultrasound device, an actuator, and a catheter having a treatment portion. The ultrasound device is communicatively coupled to the control unit. The ultrasound device includes an ultrasound probe having a subject contact surface. The actuator is coupled to the ultrasound probe and is operable to move the subject contact surface of the ultrasound prove relative to a treatment zone of a subject. The control unit is configured to determine a position of the treatment portion of the catheter as the catheter is advanced through the blood vessel, and move the subject contact surface of the ultrasound probe relative to the treatment zone of the subject with the actuator to follow the position of the catheter as the catheter is advanced through the blood vessel.

Abstract: An endovascular apparatus takes the form of an expandable tubular body having a retriever, which may include a pair of interconnected hooks. The retriever may be formed from a single piece of material forming the tubular body, and in the case of a pair of hooks thus has a thickness corresponding to approximately twice the wall thickness of the tubular body. The innermost radial portion of the hooks may be offset from a central axis of a lumen formed by the tubular body, which facilitates free insertion of a balloon or the like for purposes of expanding the tubular body. Related methods of manufacturing an endovascular apparatus with a retriever are also described herein.

Abstract: An apparatus for cutting a wall of a vessel (V), such as scoring or slicing a lesion (L) associated therewith. The device includes a cutter (10) with a single shaft (12) having a branched portion including at least two radially expandable arms. A first (16) of the expandable arms includes at least one blade (20) for slicing or scoring the lesion (L) when expanded. A second (18) of the expandable arms may also include a blade (20), or may have no blade. A sheath (S) may also be provided. The arm or arms with blades may also include a limiter (22) for limiting the cutting depth of the blade (20). An anchor may also be provided for anchoring the cutter (10) in the vessel (V).

Abstract: A blood filter extraction system for extracting a blood filter from within a blood vessel. The system includes an extraction wire, or plurality of such wires, positioned within an elongated tubular member. A plurality of extraction wires coupled to the distal end of the extraction member each include a hook for engaging filter members. Alternatively, the extraction wires may be one or more wires configured in a helical shape which engage filter members when the extraction member is rotated. The system may also include an elongated tubular member with the distal end having a conical shape. To extract a filter, the extraction wires are then pushed out of the tubular member and into the filter members. The extraction member is then withdrawn or rotated so the wires engage and draw in the filter members, after which the catheter is pushed over the conical portion of the tubular member.