Devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods disclosed herein may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.

Medical systems, devices and methods for creation of autologous tissue valves within a mammalian body are disclosed. One example of a device for creating a valve flap from a vessel wall includes an elongate tubular structure having a proximal portion and a distal portion and a longitudinal axis; a first lumen having a first exit port located on the distal portion of the elongate tubular structure; a second lumen having a second exit port located on the distal portion of the elongate tubular structure; a recessed distal surface on the distal portion of the elongate tubular structure, wherein the recessed distal surface is located distally to the first exit port; and an open trough on the recessed distal surface extending longitudinally from the first exit port.

A catheter system can include a tubular body, and at least one of a targeting system coupled to the tubular body, an expandable member, or a fluid injection port. A method of identifying a bifurcation can include inserting a catheter system into a first vessel, positioning the catheter system at a first location, expanding an expandable member to occlude the first vessel, delivering contrast material so the contrast material pooling proximate to the expandable member, and reviewing a shape of the contrast material in the first vessel under fluoroscopy.

Improved systems for diagnosing and/or treating arrhythmia of a heart makes use of an array of articulation balloons to control movement of a distal portion of a catheter inside the heart, and may be used to align a diagnostic or treatment tool with a target tissue surface region along or adjacent an inner surface of one of the chambers of the heart. The articulation balloons can generate articulation forces at the site of articulation, and the movement may provide greater dexterity than movements induced by transmitting articulation forces proximally along a catheter body that winds through a tortuous vascular pathway. One or more fluid channels may transmit pressure signals that can be used to determine engagement forces between an electrode or other surface near the distal and of an elongate flexible structure and a tissue or other surface, and those same channels may also be used to control inflation of a balloon articulation array, with the pressure signals optionally providing both force and engagement orientation information.

A positioning device is configured to selectively position or otherwise manipulate one or more organs within the body of a subject. The positioning device includes a shaped expandable element that is configured to be selectively transitioned between an unexpanded, or collapsed, state and an expanded state. While in the expanded state, the expandable element repositions or otherwise manipulates an organ. Systems that include positioning devices are also disclosed, as are methods for positioning or otherwise manipulating organs.

A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device including a flexible portion that is suited to access target anatomy. The flexibility of an elongate portion of the delivery device can be varied. Additionally, the delivery device can include structure that maintains the positioning of the delivery device in patient anatomy.

Disclosed are access devices that can be used to safely guide instruments, such as EP ablation catheters, to a therapy site such one within the pericardial space of the heart. The access devices include integrated visualization, illumination, stabilization, and safety features in a single platform that can, for example, more safely and efficiently identify and ablate several ventricular tachycardia (VT) locations on the left ventricle of the heart.

An atherectomy catheter device includes an elongate body, a drive shaft extending proximally to distally within the elongate body, and a cutter attached to the drive shaft. The cutter includes a serrated annular cutting edge formed on a distal edge of the cutter and a recessed bowl extending radially inwards from the annular cutting edge to a center of the cutter. The recessed bowl has a first curvature. The cutter further includes a plurality of grinding segments extending inwardly from the distal edge within the bowl. Each of the plurality of segments has a second curvature that is different from the first curvature.

A reentry catheter for crossing a vascular occlusion includes an elongate flexible tubular body, having a proximal end, a distal end and at least one lumen extending there through. A reentry zone on the tubular body includes at least two and preferably three sets of opposing pairs of axially spaced exit apertures in communication with the lumen. The apertures are rotationally offset from each other and aligned in a spiral pattern around the tubular body. A method of crossing a chronic total occlusion includes the steps of advancing the reentry catheter across the occlusion via a channel formed in the subintimal space, and advancing a guidewire via a selected exit port into the native lumen distally of the occlusion. The catheter may be removed, leaving the guidewire across the occlusion to guide further interventional devices.

Intravascular catheters with fluoroscopically visible indicium of rotational orientation. The catheter includes an elongate flexible tubular body, having a proximal end, a distal end and a tubular side wall defining at least one lumen extending therethrough. At least first and second opposing pairs of radiopaque rings are embedded in the side wall, spaced axially apart from each other. A first transverse axis extending through the first pair of rings is rotationally offset from a second transverse axis extending through the second pair of rings. The rings may be supported by a subassembly integrated into the wall of the catheter. The subassembly may include a tubular body having a plurality of aperture portions connected by intervening hinge portions. In one implementation, the catheter is a reentry catheter.