Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes inserting an intramural crossing device into the vascular lumen, positioning at least the distal tip of the crossing device in the vascular wall, advancing an orienting device over the crossing device such that an orienting element of the orienting device resides in the vascular wall, inserting a reentry device, and re-entering the true vascular lumen.

Introducer sheaths are described. In one embodiment, an introducer sheath comprises a sheath hub, a fixed housing coupled to the sheath hub, a rotating element rotatably coupled to the fixed housing, a sheath tube fixedly coupled to the rotating element, and a lock coupled to the rotating element. The lock is capable of preventing the rotating element and the sheath tube from rotating with respect to the sheath hub.

Apparatus for passing a blocked vein, including: (a) an intravascular catheter body defining at least one lumen; (b) a radially expandable anchor at a distal end of said catheter; and (c) a penetration tool sized and shaped to be delivered by the lumen to a point distal of the expandable anchor, the penetration tool including a tip and configured for being pushed through venous blockage more than one week old and present with a young's modulus greater than 1 MPa. Optionally, the penetration tool tip comprises a sharpened tip. Optionally or additionally, the penetration tool tip is controllably bendable.

A coaxial multilumen annulus plane catheter, including an outer pigtail catheter enclosing one or two additional lumens, each housing either a slidable shaped wire or a second pigtail catheter shaped to fit into a wide range of annulus diameters and/or depths. In embodiments, the device may include a catheter delivery handle with thumb/finger-actuated sliders that extend or retract the shaped wires and are sized to enable side-to-side or radial motion, imparting a torque to the pre-shaped wires which translates the length of the wires to enable individually controlled rotation or sweep of each wire to accommodate different annulus diameters. The delivery handle includes hemostasis controls and flush ports. In other embodiments, a handle is obviated by direct lumen axial and rotational control at a proximal end.

A catheter including: an elongated body sized to traverse vasculature, defining a longitudinal axis, and including: an outer surface; and a proximal end and a distal end disposed on opposite sides thereof; an orientation lumen formed in the elongated body and defining a curved path extending proximally from the distal end towards the proximal end and about the longitudinal axis; an orientation insert disposed within the orientation lumen, the orientation insert including an oriented pull-wire attached to the distal end of the elongated body such that tightening the oriented pull-wire deflects the distal end to form a curve; and a flexible circuit disposed on the outer surface of the elongated body, the elongated body being substantially rotationally fixed about the longitudinal axis relative to the oriented pull-wire such that the flexible circuit is disposed toward an outer bend of the curve when the oriented pull-wire is tightened.

An insertion assist system includes a guide member and a shift member. The guide member brings an outside bend of a peripheral surface of an insertion body into contact with a guide surface of the guide member. The shift member shifts a direction of the distal end of the insertion body. The shift member comes into contact with an inside bend of the peripheral surface of the insertion body when the insertion body is bent. The shift member bends the insertion body toward the guide surface about the guide surface as a fulcrum when the shift member comes into contact with the inside bend and bends the insertion body.

Systems, methods, and devices are provided for assisting or performing guided interventional procedures using specialized catheters and inserts. A bend altering device is introduced into a conduit in an organ causing it to take on a tortuous path and to assist in its visualization. A scan is performed of a patient's anatomy to identify targets critical structures and the path of the conduit. A bend altering device containing position indicating elements is placed into the conduit in the same path as before the scan. During a procedure, the pre-procedure scans may be registered to the patient using the location of the position indicating elements in the conduit. This registration may be used in an intervention to guide instruments and templates to obtain diagnostic information or provide therapy to the targets identified in the scans.

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes inserting an intramural crossing device into the vascular lumen, positioning at least the distal tip of the crossing device in the vascular wall, advancing an orienting device over the crossing device such that an orienting element of the orienting device resides in the vascular wall, inserting a reentry device, and re-entering the true vascular lumen.

Disclosed is a system including an electrode and a stylet configured to steer the electrode towards its intended position during implantation, and a method for such system's use. An electrode is provided having regions with varied flexibility. A stylet having bends that are indexed to specific regions of flexibility of the electrode may be inserted into the electrode, and upon minimal radial and/or longitudinal movement of the stylet within the electrode, will cause the magnitude of the angle to which the lead is bent to either increase or decrease so as to aid the operator in placement of the electrode.

Balloon catheters that includes inner and outer elongate shafts, each of which is secured relative to an end of an inflatable member. The inner and outer elongate shafts are secured relative to one another at one more discrete connection locations. The balloon bonding locations are disposed radially inward relative to an outer dimension of the outer elongate shaft.