Abstract: Medical devices and methods are described that include catheter systems for use in vasculature. The catheter systems include a re-entry catheter for use with numerous guide wires to direct the guide wire from the extraluminal or subintimal space back into a true lumen after the guide wire has entered the subintimal space. An example of the re-entry catheter is a single lumen catheter configured to facilitate placement and positioning of guide wires and catheters within vasculature. An embodiment places and positions guide wires and catheters within peripheral vasculature. More specifically, the re-entry catheter provides for re-entry of a guide wire back into the true lumen of peripheral vasculature from a subintimal space.

Abstract: A catheter system and corresponding methods are provided for accessing a blood vessel true lumen from a sub-intimal plane of the vessel. The catheter system includes visualization elements for determining the orientation of the true lumen with respect to the sub-intimal plane at an identified entry site from a position in the sub-intimal plane. The entry site is distal to a chronic total occlusion (CTO). The catheter system also includes a system for physically securing tissue of the sub-intimal plane at the entry site to the catheter system. The attaching system reduces or eliminates catheter float within the sub-intimal space. The catheter system further includes re-entry devices to establish and maintain a path from the sub-intimal plane back into the vessel true lumen.

Abstract: Medical devices/methods are described that include catheter systems for crossing total occlusions in vasculature. The catheter systems are for use with numerous guide wires to direct the wires from the extraluminal or subintimal space back into a blood vessel lumen after the wire has entered the subintimal space. The catheter systems comprise a catheter body having at least one lumen configured to track over a wire. An endpiece that includes at least one port in communication with the lumen couples to the distal region of the catheter body. A working element is configured to deploy through the port for delivery from a location within the extraluminal space to locations within the vessel true lumen when advanced distally through the port. A distal region of the catheter body assumes first or second configurations when the working element is retracted into the catheter body.