Balloon catheters with an elongate shaft defining a hollow body have an inflatable balloon at a distal end thereof. The balloon has a plurality of internal chambers that are inflatable to differing pressures. When inflated, the balloon has a generally hourglass shape having a neck between a distal end and a proximal end and a port at the neck that is in open communication the hollow body of the shaft and in open communication with an environment external to the balloon. The balloon catheter is inflated in a lumen of a patient to its hourglass shape with its proximal and distal ends in direct contact with normal endothelium juxtaposed to a target lesion with the neck of the balloon at the target lesion. A cutting tool is deployed through the port and an opening having a flap is cut into the target lesion and the plaque is removed thereof.

A delivery system can be provided with an ability to change its configurations to achieve both access to target anatomy and treatment thereof. Such treatments can include directing interventional devices around an occlusion. By providing different functionality at different stages, the need to exchange and replace tools at different stages can be reduced or eliminated. Accordingly, such operations can be completed more rapidly, efficiently, and safely.

The guide catheter extension system for various intravascular procedures, including the reverse CART procedure, the thrombus removal, etc., has an enhanced ”capturing” capability. It is configured with a plastically expandable scaffold member forming an expandable “funnel-like” distal opening, and, once it has been advanced into the subintimal space, provides an enhanced capability of catching the retrograde wire or a thrombus, as required by the procedure. A balloon delivered to the target location in the blood vessel, by being inflated, opens the scaffold member to enhance the delivery of the retrograde wire or the thrombus into the guide catheter extension. When the guide catheter extension is no longer needed, the flared guide extension can be easily compressed and collapsed as it is drawn in the guiding catheter. For benefits of the thrombus removal, the balloon may be formed from a material loaded with a radiopaque material and prefabricated with micro pores. A thrombolytic agent can be delivered to the thrombus before the thrombus is conveniently captured in the expanded distal opening of the scaffold member and removed from the blood vessel by aspiration. The outer or inner catheter may be configured with a distal curved portion to enhance a rotational capability for displacement between the right and left pulmonary arteries.

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.

A device includes a first end portion, a second end portion, an intermediate portion, and a graft material. The first end portion has a first end diameter. The second end portion has a second end diameter smaller than the first end diameter. The first end portion comprises a first material. The second end portion comprises a second material different than the first material. The intermediate portion is between the first end portion and the second end portion. The intermediate portion tapers between the first end portion and the second end portion. The graft material is coupled to at least the intermediate portion.

The invention provides devices with integrated intravascular imaging and methods for crossing a CTO within the true lumen of a vessel. An interventional catheter with intravascular imaging capabilities can be guided into an affected vessel and to a CTO. An included intravascular imaging device captures a 3D image of the environment. The catheter includes a crossing member that can be extended out from a distal tip of the catheter, causing the crossing member to directly cross through the CTO creating a new channel through the CTO.

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 devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a position in vessel adjacent an infusion site and advance a tissue manipulation component into the infusion site to deliver a therapeutic infusate. The infusion site can be an intraluminal space, such as within an obstructive material, adjacent the obstructive material, and/or within a boundary layer between the obstructive material and a vessel wall. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the infusion site.

The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.

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.