Vascular Re-entry Catheter

Abstract

A catheter has a guide-tip including at least one wing for crossing a CTO lesion in an artery via exploring the subintimal space. The catheter can includes one or more exit port(s) and radiopaque marker(s) for steering a re-entry wire through one of the exit ports. The catheter may include a number of spiral-cut sections with varying characteristics to provide different strength and flexibility along the axial direction.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority to U.S. provisional application No. 62 / 050,456, filed Sep. 15, 2014, and to U.S. provisional application No. 62 / 060,152, filed Oct. 6, 2014, the disclosure of each of which is incorporated by reference in their entirety.BACKGROUND[0002]Chronic Total Occlusion (“CTO”) is a complete or near complete blockage of a blood vessel, such as a coronary artery. As many as 30% of the patients with coronary artery disease have CTOs somewhere through the left or right arterial system. Traditionally CTO has usually been treated by a bypass procedure where an autologous or synthetic blood vessel is anastomotically attached to locations on the blood vessel upstream and downstream of the occlusion. While effective, such bypass procedures are quite traumatic to the patient.[0003]Recently, catheter-based intravascular procedures have been developed to treat CTO with improved success rates. Such procedures include angioplast...

AI Technical Summary

Benefits of technology

The present invention provides a catheter device with a distal catheter tube portion having a longitudinal axis and including a tube wall with at least one side port, at least one radiopaque marker, and at least one wing protruding radially outward from the tube wall. The catheter device can be used for facilitating treatment of an occlusion in a blood vessel. The invention enables the creation of a channel in the vascular wall extending longitudinally across the occlusion using a re-entry device that exits from the catheter device's side port. The technical effect of this invention is the improvement of the catheter device's ability to cross an occlusion in a blood vessel and facilitate treatment.

Problems solved by technology

While effective, such bypass procedures are quite traumatic to the patient.

However, if this is not successful, a procedure employing both the CrossBoss™ and Stingray™ catheters to cross the CTO would be needed.

While the above procedure of subintimal crossing using a combination of CrossBoss™ and Stingray™ catheters overcame certain difficulties of previous generation techniques in direct antegrade CTO access, the procedure is complex and time-consuming.

Furthermore, switching from CrossBoss™ to Stingray™ can introduce unintended errors.

For example, withdrawing the CrossBoss™ catheter from the guidewire (so that the Stingray™ catheter may be introduced over the guidewire) may cause the guidewire to shift position in the subintimal space, or worse, to retract from the subintimal space, in which case the operator would not be able to properly introduce the Stingray™ catheter over the guidewire into the subintimal space.

Additionally, advancing and inflating the distal balloon of the Stingray™ catheter in the subintimal space can create excessive delamination and substantial trauma in the layers of the vascular wall.

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