Catheter system for vascular re-entry from a sub-intimal 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.

1 . A method for accessing a true lumen of a blood vessel from a sub-intimal plane of the vessel, comprising:
 identifying a site to enter the true lumen from a position in the sub-intimal plane distal to a chronic total occlusion (CTO);   determining an orientation of the true lumen with respect to the sub-intimal plane at the selected site;   physically securing tissue of the sub-intimal plane at the selected site; and   establishing a path from the sub-intimal plane into the vessel true lumen.   
     
     
         2 . A method for crossing a chronic total occlusion (CTO) in vasculature, comprising:
 forming a track from a true lumen into a sub-intimal space of a blood vessel, wherein the track extends from a position proximal to the CTO in the true lumen to a position distal to the CTO in the sub-intimal space;   determining an orientation of the true lumen with respect to the sub-intimal plane at an identified re-entry site from a position in the sub-intimal plane, wherein the re-entry site is distal to the CTO;   physically securing tissue of the sub-intimal plane at the selected site; and   selectively forming a path from the sub-intimal plane back into the true lumen.   
     
     
         3 - 4 . (canceled)