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 . A catheter system for accessing a true lumen of a blood vessel from a sub-intimal plane of the vessel, comprising: 
 at least one visualization element for determining an 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 distal to a chronic total occlusion (CTO);    at least one system for physically securing tissue of the sub-intimal plane at the entry site to the catheter system; and    at least one re-entry device for establishing and maintaining a path from the sub-intimal plane into the vessel true lumen.    
   
   
       4 . A catheter system for crossing chronic total occlusions (CTOs) in vasculature, comprising: 
 means for 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;    means for determining an orientation of the true lumen with respect to the sub-intimal plane at an identified re-entry site, wherein the re-entry site is distal to the CTO;    means for physically securing tissue of the sub-intimal plane at the selected site; and    means for selectively forming a path from the sub-intimal plane back into the true lumen.