System and method for re-entering a vessel lumen

Abstract

This disclosure is directed to systems and methods for re-entering the true lumen of a vessel. The re-entry catheters employ deflectable struts to stabilize and support the distal tip in a subintimal location while a passageway back into the true lumen is formed. Re-entry to the true lumen can be effected with a cutting element or with a conventional guidewire.

1 . A re-entry catheter for facilitating formation of a passageway from a subintimal area to a lumen of a vessel, comprising an elongated outer tubular member having a distal end and a window adjacent the distal end, a plurality of deflectable struts arranged longitudinally within the window, and an actuating member coaxially disposed within the outer tubular member, wherein proximal ends of the deflectable struts are operatively connected to a distal end of the actuating member, such that axial motion of the actuating member relative to the outer tubular member deflects the struts radially outward. 
     
     
         2 . The re-entry catheter of  claim 1 , further comprising a lateral port in the outer tubular member in a location opposing the window. 
     
     
         3 . The re-entry catheter of  claim 1 , wherein the struts are formed from a nickel-titanium alloy. 
     
     
         4 . The re-entry catheter of  claim 1 , wherein the outer tubular member has a circumference and wherein the window occupies a portion of the circumference corresponding to a range of approximately 120° to 240°. 
     
     
         5 . The re-entry catheter of  claim 1 , wherein tension applied to the actuating member increases stiffness at the distal end of the elongated tubular member. 
     
     
         6 . The re-entry catheter of  claim 1 , further comprising a membrane supported by the struts and configured to distribute force between the struts. 
     
     
         7 . The re-entry catheter of  claim 2 , further comprising a cutting member coaxially disposed within the actuating member. 
     
     
         8 . The re-entry catheter of  claim 7 , wherein the cutting member comprises a cannula configured to be advanced out of the lateral port. 
     
     
         9 . The re-entry catheter of  claim 8 , wherein the cutting member is formed from nickel-titanium alloy. 
     
     
         10 . The re-entry catheter of  claim 1 , wherein the actuating member is operatively connected to a mechanical handle configured to move the actuating member distally in an axial direction by incremental amounts. 
     
     
         11 . The re-entry catheter of  claim 1 , wherein the catheter has a diameter in the range of approximately 6 French and smaller. 
     
     
         12 . A method for forming a passageway from a subintimal area to a lumen of a vessel comprising the steps of:
 providing a re-entry catheter with an elongated outer tubular member having a distal end and a window adjacent the distal end, a plurality of deflectable struts arranged longitudinally within the window, an actuating member coaxially disposed within the outer tubular member, wherein proximal ends of the deflectable struts are operatively connected to a distal end of the actuating member, and a lateral port positioned opposing the window;   advancing the distal end of the catheter through a subintimal area;   moving the actuating member in a distal direction to deflect the struts radially outward; and   subsequent to the step of moving the actuating member, advancing a re-entry device through the lateral port and through an intimal layer of the vessel into the lumen.   
     
     
         13 . The method of  claim 12 , wherein the step of moving the actuating member in a distal direction to deflect the struts radially outward engages an adventitial layer of the vessel and positions the lateral port against the intimal layer. 
     
     
         14 . The method of  claim 12 , wherein the step of advancing a re-entry device through the lateral port comprises advancing a guidewire. 
     
     
         15 . The method of  claim 12 , wherein the step of providing a re-entry catheter further comprises providing the catheter with the re-entry device comprising a cannula coaxially disposed within the actuating member and wherein the step of advancing a re-entry device through the lateral port comprises sliding the cannula through the actuating member. 
     
     
         16 . The method of  claim 12 , further comprising the steps of stiffening the distal end of the catheter by applying tension to the actuating member and navigating the distal end of the catheter through vasculature to reach the subintimal area. 
     
     
         17 . The method of  claim 12 , wherein the step of providing a re-entry catheter further comprises providing the catheter with a mechanical handle operative connected to the actuating member, further comprising the step of actuating the handle to move the actuating member distally in an axial direction by an incremental amount. 
     
     
         18 . The method of  claim 12 , further comprising the steps of moving the actuating member in a distal direction to deflect the struts radially outward to create a space between the intimal layer and an adventitial layer and advancing the distal tip of the catheter into the space. 
     
     
         19 . The method of  claim 12 , wherein the subintimal area is adjacent a lesion occluding the vessel and wherein the step of advancing a re-entry device through the lateral port further comprises penetrating at least a portion of the lesion.