Chronic total occlusion device with variable stiffness shaft

Abstract

The present invention relates generally to a device for adding stiffening support to a guidewire so as to enable the guidewire or device to pass through a chronic total occlusion. A method for passing a guidewire through a chronic total occlusion is also disclosed.

What is claimed is:  
     
         1 . A chronic total occlusion device, comprising: 
 an outer tubular member including a proximal end, a distal end, and a lumen extending therethrough;    an inner tubular member disposed within the lumen, the inner tubular member having an inner lumen;    an annular space between the outer tubular member and the inner tubular member; and    a stiffening member disposed within the annular space.    
     
     
         2 . The device in accordance with  claim 1 , wherein a manifold is disposed at the proximal end of the outer tubular member.  
     
     
         3 . The device in accordance with  claim 2 , wherein the manifold includes means for controlling the stiffening member.  
     
     
         4 . The device in accordance with  claim 1 , wherein the stiffening member further comprises a distal head and a proximal tail.  
     
     
         5 . The device in accordance with  claim 4 , wherein the stiffening member is movable relative to the outer tubular member.  
     
     
         6 . The device in accordance with  claim 1 , wherein the outer tubular member further comprises an expandable region.  
     
     
         7 . The device in accordance with  claim 6 , wherein the expandable region comprises a balloon.  
     
     
         8 . The device in accordance with  claim 7 , wherein the annular space is in fluid communication with the balloon.  
     
     
         9 . The device in accordance with  claim 6 , wherein the expandable region further comprises a first region having a first outside diameter and a second region having a second outside diameter.  
     
     
         10 . The device in accordance with  claim 9 , wherein the first outside diameter is less than the second outside diameter.  
     
     
         11 . The device in accordance with  claim 9 , wherein the stiffening member comprises a liquid.  
     
     
         12 . The device in accordance with  claim 9 , wherein the stiffening member comprises a gas.  
     
     
         13 . A chronic total occlusion device, comprising: 
 an outer tubular member including a proximal end, a distal end, a lumen extending therethrough, and an expandable region having a first region having a first outside diameter, and a second region having a second outside diameter;    an inner tubular member disposed within the lumen, the inner tubular member having an inner lumen;    an annular space between the outer tubular member and the inner tubular member; and    a stiffening member disposed within the annular space.    
     
     
         14 . The device in accordance with  claim 13 , wherein a manifold is disposed at the proximal end of the outer tubular member.  
     
     
         15 . The device in accordance with  claim 14 , wherein the manifold includes means for controlling the stiffening member.  
     
     
         16 . The device in accordance with  claim 13 , wherein the stiffening member further comprises a distal head and a proximal tail.  
     
     
         17 . The device in accordance with  claim 16 , wherein the stiffening member is movable relative to the outer tubular member.  
     
     
         18 . The device in accordance with  claim 13 , wherein the expandable region comprises a balloon.  
     
     
         19 . The device in accordance with  claim 18 , wherein the annular space lumen is in fluid communication with the balloon.  
     
     
         20 . The device in accordance with  claim 13 , wherein the first outside diameter is less than the second outside diameter.  
     
     
         21 . The device in accordance with  claim 13 , wherein the stiffening member comprises a liquid.  
     
     
         22 . The device in accordance with  claim 13 , wherein the stiffening member comprises a gas.  
     
     
         23 . A method for passing a guidewire through a chronic total occlusion, the method comprising the steps of: 
 placing a guidewire in a blood vessel proximate a chronic total occlusion;    providing a chronic total occlusion device, the chronic total occlusion device including an outer tubular member having a proximal end, a distal end, and a lumen extending therethrough; an inner tubular member disposed within the lumen and having an inner lumen; and an annular space between the outer tubular member and the inner tubular member;    passing the chronic total occlusion device over the guidewire such that the guidewire is disposed within the inner lumen; and    passing the guidewire through the chronic total occlusion.    
     
     
         24 . The method in accordance with  claim 23 , wherein the chronic total occlusion device further comprise a stiffening member disposed within the annular space.  
     
     
         25 . The method in accordance with  claim 24 , wherein the stiffening member further comprises a distal head and a proximal tail.  
     
     
         26 . The method in accordance with  claim 24 , wherein the stiffening member comprises a liquid.  
     
     
         27 . The method in accordance with  claim 24 , wherein the stiffening member comprises a gas.  
     
     
         28 . The method in accordance with  claim 24 , further comprising the step of actuating the stiffening member.  
     
     
         29 . The method in accordance with  claim 28 , wherein the step of actuating the stiffening member includes moving the stiffening member toward the distal end of the outer tubular member.  
     
     
         30 . The method in accordance with  claim 23 , wherein the outer tubular member further comprises an expandable region.  
     
     
         31 . The method in accordance with  claim 30 , wherein the expandable region comprises a balloon.  
     
     
         32 . The method in accordance with  claim 31 , wherein the annular space is in fluid communication with the balloon.  
     
     
         33 . The method in accordance with  claim 30 , wherein the expandable region further comprises a first region having a first outside diameter and a second region having a second outside diameter.  
     
     
         34 . The method in accordance with  claim 33 , wherein the first outside diameter is less than the second outside diameter.  
     
     
         35 . The method in accordance with  claim 23 , wherein the chronic total occlusion comprises a calcified lesion.  
     
     
         36 . The method in accordance with  claim 23 , wherein the chronic total occlusion comprises a stenosis.  
     
     
         37 . The method in accordance with  claim 23 , wherein the chronic total occlusion comprises an atherosclerotic lesion.