Endovascular aneurysm treatment device and method

Abstract

An self-expanding frame is mounted on the distal end of a shaft. The frame is sized and configured so that it can be inserted into the cavity of an aneurysm. Suction is applied to the interior of the aneurysm through the shaft or through another catheter, and the wall of the aneurysm is collapsed onto the exterior surface of the frame. The frame is then collapsed upon further suction being applied to the interior of the aneurysm, which collapses the aneurysm wall with it. The frame folds down on itself, carrying with it the aneurysm wall. The frame is detachable from the shaft and can be left in the collapsed aneurysm.

1 . A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising: 
 an elongated catheter having a proximal end, a distal end, and including at least one lumen extending therethrough;    a telescoping stretching rod positioned in the catheter;    at least one steering pull wire extending distally through the catheter and attached adjacent to the distal end of the catheter;    an inflatable member positioned adjacent the catheter distal end;    a one-way valve positioned adjacent the catheter distal end and in fluid communication with the at least one lumen, the one-way valve oriented to permit fluid flow into the catheter lumen;    an expandable clip releasably attached to the catheter distal end, the expandable clip having an unbiased, expanded condition and a biased, collapsed condition;    wherein when the expandable clip is positioned inside the cavity of an aneurysm and expands, when the inflatable member is inflated to substantially seal the neck of the aneurysm from the blood vessel, and when suction is applied through the catheter lumen and through the one-way valve, the aneurysm wall at least partially collapses on the expanded clip.    
     
     
         2 . A system in accordance with  claim 1 , further comprising: 
 a flexible spring positioned adjacent the catheter distal end, the spring including a distal end, at least one steering pull wire attached to the catheter adjacent to the spring distal end.    
     
     
         3 - 7 . (canceled)  
     
     
         8 . A catheter useful for accessing a vascular location adjacent to an aneurysm, comprising: 
 a hollow shaft including a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, a port in a distal portion of the shaft, and including at least one lumen extending therethrough;    an inflatable member mounted on the shaft adjacent to the shaft distal end, the inflatable member in fluid communication with the shaft at least one lumen, the inflatable member including a proximal end, a distal end, and a wall between the proximal end and the distal end which extends to the shaft so that the shaft port is directly exposed to the exterior of the balloon, the wall delimiting a central working channel.    
     
     
         9 . A catheter in accordance with  claim 8 , further comprising: 
 a longitudinally movable steering wire extending along the shaft; and    a deflectable tube mounted at the shaft port, the steering wire attached to the deflectable tube so that when the steering wire is pulled proximally, the deflectable tube deflects laterally.    
     
     
         10 . A catheter in accordance with  claim 8 , further comprising: 
 a suction port on a distal portion of the shaft directly exposed to the exterior of the balloon; and    a suction lumen extending through the shaft from the shaft proximal end to the suction port.    
     
     
         11 . A catheter in accordance with  claim 8 , further comprising: 
 at least one radiopaque marker mounted immediately adjacent to the central working channel.    
     
     
         12 . A method of treating an aneurysm in a patient comprising the steps of: 
 advancing a compressed clip through the distal end of a catheter and into the aneurysm;    expanding portions of the clip inside the aneurysm;    folding a distal segment of the clip on itself together with the adjacent wall of the aneurysm as it becomes dislodged from the stretching bar.    
     
     
         13 . A method in accordance with  claim 12 , further comprising verifying complete occlusion of the neck by injection of contrast agent through multiple side holes just proximal to the balloon and simultaneously applied suction through the one-way valve at the distal end of the catheter until no inflow of the contrast is demonstrated together with deformation of the aneurysm with suction, indicating that the aneurysm neck is completely closed.  
     
     
         14 . A method in accordance with  claim 13 , further comprising continuing suction with the aneurysm neck completely closed to almost completely collapse the aneurysm by creating a vacuum within the aneurysm.  
     
     
         15 . A method in accordance with  claim 12 , further comprising measuring transverse and longitudinal dimensions of the aneurysm.  
     
     
         16 . A method in accordance with  claim 13 , further comprising maintaining vacuum within the aneurysm with continuous suction and adhering the aneurysm wall to sides of the clip.  
     
     
         17 . A method in accordance with  claim 16 , further comprising repeating the pulling step until successive segments fold and complete collapse of the aneurysm is achieved.  
     
     
         18 . A method in accordance with  claim 12 , further comprising performing a road-mapping arteriogram with measurement of the three dimensional size of the aneurysm and its neck.  
     
     
         19 . A method in accordance with  claim 12 , further comprising accessing the aneurysm neck using a steerable catheter.  
     
     
         20 . A method in accordance with  claim 19 , further comprising locking the distal end of the catheter in a position perpendicular to the center of the neck transverse axis.  
     
     
         21 . A method in accordance with  claim 12 , further comprising inflating a balloon mounted on the distal end of a catheter with a diluted contrast to the previously measured size of the neck.  
     
     
         22 . A method in accordance with  claim 12 , further comprising: 
 pulling a stretching bar to telescope a very distal segment of the stretching bar into the next proximal segment of the stretching bar.    
     
     
         23 . A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising: 
 an elongated shaft having a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, and including at least one lumen extending therethrough;    a self-expanding frame positioned at the distal end of the shaft, the frame including a plurality of self-expanding sections disposed in the longitudinal direction, each of said self-expanding sections being connected to an adjacent self-expanding section via a separate joint, each of the plurality of self-expanding sections having an unbiased, expanded condition and a biased, collapsed condition, each of the plurality of self-expanding sections being foldable in the longitudinal direction and about the separate joint when in a biased, collapsed condition,    wherein the at least one joint being oriented longitudinally when the plurality of self-expanding sections are in the unbiased, expanded condition.    
     
     
         24 . A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising: 
 an elongated shaft having a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, and including at least one lumen extending therethrough;    a self-expanding frame positioned at the distal end of the shaft, the frame including a plurality of self-expanding sections disposed in the longitudinal direction, each of said self-expanding sections being connected to an adjacent self-expanding section via a separate joint, each of the plurality of self-expanding sections having an unbiased, expanded condition and a biased, collapsed condition, each of the plurality of self-expanding sections being foldable in the longitudinal direction and about the separate joint when in a biased, collapsed condition,    wherein the at least one joint being oriented in a V-shape when the plurality of self-expanding sections are in the biased condition.    
     
     
         25 . A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising: 
 an elongated shaft having a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, and including at least one lumen extending therethrough;    a self-expanding frame positioned at the distal end of the shaft, the frame including a plurality of self-expanding sections disposed in the longitudinal direction, each of said self-expanding sections being connected to an adjacent self-expanding section via a separate joint, each of the plurality of self-expanding sections having an unbiased, expanded condition and a biased, collapsed condition, each of the plurality of self-expanding sections being foldable in the longitudinal direction and about the separate joint when in a biased, collapsed condition,    wherein the at least one joint collapses to a position parallel to an artery of the patient.