Vascular medical devices with sealing elements and procedures for the treatment of isolated vessel sections

Abstract

Devices for the isolation of a selected portion of a vessel are described. In some embodiments, the device comprises an introducer sheath and a sealing catheter that are movable relative to each other to create an isolated volume with adjustable size and location. The methods for the treatment of vascular aneurysms using the devices are described. The treatment is achieved through the delivery of an effective amount of stabilization agent to an isolated volume that encompass the aneurysm. The device optionally has an aspiration means to improve the effectiveness of the treatment.

1 - 22 . (canceled) 
     
     
         23 . A device for treating an aneurysm, the device comprising:
 a catheter having a proximal end and a distal end, the catheter comprising:
 a first expandable blood vessel sealing element disposed at or near the distal end of the catheter; and 
 a fluid exchange port located proximal to the first blood vessel sealing element for introducing a therapeutic agent into the blood vessel; and 
   a second expandable blood vessel sealing element configured to be expanded proximal to the first expandable blood vessel element to create a sealed fluid volume between the first and second expandable blood vessel sealing elements;   wherein the fluid exchange port is configured to introduce the therapeutic agent into the blood vessel at a location within the sealed fluid volume, and   wherein the sealed fluid volume is sized to span a length of a blood vessel such that the sealed fluid volume encompasses the aneurysm.   
     
     
         24 . The device of  claim 23 , wherein the first expandable blood vessel sealing element comprises a balloon. 
     
     
         25 . The device of  claim 24 , wherein the catheter comprises an inflation lumen extending from the proximal end of the catheter to the first expandable blood vessel sealing element. 
     
     
         26 . The device of  claim 25 , wherein the inflation lumen extends through the second expandable blood vessel sealing element. 
     
     
         27 . The device of  claim 24 , wherein the balloon comprises a compliant polymer material. 
     
     
         28 . The device of  claim 23 , wherein the second expandable blood vessel sealing element comprises a balloon. 
     
     
         29 . The device of  claim 23 , wherein the catheter comprises a fluid delivery lumen extending from the proximal end of the catheter to the fluid exchange port. 
     
     
         30 . The device of  claim 23 , wherein the catheter comprises a shaft extending from the proximal end to the distal end, the shaft extending through the second expandable blood vessel sealing element. 
     
     
         31 . The device of  claim 30 , wherein the second expandable blood vessel element is a balloon comprising a generally annular shape forming an opening through which the shaft extends. 
     
     
         32 . The device of  claim 30 , wherein the first expandable blood vessel element is positioned at the distal end of the shaft such that the shaft does not extend distally beyond the first expandable blood vessel element. 
     
     
         33 . The device of  claim 23 , wherein the first expandable blood vessel sealing element and the second blood vessel sealing element are independently expandable. 
     
     
         34 . A method of treating an aneurysm comprising:
 inserting a catheter into a blood vessel;   creating an isolated volume within the blood vessel, the creating comprising:
 expanding a first blood vessel sealing element disposed on a distal end of the catheter; and 
 expanding a second blood vessel sealing element located proximal to the first blood vessel sealing element; 
   wherein the isolated volume extends between the first blood vessel sealing element and the second blood vessel sealing element,   wherein blood flow is prevented from entering the isolated volume while the first and second blood sealing elements are expanded, and   wherein the aneurysm is located within the isolated volume;   introducing a therapeutic agent through at least one opening in the catheter into the blood vessel at a location within the isolated volume for treatment of the aneurysm.   
     
     
         35 . The method of  claim 34 , wherein the first blood vessel sealing element is a balloon and expanding the first blood vessel expanding element comprises inflating the balloon. 
     
     
         36 . The method of  claim 34 , wherein the second blood vessel sealing element is a balloon and expanding the second blood vessel sealing element comprises inflating the balloon. 
     
     
         37 . The method of  claim 34 , further comprising restoring blood flow to the isolated volume, wherein proximal and distal blood flow is occluded from the isolated volume for no longer than 10 minutes. 
     
     
         38 . The method of  claim 37 , wherein proximal and distal blood flow is occluded form the isolated volume for no longer than 5 minutes. 
     
     
         39 . The method of  claim 34 , wherein the therapeutic agent comprises pentagalloylglucose (PGG). 
     
     
         40 . The method of  claim 34 , wherein introducing the therapeutic agent comprises substantially filling the isolated volume with therapeutic agent. 
     
     
         41 . The method of  claim 34 , wherein expanding the second blood vessel sealing element occurs after completion of expanding the first blood vessel sealing element. 
     
     
         42 . A method for treating an isolated portion of a blood vessel, the method comprising:
 positioning an isolation device within the blood vessel wherein the isolation device comprises a sealing catheter and an introducer sheath, and the positioning of the isolation device comprises positioning the introducer sheath into the femoral artery in one of the legs of a patient and delivering the sealing catheter through the introducer sheath to place the first extendable element in the aorta,
 wherein the sealing catheter comprises a first extendable element, a first fluid exchange opening, a first fluid exchange lumen, and a first proximal connection port, 
 wherein the introducer sheath comprises a second extendable element, a second fluid exchange opening, and a second fluid exchange lumen, 
 wherein the extendable elements are movable relative to each other, 
 wherein a first flow path extends from the first proximal connection port through the first fluid exchange lumen to the first fluid exchange opening of the sealing catheter, and 
 wherein a second flow path extends from the second proximal connection port through the second fluid exchange lumen to the second fluid exchange opening of the introducer sheath; 
   isolating the selected portion of the blood vessel by adjusting the relative positions of the extendable elements and extending the two extendable elements to contact the walls of the vessel to form the isolated portion;   aspirating fluid from the isolated portion through the second flow path; and   delivering a therapeutic composition to the isolated segment of the blood vessel through the first flow path after aspiration of fluid from the isolated portion of the blood vessel.