Double balloon catheter and methods for homogeneous drug delivery using the same

Abstract

The present disclosure is directed to a catheter for site-specific delivery of a therapeutic agent to a blood vessel of a patient. The catheter further includes an elongated shaft having at least one inner lumen, a distal end and a proximal end and proximal and distal vessel-conforming balloons where each is separately positionable and inflatable, and when inflated, substantially restricts blood flow in the vessel and creates a treatment window of a defined but variable length for delivery of the therapeutic agent. The catheter optionally includes at least one marker band adjacent to the proximal balloon and at least one marker band adjacent to the distal balloon. At least one lateral aperture positioned in the window is in fluid communication with a drug delivery conduit located within either the inner shaft or the outer shaft to provide a homogeneous concentration of the therapeutic agent to the window.

1 . (canceled) 
     
     
         2 . A method for site-specific delivery of an antiproliferative agent to a blood vessel of a patient comprising:
 inflating first and second balloons of a catheter to define a treatment window between the first and second balloons, the treatment window including a fluid;   delivering the antiproliferative agent to the treatment window;   maintaining the antiproliferative agent within the treatment window for a predetermined time period sufficient to enable a predetermined concentration of the antiproliferative agent to be absorbed by the blood vessel; and   deflating the first and second balloons to wash out an unabsorbed concentration of the antiproliferative agent remaining in the blood vessel after the predetermined time period.   
     
     
         3 . The method of  claim 2 , further including selectively opening a closed drain passage that extends through the catheter to allow the fluid within the treatment window to be displaced from within the treatment window and into the catheter through a leak aperture defined within a shaft of the catheter. 
     
     
         4 . The method of  claim 2 , wherein delivering the antiproliferative agent to the treatment window includes filling the treatment window with a homogenous concentration of the antiproliferative agent. 
     
     
         5 . The method of  claim 2 , further including:
 opening a drain passage communicating with the treatment window to allow a fluid within the treatment window to be displaced through the drain passage from within the treatment window upon delivering the antiproliferative agent to the treatment window.   
     
     
         6 . The method of  claim 5 , wherein opening the drain passage includes uncovering a leak aperture to allow the fluid within the treatment window to be displaced from the treatment window through the drain passage and from an opening defined in a distal end of the catheter distally of the first and second balloons. 
     
     
         7 . The method of  claim 2 , wherein delivering the antiproliferative agent to the treatment window includes delivering the antiproliferative agent through the catheter to the treatment window. 
     
     
         8 . The method of  claim 2 , wherein the antiproliferative agent is paclitaxel. 
     
     
         9 . The method of  claim 2 , wherein inflating the first and second balloons includes inflating the first and second balloons to conform to an inner surface of the blood vessel to inhibit blood flow through the blood vessel. 
     
     
         10 . The method of  claim 2 , further including establishing at least one predetermined location in the blood vessel for inflating at least one of the first and second balloons with at least one marker supported on the catheter. 
     
     
         11 . The method of  claim 2 , further including changing a length of the treatment window. 
     
     
         12 . A method for site-specific delivery of an antiproliferative agent to a blood vessel of a patient comprising:
 inflating first and second balloons of a catheter to define a treatment window between the first and second balloons;   delivering the antiproliferative agent to the treatment window to displace fluid within the treatment window through a leak aperture communicating with the treatment window; and   positioning a guidewire within the catheter to block the leak aperture and maintain the antiproliferative agent within the treatment window for a predetermined time period sufficient to enable a predetermined concentration of the antiproliferative agent to be absorbed by the blood vessel.   
     
     
         13 . The method of  claim 12 , wherein inflating the first and second balloons includes inflating the first and second balloons to conform to an inner surface of the blood vessel to inhibit blood flow through the blood vessel. 
     
     
         14 . The method of  claim 12 , further including establishing at least one predetermined location in the blood vessel for inflating at least one of the first and second balloons with at least one marker supported on the catheter. 
     
     
         15 . The method of  claim 12 , further including changing a length of the treatment window. 
     
     
         16 . The method of  claim 15 , further including selectively moving an inner shaft of the catheter relative to an outer shaft of the catheter to change the length of the treatment window. 
     
     
         17 . The method of  claim 12 , wherein the antiproliferative agent is paclitaxel. 
     
     
         18 . A method of site-specific delivery of an antiproliferative agent to a blood vessel of a patient comprising:
 inserting a catheter into the blood vessel;   inflating a proximal balloon of the catheter to restrict blood flow through the blood vessel;   inflating a distal balloon of the catheter to form a treatment window between the proximal balloon and the distal balloon;   moving a guidewire to uncover a distal leak aperture that communicates with the treatment window; and   delivering the antiproliferative agent to the treatment window through at least one of aperture to displace a fluid disposed within the treatment window through the distal leak aperture; and   positioning a guidewire to cover the distal leak aperture to maintain the antiproliferative agent within the treatment window for a predetermined time period sufficient to enable a predetermined concentration of the antiproliferative agent to be absorbed by the blood vessel.   
     
     
         19 . The method of  claim 18 , wherein delivering the antiproliferative agent to the treatment window includes filling the treatment window with a homogenous concentration of the antiproliferative agent. 
     
     
         20 . The method of  claim 18 , wherein the antiproliferative agent is paclitaxel. 
     
     
         21 . The method of  claim 18 , further including changing a length of the treatment window.