Catheter system and method for injection of a liquid embolic composition and a solidification agent

Abstract

A catheter according to the present invention includes a multiple lumen catheter for delivery of a liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen. The catheter allows adjustment of the relative longitudinal position of the two lumens to control the solidification of the embolic composition within a blood vessel. The multiple lumen catheter system is used by inserting the catheter endovascularly into an aneurysm site and injecting a liquid embolic composition through the first lumen while injecting a solidification agent through the second lumen to wash the area of the aneurysm of blood which has become saturated with solvent, while replacing it with a fresh solidification agent. The controlled solidification of the liquid embolic composition by use of the solidification agent allows the aneurysm to be filled precisely and rapidly even when the aneurysm is located such that gravity does not cause the liquid embolic composition to flow into the aneurysm.

What is claimed is:  
     
         1 . A catheter system for controlling solidification in vivo of liquid embolic compositions which catheter system comprises: 
 (a) a multiple lumen catheter having a first lumen and a second lumen for delivery of fluid;    (b) a first fluid delivery port for delivery of fluid to the first lumen;    (c) a second fluid delivery port for delivery of fluid to the second lumen;    (d) a liquid supply connected to the first fluid delivery port for delivery of a liquid embolic composition through the first lumen; and    (e) a solidification agent supply connected to the second fluid delivery port for delivery of a solidification agent through the second lumen to enhance solidification of the liquid embolic composition when delivered in vivo through the first lumen.    
     
     
         2 . The catheter system according to  claim 1 , wherein the multiple lumen catheter includes an inner tube and an outer tube coaxially surrounding the inner tube.  
     
     
         3 . The catheter system according to  claim 2 , wherein the inner tube is longitudinally movable within the outer tube to adjust a relative position of an outlet of the inner tube with respect to an outlet of the outer tube.  
     
     
         4 . The catheter system according to  claim 3 , further comprising a locking mechanism for locking a position of the inner tube with respect to the outer tube.  
     
     
         5 . The catheter system according to  claim 3 , wherein the relative positions of the inner tube and the outer tube are movable from a first position in which the inner tube extends from the outlet of the outer tube, to a second position in which the outlet of the inner tube is positioned within the lumen of the outer tube, wherein the relative motion of the inner and outer tubes from the first position to the second position detaches a solidified mass of the embolic composition from the multiple lumen catheter.  
     
     
         6 . The catheter system according to  claim 1 , wherein an outlet of the first lumen and an outlet of the second lumen of the multiple lumen catheter are longitudinally movable with respect to one another to change relative longitudinal positions of the outlets of the first and second lumens to control solidification of the liquid embolic composition.  
     
     
         7 . The catheter system according to  claim 1 , wherein the liquid embolic composition comprises a water-insoluble, biocompatible polymer dissolved in a biocompatible solvent and the catheter is compatible with the biocompatible solvent.  
     
     
         8 . The catheter system according to  claim 7 , wherein the biocompatible solvent is DMSO.  
     
     
         9 . The catheter system according to  claim 8 , wherein the multiple lumen catheter is DMSO compatible.  
     
     
         10 . The catheter system according to  claim 1 , wherein the biocompatible polymer is water insoluble and the solidification agent is selected from the group consisting of water, saline, Dextrose 5% water, lactated Ringers solution, and aqueous based contrast agents.  
     
     
         11 . A catheter for controlling solidification in vivo of liquid embolic compositions comprising: 
 (a) a first tube formed of a DMSO compatible material;    (b) a second tube connected to the first tube;    (c) an actuator for sliding the first tube longitudinally with respect to the second tube;    (d) a first fluid delivery port connected to a lumen of the first tube for delivery of a liquid embolic composition which composition comprises a biocompatible, water-insoluble polymer dissolved in DMSO, the first delivery port formed of a DMSO compatible material; and    (e) a second fluid delivery port connected to a lumen of the second tube for delivery of a solidification agent which encourages solidification of the liquid embolic composition.    
     
     
         12 . The catheter according to  claim 11 , further comprising a locking mechanism for locking a longitudinal position of the first tube with respect to the second tube.  
     
     
         13 . The catheter according to  claim 11 , wherein the second tube coaxially surrounds the first tube.  
     
     
         14 . The catheter according to  claim 13 , further comprising an anti-kinking mechanism for preventing kinking of the first tube as it slides in the second tube, the anti-kinking mechanism including a rigid tube connected to the first tube and slidable within a sleeve.  
     
     
         15 . The catheter according to  claim 13 , wherein a distal end of the second tube includes a plurality of side holes for delivery of the solidification agent.  
     
     
         16 . The catheter according to  claim 11 , wherein the first and second tubes each have a proximal portion with a durometer of between about 40 Shore D and 90 Shore D.  
     
     
         17 . The catheter according to  claim 16 , wherein the first and second tubes each have a distal portion with a durometer of between about 40 Shore A and 45 Shore D.  
     
     
         18 . The catheter according to  claim 17 , wherein a joint between the distal and proximal portions of the first tube is longitudinally displaced from a joint between the distal and proximal portions of the second tube at all relative positions of the catheter which are achieved by manipulation of the actuator.  
     
     
         19 . A method of treating aneurysms with a liquid embolic composition comprising: 
 inserting a multiple lumen catheter endovascularly to an aneurysm site;    injecting a liquid embolic composition through a first lumen of the multiple lumen catheter at the aneurysm site; and    controlling the solidification of the liquid embolic composition within the aneurysm by injecting a solidification agent through a second lumen of the multiple lumen catheter at the aneurysm site.    
     
     
         20 . The method of treating aneurysms according to  claim 19 , wherein the multiple lumen catheter is a coaxial catheter and the solidification agent is injected through an annulus between an inner and outer tube of the coaxial catheter.  
     
     
         21 . The method of treating aneurysms according to  claim 19 , wherein an outlet the first lumen and an outlet of the second lumen of the multiple lumen catheter are longitudinally movable with respect to one another. 22 .  
     
     
         22 . The method of treating aneurysms according to  claim 21 , wherein the liquid embolic composition and the solidification agent are injected when the outlets of the first and second lumens are longitudinally spaced with respect to each other.  
     
     
         23 . The method of treating aneurysms according to  claim 22 , wherein the outlets of the first and second lumens of the multiple lumen catheter are manipulated with respect to one another to detach a solidified mass of embolic composition from the multiple lumen catheter.  
     
     
         24 . The method of treating aneurysms according to  claim 21 , wherein a fluid is injected through one of the first and second lumens to improve longitudinal motion of the outlets of the first and second lumens with respect to one another.  
     
     
         25 . The method of treating aneurysms according to  claim 19 , wherein the injected liquid embolic composition includes a biocompatible polymer composition dissolved in a solvent.  
     
     
         26 . The method of treating aneurysms according to  claim 25 , wherein the first lumen is flushed-with a barrier fluid prior to injection of the liquid embolic composition to prevent aqueous fluids in the first lumen from coming into contact with the liquid embolic composition passing through the first lumen.  
     
     
         27 . The method of treating aneurysms according to  claim 26 , wherein the barrier fluid includes the solvent.  
     
     
         28 . The method of treating aneurysms according to  claim 27 , wherein the solidification agent is injected through the second lumen during the flushing of the first lumen with the barrier fluid to lower a concentration of the solvent being delivered to the patient.  
     
     
         29 . The method of treating aneurysms according to  claim 19 , wherein the liquid embolic composition and the solidification agent are injected at the same time.  
     
     
         30 . The method of treating aneurysms according to  claim 19 , wherein the liquid embolic composition and the solidification agent are injected alternately.  
     
     
         31 . A method for reducing toxic effects of a non-aqueous solvent delivered intravascularly which method comprises: 
 positioning a multiple lumen catheter into a vascular site of a mammal;    injecting a composition comprising a non-aqueous solvent through a first lumen of the multiple lumen catheter at the vascular site; and    injecting an aqueous solution through at least a second lumen of the multiple lumen catheter at the vascular site to dilute the non-aqueous solvent and reduce toxic effects of the non-aqueous,-solvent on surrounding tissue.    
     
     
         32 . The method for reducing toxic effects of a non-aqueous solvent according to  claim 31 , wherein the non-aqueous solvent is DMSO.  
     
     
         33 . A kit for controlled delivery in vivo of a liquid embolic composition comprising; 
 a liquid embolic composition; and    a multiple lumen catheter for delivery of the liquid embolic composition through a first lumen and delivery of a solidification agent through a second lumen.    
     
     
         34 . The kit according to  claim 33 , wherein the multiple lumen catheter includes an inner tube longitudinally movable within a coaxial outer tube.  
     
     
         35 . The kit according to  claim 34 , wherein the multiple lumen catheter further comprises a connector introducing the liquid embolic composition and the solidification agent to the first and second lumens, the connector including an anti-kinking mechanism allowing the inner tube to move within the outer tube without kinking.