Methods, Devices and Systems for Treating Venous Insufficiency

Abstract

Methods and systems for improving the competency of a venous valve wherein one or more compressor(s) (e.g., space occupying material(s) or implantable device(s)) is/are delivered to one or more location(s) adjacent to a venous valve to compress the venous valve in a manner that causes one or both leaflets of the valve to move toward the other, thereby improving closure or coaptation of the valve leaflets. The compressor(s) may be delivered by an open surgical approach, by a direct percutaneous approach or by a transluminal catheter-based approach.

1 . (canceled) 
     
     
         2 : A method for improving function of a venous valve that comprises valve leaflets, the venous valve being located in a vein that has a wall and a lumen, the method comprising the steps of:
 positioning, within the lumen of the vein in which the venous valve is located or within the lumen of another blood vessel that has a wall and is located near the venous valve, a tissue penetrating catheter that has a penetrator that is advanceable from the catheter;   advancing the penetrator from the tissue penetrating catheter through the wall of the vein or other blood vessel in which the catheter is positioned toward a first location outside of the vein;   delivering a first compressor through the penetrator to the first location;   retracting the penetrator;   repositioning the tissue penetrating catheter;   advancing the penetrator from the tissue penetrating catheter through the wall of the vein or other blood vessel in which the catheter is positioned toward a second location outside of the vein, wherein the second location is on an opposite side of the venous valve relative to the first location;   delivering a second compressor through the penetrator to the second location;   retracting the penetrator; and   removing the tissue penetrating catheter, wherein the first and second compressors at the first and second locations cause sufficient inward compression of the wall of the vein in the area of the venous valve to improve closure of the venous valve leaflets, wherein the first compressor and the second compressor comprise a space occupying injectable substance and wherein the space occupying injectable substance is delivered to at least one interstitial location where it causes compression of the venous valve.   
     
     
         3 . (canceled) 
     
     
         4 : A method for improving function of a venous valve that comprises valve leaflets, the venous valve being located in a vein that has a wall and a lumen, the method comprising the steps of:
 positioning, within the lumen of the vein in which the venous valve is located or within the lumen of another blood vessel near the venous valve, a tissue penetrating catheter that has a penetrator that is advanceable from the tissue penetrating catheter;   advancing the penetrator from the tissue penetrating catheter to a target location outside of the venous valve; and   delivering an injectable substance through the penetrator, wherein the injectable substance is delivered to at least one interstitial location where it causes compression of the venous valve.   
     
     
         5 : A method according to  claim 4  wherein the tissue penetrating catheter is equipped with an orientation apparatus useable to determine a projected penetrator path on which the penetrator will subsequently advance from the tissue penetrating catheter and wherein the method further comprises the steps of:
 using the orientation apparatus to determine a projected penetrator path relative to the target location; and 
 adjusting the rotational orientation of the tissue penetrating catheter as needed so that the projected penetrator path indicates that the penetrator will advance toward the target location. 
 
     
     
         6 : A method according to  claim 4  wherein the tissue penetrating catheter is positioned in a vein. 
     
     
         7 : A method according to  claim 4  wherein the tissue penetrating catheter is positioned is the vein in which the venous valve is located. 
     
     
         8 : A method according to  claim 4  wherein the tissue penetrating catheter is positioned in a vein other than the vein in which the venous valve is located. 
     
     
         9 : A method according to  claim 4  wherein the tissue penetrating catheter is positioned in an artery. 
     
     
         10 : A method according to  claim 2  wherein the space occupying injectable substance is selected from the group consisting of:
 collagens; 
 hyaluronic acid; 
 polymeric materials; and 
 hydrogels. 
 
     
     
         11 : A method according to  claim 2  wherein the space occupying injectable substance expands after it has been delivered to the interstitial location. 
     
     
         12 - 17 . (canceled) 
     
     
         18 : A method according to  claim 6  wherein the catheter is inserted proximal to the venous valve and advanced through one or more veins in the direction opposite normal venous blood flow. 
     
     
         19 : A method according to  claim 6  wherein the catheter is inserted distal to the venous valve and advanced through one or more veins in the direction of normal venous blood flow. 
     
     
         20 : A method according to  claim 6  wherein the catheter has a lubricious outer coating. 
     
     
         21 - 23 . (canceled) 
     
     
         24 : A method according to  claim 2  further comprising the step of using contrast radiography, ultrasound or other imaging to determine during performance of the method when the venous valve leaflets have been sufficiently repositioned to improve closure.