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 . A method for improving function of a venous valve comprising the step of:
 A) implanting a compressor at a location which compresses the venous valve in a manner that improves closure of the venous valve leaflets.   
   
   
       2 . A method according to  claim 1  wherein the compressor comprises an injectable substance and wherein Step A comprises delivering said substance to at least one interstitial location where it causes compression of the venous valve. 
   
   
       3 . A method according to  claim 1  wherein the compressor comprises at least one device and wherein Step A comprises implanting said at least one device in at least one location adjacent to the venous valve. 
   
   
       4 . A method according to  claim 1  wherein Step A comprises:
 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 catheter;   advancing the penetrator from the tissue penetrating catheter to a target location outside of the venous valve; and   delivering the compressor over or through the penetrator.   
   
   
       5 . A method according to  claim 4  wherein the tissue penetrating catheter is equipped with orientation apparatus useable to determine a projected penetrator path on which the penetrator will subsequently advance from the 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 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 6  wherein the tissue penetrating catheter is positioned in the vein in which the venous valve is located. 
   
   
       8 . A method according to  claim 6  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 6  wherein the tissue penetrating catheter is positioned in an artery. 
   
   
       10 . A method according to  claim 2  wherein the space occupying substance is selected from the group consisting of:
 collagens;   hyaluronic acid;   polymeric materials; and   hydrogels.   
   
   
       11 . A method according to  claim 2  wherein the injectable substance expands after it has been delivered to the interstitial location. 
   
   
       12 . A method according to  claim 3  wherein the compressor is selected from the group consisting of beads, balls, filaments, springs, stents, cages, expandable structures, implantable balloons, implantable balloons filled with solid or gelatinous material and implantable tissue expanders. 
   
   
       13 . A method according to  claim 3  wherein the compressor comprises a device that is expandable from a non-expanded configuration to an expanded configuration and wherein the method comprises:
 i) advancing the compressor to a location outside of the venous valve while in a non-expanded configuration; and   ii) causing the device to expand to its expanded configuration.   
   
   
       14 . A method according to  claim 13  wherein the compressor device self-expands and wherein constraint is applied to the device so that it is constrained in a non-expanded configuration while being delivered to the interstitial location and, thereafter, the constraint is removed to allow the device to self-expand to an expanded configuration. 
   
   
       15 . A method according to  claim 13  wherein the device is plastically deformable to its expanded configuration and wherein the device is delivered to the interstitial location while in its non-expanded configuration and is thereafter plastically deformed to its expanded configuration. 
   
   
       16 . A method according to  claim 15  wherein the compressor is delivered by a delivery catheter that has a balloon, and wherein, during delivery of the device, the balloon is deflated and the compressor is mounted on the deflated balloon in a non-expanded configuration and, thereafter, the balloon is inflated thereby causing the device to expand to its expanded configuration. 
   
   
       17 . A method according to  claim 3  wherein the compressor has an indented side and a non-indented side and wherein the indented side of the compressor is positioned adjacent to the venous valve such that the compressor extends part way around the venous valve. 
   
   
       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 . A method according to  claim 1  wherein the compressor is advanced at least partially around the venous valve while in a first configuration and subsequently contracts to a second configuration whereby it compresses the venous valve in a manner that improves closure of the venous valve leaflets. 
   
   
       22 . A method according to  claim 21  wherein the compressor has a lumen or passage into which a mandrel member is inserted, said mandrel member holding the compressor in the first configuration as the compressor is advanced at least partially around the venous valve, said mandrel member being thereafter removed from the compressor thereby allowing the compressor to contract to its second configuration. 
   
   
       23 . A method according to  21  wherein the compressor comprises a biodegradable component that maintains the compressor in the first configuration and wherein the compressor contracts to the second configuration after the biodegradable component has degraded.