External venous valve stents for the correction of incompetent venous valves

Abstract

Improvements to external stents to render incompetent venous valves competent are disclosed. The device is an inelastic bio-compatible cuff that encircles the venous valve cusps decreasing the internal diameter of the vein wall to allow apposition of the cusps and create competence. The improvements over previous designs include the addition of calibrated known diameters to create competence for different phenotypes. The different diameters are indicated by holes in the body. The buckle attachment allows the body of the device to become conical or inverted to become pyramidal as appropriate. The buckle is wider than prior art designs to allow the device to become elliptical at smaller diameters. The angle of the notches in the device are approximately 150 to allow better overriding at the sapheno-femoral junction which allowing for better competence of the valve.

1 . A venous valve cuff for restoring competence to an incompetent venous valve, comprising:
 (a) an elongated strap;   (b) a buckle integrally formed as a part of the elongated strap,   wherein the strap has a first end portion, a second end portion having a tapered end, and a central portion positioned between the first end portion and the second end portion, wherein the buckle is provided with an opening through which the second end portion may pass, and wherein the strap comprises at least one hole located in the central portion, the at least one hole aiding in the calibration of variable diameters of the cuff.   
   
   
       2 . The venous valve cuff of  claim 1 , wherein the strap and the buckle are made of a textile and polymer composite. 
   
   
       3 . The venous valve cuff of  claim 1 , wherein the strap comprises at least three centrally located holes. 
   
   
       4 . The venous valve cuff of  claim 1 , wherein the buckle further comprises sides slightly longer than the width of the strap so that the cuff may assume a conical shape during use. 
   
   
       5 . The venous valve cuff of  claim 1 , wherein the buckle and the cuff are made of the same composite material. 
   
   
       6 . The venous valve cuff of  claim 1 , wherein the composite material comprises a DACRON™ and silicone composite. 
   
   
       7 . The venous valve cuff of  claim 1 , wherein the incompetent venous valve has a superficial aspect, wherein the superficial aspect has a top, and wherein the buckle has a width that allows flattening of the top of the superficial aspect. 
   
   
       8 . The venous valve cuff of  claim 1 , wherein the cuff further comprises a notch positioned near the buckle. 
   
   
       9 . The venous valve cuff of  claim 8 , wherein the notch comprises sides that are curved. 
   
   
       10 . The venous valve cuff of  claim 9 , wherein the sides form an arc of approximately 15°.