Prosthetic venous valve devices and associated methods

Abstract

A prosthetic venous valve device is disclosed and described, having a valve base including a cylindrical shape with a lumen configured for axial blood flow, the valve base further including an anterograde end and a retrograde end, a pair of flexure pivots coupled to opposite sides of the valve base at the anterograde end, and a pair of leaflets opposingly positioned with respect to one another and each pivotally coupled to one of the pair of flexure pivots, the pair of leaflets being separated from one another in a default open position, wherein the pair of leaflets are structurally configured to pivot from the default open position toward one another to close the prosthetic venous valve to limit retrograde venous blood flow under normal physiologic venous conditions.

1 . A prosthetic venous valve, comprising:
 a valve base having a cylindrical shape with a lumen configured for axial blood flow, the valve base further including an anterograde end and a retrograde end;   a pair of flexure pivots coupled to opposite sides of the valve base at the anterograde end; and   a pair of leaflets opposingly positioned with respect to one another and each pivotally coupled to one of the pair of flexure pivots, the pair of leaflets being separated from one another in a default open position,   wherein the pair of leaflets are structurally configured to pivot from the default open position toward one another to close the prosthetic venous valve to limit retrograde venous blood flow under normal physiologic venous conditions.   
     
     
         2 . The prosthetic venous valve of  claim 1 , wherein each leaflet further comprises a pair of leaflet flaps, with each leaflet flap coupled along a bottom edge of the leaflet on opposite sides of the flexural pivot. 
     
     
         3 . The prosthetic venous valve of  claim 1 , wherein the pair of leaflets are structurally configured to pivot from the default open position toward one another to close the prosthetic venous valve at a retrograde hydrostatic pressure of from about 15 mmHg to about 25 mmHg at the anterograde end. 
     
     
         4 . The prosthetic venous valve of  claim 1 , wherein the pair of leaflets are structurally configured to pivot from the default open position toward one another to close the prosthetic venous valve at a retrograde hydrostatic pressure of about 20 mmHg at the anterograde end. 
     
     
         5 . The prosthetic venous valve of  claim 1  having a maximum shear rate of less than or equal to about 2,100 s −1  for anterograde venous blood flow. 
     
     
         6 . The prosthetic venous valve of  claim 1  having a maximum shear rate of less than or equal to about 1,100 s −1  for anterograde venous blood flow. 
     
     
         7 . The prosthetic venous valve of  claim 1  having a maximum shear rate of less than or equal to about 300 s −1  for anterograde venous blood flow. 
     
     
         8 . The prosthetic venous valve of  claim 1 , wherein the valve base, the pair of flexural pivots, and the leaflets are made of a biocompatible material. 
     
     
         9 . The prosthetic venous valve of  claim 8 , wherein the biocompatible material is carbon-infiltrated carbon nanotubes (CI-CNTs). 
     
     
         10 . The prosthetic venous valve of  claim 1 , wherein the valve base further comprises an adjustment seam to allow the valve base to be sized to fit a given vein. 
     
     
         11 . The prosthetic venous valve of  claim 1 , wherein the pair of leaflets are aligned with the cylindrical shape of the valve base when in the default open position. 
     
     
         12 . A prosthetic venous valve, comprising:
 a valve base having a cylindrical shape with a lumen configured for axial blood flow, the valve base further including an anterograde end and a retrograde end;   a pair of flexure pivots coupled to opposite sides of the valve base at the anterograde end;   a pair of leaflets opposingly positioned with respect to one another and each pivotally coupled to one of the pair of flexure pivots, the pair of leaflets being positioned against one another at a center of the valve base in a default closed position,   wherein the pair of leaflets are structurally configured to pivot from the default closed position away from one another to open the prosthetic venous valve to allow anterograde venous blood flow under normal physiologic venous conditions.   
     
     
         13 . The prosthetic venous valve of  claim 12 , wherein each leaflet further comprises a pair of leaflet flaps, with each leaflet flap coupled along a bottom edge of the leaflet on opposite sides of the flexural pivot. 
     
     
         14 . The prosthetic venous valve of  claim 12 , wherein the pair of leaflets are structurally configured to pivot from the default closed position away from one another to open the prosthetic venous valve at an anterograde hydrostatic pressure of from about 3 mmHg to about 8 mmHg at the retrograde end. 
     
     
         15 . The prosthetic venous valve of  claim 12 , wherein the pair of leaflets are structurally configured to pivot from the default closed position away from one another to open the prosthetic venous valve at an anterograde hydrostatic pressure of about 5 mmHg at the retrograde end. 
     
     
         16 . The prosthetic venous valve of  claim 12  having a maximum shear rate of less than or equal to about 2,100 s −1  for anterograde venous blood flow. 
     
     
         17 . The prosthetic venous valve of  claim 12  having a maximum shear rate of less than or equal to about 1,100 s −1  for anterograde venous blood flow. 
     
     
         18 . The prosthetic venous valve of  claim 12  having a maximum shear rate of less than or equal to about 300 s −1  for anterograde venous blood flow. 
     
     
         19 . The prosthetic venous valve of  claim 12 , wherein the valve base, the pair of flexural pivots, and the leaflets are made of a biocompatible material. 
     
     
         20 . The prosthetic venous valve of  claim 19 , wherein the biocompatible material is carbon-infiltrated carbon nanotubes (CI-CNTs). 
     
     
         21 . The prosthetic venous valve of  claim 12 , wherein the valve base further comprises an adjustment seam to allow the valve base to be sized to fit a given vein. 
     
     
         22 . The prosthetic venous valve of  claim 12 , wherein the pair of leaflets are aligned with the cylindrical shape of the valve base when in the open position.