Vascular prosthesis including torsional stabilizer and methods of use

Abstract

The present invention is directed to an implantable vascular prosthesis configured for use in a wide range of applications, such as treating aneurysms, maintaining patency in a vessel, and allowing for the controlled delivery of therapeutic agents to a vessel wall. The prosthesis comprises a helical proximal section coupled to a distal anchoring section having a generally zig-zag or cell-like configuration. The prosthesis is configured to conform to a vessel wall without substantially remodeling the vessel, and further is configured to be precisely deployed in a vessel without shifting during deployment. The prosthesis also has a substantially small delivery profile compared to other known stents, while having an increased surface area to enhance delivery of therapeutic agents.

1 . A vascular prosthesis for implantation in a body vessel having a vessel wall, the vascular prosthesis comprising: 
 a proximal section comprising a plurality of helical turns and a distal end;    a distal section joined to the distal end, the distal section forming a self-expanding anchor; and    a torsional stabilizer coupled to the distal end of the proximal section.    
   
   
       2 . The vascular prosthesis of  claim 1 , wherein the proximal section, distal section and torsional stabilizer each are capable of assuming a contracted state suitable for transluminal insertion into the body vessel and a deployed state wherein the proximal section, distal section and torsional stabilizer engage the vessel wall.  
   
   
       3 . The vascular prosthesis of  claim 2 , wherein the distal section is configured to be deployed within the body vessel before the proximal section and torsional stabilizer are deployed.  
   
   
       4 . The vascular prosthesis of  claim 2 , wherein the torsional stabilizer is configured to be deployed before the proximal section is deployed, but after the distal section is deployed.  
   
   
       5 . The vascular prosthesis of  claim 2 , wherein the distal section is configured to engage the vessel wall to retain the vascular prosthesis in position during deployment of the torsional stabilizer and proximal section.  
   
   
       6 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer enhances frictional engagement with the vessel wall.  
   
   
       7 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer comprises a loop.  
   
   
       8 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer comprises a continuation of the proximal section.  
   
   
       9 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer is configured to partially overlap the distal section.  
   
   
       10 . The vascular prosthesis of  claim 1 , wherein, in a fully deployed configuration, the torsional stabilizer and the distal section are oriented substantially parallel to one another.  
   
   
       11 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer is biased outwardly to provide increased frictional contact with the vessel wall.  
   
   
       12 . The vascular prosthesis of  claim 1 , wherein the proximal section, distal section and torsional stabilizer comprise a nickel titanium alloy.  
   
   
       13 . The vascular prosthesis of  claim 1 , wherein the proximal and distal sections may be manufactured as two distinct sections, then coupled together.  
   
   
       14 . The vascular prosthesis of  claim 1 , further comprising at least one through-hole disposed on a solid portion of the torsional stabilizer, the through-hole configured to contain a therapeutic agent.  
   
   
       15 . The vascular prosthesis of  claim 1 , wherein the torsional stabilizer is used to orient the prosthesis axially within the body vessel.  
   
   
       16 . A vascular prosthesis for implantation in a body vessel having a vessel wall, the vascular prosthesis including a longitudinal axis, the vascular prosthesis comprising: 
 a proximal section comprising a plurality of helical turns and a distal end;    a self-expanding distal section coupled to the distal end of the helical body at a junction; and    a torsional stabilizer coupled to the distal end of the proximal section.    
   
   
       17 . The vascular prosthesis of  claim 16 , wherein the junction defines an origin of an X-Y coordinate system, wherein an X-axis is substantially parallel to a longitudinal axis of vascular prosthesis and a Y-axis is substantially orthogonal to the longitudinal axis of vascular prosthesis.  
   
   
       18 . The vascular prosthesis of  claim 16 , wherein the torsional stabilizer extends past a plane of the X-axis.  
   
   
       19 . The vascular prosthesis of  claim 16 , wherein the torsional stabilizer extends past a plane of the Y-axis.  
   
   
       20 . The vascular prosthesis of  claim 16 , wherein the torsional stabilizer includes one or more radiopaque markers to facilitate alignment of the vascular prosthesis at a desired radial orientation within the vessel.