Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same

Abstract

The invention is directed to an implantable stent prosthesis comprising a sidewall and at least one channel for containing a biologically active material. A method for making such stent prosthesis is also disclosed. In the method, at least one tube or mandrel is placed in contact with a covering material on a stent and surrounded by the covering material to form a channel. Alternatively, a channel can be formed by covering the tube or mandrel with a channel material and exposing the covered tube or mandrel to an appropriate treatment. The channel can be attached to a sidewall of a stent or attached to a strut material to form a stent wire. A method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.

1 - 14 . (canceled)  
   
   
       15 . An implantable stent for delivery of a biologically active material to a blood vessel of a patient, wherein the stent comprises: 
 (a) a stent sidewall having a portion comprising a plurality of struts defining a plurality of openings, each strut having an exterior surface, wherein the stent sidewall comprises a metal; and    (b) at least one channel for containing a biologically active material, wherein the channel is attached to the sidewall and the channel comprises a channel space defined by a channel wall.    
   
   
       16 . The stent of  claim 15 , wherein the stent is a balloon-expandable stent.  
   
   
       17 . The stent of  claim 15 , wherein the stent sidewall has an interior luminal surface and an opposed exterior surface extending along a longitudinal stent axis; and wherein the stent further comprises a stent covering made of a covering material disposed over at least the interior luminal surface or the exterior surface of the stent sidewall.  
   
   
       18 . The stent of  claim 17 , wherein the channel is positioned within the covering.  
   
   
       19 . The stent of  claim 18 , wherein at least a portion of the channel wall comprises a portion of the exterior surface of a strut.  
   
   
       20 . The stent of  claim 18 , wherein the covering is disposed over the exterior surface of the stent sidewall.  
   
   
       21 . The stent of  claim 18 , wherein the covering is disposed over the interior luminal surface of the stent sidewall.  
   
   
       22 . The stent of  claim 18 , wherein the covering comprises two or more layers of covering material and wherein the channel is positioned between two layers.  
   
   
       23 . The stent of  claim 17 , wherein the channel wall comprises at least one layer of a channel material and wherein the channel is positioned within the covering.  
   
   
       24 . The stent of  claim 23 , wherein the channel material allows controlled release of the biologically active material.  
   
   
       25 . The stent of  claim 15 , wherein the biologically active material is an anti-proliferative agent, anti-inflammatory agent, antibiotic, antineoplastic agent, anti-miotic agent or a combination thereof.  
   
   
       26 . The stent of  claim 15 , wherein the biologically active material is paclitaxel or an analog or derivative thereof.  
   
   
       27 . The stent of  claim 15 , wherein at least a portion of the stent sidewall is formed by the channel, and wherein the channel wall comprises at least one layer of a channel material.  
   
   
       28 . The stent of  claim 27 , wherein at least one of the struts is fused to the channel wall.  
   
   
       29 . The stent of  claim 27 , wherein at least one of the struts is woven with the channel.  
   
   
       30 . The stent of  claim 15 , wherein the channel is positioned parallel to a longitudinal axis of the stent.  
   
   
       31 . The stent of  claim 15 , wherein the channel is positioned along a circumference of the stent.  
   
   
       32 . The stent of  claim 15 , wherein the channel has a circular-shaped, oblong-shaped, square-shaped or star-shaped cross section.  
   
   
       33 . The stent of  claim 15 , wherein the channel has at least one open end, wherein a tube having an end is positioned in the channel, and wherein the end of the tube protrudes from the open end of the channel.  
   
   
       34 . The stent of  claim 15 , wherein the metal is stainless steel.