Temporal intraluminal stent

Abstract

A biodegradable polymer stent with radiopacity and a method of making and using a stent with enhanced mechanical strength and/or controlled degradation for use in a bodily lumen is described.

What is claimed is: 
     
         1 . A tubular stent comprising a biocompatible polymer wherein the stent is made from:
 (a) dip-coating a mandrel with a solution comprising one or more biocompatible polymers to form a polymer tube;   (b) spin-drying the polymer tube around its longitudinal axis;   (c) solvent-polishing and vacuum drying the polymer tube; and,   (d) necking the polymer tube by drawing the mandrel bearing the polymer tube through one or more necking dies of decreasing diameter, wherein said necking is carried out at a temperature above the glass transition temperature of the polymer and below the melting temperature of the polymer.   
     
     
         2 . The stent of  claim 1 , having first and second locking members that interlock by means of teeth or barbs. 
     
     
         3 . The stent of  claim 1 , wherein said stent is formed of a polymer selected from the group consisting of biodegradable, bioabsorbable, and bioerodible polymers. 
     
     
         4 . The stent of  claim 1 , further including at least one pharmaceutical agent incorporated in the polymer and which is released from the polymer. 
     
     
         5 . The stent of  claim 1 , wherein said iodinated contrast agent is applied as a coating at least abluminally. 
     
     
         6 . The stent of  claim 1 , further comprising:
 the strength module having at least two circumferential restraint bands facing opposite of a crown valley of the expandable tubular elements, said expandable tubular elements having four or fewer crown peaks, wherein the length of the circumferential restraint band defines a size of the stent when deployed and a length of each circumferential restraint band is less than a length of the expandable tubular elements.   
     
     
         7 . The stent of  claim 1 , wherein the stent is created by laser cutting said polymer tube. 
     
     
         8 . The stent of  claim 1 , wherein the polymer contains an iodinated contrast agent. 
     
     
         9 . A polymer stent with enhanced mechanical strength wherein the stent is made by the steps comprising:
 (a) dip-coating a mandrel with a solution comprising one or more biocompatible polymers to form a polymer tube;   (b) spin-drying the polymer tube around its longitudinal axis;   (c) solvent-polishing and vacuum drying the polymer tube;   (d) repeating steps a-c until the polymer tube reaches a desired thickness;   (e) necking the polymer tube by drawing the mandrel bearing the polymer tube through one or more necking dies of decreasing diameter, wherein said necking is carried out at a temperature above the glass transition temperature of the polymer and below the melting temperature of the polymer;   (f) annealing the polymer tube with an inert gas;   (g) removing the polymer tube from the mandrel; and   (h) creating a design in said polymer tube.   
     
     
         10 . The stent of  claim 9  having a tubular structure formed of a polymer and including an iodinated contrast agent, said structure comprising one or more strength modules comprising one or more radially expandable tubular elements, said strength modules being interconnected by one or more axial linking elements for stent flexibility, wherein said tubular structure is radially expandable between at least an unexpanded diameter and an expanded diameter, and
 wherein at least one of the strength modules has a locking mechanism comprising a first and a second locking member, said first locking member being fixedly attached at a valley of the tubular element and said second locking member being fixedly attached at the valley of the tubular element, 
 wherein said first and second locking members are located opposite each other on radially expandable tubular elements such that said first and second locking members are not interlocked with one another when said tubular structure is in the unexpanded diameter and said first and second locking members are interlocked with one another when said tubular structure is in said expanded diameter, and 
 wherein said tubular structure is radially expandable between said unexpanded diameter and two or more discrete expanded diameters, and lockable at any of said two or more expanded diameters. 
 
     
     
         11 . The stent of  claim 9 , wherein said stent is formed of a polymer selected from the group consisting of biodegradable, bioabsorbable, and bioerodible polymers. 
     
     
         12 . The stent of  claim 1 , further including at least one pharmaceutical agent incorporated in the polymer and which is released from the polymer. 
     
     
         13 . The stent of  claim 1 , wherein said iodinated contrast agent is applied as a coating at least abluminally. 
     
     
         14 . The stent of  claim 9  wherein the polymer is an aliphatic polyesteric polymer. 
     
     
         15 . The stent of  claim 14  wherein the aliphatic polyesteric polymer is polyl-L-lactide. 
     
     
         16 . The stent of  claim 9 , further comprising: the strength module having at least two circumferential restraint bands facing opposite of a crown valley of the expandable tubular elements, said expandable tubular elements having four or fewer crown peaks, wherein the length of the circumferential restraint band defines a size of the stent when deployed and a length of each circumferential restraint band is less than a length of the expandable tubular elements. 
     
     
         17 . The stent of  claim 9 , wherein said stent is created by laser cutting said polymer tube. 
     
     
         18 . The stent of  claim 1 , wherein one or more biocompatible polymers forming the polymer tube includes an iodinated contrast agent. 
     
     
         19 . The stent of  claim 9 , wherein one or more biocompatible polymers forming the polymer tube includes an iodinated contrast agent.