Shape memory tubular stent with grooves

Abstract

An implantable, radially distensible stent includes a tubular structure having opposed open ends. The wall of the stent is made from a shape memory polymeric material. Grooves may be disposed within an outer surface of stent wall to improve flexibility and drainage of the stent.

1 . An implantable, radially distensible device comprising:
 a tubular structure having an open first end and an opposed open second end, the tubular structure having a wall between said first open end and said second end to define an open lumen therethrough, the wall having an outer surface and an opposed inner surface defining a wall thickness therebetween; the wall comprising a shape memory polymeric material;   wherein the tubular structure is a self-supporting wall structure.   
   
   
       2 . The device of  claim 1 , wherein the tubular structure has a substantially solid wall and has a plurality of grooves disposed within the outer surface of said wall. 
   
   
       3 . The device of  claim 2 , wherein the grooves are present in the wall when the device is in a radially contracted state and in a radially expanded state. 
   
   
       4 . The device of  claim 2 , wherein the grooves are selected from the group consisting of a semicircular groove, a truncated circular groove, a semicircular groove with rounded surfaces, a groove having a flat bottom portion and smoothly rounded sides, a triangular-shaped groove, a groove having a flat bottom portion and sloped sides, a square-shaped groove, a rectangular-shaped groove, and combinations thereof. 
   
   
       5 . The device of  claim 2 , wherein the grooves are a plurality of radially orientated grooves. 
   
   
       6 . The device of  claim 2 , wherein the grooves are a plurality of helically orientated grooves. 
   
   
       7 . The device of  claim 2 , wherein the grooves are a plurality of interconnected helically orientated grooves having a first helical pattern and a second helical pattern. 
   
   
       8 . The device of  claim 11 , wherein the grooves are crisscrossed helical grooves. 
   
   
       9 . The device of  claim 2 , wherein the grooves are interconnected grooves. 
   
   
       10 . The device of  claim 1 , wherein the shape memory polymeric material of the wall of the device comprises shape memory polymeric polycyclooctene. 
   
   
       11 . The device of  claim 2 , wherein the grooves comprise a depth and wherein the depth the grooves are from about 5% to about 50% of the wall thickness. 
   
   
       12 . The device of  claim 1 , further comprising:
 at least two tubular structures and a graft engaging the at least two tubular structures,   wherein the at least two tubular structures are spaced apart from one and the other.   
   
   
       13 . A method of making a stent, comprising:
 providing a shape memory polymer;   forming the shape memory polymer into a tubular structure having an open first end and an opposed open second end, the tubular structure having a wall between said first open end and said second end to define an open lumen therethrough, the wall having an outer surface and an opposed inner surface defining a wall thickness therebetween; and   disposing grooves within the outer surface of the wall.   
   
   
       14 . The method of  claim 13 , wherein the step of providing the shape memory polymer further comprises providing shape memory polymeric polycyclooctene. 
   
   
       15 . The method of  claim 13 , wherein the step of forming the shape memory polymer into the tubular structure is selected from the group consisting of molding the shape memory polymer, casting the shape memory polymer, extruding the shape memory polymer, and combinations thereof 
   
   
       16 . The method of  claim 13 , wherein the step of disposing grooves within the outer surface of the wall is selected from the group consisting of mechanically forming the grooves, milling the outer surface of the wall, grinding the outer surface of the wall, cutting the outer surface of the wall, laser cutting the outer surface of the wall, etching the outer surface of the wall, masking the outer surface of the wall, removing a sacrificial layer or filament from the outer surface, molding the grooves within the outer surface of the wall, and combinations thereof. 
   
   
       17 . A method for intraluminal delivery of a stent, comprising providing an assembly, comprising:
 a delivery device having an elongate tube; and   a radially distensible stent comprising:
 a tubular structure having an open first end and an opposed open second end, the tubular structure having a wall between said first open end and said second end to define an open lumen therethrough, the wall having an outer surface and an opposed inner surface defining a wall thickness therebetween; the wall comprising a shape memory polymeric material; and 
 grooves disposed within the outer surface of said wall; wherein the stent is disposed in a contracted state on the elongate tube of the delivery device; 
   advancing the assembly to a site within a bodily lumen;   radially expanding the stent within the bodily lumen; and   withdrawing the delivery device to leave the stent within the bodily lumen.   
   
   
       18 . The method of  claim 17 , wherein the step of radially expanding the stent within the bodily lumen further comprises supplying heat from a heat source to the stent to radially expand the stent. 
   
   
       19 . The method of  claim 17 , wherein the step of radially expanding the stent within the bodily lumen further comprises providing an expandable member to mechanically radially expand the stent. 
   
   
       20 . The method of  claim 17 , further comprising:
 providing an expandable member to mechanically expand the stent.