Methods of using a self-adjusting stent assembly and kits including same

Abstract

A method of using a self-adjusting stent assembly includes estimating body lumen diameter(s) associated with a portion of a body lumen in which a stent assembly will be placed; determining, based on the estimated diameter(s), target expanded stent diameter(s) of the stent assembly which is to be placed in the portion of the body lumen; selecting the stent assembly for stenting the portion of the body lumen, wherein the stent assembly is configured to: expand from an initial to expanded diameters within a range of expanded diameters; wherein the range of expanded diameters is from about 9 mm to about 5.5 mm; and wherein the target expanded stent diameter(s) is/are within the range of expanded diameters; and apply a chronic radial force to a wall that forms the portion of the lumen, wherein the radial force is less than about 0.33 N/mm.

What is claimed is: 
     
         1 . A method of selecting a stent assembly for stenting, which comprises:
 estimating a base reference diameter associated with a portion of a body lumen in which a stent assembly will be placed;   determining, based on the estimated base reference diameter, a target expanded stent diameter of the stent assembly which is to be placed in the portion of the body lumen; and   select the stent assembly for stenting the portion of the body lumen based on the target expanded stent diameter,   wherein the stent assembly comprises:
 a porous structure, comprising an expansible mesh structure; and 
 an expansible stent, having a tubular shape, operatively associated with the porous structure and configured to expand in any body lumen having a diameter in a range between a first deployed diameter and a second deployed diameter, smaller than the first deployed diameter by more than 2 millimeters, to an extent such that the stent assembly applies a chronic radial force to a wall of the body lumen, 
 wherein the stent assembly is configured to apply a chronic radial force of less than about 0.33 N/mm, when expanded to any diameter within the range. 
   
     
     
         2 . The method of  claim 1 , wherein the portion of the body lumen defines varying body lumen diameters and wherein determining the target expanded stent diameter comprises determining two different target diameters within the range. 
     
     
         3 . The method of  claim 1 , wherein when the stent assembly is expanded to the first deployed diameter, the stent assembly applies a radial force of at least 50% of the radial force it applies when expanded to the second deployed diameter. 
     
     
         4 . The method of  claim 1 , wherein the stent assembly is configured to act as either a straight stent or a tapered stent and is not designed for a pre-determined tapering of the expanded diameter, but instead adapts upon deployment in a body lumen to the diameter of the body lumen even across a non-uniform-diameter body lumen within the range between the first deployed diameter and the second deployed diameter. 
     
     
         5 . The method of  claim 4 , wherein the stent assembly is configured to act as either a straight stent or a tapered stent and is not designed for a pre-determined tapering of the expanded diameter, but instead adapts upon deployment in a body lumen to the diameter of the body lumen even across a non-uniform-diameter body lumen. 
     
     
         6 . The method of  claim 1 , wherein the porous structure comprises an expansible knitted mesh structure formed from fibers having a diameter between about 7 micrometers and about 40 micrometers. 
     
     
         7 . The method of  claim 6 , wherein the expansible knitted mesh structure comprises a retracted state that is associated with the initial diameter and a deployed state that is associated with the one or more expanded diameters, wherein the expansible mesh structure defines apertures having a minimum center dimension greater than about 100 micrometers and no more than about 300 micrometers before implantation and when the expansible mesh structure is in the deployed state, wherein the expansible mesh structure has a thickness of greater than about 12.5 micrometers to no more than about 100 micrometers. 
     
     
         8 . The method of  claim 1 , wherein the porous structure is constructed from one or more fibers of metal. 
     
     
         9 . The method of  claim 1 , wherein the porous structure is constructed from one or more polymer fibers. 
     
     
         10 . The method of  claim 1 , wherein the porous structure controls a local pressure exerted by the expansible stent on a body lumen wall in which the stent assembly is implanted. 
     
     
         11 . The method of  claim 1 , wherein when the stent assembly is expanded to a diameter of at least 5.5 millimeters, the stent assembly applies a radial force which is greater than about 0.20 N/mm. 
     
     
         12 . The method of  claim 1 , wherein the expansible stent comprises a self-expandable stent. 
     
     
         13 . The method of  claim 1 , wherein the first deployed diameter is 10 millimeters, and the second deployed diameter is 5 millimeters. 
     
     
         14 . The method of  claim 1 , wherein the first deployed diameter is 9 millimeters, and the second deployed diameter is 5.5 millimeters. 
     
     
         15 . The method of  claim 1 , wherein the first deployed diameter is 7 millimeters, and the second deployed diameter is 4 millimeters. 
     
     
         16 . A method of stenting, which comprises:
 providing a plurality of identical stent assemblies, comprising:
 an expansible stent, having a tubular shape, configured to expand in any body lumen having a diameter in a range between a first deployed diameter and a second deployed diameter, smaller than the first deployed diameter by more than 2 millimeters, to an extent such that the stein assembly applies a chronic radial force to a wall of the body lumen, 
 wherein the stent assembly is configured to apply a chronic radial force of less than about 0.33 N/mm, when expanded to any diameter within the range; 
   implanting a first one of the identical stent assemblies in a first patient in a body lumen having a diameter of the first deployed diameter; and   implanting a second one of the identical stent assemblies in a second patient in a body lumen having a diameter of the second deployed diameter.   
     
     
         17 . The method of  claim 16 , wherein when the stent assembly is expanded to the first deployed diameter, the stent assembly applies a radial force of at least 50% of the radial force it applies when expanded to the second deployed diameter. 
     
     
         18 . The method of  claim 16 , wherein the plurality of identical stent assemblies further comprises a porous structure, comprising an expansible mesh structure, surrounding the expansible stent, having the tubular shape. 
     
     
         19 . The method of  claim 18 , wherein the porous structure comprises an expansible knitted mesh structure formed from fibers having a diameter between about 7 micrometers and about 40 micrometers. 
     
     
         20 . The method of  claim 19 , wherein the expansible knitted mesh structure comprises a retracted state that is associated with the initial diameter and a deployed state that is associated with the one or more expanded diameters, wherein the expansible mesh structure defines apertures having a minimum center dimension greater than about 100 micrometers and no more than about 300 micrometers before implantation and when the expansible mesh structure is in the deployed state, wherein the expansible mesh structure has a thickness of greater than about 12.5 micrometers to no more than about 100 micrometers. 
     
     
         21 . The method of  claim 18 , wherein the porous structure is constructed from one or more fibers of metal. 
     
     
         22 . The method of  claim 18 , wherein the porous structure is constructed from one or more polymer fibers. 
     
     
         23 . The method of  claim 16 , wherein the first deployed diameter is 10 millimeters, and the second deployed diameter is 5 millimeters. 
     
     
         24 . The method of  claim 16 , wherein the first deployed diameter is 9 millimeters, and the second deployed diameter is 5.5 millimeters.