Compacted catheter balloon and method of incremental compaction

Abstract

A catheter balloon or other expandable tubular medical device or component, having at least a first layer with a first section and a second section longitudinally compacted by more than the first section. In a presently preferred embodiment, the second section of the first layer extends at least in part along a central portion of the length of the first layer. The longitudinal compaction of the material of the first layer preferably results in a balloon or other expandable tubular medical device or component having improved performance characteristics such as compliance and dimensional stability. One aspect of the invention is directed to a method of longitudinally compacting a porous polymeric tube incrementally along the length of the tube, to compact sections of the tube.

1 - 25 . (canceled)  
   
   
       26 . A method of making at least a first layer of an expandable tubular medical device or component, comprising: 
 a) placing a porous polymeric tube having a length and an outer diameter on a mandrel, with a diameter limiting member around at least a portion of the tube;    b) releasably securing at least a first compactor member to the tube at a first location on the tube, the secured compactor member being slidably disposed relative to the mandrel;    c) moving the compactor member a distance, to compact a first segment of the tube in the diameter limiting member and having a length less than the entire length of the tube, and releasing the compactor member;    d) releasably securing the compactor member to the tube at a second location on the tube; and    e) moving the compactor member a distance, to compact a second segment of the tube in the diameter limiting member which has a length less than the entire length of the tube, and releasing the compactor member.    
   
   
       27 . The method of  claim 26  wherein the diameter limiting member is selected from the group consisting of a die, a polymeric tube, a mold, and a sheet of polymeric material wrapped around the porous polymeric tube, and compacting the tube comprises pushing the tube in a lumen defined by the diameter limiting member so that the segment of the tube compacts and the outer diameter of the tube does not increase to greater than the inner diameter of the lumen of the diameter limiting member.  
   
   
       28 . The method of  claim 26  including a second compactor member releasably secured to the tube at a location on the tube longitudinally spaced apart from the at least a first compactor member and slidably disposed relative to the mandrel, and compacting the segment of the tube comprises moving the first and second compactor members together toward a center of the length of the tube.  
   
   
       29 . The method of  claim 26  including a fixing member releasably securing the tube to the mandrel, and compacting the segment of the tube comprises moving the first compactor member towards the fixing member.  
   
   
       30 . The method of  claim 29  wherein the diameter limiting member is a die, and the fixing member is on the tube at an outlet of the die, and the distance of c) equals the distance between the first location on the tube and an inlet of the die.  
   
   
       31 . The method of  claim 26  wherein the second segment is compacted by an amount different than the first section.  
   
   
       32 . The method of  claim 31  wherein the first segment has a length equal to the second segment, and the distance the compactor is moved in e) is different than the distance the compactor is moved in b).  
   
   
       33 . The method of  claim 31  wherein the first segment has a length greater than the second segment, and the distance the compactor is moved in e) is equal to the distance the compactor is moved in b).  
   
   
       34 . A method of making at least a first layer of a catheter balloon, the balloon having an inflatable working length and inflatable sections proximal and distal to the working length, comprising: 
 a) placing a porous polymeric tube having a length and an outer diameter on a mandrel with a portion of the polymeric tube in a die, the die having an inlet and an outlet;    b) releasably securing a compactor member to the tube at a location on the tube spaced from the inlet of the die, the secured compactor member being slidably disposed relative to the mandrel, and releasably securing the tube to the mandrel with a fixing member at a location on the tube adjacent the outlet of the die;    c) moving the compactor member toward the inlet of the die, to compact a first segment of the tube located between the compactor and the die outlet, the first segment having a length less than the entire length of the tube, releasing the compactor member and fixing member and repositioning the tube to place a noncompacted portion of the tube in the lumen of the die;    d) releasably securing the compactor member to the tube at a location on the tube spaced from the inlet of the die and releasably securing the tube to the mandrel with the fixing member at a location on the tube adjacent the outlet of the die; and    e) moving the compactor member toward the inlet of the die, to compact a second segment of the tube located between the compactor and the die outlet, the second segment having a length less than the entire length of the tube.    
   
   
       35 . The method of  claim 34  wherein the first segment is compacted by the same amount as the second segment.  
   
   
       36 . The method of  claim 35  wherein the first and second segments form a first compacted section at least in part forming one of the proximal or distal inflatable sections of the balloon.  
   
   
       37 . The method of  claim 36  wherein the first and second segments are each compacted by about 5% to about 15%.  
   
   
       38 . The method of  claim 36  including after e) compacting one or more additional segments of the tube to form a second compacted section at least in part forming the working length of the balloon.  
   
   
       39 . The method of  claim 38  wherein the second compacted section is compacted by about 30% to about 50%.  
   
   
       40 . The method of  claim 38  including after forming the second compacted section, compacting one or more additional segments of the tube to form a third compacted section at least in part forming the distal tapered section of the balloon.  
   
   
       41 . The method of  claim 40  wherein the third compacted section is compacted by about 5% to about 15%.