Method of thermal treatment of a thermally responsive material of medical devices

Abstract

The present invention relates to a method of thermal treatment of thermally responsive material wherein areas in or on the material to be thermally treated are defined and thermal energy is inputted on or into the defined areas in order to change/influence the material characteristics. The present invention further relates to medical devices or parts thereof manufactured at least in part from thermally responsive material by a process comprising at least one step of thermal treatment of this thermally responsive material.

What is claim is: 
     
         1 . A method of manufacturing a catheter, comprising:
 forming a reinforcement pattern on a catheter tube having a proximal end and a distal end, wherein the reinforcement pattern is formed by annealing at least one longitudinal pattern along a length of the catheter tube and annealing at least one circumferential ring disposed about the catheter tube, wherein the at least one annealed circumferential ring intersects the at least one annealed longitudinal pattern.   
     
     
         2 . The method of  claim 1 , wherein the annealing includes thermal transfer heating selected portions of the catheter tube to form the reinforcement pattern. 
     
     
         3 . The method of  claim 1 , the catheter tube comprising a polymer doped with a doping agent, the doping agent being selected from a crosslinking agent, a nucleating agent or a clarifying agent, wherein the doping agent is distributed uniformly through at least a portion of the polymer such that the doping agent is uniformly distributed through a thickness of the catheter tube. 
     
     
         4 . The method of  claim 1 , further comprising annealing two longitudinal patterns on opposite sides of the catheter tube. 
     
     
         5 . The method of  claim 1 , wherein the distal end of the catheter tube is fabricated from soft Polyester Block Amide. 
     
     
         6 . The method of  claim 1 , further comprising forming a proximal guidewire exit wherein the reinforcement pattern is disposed about the proximal guidewire exit. 
     
     
         7 . A method for manufacturing a catheter, comprising:
 annealing an area of an inner tube to have a higher stiffness, the annealed area of higher stiffness comprising at least one annealed longitudinal pattern along a length of the inner tube and at least one annealed circumferential ring disposed about the inner tube and intersecting the at least one annealed longitudinal pattern;   disposing an outer tube substantially around the inner tube; and   affixing a balloon having a proximal balloon sleeve and a distal balloon sleeve to the inner and outer tubes, the proximal balloon sleeve being coupled to the outer tube and the distal balloon sleeve being coupled to the inner tube.   
     
     
         8 . The method of  claim 7 , wherein the annealing includes thermal transfer heating selected portions of the inner tube to form a reinforcement pattern. 
     
     
         9 . The method of  claim 7 , wherein the annealed area is of higher stiffness than a distal portion of the inner tube. 
     
     
         10 . The method of  claim 7 , the inner tube comprising a polymer doped with a doping agent, the doping agent being selected from a crosslinking agent, a nucleating agent or a clarifying agent, wherein the doping agent is distributed uniformly through at least a portion of the polymer such that the doping agent is uniformly distributed through a thickness of the inner tube. 
     
     
         11 . The method of  claim 7 , the annealed area extending towards a distal portion, the stiffness of the annealed area decreasing towards the distal portion. 
     
     
         12 . The method of  claim 7 , further comprising forming the outer tube from a plurality of tube portions and a plurality of other reinforced areas, the other reinforced areas transitioning stiffness of adjacent tube portions of the plurality of tube portions. 
     
     
         13 . The method of  claim 7 , further comprising forming the inner tube from a plurality of inner tube portions and a plurality of inner reinforced areas, the inner reinforced areas transitioning stiffness of adjacent inner tube portions of the plurality of inner tube portions. 
     
     
         14 . The method of  claim 7 , further comprising forming at least one reinforced region on the balloon. 
     
     
         15 . The method of  claim 14 , wherein the at least one reinforced region comprises a reinforced line. 
     
     
         16 . The method of  claim 7 , further, wherein the annealing includes applying wave energy to a temperature above the glass transition temperature (T E ) and below the melting temperature (T M ) of the annealed area. 
     
     
         17 . A method for manufacturing a catheter, comprising:
 positioning an outer tube substantially around an inner tube;   coupling a balloon to the inner tube and the outer tube; and   annealing at least one reinforced line extending over at least a portion of a length of the balloon and annealing at least one circumferential ring disposed about the balloon, the at least one annealed circumferential ring intersecting the at least one annealed reinforced line, the annealed reinforced line comprising a polymer doped with a doping agent, the doping agent being selected from a crosslinking agent, a nucleating agent or a clarifying agent, wherein the doping agent is distributed uniformly through at least a portion of the polymer such that the doping agent is uniformly distributed through a thickness of the balloon.   
     
     
         18 . The method of  claim 17 , further comprising extending the at least one annealed reinforced line from a proximal end to a distal end of the balloon. 
     
     
         19 . The method of  claim 17 , further comprising forming the balloon from a thermally responsive material. 
     
     
         20 . The method of  claim 17 , further comprising forming each of the inner tube and the outer tube from a plurality of tube portions. 
     
     
         21 . The method of  claim 17 , further comprising extending the annealed reinforced line between adjacent circumferential rings. 
     
     
         22 . The method of  claim 17 , wherein the catheter comprises a Polyester Block Amide layer and a high-density polyethylene layer.