Temperature controlled crimping

Abstract

This disclosure describes a method for crimping a stent with a polymer coating onto a catheter for percutaneous transluminal coronary angioplasty or other intraluminal interventions. The method comprises crimping the stent onto a catheter when the polymer coating is at a target temperature other than ambient temperature. The polymer coating can optionally comprise drug(s).

What is claimed is: 
     
         1 . A method of manufacturing a stent-balloon assembly, comprising:
 (a) providing a stent having a coating comprising a polymer and a drug, the polymer having (1) a glass transition temperature above room temperature and (2) a shore hardness of 60D to 95D or 65D to 90D;   (b) positioning the stent on a balloon of a catheter assembly;   (c) increasing the temperature of the polymer to a temperature to change the polymer to a softer state; and   (d) mounting the stent on the balloon while the polymer is in a softer state, such that after mounting, the polymer becomes harder, wherein the softer state is defined as decreasing the shore hardness of the polymer by 10 to 50 percent.   
     
     
         2 . The method of  claim 1 , wherein the act of increasing the temperature is done contemporaneously with the process of mounting the stent on the balloon. 
     
     
         3 . The method of  claim 1 , wherein the act of increasing the temperature is done prior to the act of mounting the stent on the balloon. 
     
     
         4 . The method of  claim 1 , wherein the temperature of the polymer is increased to greater than a glass transition temperature of the polymer. 
     
     
         5 . The method of  claim 1 , wherein the temperature is above 70 deg. C. 
     
     
         6 . The method of  claim 1 , wherein the temperature is between room temperature and a glass transition temperature of the polymer. 
     
     
         7 . The method of  claim 1 , wherein the temperature is between room temperature and 100 deg. C. 
     
     
         8 . A method of manufacturing a stent-balloon assembly, comprising:
 (a) providing a stent having a polymer component, the polymer component having (1) a glass transition temperature above room temperature or (2) a shore hardness of 60D to 95D or 65D to 90D;   (b) positioning the stent on a balloon of a catheter assembly;   (c) increasing the temperature of the polymer component to a temperature to change the polymer component to a softer state; and   (d) crimping the stent on the balloon while the polymer component is in a softer state, such that after crimping, the polymer component becomes harder, wherein the softer state is defined as decreasing the shore hardness of the polymer by 10 to 50 percent.