US2002103455A1PendingUtilityA1

Balloon forming process

45
Assignee: ADVANCED CARDIOVASCULAR SYSTEMPriority: Jan 13, 2000Filed: Nov 20, 2001Published: Aug 1, 2002
Est. expiryJan 13, 2020(expired)· nominal 20-yr term from priority
Inventors:Michael Y. ZhangKerry J. WilliamsJohann J. SkinnerChicheng Wang
B29C 2949/08B29C 49/6472Y10S264/903A61M 25/1029Y10S264/904B29C 55/24B29C 35/045B29C 67/0014B29L 2031/7542B29K 2105/258B29C 49/6605
45
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Claims

Abstract

The present invention is directed to apparatus and method for forming balloons with improved dimensional stability and balloons formed by the same. The method of the present invention provides for a very accurate control of the temperature profile of the balloon material during its making. The attributes of the balloon can be affected by how the balloon is treated during the blowing stage and after the initial blowing, i.e., heat-setting. Using the present method, the balloon will form more uniformly and evenly (e.g., wall thickness and outer diameter of the balloon). The present method significantly increases the dimensional stability of the balloon which provides a balloon that is more predictable in use. The present heat-set process also provides the means for the working length to be located more accurately on dilation catheters and stent delivery systems.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . A method for forming a balloon; comprising: 
 disposing a polymeric tubular product having an effective length with first and second ends within a mold;    applying internal pressure to the tubular product;    heating at least a portion of the tubular product to a first elevated temperature for a first predetermined period of time to form the tubular product into a balloon;    maintaining the temperature of the tubular product to a minimal temperature differential from the first temperature;    heating the tubular product to a second elevated temperature for a second predetermined period of time to heat set the formed balloon;    cooling down the tubular product to substantially ambient temperature;    removing the tubular product from the mold.    
     
     
         2 . The method of  claim 1  wherein the temperature differential is less than about 100° C.  
     
     
         3 . The method of  claim 1  wherein the temperature differential is less than about 50° C.  
     
     
         4 . The method of  claim 1  wherein the temperature differential is less than about 20° C.  
     
     
         5 . The method of  claim 1  wherein the first elevated temperature is greater than the glass transition temperature of the polymeric material forming the tubular product.  
     
     
         6 . The method of  claim 5  wherein the first elevated temperature is at least 10° C. greater than the glass transition temperature of the polymeric material forming the tubular product.  
     
     
         7 . The method of  claim 6  wherein the first elevated temperature is at least 20° C. greater than the glass transition temperature of the polymeric material forming the tubular product.  
     
     
         8 . The method of  claim 7  wherein the first elevated temperature is at least 40° C. greater than the glass transition temperature of the polymeric material forming the tubular product.  
     
     
         9 . The method of  claim 5  wherein the first elevated temperature is less than the melting temperature of the polymeric material forming the tubular product.  
     
     
         10 . The method of  claim 1  wherein the second elevated temperature is substantially equal to the first elevated temperature.  
     
     
         11 . The method of  claim 1  wherein the second elevated temperature is greater than the first elevated temperature.  
     
     
         12 . The method of  claim 11  wherein the second elevated temperature is sufficiently high to thermoset the polymeric material forming the tubular product.  
     
     
         13 . A method for forming a balloon; comprising: 
 disposing a polymeric tubular product having an effective length with first and second ends within a mold;    applying internal pressure to the tubular product;    heating at least a portion of the tubular product to a first elevated temperature for a predetermined period of time to form the tubular product into a balloon;    heating the tubular product uniformly between the first and second ends to a second elevated temperature for a predetermined period of time to heat set the formed balloon;    cooling down the tubular product to substantially ambient temperature;    removing the tubular product from the mold.    
     
     
         14 . The method of  claim 12  wherein the tubular product temperature difference between the first and second ends is less than about 30° C.  
     
     
         15 . The method of  claim 14  wherein the tubular product temperature difference between the first and second ends is less than about 15° C.  
     
     
         16 . The method of  claim 15  wherein the tubular product temperature difference between the first and second ends is less than about 10° C.  
     
     
         17 . A method for forming a balloon; comprising: 
 disposing a polymeric tubular product having an effective length with first and second ends within a mold;    applying internal pressure to the tubular product;    heating at least a portion of the tubular product to a first elevated temperature with a first heating member for a predetermined period of time to form the tubular product into a balloon;    heating the tubular product to a second elevated temperature with a second heating member having an effective length at least substantially the same as the effective length of the tubular product;    cooling down the tubular product to substantially ambient temperature;    removing the tubular product from the mold.    
     
     
         18 . The method of  claim 17  wherein the first heating member applies heat to the tubular product as it traverses from one end of the tubular product to the other end.  
     
     
         19 . The method of  claim 17  wherein the first heating member has an effective length at least substantially the same as the effective length of the tubular product.  
     
     
         20 . The method of  claim 19  wherein the first heating member applies heat to the tubular product simultaneously across the effective length of the tubular product.  
     
     
         21 . The method of  claim 17  wherein the second heating member applies heat to the tubular product as it traverses from one end of the tubular product to the other end.  
     
     
         22 . The method of  claim 17  wherein the second heating member applies heat to the tubular product simultaneously across the effective length of the tubular product.  
     
     
         23 . The method of  claim 17  wherein the first heating member and the second heating member are integral with one another.  
     
     
         24 . The method of  claim 17  wherein the first heating member and the second heating member are on different heating heads.  
     
     
         25 . The method of  claim 17  wherein the second elevated temperature is different from the first elevated temperature.  
     
     
         26 . A medical balloon having a reduced radial shrinkage and reduced axial growth.  
     
     
         27 . The balloon of  claim 26  wherein the radial shrinkage is less than about 10%.  
     
     
         28 . The balloon of  claim 27  wherein the radial shrinkage is less than about 6%.  
     
     
         29 . The balloon of  claim 28  wherein the radial shrinkage is less than about 4%.  
     
     
         30 . The balloon of  claim 26  wherein the axial growth is less than about 10%.  
     
     
         31 . The balloon of  claim 29  wherein the axial growth is less than about 6%.  
     
     
         32 . The balloon of claim  30  wherein the axial growth is less than about 4%.

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