Balloon catheters and methods for manufacturing balloons for balloon catheters

Abstract

Catheters, balloons, and methods of manufacturing balloons for balloon catheters using lasers are disclosed. A catheter with a shaft sized for use with a 0.014 inch guide wire includes a polymeric balloon having a body portion with an inflated outer diameter of more than 6 millimeters. An inflatable balloon includes an inflated outer diameter to inner waist diameter ratio of 12.5 to 1. An inflatable polymeric balloon that has a body portion with two regions that have different molecular orientations is also provided. A method of processing an elongate polymeric material includes heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material. A method of manufacturing a balloon includes heating and longitudinally stretching a first and second portion of an elongate polymeric tube to form first and second end portion. The remaining body portion is radially expanded to form the balloon.

1 . A method of manufacturing a balloon for a balloon catheter, the method comprising: 
 heating and longitudinally stretching a first portion of an elongate polymeric tube to form a first reduced diameter portion of the tube that serves as a first end portion for the balloon;    heating and longitudinally stretching a second portion of the tube to form a second reduced diameter portion of the tube that serves as a second end portion for the balloon that is opposite the first end portion, there remaining a body portion located between the first and second end portions; and    expanding the body portion of the tube radially to form the balloon.    
     
     
         2 . The method of  claim 1  wherein the heating of the first and second portions is performed by a laser.  
     
     
         3 . The method of  claim 2  wherein the laser emits a beam in the infrared frequency range to heat the first and second portions.  
     
     
         4 . The method of  claim 1  wherein before the method is performed the elongate polymeric tube has a uniform diameter.  
     
     
         5 . The method of  claim 1  wherein the formed balloon has an inflatable body portion with sufficient hoop strength for use in an angioplasty procedure.  
     
     
         6 . The method of  claim 5  wherein the balloon's inflated outer diameter is more than about 7 millimeters.  
     
     
         7 . The method of  claim 6  wherein the balloon's inflated outer diameter is about 9 millimeters.  
     
     
         8 . The method of  claim 1  wherein the first end portion of the balloon includes a first waist section and the second end portion of the balloon includes a second waist section, the first and second waist sections having an inner diameter such that the balloon may be affixed to a catheter shaft that has an inner lumen sized appropriately to accommodate a guide wire having a diameter of at most about 0.014 inches.  
     
     
         9 . The method of  claim 1  wherein the first end portion of the balloon includes a first waist section and the second end portion of the balloon includes a second waist section, the first and second waist sections having an inner diameter of no more than 0.028 inches.  
     
     
         10 . The method of  claim 1  wherein the formed balloon has an inflatable body portion that has a longitudinal length suitable for use in an angioplasty procedure.  
     
     
         11 . The method of  claim 1  wherein the formed balloon has an inflatable body portion that has a longitudinal length of no more than about 30 millimeters.  
     
     
         12 . A catheter comprising: 
 an elongate shaft having a lumen that extends longitudinally through the shaft, the lumen sized appropriately to accommodate a guide wire having a diameter of at most about 0.014 inches; and    an inflatable polymeric balloon affixed circumferentially about the shaft near the distal end of the shaft, the balloon having a body portion with an inflated outer diameter of more than about 7 millimeters.    
     
     
         13 . The catheter of  claim 12  wherein the balloon's body portion has an inflated outer diameter of 9 millimeters.  
     
     
         14 . The catheter of  claim 12  wherein the balloon has an inflatable body portion suitable for use in an angioplasty procedure.  
     
     
         15 . The catheter of  claim 12  wherein the balloon has a first end portion that includes a first waist section and a second end portion that includes a second waist section, the first and second waist sections having an inner diameter of no more than about 0.028 inches.  
     
     
         16 . The catheter of  claim 12  wherein the balloon is formed by heating and longitudinally stretching a first portion of an elongate polymeric tube to form a first reduced diameter portion of the tube that serves as a first end portion for the balloon; heating and longitudinally stretching a second portion of the tube to form a second reduced diameter portion of the tube that serves as a second end portion for the balloon that is opposite the first end portion, there remaining the body portion located between the first and second end portions; and expanding the body portion of the tube radially to form the balloon.  
     
     
         17 . The catheter of  claim 16  wherein before the balloon is formed the elongate polymeric tube has a uniform diameter.  
     
     
         18 . The catheter of  claim 16  wherein the heating of the first and second portions is performed by a laser.  
     
     
         19 . The catheter of  claim 16  wherein the laser emits a beam in the infrared frequency range to heat the first and second portions.  
     
     
         20 . An inflatable polymeric balloon for a balloon catheter, the balloon comprising: 
 a waist portion having an inner diameter that fits circumferentially around and is affixable to an elongate shaft that has an inner lumen sized appropriately to accommodate a guide wire having a diameter of at most about 0.014 inches; and    a body portion that has an inflated outer diameter, the ratio of the outer diameter of the body portion to the inner diameter of the waist portion being more than about 12.5 to 1.    
     
     
         21 . The balloon of  claim 20  wherein the inner diameter of the waist portion is no more than about 0.028 inches.  
     
     
         22 . The balloon of  claim 20  wherein the balloon has an inflatable body portion with sufficient hoop strength for use in an angioplasty procedure.  
     
     
         23 . The balloon of  claim 20  wherein the balloon has an inflated outer diameter of more than about 7 millimeters.  
     
     
         24 . The balloon of  claim 23  wherein the balloon has an inflated outer diameter of about 9 millimeters.  
     
     
         25 . The balloon of  claim 20  wherein the elongate polymeric tube has a uniform diameter before the heating and stretching of the portion of the tube.  
     
     
         26 . The balloon of  claim 20  wherein the waist portion of the balloon is formed by heating and longitudinally stretching a portion of an elongate polymeric tube.  
     
     
         27 . The balloon of  claim 26  wherein the heating of the portion of the tube is performed by a laser.  
     
     
         28 . The balloon of  claim 27  wherein the laser emits a beam in the infrared frequency range to heat the portion of the tube.  
     
     
         29 . A method of processing an elongate polymeric material for use in a medical device that is placed inside a body, the method comprising: 
 heating a portion of the polymeric material with a laser while longitudinally stretching the portion of the polymeric material.    
     
     
         30 . The method of  claim 29  wherein the laser emits a beam in the infrared frequency range to heat the polymeric material.  
     
     
         31 . The method of  claim 29  wherein the heating area of the laser is no more than about two millimeters.  
     
     
         32 . The method of  claim 29  further comprising cooling the heated portion of the polymeric material after it has been longitudinally stretched to the desired dimension.  
     
     
         33 . The method of  claim 29  wherein a control system controls the heating and stretching of the polymeric material.  
     
     
         34 . The method of  claim 29  wherein the polymeric material is Nylon 12, PEBAX, PET, or PEEK.  
     
     
         35 . An inflatable balloon for a balloon catheter, the balloon being constructed of a single polymeric material and having a first region wherein the polymeric material is oriented in a fashion that results from the balloon's body portion being stretched while being heated by a laser, and the balloon further having a second region wherein the polymeric material is oriented differently from the first region.  
     
     
         36 . The balloon of  claim 35  wherein the balloon has an inflatable body portion that has a longitudinal length suitable for use in an angioplasty procedure.  
     
     
         37 . The balloon of  claim 35  wherein the balloon has an inflatable body portion that has a longitudinal length of at most about 30 millimeters.  
     
     
         38 . The balloon of  claim 35  wherein the laser emits a beam in the infrared frequency range to heat the polymeric material.  
     
     
         39 . The balloon of  claim 35  wherein the polymeric material is Nylon 12, PEBAX, PET, or PEEK.