Adhesive-Free Bonded Balloon for a Balloon Guide Catheter With Minimal Outer Profile

Abstract

A balloon guide catheter with a catheter shaft having an outer layer made of a reflowable material and a balloon having a bond interface area with a plurality of punctures defined therein secured about the outer layer of the catheter shaft via seepage of the reflowable material of the outer layer into the plurality of punctures forming a radially outward reflow bond between the catheter shaft and the balloon without the use of an adhesive. One or more reflow jackets made of a reflowable material may also be disposed about the bond interface area of the balloon seeping into the plural punctures forming a radially inward reflow bond.

What is claimed is: 
     
         1 . A balloon guide catheter comprising:
 a catheter shaft having an outer layer made of a reflowable material; and   a balloon having a bond interface area with a plurality of punctures defined therein secured about the outer layer of the catheter shaft via seepage of the reflowable material of the outer layer into the plurality of punctures forming a radially outward reflow bond between the catheter shaft and the balloon;   wherein the balloon is secured to the catheter shaft without an adhesive.   
     
     
         2 . The balloon guide catheter according to  claim 1 , wherein the reflowable material of the outer layer comprises a medical grade thermoplastic polyurethane. 
     
     
         3 . The balloon guide catheter according to  claim 1 , wherein the balloon is a sleeve and the bond interface area comprises a proximal bond interface area and an opposite distal bond interface area; wherein the plurality of punctures is arranged 360° radially in the proximal and distal bond interface areas of the balloon sleeve. 
     
     
         4 . The balloon guide catheter according to  claim 3 , each of the proximal and distal bond interface areas of the balloon sleeve having the plurality of punctures defined therein is approximately 2 mm in an axial direction. 
     
     
         5 . The balloon guide catheter according to  claim 3 , further comprising:
 a proximal reflow jacket disposed about the balloon covering the proximal bond interface area; and   a distal reflow jacket disposed about the balloon covering the distal bond interface area; the distal reflow jacket being separated in an axial direction from the proximal reflow jacket forming a 360° radial gap therebetween through which a portion of the balloon is exposed;   wherein each of the proximal and distal reflow jackets is made of a reflowable material; the proximal and distal reflow jackets being securable to the balloon via the reflowable material of the proximal and distal outer jackets seepable into the plural punctures forming a radially inward reflow bond;   wherein the proximal and distal reflow jackets are secured to the balloon without an adhesive.   
     
     
         6 . The balloon guide catheter according to  claim 5 , wherein the reflowable material of the proximal and distal reflow jackets is the same as the reflowable material of the outer layer of the catheter shaft. 
     
     
         7 . The balloon guide catheter according to  claim 1 , wherein the balloon is a patch or a sleeve. 
     
     
         8 . The balloon guide catheter according to  claim 7 , further comprising: a single reflow jacket made of a reflowable material; the single reflow jacket having an opening defined therein aligned with the balloon; and wherein along the bond interface area about the perimeter of the opening in the balloon, the single reflow jacket is secured to the balloon via seepage of the reflowable material of the single reflow jacket into the plural punctures of the balloon forming a radially inward reflow bond. 
     
     
         9 . The balloon guide catheter according to  claim 8 , wherein the reflowable material of the single reflow jacket is the same as the reflowable material of the outer layer of the catheter shaft. 
     
     
         10 . A method for assembling a balloon guide catheter, the method comprising the steps of:
 piercing a plurality of punctures in a bond interface area of a balloon where securable to an outer layer made of a reflowable material of a catheter shaft;   arranging the balloon with the plurality of punctures pierced therein about the outer layer of the catheter shaft; and   subjecting to heat along the bond interface area causing the reflowable material of the outer layer of the catheter shaft to seep into the plurality of punctures creating a radially outward reflow bond between the outer layer of the catheter shaft and the balloon;   wherein the balloon is secured to the catheter shaft without an adhesive.   
     
     
         11 . The method according to  claim 10 , wherein the reflowable material of the outer layer comprises a medical grade thermoplastic polyurethane. 
     
     
         12 . The method according to  claim 10 , wherein the balloon is a sleeve and the bond interface area comprises a proximal bond interface area and an opposite distal bond interface area; wherein the plurality of punctures is arranged 360° radially in the proximal and distal bond interface areas of the balloon sleeve. 
     
     
         13 . The method according to  claim 12 , wherein each of the proximal and distal bond interface areas of the balloon sleeve having the plurality of punctures defined therein is approximately 2 mm in an axial direction. 
     
     
         14 . The method according to  claim 13 , further comprising the step of:
 positioning a proximal reflow jacket disposed about the balloon covering the proximal bond interface area and a distal reflow jacket disposed about the balloon covering the distal bond interface area;   wherein the distal reflow jacket is separated in an axial direction from the proximal reflow jacket forming a 360° radial gap therebetween through which a portion of the balloon is exposed;   wherein each of the proximal and distal reflow jackets is made of a reflowable material;   further securing the balloon to the outer layer of the catheter shaft by heating of the reflow material of the proximal and distal reflow jackets causing seepage into the plurality of punctures forming a radially inward reflow bond.   
     
     
         15 . The method according to  claim 14 , wherein the reflowable material of the proximal and distal reflow jackets is the same as the reflowable material of the outer layer of the catheter shaft. 
     
     
         16 . The method according to  claim 15 , further comprising the step of:
 positioning a single reflow jacket made of a reflowable material disposed about the balloon covering the bond interface area; the single reflow jacket having an opening defined therein aligned with the balloon;   and wherein along the bond interface area about a perimeter of the opening in the balloon, securing the single reflow jacket to the balloon by heating of the reflowable material of the single reflow jacket causing seepage into the plural punctures of the balloon forming a radially inward reflow bond.   
     
     
         17 . The method according to  claim 16 , wherein the reflowable material of the single reflow jacket is the same as the reflowable material of the outer layer of the catheter shaft.