Catheter balloons with integrated non-distensible seals

Abstract

A catheter balloon with integral non-distending regions having a plurality of layers which wind around the balloon material and overlap to form an angle of between 45 and 90 degrees relative to each other upon inflation, and methods of making the non-distending regions are provided.

1 . A catheter balloon comprising at least one balloon material and at least one integral non-distending region comprising a plurality of layers which wind around the balloon material and overlap to form an angle of between 0 and 90 degrees relative to each other upon inflation at an angle that reduces the compliance of said region. 
     
     
         2 . The balloon of  claim 1  wherein said non-distending region is located between two or more balloon material layers. 
     
     
         3 . The balloon of  claim 1  wherein said non-distending region is located on the surface of a balloon material. 
     
     
         4 . The balloon of  claim 1  wherein said plurality of non-distending layers form non-distending regions. 
     
     
         5 . The balloon of  claim 4  wherein said plurality of non-distending layers impart a shape to the balloon material upon inflation. 
     
     
         6 . The balloon of  claim 1  wherein the non-distending regions impart a form to the balloon that renders the balloon non-cylindrical. 
     
     
         7 . The balloon of  claim 1  wherein the length of the non-distending region is wider than the final diameter of the balloon. 
     
     
         8 . The balloon of  claim 1  wherein the length of the non-distending region is narrower than final diameter of balloon. 
     
     
         9 . The balloon of  claim 1  wherein the non-distending regions is polytetrafluoroethylene. 
     
     
         10 . The balloon of  claim 9  wherein the polytetrafluoroethylene is wrapped so that an angle of between 0 and 90 degrees is achieved upon inflation which reduces load on the seal of the inflated balloon when attached to a catheter. 
     
     
         11 . The balloon of  claim 1  wherein said non-distending regions are made from dissimilar material than the balloon. 
     
     
         12 . The balloon of  claim 1  wherein said non-distending regions are made from the same material as the balloon. 
     
     
         13 . A balloon catheter comprising a catheter shaft and a catheter balloon comprising at least one balloon material and at least one non-distending region comprising a plurality of elastomer-imbibed polytetrafluoroethylene layers which wind around the balloon material and overlap to form an angle of between 0 and 90 degrees relative to each other upon inflation and retain pressure in the balloon. 
     
     
         14 . A method of forming a continuous integrated seal on an inflatable balloon comprising:
 a. providing a first balloon material layer configured to form a desired balloon shape;   b. wrapping a wrap layer around said first balloon material layer;   c. changing angle of the wrap to wrap at least one layer at an angle sufficient to create a seal over the first balloon material layer;   d. wrapping a second balloon material layer around the seal to increase the bonding surface area of the seal; and   e. forming an integrated non-distensible region upon inflation.   
     
     
         15 . A method of forming a continuous exposed integrated seal on an inflatable balloon comprising:
 a. providing a balloon material layer configured to form a desired balloon shape;   b. wrapping at least two layers of a wrap around said first balloon material layer;   c. changing angle to wrap one layer at an angle to the next layer sufficient to create a seal over a first balloon material layer; and   d. forming an integrated non-distensible region on an inflatable balloon.   
     
     
         16 . A method of forming a discontinuous non-exposed integrated seal on an inflatable balloon comprising:
 a. providing a first balloon material layer configured to form a desired balloon shape;   b. wrapping at least one layer of a second wrap around said first wrap at an angle sufficient to create a seal over a first balloon material layer;   c. wrapping a second balloon material layer around the seal to increase the bonding surface area of the seal; and   d. forming an integrated non-distensible region in an inflatable balloon.   
     
     
         17 . A method of forming a discontinuous exposed integrated seal on an inflatable balloon comprising:
 a. providing a first balloon material layer configured to form a desired balloon shape;   b. wrapping at least one layer of a second wrap around said first wrap at an angle sufficient to create a seal over a first balloon material layer; and   c. forming an integrated non-distensible region on an inflatable balloon.   
     
     
         18 . The balloon of  claim 1  wherein the catheter shaft comprises ridges in contact with the integral non-distending of the balloon. 
     
     
         19 . The balloon of  claim 1  wherein the length of the non-distending region is equal to final diameter of balloon 
     
     
         20 . A balloon of  claim 1  where the non-distensible regions provide a diffused burst event with non-catastrophic seal failure.