Medical balloon with incorporated fibers

Abstract

A balloon catheter assembly comprises a balloon having attached to or in its wall one or more filar elements, extending from one end of the balloon to the other. The filar elements are made of a material which is at least as flexible as the material forming the walls of the balloon. In the event of circular burst of the balloon, the filar element(s) prevent disconnection of the material of the balloon into two or more separate pieces. The filar element(s) become attached to or in the material of the balloon wall when the raw material is inflated to the shape of a mold. The filar elements may comprise a natural fiber, a synthetic fiber or a metal wire.

What is claimed is: 
     
         1 . A balloon catheter assembly including:
 a catheter;   an inflatable balloon having a longitudinal direction and comprising a balloon wall made from at least one balloon material and provided with a body portion, first and second end cones, and first and second neck portions, which neck portions are attached to the catheter; and   one or more filar elements formed of at least one filar material attached to or embedded in the balloon wall, wherein the one or more filar elements extend solely in the longitudinal direction of the balloon from the first neck portion to the second neck portion;   wherein the one or more filar elements provide a barrier to circumferential tear propagation.   
     
     
         2 . An assembly according to  claim 1 , wherein the one or more filar elements are at least as flexible as the balloon wall. 
     
     
         3 . An assembly according to  claim 1 , wherein the one or more filar elements provide no material scoring or abrading function. 
     
     
         4 . An assembly according to  claim 1 , wherein the filar elements are at least as flexible as the balloon wall at least in a longitudinal direction of the balloon. 
     
     
         5 . An assembly according to  claim 1 , wherein the filar element or elements are compressible. 
     
     
         6 . An assembly according to  claim 1 , wherein the balloon wall has a thickness of between about 0.005 millimeters and about 0.080 millimeters. 
     
     
         7 . An assembly according to  claim 1 , wherein the at least one filar element has a diameter of between around 0.01 millimeters and 0.05 millimeters. 
     
     
         8 . An assembly according to  claim 1 , wherein the at least one filar element has a linear density (dtex) of between 10 and 60. 
     
     
         9 . An assembly according to  claim 1 , wherein the at least one filar element is multi-filamentary, each having from around 5 to 50 strands per element. 
     
     
         10 . An assembly according to  claim 9 , wherein the at least one filar element has around 25 strands. 
     
     
         11 . An assembly according to  claim 9 , wherein each strand has a density of around 0.5 to 2 denier. 
     
     
         12 . An assembly according to  claim 1 , wherein the at least one filar element has a tensile strength of between around 4N to around 20N. 
     
     
         13 . An assembly according to  claim 1 , wherein the at least one filar element exhibits an elongation at break of no more than around 5%. 
     
     
         14 . An assembly according to  claim 1 , wherein the at least one filar element is at least one of: completely embedded in the balloon wall and partially embedded in the balloon wall. 
     
     
         15 . An assembly according to  claim 1 , wherein the at least one filar material comprises natural and/or synthetic fiber. 
     
     
         16 . An assembly according to  claim 15 , wherein the at least one filar material comprises as least one of: para-aramid synthetic fiber, ultra high molecular weight polyethylene, polytetrafluoroethylene fiber, carbon fiber, cotton and the like. 
     
     
         17 . An assembly according to  claim 1 , wherein the balloon wall comprises an outer layer of a first material and an inner layer of a second material, wherein a softening or melting temperature of the first material is lower than a softening or melting temperature of the second material. 
     
     
         18 . A method of forming a balloon for a balloon catheter, including the steps of:
 providing a mold;   providing one or more filar elements along the entire length of the mold;   heating a balloon material in the mold; and   inflating the balloon material to the shape of the mold to form the balloon, said balloon having a longitudinal direction;   wherein the heating and inflating steps attach or embed the one or more filar elements on or in the balloon wall with the one or more elements extending solely in the longitudinal direction of the balloon.   
     
     
         19 . A method according to  claim 18 , wherein the balloon material is formed by co-extruding raw material to form a balloon wall comprising an outer layer of a first material and an inner layer of a second material, wherein a softening or melting temperature of the first material is lower than a softening or melting temperature of the second material. 
     
     
         20 . A method according to  claim 19 , wherein the heating and inflating steps completely embed the at least one filar element in the balloon wall.