Radiopaque medical balloon

Abstract

A medical balloon ( 10 ) is made radiographic, such as by incorporating a radiopaque foil ( 36 ) or film layer ( 35 ). The radiopaque foil or film layer may be placed between an inner layer ( 30 ) and an outer layer ( 32 ) of a non-compliant balloon wall. The foil or film may provide the balloon with a radiographic quality from a first end to a second end in the absence of an inflation fluid. The balloon may be provided with the foil or film in a manner that provides a first section, such as the barrel ( 16 ), with a first radiographic quality, and a second section, such as the cone ( 18, 20 ), with a second radiographic quality. The film may also be applied as a decal or applique to the external surface of a balloon-shaped body. Related methods are also disclosed.

1 . A non-compliant medical balloon for performing an angioplasty, comprising:
 a body including a non-compliant wall having an inner layer, an outer layer, and a discrete, intermediate layer at least partially between the inner and outer layer, at least the intermediate layer comprising a film including a radiopaque material,   wherein the film is provided on a selected portion of the balloon and   wherein the film has a first radiographic quality, and further including a second radiopaque material having a second radiographic quality different to the first radiographic quality applied to a second portion of the balloon different from the first portion of the balloon and incorporated in a second film.   
     
     
         2 . The balloon of  claim 1 , further including an adhesive for laminating the film to the inner or outer layer. 
     
     
         3 . The balloon of  claim 1 , wherein the radiopaque material comprises a metal. 
     
     
         4 . The balloon of  claim 1 , wherein the radiopaque material is selected from the group consisting of silver, platinum, gold, tin, indium, zirconium, bismuth, lead, cerium, rare earth metals, or alloys containing these elements. 
     
     
         5 . The balloon of  claim 1 , wherein the film comprises a polymer in which the radiopaque material is dispersed. 
     
     
         6 . The balloon of  claim 1 , wherein the outer layer comprises a thermoplastic film. 
     
     
         7 . The balloon of  claim 1 , wherein the outer layer comprises a thermoset film. 
     
     
         8 . The balloon of  claim 1 , wherein the outer layer comprises a thermoplastic material applied as a solution or dispersion. 
     
     
         9 . The balloon of  claim 1 , wherein the outer layer comprises a thermoset material applied as a solution or dispersion. 
     
     
         10 . The balloon of  claim 1 , wherein the selected portion is a cylindrical barrel portion of the balloon. 
     
     
         11 . The balloon of  claim 1 , wherein the selected portion is a conical portion of the balloon. 
     
     
         12 . The balloon of  claim 2 , wherein the first film comprises a strip of film. 
     
     
         13 . The balloon of  claim 1 , wherein the first radiopaque material is present in an amount of up to 65% by weight. 
     
     
         14 . The balloon of  claim 1 , wherein the first radiopaque material is present in an amount of about 50% by weight. 
     
     
         15 . The balloon of  claim 1 , wherein the second radiopaque material is present in an amount of up to 65% by weight. 
     
     
         16 . The balloon of  claim 1 , wherein the second radiopaque material is present in an amount of about 43% by weight. 
     
     
         17 . The balloon of  claim 1 , further including a third radiopaque material applied to the balloon. 
     
     
         18 . The balloon of  claim 17 , wherein the third radiopaque material is applied to the first and second portions of the balloon. 
     
     
         19 . The balloon of  claim 1 , wherein one or more of the layers includes a fiber.