Medical balloon and balloon catheter assembly

Abstract

A medical balloon of a balloon catheter assembly includes a balloon wall formed of at least two layers. The first layer is made of an impervious polymeric material. The second layer, which is integral with the first layer is made of a radiopaque and/or echogenic material and a polymeric material. In the preferred embodiment, there is provided 60 to 80% by weight of radiopaque material in the second layer. It has been found that these concentrations of radiopaque material provide good visibility of the balloon under ultrasonic imaging.

1 . A method of manufacturing a medical balloon for endoluminal location within a patient, the balloon including a first balloon layer made of impervious polymeric material, and a second balloon layer integral with the first balloon layer, which second balloon layer includes a combination of radiopaque and/or echogenic material and polymeric material, whereby the medical balloon is echogenic and/or radiopaque, the method comprising:
 coextruding the first and second balloon layers.   
     
     
         2 . The medical balloon according to  claim 1 , wherein the first balloon layer is made solely of polymeric material. 
     
     
         3 . The medical balloon according to  claim 1 , wherein the second balloon layer is coextruded with the first balloon layer. 
     
     
         4 . The medical balloon according to  claim 1 , wherein the second balloon layer is disposed concentrically within the first balloon layer. 
     
     
         5 . A medical balloon according to  claim 1 , wherein the second balloon layer overlies the first balloon layer. 
     
     
         6 . A medical balloon according to  claim 5 , including a third balloon layer overlying the second balloon layer. 
     
     
         7 . A medical balloon according to  claim 6 , wherein the third balloon layer is made from the same polymeric material as the first balloon layer. 
     
     
         8 . The medical balloon according to  claim 1 , wherein the polymeric materials of the first and second balloon layers are the same. 
     
     
         9 . The medical balloon according to  claim 1 , wherein the polymeric materials of the first and second balloon layers are different. 
     
     
         10 . A medical balloon for endoluminal location within a patient, the balloon including a first, inner balloon layer consisting of impervious polymeric material, a second, middle balloon layer integrally coextruded with the first balloon layer, and a third, outer balloon layer integrally coextruded with the second balloon layer and consisting of polymeric material, which second balloon layer includes a combination of radiopaque and/or echogenic material and polymeric material, the polymeric material of the first balloon layer and the polymeric material of the second balloon layer mixing at the boundary between the first balloon layer and the second balloon layer, the second balloon layer including between 60 and 80% by weight or radiopaque and/or echogenic material, whereby the medical balloon is echogenic and/or radiopaque,
 wherein the third balloon layer consists of the same polymeric material as the first balloon layer and as the polymeric material of the second balloon layer;   wherein the third balloon layer is made from the polymeric material as the first balloon layer.   
     
     
         11 . The medical balloon according to  claim 10 , wherein the third balloon layer is made solely of polymeric material. 
     
     
         12 . The medical balloon according to  claim 10 , wherein the third balloon layer is made of material that is not impervious. 
     
     
         13 . The medical balloon according to  claim 10 , wherein the first balloon layer and the third balloon layer have different polymeric material.