Balloon assemblies having controllably variable topographies

Abstract

Various embodiments provide a device comprising a balloon assembly including a balloon, a film template, and a rigid element. The film template may have a fixed upper distension limit and may include at least one aperture. The rigid element may lay substantially flush with an outer surface of the balloon at a first inflated state of the balloon. The first upper distension limit of the balloon may be greater than the fixed upper distension limit of the film template and the balloon may outwardly protrude through the at least one aperture at a second inflated state. The rigid element may be extended in a radial direction away from the outer surface of the balloon as the balloon outwardly protrudes through the at least one aperture relative to the outer surface of the film template.

What is claimed is: 
     
         1 . A medical balloon comprising
 an inflatable balloon element;   a template having an outer surface and extending along at least a portion of the inflatable balloon element for at least a portion of its length and having an first distension profile and a second distension profile;   wherein the template includes at least one aperture,   wherein the inflatable balloon element outwardly extends about the at least one aperture relative to the outer surface of the template when inflated to the first distention profile, and   wherein the inflatable balloon element forms a relatively smooth surface about the at least one aperture relative to the outer surface of the film template when inflated to the second distention profile.   
     
     
         2 . The medical balloon of  claim 1 , wherein the template comprises a first nominal size at the first distention profile and a second nominal size at the second distension profile, wherein the the first nominal size is less than the second nominal size. 
     
     
         3 . The medical balloon of  claim 2 , wherein when the inflatable balloon element is inflated to a first pressure, the template is at a first distension pressure and when the inflatable balloon element is inflated to a second pressure, the template is at a second distension profile. 
     
     
         4 . The medical balloon of  claim 1 , wherein the inflatable balloon element is size limited. 
     
     
         5 . The medical balloon of  claim 4 , wherein the inflatable balloon element is strained during inflation. 
     
     
         6 . The assembly of  claim 1 , wherein inflatable balloon comprises a size limiting layer. 
     
     
         7 . The assembly of  claim 4 , wherein the size limiting layer comprises at least two layers of a helically wrapped polymeric tape. 
     
     
         8 . The assembly of  claim 1 , further comprising a therapeutic agent underlying the film template, wherein at least a portion of the therapeutic agent is conveyed out of at least one aperture upon the balloon extending through the aperture. 
     
     
         9 . The assembly of  claim 1 , wherein the film template comprises a rigid element. 
     
     
         10 . The assembly of  claim 9 , wherein the inflatable balloon element outwardly rotates the rigid element during inflation. 
     
     
         11 . The assembly of  claim 1 , wherein the inflatable balloon element is configured to perfuse. 
     
     
         12 . The assembly of  claim 1 , wherein the template comprises a high-strength ePTFE.