Composite Balloon

Abstract

A reinforced composite balloon may comprise a body layer and a reinforcing layer. The reinforcing layer may comprise a single-layer structural network having a plurality of apertures. The reinforcing layer may be molded from a reinforcing tube having a plurality of apertures or aperture precursor holes.

1 . A catheter comprising:
 a catheter shaft and a balloon; the balloon comprising a proximal cone portion, a distal cone portion and a body portion; the balloon further comprising a first layer and a second layer, the second layer having a radial dimension oriented in a radial direction of the balloon; the second layer having a plurality of perforations extending radially into the second layer.   
     
     
         2 . The catheter of  claim 1 , wherein a plurality of perforations each comprise a shape having continuous curvature. 
     
     
         3 . The catheter of  claim 1 , wherein a plurality of perforations located in said balloon body portion comprise a similar shape. 
     
     
         4 . The catheter of  claim 1 , wherein the second layer comprises a material having a higher yield strength than the first layer. 
     
     
         5 . The catheter of  claim 1 , comprising a first perforation of a first shape and a second perforation of a second shape that is different from the first shape, the first perforation and the second perforation located in the balloon body portion. 
     
     
         6 . The catheter of  claim 1 , wherein the second layer is oriented about the body layer. 
     
     
         7 . The catheter of  claim 6 , wherein the perforations extend into the second layer from an outer surface of the balloon. 
     
     
         8 . The catheter of  claim 1 , wherein the first layer and the second layer are biaxially oriented. 
     
     
         9 . The catheter of  claim 1 , wherein the first layer is oriented about the second layer. 
     
     
         10 . The catheter of  claim 9 , wherein the perforations extend from an inner surface of the first layer into the second layer. 
     
     
         11 . The catheter of  claim 1 , wherein the second layer further comprises a plurality of apertures, each aperture extending through the radial dimension of the second layer. 
     
     
         12 . The catheter of  claim 1 , comprising a cavity in the second layer. 
     
     
         13 . The catheter of  claim 1 , wherein said second layer comprises at least one slit located in the proximal cone portion. 
     
     
         14 . The catheter of  claim 1 , wherein a plurality of said perforations are oriented such that at least a portion of said second layer abuts a side portion of a stent. 
     
     
         15 . The catheter of  claim 1 , further comprising a drug coating, wherein a portion of the drug coating is oriented within a perforation. 
     
     
         16 . The catheter of  claim 1 , wherein a plurality of perforations of the second layer located in said body portion are aligned in a circumferential direction of the balloon. 
     
     
         17 . The catheter of  claim 16 , wherein a second plurality of perforations of the second layer located in said body portion are aligned in a circumferential direction of the balloon; the first plurality of perforations being circumferentially offset from the second plurality of perforations. 
     
     
         18 . The catheter of  claim 1 , formed by a process comprising:
 providing a perforated tube;   providing a parison;   orienting the perforated tube and parison coaxially to form a balloon preform and orienting the balloon preform within a mold; and   molding said balloon preform to form a composite balloon.   
     
     
         19 . A catheter comprising:
 a catheter shaft and a balloon; the balloon comprising a proximal cone, a distal cone and a body portion; the balloon further comprising a first layer and a second layer; the second layer oriented about the body layer; the second layer comprising a single layer network of reinforcing material having a plurality of apertures.   
     
     
         20 . The catheter of  claim 20 , wherein the first and second layers are biaxially oriented.