Medical balloon having strengthening rods

Abstract

A non-compliant medical balloon may be changed from a deflated state to an inflated state by increasing the internal pressure within the balloon. The balloon comprises a balloon layer having an outer surface, the balloon layer including a base layer, a first reinforcing layer and a second reinforcing layer. The base layer is formed of a polymer material. The first reinforcing layer is one of either a plurality of discrete inelastic fibers oriented substantially parallel to the long axis of the balloon and a first layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. The second reinforcing layer is one of either at least one inelastic fiber wrapped around the circumference of the balloon substantially transverse to the long axis of the balloon and a second layer of textile fabric material, the textile fabric material being one of a woven, knitted, braided and non-woven fabric. At least one of the first and second reinforcing layers is a layer of textile fabric material. At least one strengthening rod is connected to the outer surface of the balloon layer.

1 . A non-compliant medical balloon, comprising:
 a base balloon;   a fiber layer comprising a plurality of substantially inelastic fibers applied to the base balloon;   a polymeric coating applied to the fiber layer; and   a protective covering for the outer polymeric coating.   
     
     
         2 . The balloon of  claim 1 , wherein the protective covering comprises a final layer. 
     
     
         3 . The balloon of  claim 1 , wherein the protective covering comprises a film. 
     
     
         4 . The balloon of  claim 1 , wherein the protective covering comprises a spray coating. 
     
     
         5 . The balloon of  claim 1 , wherein the plurality of substantially inelastic fibers comprise substantially parallel fibers. 
     
     
         6 . The balloon of  claim 5 , wherein the plurality of substantially inelastic fibers further comprise hoop fibers. 
     
     
         7 . The balloon of  claim 1 , wherein the plurality of substantially inelastic fibers comprise a plurality of hoop fibers. 
     
     
         8 . The balloon of  claim 1 , wherein the plurality of substantially inelastic fibers are substantially parallel to a longitudinal axis of the balloon. 
     
     
         9 . The balloon of  claim 1 , wherein the balloon comprises a cylindrical barrel section with a first diameter, two conical sections adjoining the cylindrical barrel section, and two cylindrical end sections, each with a second diameter smaller than the first diameter. 
     
     
         10 . The balloon of  claim 1 , wherein the fibers comprise a polymer from the following materials: cellulosic polymers, proteins, polyamides, polyester (PET), olefins, vinyls, acrylics, polytetrafluoroethylene (PTFE), polyphenylene sulfide (PPS), aramids, and polyurethanes. 
     
     
         11 . The balloon of  claim 1 , wherein the polymeric coating comprises a polymer or copolymer selected from the following materials: polyethylene, nylons, polyethylene terephthalate (PET), polycaprolactam, polyesters, polyethers, polyamides, polyurethanes, polyimides, ABS copolymers, polyester/polyether block copolymers, ionomer resins, liquid crystal polymers, and rigid rod polymers. 
     
     
         12 . A non-compliant medical balloon, comprising:
 a base balloon;   a fiber layer comprising a plurality of substantially inelastic fibers over the base balloon;   a polymeric coating for the fiber layer; and   a final covering over the polymeric coating.   
     
     
         13 . The balloon of  claim 12 , wherein the final covering comprises a film. 
     
     
         14 . The balloon of  claim 12 , wherein the plurality of substantially inelastic fibers comprise substantially parallel fibers. 
     
     
         15 . The balloon of  claim 12 , wherein the plurality of substantially inelastic fibers comprise longitudinal fibers. 
     
     
         16 . The balloon of  claim 12 , wherein the plurality of substantially inelastic fibers comprise hoop fibers. 
     
     
         17 . The balloon of  claim 12 , wherein the fiber layer comprises a woven layer. 
     
     
         18 . A non-compliant medical balloon, comprising:
 a base balloon;   a fabric layer comprising a plurality of substantially inelastic fibers over the base balloon;   a polymeric coating for the fabric layer; and   a final covering over the polymeric coating.   
     
     
         19 . The balloon of  claim 18 , wherein the plurality of substantially inelastic fibers comprise first fibers extending in a direction parallel to a longitudinal axis of the base balloon and second fibers extending in a direction transverse to a longitudinal axis of the base balloon. 
     
     
         20 . The balloon of  claim 19 , wherein the first fibers and second fibers are interwoven. 
     
     
         21 . A method of forming a non-compliant medical balloon, comprising:
 providing a polymer base layer in the shape of an inflated medical balloon having a long axis and a circumference;   applying an adhesive to the base layer;   forming an inelastic-fiber-containing first fiber layer over the base layer wherein the first fiber layer comprises a woven, knitted, braided, or non-woven fabric and the layer is at least partially held in place by the adhesive layer applied to the base layer;   providing a protective covering over the inelastic-fiber-containing first fiber layer;   
       wherein
 the medical balloon may transition from deflated to inflated by increasing the medical balloon's internal pressure, 
 and 
 the length and diameter of a fully inflated medical balloon do not substantially change upon further pressure increases. 
 
     
     
         22 . The method of  claim 21  further comprising applying a polymer solution to the first fiber layer to form a first reinforcing layer. 
     
     
         23 . The method of  claim 22  further comprising
 forming an inelastic-fiber-containing second fiber layer over at least part of the first reinforcing layer 
 and 
 applying a polymer solution to the second fiber layer to form a second reinforcing layer. 
 
     
     
         24 . The method of  claim 22  wherein the first-layer inelastic fiber lies substantially parallel to a longitudinal axis of the medical balloon. 
     
     
         25 . The method of  claim 23  wherein the second layer fiber lies substantially circumferentially to the medical balloon. 
     
     
         26 . The method of  claim 22  wherein the first layer fiber is substantially oblique to a longitudinal axis of the non-compliant medical balloon. 
     
     
         27 . The method of  claim 21  wherein the fabric comprises at least two inelastic fibers woven or braided together and wherein both of the fibers lie substantially oblique to the longitudinal axis. 
     
     
         28 . The method of  claim 22  wherein the second layer fiber is substantially oblique to a longitudinal axis of the medical balloon. 
     
     
         29 . The method of  claim 22  wherein the second layer fiber lies substantially circumferentially to the balloon. 
     
     
         30 . The method of  claim 21  further comprising:
 forming an inelastic-fiber-containing second fiber layer over at least part of the first fiber layer; 
 and 
 applying a polymer solution to the first and second fiber layers to form first and second reinforcing layers. 
 
     
     
         31 . The method of  claim 21  wherein the first-layer inelastic fiber lies substantially parallel to a longitudinal axis of the medical balloon. 
     
     
         32 . The method of  claim 21  wherein the second layer fiber lies substantially circumferentially to the medical balloon. 
     
     
         33 . The method of  claim 21  wherein forming a base layer comprises applying a polymer in liquid form over a mandrel having the shape desired for the inflated medical balloon; and curing the polymer into a solid form having the shape of the mandrel.