Single piece double wall dilation balloon catheter

Abstract

The present invention relates to medical devices for dilating or enlarging strictures or narrowed regions of body vessels. Specifically, the present invention relates to a high pressure dilation balloon catheter that includes an elongate shaft extending between a proximal end and a distal end, the proximal end being adapted for attachment to a source of inflation fluid, and a lumen extending through the shaft adapted for the passage of the inflation fluid; and a balloon disposed on the distal end of the shaft and having a balloon body extending between a proximal end and a distal end of the balloon. The balloon body includes a first layer, a second layer disposed about at least a portion of the first layer, a plurality of longitudinally extending rib members disposed between the first and the second layers and configured to form a plurality of sealed cavities between the first and the second layers; and a balloon chamber within the first layer, the balloon chamber being in a communication with the lumen of the shaft for inflating and deflating the balloon.

1 . A dilation balloon catheter comprising:
 an elongate shaft extending between a proximal end and a distal end, the proximal end being adapted for attachment to a source of inflation fluid, and a lumen extending through the shaft adapted for the passage of the inflation fluid;   a balloon disposed on the distal end of the shaft and having a balloon body extending between a proximal end and a distal end of the balloon, the balloon body comprising:
 a first layer, 
 a second layer disposed about at least a portion of the first layer, 
 a plurality of longitudinally extending rib members disposed between the first and the second layers and configured to form a plurality of sealed cavities between the first and the second layers, and 
 a balloon chamber within the first layer, the balloon chamber being in a communication with the lumen of the shaft for inflating and deflating the balloon. 
   
     
     
         2 . The dilation balloon catheter of  claim 1 , wherein the first layer, the second layer and the rib members are formed from a single piece of a substantially non-compliant non-porous elastomeric material. 
     
     
         3 . The dilation balloon catheter of  claim 2 , wherein the substantially non-porous elastomeric material is selected from the group consisting of Nylon (Nylon 12), polyether block amide (PEBAX), PEBAX 4033, PEBAX 5533, PEBAX 6333, and poly(ethylene terephthalate) (PET). 
     
     
         4 . The dilation balloon catheter of  claim 1 , wherein the balloon has a predetermined inflated diameter anywhere in the range of from about 2 millimeters to about 30 millimeters. 
     
     
         5 . The dilation balloon catheter of  claim 1 , wherein the first layer has thickness from about 0.014 millimeters to about 0.060 millimeters. 
     
     
         6 . The dilation balloon catheter of  claim 1 , wherein the second layer has thickness from about 0.008 millimeters to about 0.047 millimeters. 
     
     
         7 . The dilation balloon catheter of  claim 1 , wherein the proximal and the distal ends of the balloon body are each tapered. 
     
     
         8 . The dilation balloon catheter of  claim 1 , wherein the balloon body comprises from 2 to 5 rib members circumferentially disposed about the first layer of the balloon body. 
     
     
         9 . The dilation balloon catheter of  claim 1 , wherein the rib members longitudinally extend though the entire length of the balloon body. 
     
     
         10 . The dilation balloon catheter of  claim 1 , further comprising a lubricant disposed in each of the cavities. 
     
     
         11 . The dilation balloon catheter of  claim 10 , wherein the lubricant is silicone. 
     
     
         12 . The dilation balloon catheter of  claim 1 , wherein the first and the second layers comprise different materials. 
     
     
         13 . The dilation balloon catheter of  claim 1 , wherein the first and the second layers comprise different thicknesses. 
     
     
         14 . The dilation balloon catheter of  claim 1 , wherein the balloon is configured to exert an outward pressure of from about 12 atmospheres to about 30 atmospheres when inflated. 
     
     
         15 . The dilation balloon catheter of  claim 1 , wherein the shaft further comprises a wireguide lumen extending through at least a portion thereof. 
     
     
         16 . The dilation balloon catheter of  claim 15 , wherein the wireguide lumen is disposed adjacent to the lumen of the shaft. 
     
     
         17 . The dilation balloon catheter of  claim 16 , wherein the wireguide lumen extends through a substantial portion of the shaft and terminates in a proximal port near the proximal end of the shaft. 
     
     
         18 . The dilation balloon catheter of  claim 15 , wherein the shaft comprises a port through a side wall thereof in communication with the wireguide lumen, the port being located proximal of the balloon and a substantial distance from the proximal end of the shaft. 
     
     
         19 . The dilation balloon catheter of  claim 15 , wherein the wireguide lumen is coaxially disposed within the lumen of the shaft. 
     
     
         20 . The dilation balloon catheter of  claim 1 , wherein the rib members have height from about 0.03 millimeters to about 0.50 millimeters. 
     
     
         21 . The dilation balloon catheter of  claim 1 , wherein the rib members have a substantially uniform cross-sectional profile. 
     
     
         22 . The dilation balloon catheter of  claim 1 , wherein the rib members have a non-uniform cross-sectional profile. 
     
     
         23 . A method for dilating a vessel stricture comprising:
 providing the dilation balloon catheter of  claim 1 ;   positioning the balloon within or near the vessel stricture; and   inflating the balloon to dilate or widen the vessel stricture.   
     
     
         24 . The method of  claim 23 , further comprising the steps of:
 providing a stent;   compressing the stent about the balloon when the balloon is in an uninflated state; and
 expanding the balloon to expand and deploy the stent.