Catheter Balloon Drug Adherence Techniques and Methods

Abstract

Various methods for optimizing coating of medical devices, such as balloon catheters are disclosed. One method configures catheter balloon folds based on balloon diameter and volume. Other methods include using a specifically-sized protective sheath, using a vacuum, using pressure, pulling the balloon through a coating solution, using at least one spacer or a wick between at least one fold for metering a therapeutic coating into the folds of the balloon, placing an intermediate layer between the balloon and the therapeutic coating, placing a soluble film having a therapeutic agent around the catheter balloon or inside the folds, and any combination thereof. Balloon catheters and catheter balloons having a specific folding configuration, a specifically-sized protective sheath, an intermediate layer, or a soluble film are also disclosed.

1 - 46 . (canceled) 
     
     
         47 . A catheter balloon comprising an intermediate layer between said catheter balloon and a therapeutic coating. 
     
     
         48 . The catheter balloon of  claim 47 , wherein the intermediate layer is selected from the group consisting of Teflon, PET, PP, Pebax, Urethane, and Nylon. 
     
     
         49 . A method of coating a catheter balloon with a therapeutic agent, said method comprising placing an intermediate layer between said balloon and said therapeutic agent. 
     
     
         50 . The method of  claim 49 , wherein the step of placing comprises extruding a thin, second layer of material onto a balloon tubing before said catheter balloon is formed. 
     
     
         51 . The method of  claim 49 , wherein the step of placing comprises adhesively bonding said intermediate layer to said catheter balloon after extrusion of said catheter balloon but before folding and heat setting of said catheter balloon. 
     
     
         52 . The method of  claim 49 , wherein the step of placing comprises plasma depositing said intermediate layer. 
     
     
         53 . The method of claim of  claim 49 , wherein the intermediate layer is selected from the group consisting of Teflon, PET, PP, Pebax, Urethane, and Nylon. 
     
     
         54 - 69 . (canceled) 
     
     
         70 . The catheter balloon of  claim 47 , wherein said therapeutic agent is a restenosis-inhibiting agent. 
     
     
         71 . The catheter balloon of  claim 70 , wherein said therapeutic agent is paclitaxel. 
     
     
         72 . The catheter balloon of  claim 47  which is a folded balloon. 
     
     
         73 . The catheter balloon of  claim 47 , wherein the folded catheter balloon has a specific diameter, wherein said catheter balloon has a specific number of folds with a predetermined volume and shape. 
     
     
         74 . The catheter balloon of  claim 73 , wherein said predetermined volume and shape are determined by a fold depth and a fold width. 
     
     
         75 . The catheter balloon of  claim 74 , wherein said fold depth is about 1.5 millimeters ±50%. 
     
     
         76 . The catheter balloon of  claim 74 , wherein said fold width is about 0.11 millimeters ±100%. 
     
     
         77 . The method of coating a catheter balloon of  claim 49 , wherein said therapeutic agent is a restenosis-inhibiting agent. 
     
     
         78 . The method of coating a catheter balloon of  claim 77 , wherein said therapeutic agent is paclitaxel. 
     
     
         79 . The method of coating a catheter balloon of  claim 49 , wherein the catether balloon is a folded balloon.