Expandable fluoropolymer device for delivery of therapeutic agents and method of making

Abstract

A method of making a radially expandable fluid delivery device includes providing a tube of biocompatible fluoropolymer material with a predetermined porosity based on an extrusion and expansion forming process, applying a radial expansion force to the tube expanding the tube to a predetermined diameter dimension, and removing the radial expansion force. The tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force, such that the expanded configuration occurs upon inflation to the predetermined diameter dimension. The fluid delivery device is constructed of a microporous, biocompatible fluoropolymer material having a microstructure that can provide a controlled, uniform, low-velocity fluid distribution through the walls of the fluid delivery device to effectively deliver fluid to the treatment site without damaging tissue proximate the walls of the device.

Having described the invention, what is claimed as new and desired to be secured by Letters Patent is: 
     
         1 - 20 . (canceled) 
     
     
         21 . A method of delivering one or more therapeutic agents to a body passage or location in need of treatment, comprising the steps of:
 substantially controlling permeation of fluid through a wall of a radially expandable fluid delivery device by predetermining porosity of the wall, wherein the wall has at least one microporous portion comprising micro-channels so the wall has a porosity sufficient for a fluid to expand the fluid delivery device and permeate through the micro-channels;   locating the radially expandable fluid delivery device within a body passage or a location in need of treatment; and   expanding the radially expandable fluid delivery device with a fluid containing the one or more therapeutic agents so that the fluid containing the one or more therapeutic agents is delivered through the micro-channels of the wall of the radially expandable fluid delivery device to the body passage or location.   
     
     
         22 . The method according to  claim 21 , wherein the expansion of the radially expandable fluid device with the fluid containing the one or more therapeutic agents includes radial expansion of the fluid delivery device. 
     
     
         23 . A method of manufacturing a radially expandable fluid delivery device, comprising the steps of:
 applying a radial expansion force to a tube so as to expand the tube to a predetermined diameter dimension, wherein the tube comprises a biocompatible fluoropolymer material having a microstructure of nodes interconnected by fibrils, wherein the microstructure has a predetermined porosity based on an extrusion and expansion forming process; and   removing the radial expansion force,   wherein the tube is radially inelastic while sufficiently pliable to be collapsible and inflatable from a collapsed configuration to an expanded configuration upon introduction of an inflation force so that the expanded configuration occurs upon inflation to the predetermined diameter dimension.