Controlled porosity devices for tissue treatments, methods of use, and methods of manufacture

Abstract

In various embodiments, a device is provided comprising a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being the same or greater than the first pressure. In various embodiments, a method comprising fabricating a balloon configured to expand to an expanded state in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at or greater than the first pressure, disposing the balloon on an elongate member having a lumen, placing the lumen in fluid communication with an interior volume of the balloon.

1 . A method comprising:
 fabricating a balloon comprising a weeping control layer and a reinforcing layer and defining an interior volume, the balloon configured to expand to a nominal size in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon above a second pressure, the second pressure being at least one of equal to and greater than the first pressure;   disposing the balloon on an elongate member having a lumen; and   placing the interior volume of the balloon in fluid communication with the lumen.   
     
     
         2 . The method of  claim 1 , wherein the balloon minimally distends beyond the nominal size. 
     
     
         3 . The method of  claim 1 , wherein the balloon further comprises a seal layer. 
     
     
         4 . The method of  claim 1 , wherein fabricating the balloon comprises tape wrapping a first porous membrane to form the weeping control layer and tape wrapping a second porous membrane around at least a portion of the first porous membrane to form the reinforcing layer. 
     
     
         5 . The method of  claim 4 , wherein the weeping control layer and the reinforcing layer comprise ePTFE. 
     
     
         6 . The method of  claim 1 , wherein the first pressure is between at least 4 atm to about 50 atm. 
     
     
         7 . The method of  claim 1 , wherein the second pressure is about 13 atm. 
     
     
         8 . The method of  claim 1 , further comprising coating the weeping control layer with a therapeutic agent. 
     
     
         9 . A method of making a balloon catheter, the method comprising:
 associating a weeping control layer with a reinforcing layer; and   arranging the weeping control layer and the reinforcing layer to produce a balloon defining an interior volume, the balloon being configured to expand to a nominal size in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon at a second pressure that is greater than the first pressure.   
     
     
         10 . The method of  claim 9 , further comprising:
 disposing the balloon on an elongate member having a lumen; and   placing the interior volume of the balloon in fluid communication with the lumen.   
     
     
         11 . The method of  claim 9 , wherein the weeping control layer is disposed coaxially with the reinforcing layer. 
     
     
         12 . The method of  claim 9 , wherein the weeping control layer is comprised of a first material and the reinforcing layer is comprised of a second material. 
     
     
         13 . The method of  claim 12 , further comprising bringing the balloon to a temperature above the melting point of the first material and the second material after the weeping control layer and the reinforcing layer are arranged. 
     
     
         14 . The method of  claim 13 , wherein the weeping control layer and the reinforcing layer each maintain their respective microstructures. 
     
     
         15 . The method of  claim 12 , wherein the first material and the second material are the same material. 
     
     
         16 . The method of  claim 9 , wherein the weeping control layer and the reinforcing layer comprise different microstructures. 
     
     
         17 . The method of  claim 9 , wherein the weeping control layer and the reinforcing layer are permanently bonded. 
     
     
         18 . A method of fabricating a balloon, comprising:
 arranging a first layer comprising a first material and a second layer comprising a second material to produce a balloon defining an interior volume;   bonding the first layer and the second layer, the first layer and the second layer each maintaining their respective microstructure;   the balloon being configured to expand to a nominal size in response to introduction of a fluid at a first pressure, wherein the fluid perfuses through the balloon at a second pressure that is greater than the first pressure.   
     
     
         19 . The method of  claim 18 , further comprising arranging a third layer comprising a third material with the first layer and the second layer. 
     
     
         20 . The method of  claim 19 , wherein the first layer, the second layer, and the third layer each maintain a microstructure independent of each other.