Coated balloons for blood vessel stabilization

Abstract

A coated balloon device for stabilizing a section of a blood vessel in a living subject is disclosed. The coating layer of the coated balloon comprises a phenolic compound having a plurality of phenolic groups connected to form a hydrophobic core with peripheral phenolic hydroxyl groups. The coating layer of the coated balloon may contain a hydrophilic polymer to facilitate the release of the phenolic compound. The balloon in general is made of a compliant polymer for atraumatic contact with the blood vessel. In some embodiments, the coating of the coated balloon device further comprises a hydrophilic undercoat layer between the balloon and the coating layer. In some embodiments, the coated balloon device further comprises a sacrificial top coating that dissolves upon delivery into the section of the blood vessel and comprises a hydrophilic composition including sugar, sugar derivatives, or a combination thereof.

1 - 49 . (canceled) 
     
     
         50 . A device for treating an aneurism in a blood vessel, the device comprising:
 a shaft having a proximal end and a distal end;   a dual layer balloon supported by the shaft at or near the distal end of the shaft, the dual layer balloon comprising:
 an inner balloon element comprising an inflatable structure and 
 an outer balloon element annularly surrounding the inner balloon element, wherein the outer balloon element comprises a fenestrated expandable material having a plurality of fenestrations; and 
   a therapeutic composition disposed between the inner balloon element and the outer balloon element,   wherein a portion of the outer balloon element is configured to form a tight fluid seal with the blood vessel.   
     
     
         51 . The device of  claim 50 , wherein the dual layer balloon comprises an un-inflated configuration and an expanded configuration. 
     
     
         52 . The device of  claim 51 , wherein the therapeutic composition is configured to be released through the plurality of fenestrations as the dual layer balloon moves from the un-inflated configuration to the expanded configuration. 
     
     
         53 . The device of  claim 50 , wherein the therapeutic composition comprises an elastin stabilization agent. 
     
     
         54 . The device of  claim 53 , wherein the elastin stabilization agent is a phenolic compound. 
     
     
         55 . The device of  claim 54 , wherein the phenolic compound is pentagalloylglucose. 
     
     
         56 . The device of  claim 55 , wherein the therapeutic composition comprises no more than about 5 wt. % unbound gallic acid. 
     
     
         57 . The device of  claim 55 , wherein the pentagalloylglucose is essentially pure. 
     
     
         58 . The device of  claim 50 , wherein the fenestrations comprise pores. 
     
     
         59 . The device of  claim 58 , wherein the pores are smaller when the dual layer balloon is in the un-inflated configuration than when the dual layer balloon is in the expanded configuration. 
     
     
         60 . The device of  claim 50 , wherein the shaft comprises a catheter in fluid communication with the inner balloon and wherein the inner balloon is inflated from the un-inflated configuration to the expanded configuration by injecting an expansion fluid into the catheter. 
     
     
         61 . The device of  claim 50 , wherein the dual layer balloon essentially completely occludes blood flow through a blood vessel when the dual layer balloon is disposed within the blood vessel and the dual layer balloon is in the expanded configuration. 
     
     
         62 . A method for treating an aneurism comprising:
 inserting a device into a blood vessel, the device comprising:
 a catheter having a proximal end and a distal end; 
 a dual layer balloon supported by the shaft at or near the distal end of the catheter, the dual layer balloon comprising:
 an inner balloon element comprising an inflatable structure and 
 an outer balloon element annularly surrounding the inner balloon element, wherein the outer balloon element comprises a fenestrated expandable material having a plurality of fenestrations, and wherein the catheter is in fluid communication with the inner balloon element; and 
 
 a therapeutic composition disposed between the inner balloon element and the outer balloon element; and 
   introducing an expansion fluid into the catheter to inflate the inner balloon element to a configuration in which at least a portion of the balloon forms a tight fluid seal with the blood vessel.   
     
     
         63 . The method of  claim 62 , wherein the therapeutic composition is delivered to the blood vessel when the expansion fluid is introduced into the catheter. 
     
     
         64 . The method of  claim 62 , wherein the dual layer balloon essentially completely occludes blood flow through the blood vessel when the dual layer balloon is in the expanded configuration. 
     
     
         65 . The method of  claim 62 , wherein the therapeutic composition is pentagalloylglucose. 
     
     
         66 . The method of  claim 65 , wherein the therapeutic composition comprises no more than about 5 wt. % unbound gallic acid. 
     
     
         67 . The method of  claim 65 , wherein the pentagalloylglucose is essentially pure. 
     
     
         68 . A method for treating an aneurism comprising:
 inserting a device into a blood vessel, the device comprising:
 a shaft having a proximal and a distal end; 
 a first balloon element comprising an inflatable structure, wherein the first balloon element is supported by the shaft at or near the distal end of the shaft; and 
 a second balloon element comprising an inflatable structure, wherein the second balloon element is supported by the shaft at or near the proximal end of the shaft; 
   inflating the first balloon element to form a distal seal with the blood vessel and inflating the second balloon element to form a proximal seal with the blood vessel so as to occlude blood flow to the portion of the blood vessel between the distal and proximal seals; and   delivering a therapeutic composition from a balloon element into the blood vessel between the distal and proximal seals.   
     
     
         69 . The method of  claim 68 , wherein the therapeutic composition is an elastin stabilization agent.