Devices for material delivery, electroporation, sonoporation, and/or monitoring electrophysiological activity

Abstract

The invention relates generally to systems and devices for material delivery, energy delivery, and/or monitoring electrophysiological activity, and method of use thereof. In particular, the present invention provides devices and systems, and methods of use thereof, configured to deliver therapeutic compositions, to provide electroporation and/or sonoporation to increase therapeutic efficiency, and to monitor electrophysiological activity, for example, before and after treatment.

1 . A device comprising:
 a) an elongate member with an inner lumen, wherein said inner lumen is configured for delivery of a therapeutic agent to a treatment site within a subject;   b) an energy-delivery element, wherein said energy-delivery element is configured to deliver energy to said treatment site within a subject; and   c) an electrophysiology monitoring element, wherein said electrophysiology monitoring element is configured to monitor electrical signals.   
     
     
         2 . The device of  claim 1 , wherein said energy-delivery element is located at the distal tip of said elongate member. 
     
     
         3 . The device of  claim 2 , wherein said energy-delivery element comprises an electroporation element. 
     
     
         4 . The device of  claim 3 , wherein said electroporation element comprises a plurality of electroporation electrodes. 
     
     
         5 . The device of  claim 2 , wherein said energy-delivery element comprises a sonoporation element. 
     
     
         6 . The device of  claim 1 , wherein said electrophysiology monitoring element comprises a plurality of monitoring electrodes. 
     
     
         7 . The device of  claim 6 , wherein said plurality of monitoring electrodes comprises one or more distal monitoring electrodes and one or more proximal monitoring electrodes. 
     
     
         8 . The device of  claim 1 , further comprising a control handle, wherein said control handle is located at the proximal end of said device. 
     
     
         9 . The device of  claim 8 , wherein said handle comprises one or more control elements. 
     
     
         10 . The device of  claim 8 , wherein said handle comprises one or more injection ports, wherein said injection ports are in fluid communication with said inner lumen. 
     
     
         11 . The device of  claim 8 , wherein said one or more injection ports are configured for the loading therapeutic agents into said inner lumen of said elongate member. 
     
     
         12 . The device of  claim 1 , further comprising an inflatable and deflatable balloon element located at the distal tip of said elongate member. 
     
     
         13 . The device of  claim 12 , wherein said energy-delivery element is located on said balloon element. 
     
     
         14 . The device of  claim 12 , wherein said electrophysiology monitoring element is located on said balloon element. 
     
     
         15 . A method of treating a disease or condition in a subject comprising:
 a) inserting a catheter into said subject and placing the distal end of said catheter at a treatment site;   b) delivering a therapeutic agent to said treatment site through the lumen of said catheter;   c) electroporating or sonoporating said treatment site with electrodes located on the distal end of said catheter.   
     
     
         16 . The method of  claim 15 , further comprising an initial step of monitoring or recording electrical signals at said treatment site with an electrophysiology monitoring element of said catheter. 
     
     
         17 . The method of  claim 16 , further comprising:
 (d) recording electrical signals at said treatment site with an electrophysiology monitoring element of said catheter.   
     
     
         18 . The method of  claim 17 , further comprising:
 (e) comparing electrical signals from said initial step with electrical signals of step (d).   
     
     
         19 . The method of  claim 18 , further comprising:
 (f) determining the effectiveness of said treating based on comparison of said electrical signals from said initial step with electrical signals of step (d).   
     
     
         20 . The method of  claim 15 , wherein said therapeutic agent comprises one or more gene therapy reagents.