Contactless electropermeabilization electrode and method

Abstract

Devices and methods for delivering an electropermeabilizing pulse of electric energy to a tissue surface to enable delivery into cells in the tissue therapeutic substances. The device incorporates a source capable of generating a sufficient voltage potential to deliver a spark across a gap and delivers same to the tissue surface.

What is claimed is: 
     
         1 . A method of enabling the delivery of therapeutic substances into cells of tissue of a mammal by using a spark electropermeabilizing device to deliver an electropermeabilizing electric voltage potential to the surface of a mammalian tissue, comprising:
 generating a voltage potential sufficient to jump a gap of predetermined distance;   delivering said generated voltage potential in the form of a spark that can jump said gap to the surface of the mammalian tissue without causing macroscopic damage to an integrity of the surface of the mammalian tissue; and   delivering the therapeutic substances to cells within the mammalian tissue.   
     
     
         2 . The method of  claim 1 , wherein the delivering step comprises:
 delivering the voltage potential across a spark-gap regulator having a space gap; wherein the spaced gap is the gap of predetermined distance.   
     
     
         3 . The method of  claim 1 , wherein the generated voltage potential is from 0.9 kV to 109 kV. 
     
     
         4 . The method of  claim 1 , wherein the delivered voltage potential further comprises a total electric charge of about between 2.8×10E-8 and 2.5×10E-6 Coulombs. 
     
     
         5 . The method of  claim 1 , wherein the delivered voltage potential imparts a total energy to the surface of a mammalian tissue about between 0.000025 and 0.27 Joules. 
     
     
         6 . The method of  claim 1 , wherein the delivered voltage potential has a pulse length of about between 5 nanoseconds and 5 microseconds. 
     
     
         7 . The method of  claim 1 , wherein the delivering step is repeated a multiplicity of times between 2 and 20 pulses. 
     
     
         8 . The method of  claim 1 , wherein the therapeutic substance comprises a polynucleotide encoding an expressible polypeptide. 
     
     
         9 . The method of  claim 1 , wherein the therapeutic substance comprises a polypeptide. 
     
     
         10 . The method of  claim 1 , wherein the energy source of the electric voltage potential is selected from one of a 1, 3, 9 or 12V battery, a piezoelectric crystal, a charged induction coil, a van de Graaff generator, and a charged capacitor. 
     
     
         11 . The method of  claim 2 , further comprising:
 discharging from the electrode directly to the surface of the mammalian tissue.   
     
     
         12 . The method of  claim 2 , further comprising:
 providing the spark-gap regulator having a housing comprising an electrically inert material;   providing a supply electric lead and a receiving electric lead that are each placed within the housing and that are electrically isolated from one another;   providing a space gap between the supply electric lead and the receiving electric lead inside the housing; and   adjusting an atmospheric pressure in the housing to a predetermined value.   
     
     
         13 . The method of  claim 12 , wherein the space gap has a measurement of between 0.01 cm and 4 cm.