Method and apparatus for delivery of therapeutic agents

Abstract

Methods and apparatus for the reproducible, consistent and efficacious delivery of a therapeutic agent to a patient. The invention includes controlled administration of the therapeutic agent through an orifice to the patient, a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to the orifice, and an electrical signal generator operatively connected to the electrodes.

1 - 20 . (canceled) 
     
     
         21 . An apparatus for the intracellular delivery of a therapeutic agent to a predetermined site within the tissue of a patient comprising:
 means for the administration of said therapeutic agent to said patient comprising a reservoir for the therapeutic agent, at least one orifice through which the agent is administered, and an inanimate source of energy sufficient to transfer a predetermined amount of the therapeutic agent from said reservoir through said orifice to the predetermined site within the tissue of the patient;   a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to said orifice;   and means configured for generating an electrical field which facilitates the intracellular delivery of said therapeutic agent said means operatively connected to said electrodes.   
     
     
         22 . The apparatus as recited in  claim 21  wherein the electrodes comprise a subassembly that can be separated from the orifice. 
     
     
         23 . The apparatus as recited in  claim 21  further comprising means for adjusting the predetermined spatial relationship between said electrodes and said orifice. 
     
     
         24 . The apparatus as recited in  claim 23  wherein said means for adjusting the spatial relationship comprises a source of energy. 
     
     
         25 . The apparatus as recited in  claim 21  wherein the electrodes comprise a conductive, electrochemically stable compound. 
     
     
         26 . The apparatus as recited in  claim 21  wherein the electrodes comprise a conductive metal coated with a conductive, electrochemically stable compound. 
     
     
         27 . The apparatus as recited in  claim 25  wherein said conductive, electrochemically stable compound consists of at least one of the following materials: titanium nitride, platinum, platinum iridium, iridium oxide. 
     
     
         28 . The apparatus as recited in  claim 21  wherein the means for administration of the therapeutic agent is a jet injector. 
     
     
         29 . The apparatus as recited in  claim 28  wherein the source of energy to transfer the therapeutic agent is at least one compressed gas. 
     
     
         30 . The apparatus as recited in  claim 28  wherein the source of energy to transfer the therapeutic agent is at least one spring. 
     
     
         31 . The apparatus as recited in  claim 28  wherein the jet injector comprises means for controlling the rate at which the agent is transferred through the orifice. 
     
     
         32 . The apparatus as recited in  claim 21  wherein the means for administration of the therapeutic agent is an automatic injection device. 
     
     
         33 . The apparatus as recited in  claim 32  wherein said reservoir is a syringe including a penetrating hypodermic needle. 
     
     
         34 . The apparatus as recited in  claim 32  wherein the source of energy to transfer the therapeutic agent is at least one compressed gas. 
     
     
         35 . The apparatus as recited in  claim 32  wherein the source of energy to transfer the therapeutic agent is at least one spring. 
     
     
         36 . The apparatus as recited in  claim 33  wherein the automatic injection device comprises means for controlling the depth of penetration of said needle into the patient. 
     
     
         37 . The apparatus as recited in  claim 32  wherein the automatic injection device comprises means for controlling the rate at which the agent is transferred through the orifice. 
     
     
         38 . The apparatus as recited in  claim 26  wherein said conductive, electrochemically stable compound consists of at least one of the following materials: titanium nitride, platinum, platinum iridium, iridium oxide. 
     
     
         39 . The apparatus as recited in  claim 21  wherein the means for generating an electrical field is configured to induce an electrical field of from approximately 50 to approximately 300 V/cm between at least two of said electrodes. 
     
     
         40 . The apparatus as recited in  claim 21  wherein die means for generating an electrical field is configured to deliver a signal for a duration of from approximately 1 microsecond to approximately 100 milliseconds and at a frequency of from approximately 0.1 Hertz to approximately 1 megahertz to at least two of said electrodes.