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 disclosure comprises means for the 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 means for generating an electrical signal operatively connected to the electrodes.

What is claimed is: 
     
         1 . An apparatus for the delivery of a therapeutic agent to a predetermined site within 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 a controlled source of energy sufficient to transfer a predetermined amount of the therapeutic agent at a predetermined rate from said reservoir through said orifice to the predetermined site within the patient;   a plurality of penetrating electrodes arranged with a predetermined spatial relationship relative to said orifice; and   means for generating an electrical signal operatively connected to said electrodes.   
     
     
         2 . The apparatus as recited in  claim 1  wherein the electrodes comprise a subassembly that can be separated from the orifice. 
     
     
         3 . The apparatus as recited in  claim 1  further comprising means for adjusting the predetermined spatial relationship between said electrodes and said orifice. 
     
     
         4 . The apparatus as recited in  claim 3  wherein said means for adjusting the spatial relationship comprises a source of energy. 
     
     
         5 . The apparatus as recited in  claim 1  wherein the electrodes comprise-a conductive, electrochemically stable compound. 
     
     
         6 . The apparatus as recited in  claim 5  wherein the electrodes comprise a conductive metal coated with said conductive, electrochemically stable compound. 
     
     
         7 . The apparatus as recited in  claim 5  wherein said conductive, electrochemically stable compound consists of at least one of the following materials: titanium nitride, platinum, platinum iridium, iridium oxide. 
     
     
         8 . The apparatus as recited in  claim 1  wherein the means for administration of the therapeutic agent is a jet injector. 
     
     
         9 . The apparatus as recited in  claim 8  wherein the source of energy to transfer the therapeutic agent is at least one compressed gas. 
     
     
         10 . The apparatus as recited in  claim 8  wherein the source of energy to transfer the therapeutic agent is at least one spring. 
     
     
         11 . The apparatus as recited in  claim 8  wherein the jet injection comprises means for controlling the rate at which the agent is transferred through the orifice. 
     
     
         12 . The apparatus as recited in  claim 1  wherein the means for administration of the therapeutic agent is an automatic injection device. 
     
     
         13 . The apparatus as recited in  claim 12  wherein said reservoir is a syringe including a penetrating hypodermic needle having a medial and a distal end and said orifice is located at the distal end of said needle. 
     
     
         14 . The apparatus as recited in  claim 12  wherein the source of energy to transfer the therapeutic agent is at least one compressed gas. 
     
     
         15 . The apparatus as recited in  claim 12  wherein the source of energy to, transfer the therapeutic agent is at least one spring. 
     
     
         16 . The apparatus as recited in  claim 13  wherein the automatic injection device comprises means for controlling the depth of penetration of said needle into the patient. 
     
     
         17 . The apparatus as recited in  claim 12  wherein the automatic injection device comprises means for controlling the rate at which the agent is transferred through the orifice.