Interventional drug delivery system and associated methods

Abstract

A delivery system for local drug delivery to a target site of internal body tissue is provided. The delivery system comprises a source electrode adapted to be positioned proximate to a target site of internal body tissue. A counter electrode is in electrical communication with the source electrode, and is configured to cooperate with the source electrode to form a localized electric field proximate to the target site. A reservoir is configured to be disposed such that the reservoir is capable of interacting with the localized electric field. The reservoir is configured to carry a cargo capable of being delivered to the target site when exposed to the localized electric field. Associated methods are also provided.

1 . A delivery system for local drug delivery to a target site of internal body tissue, comprising:
 a source electrode adapted to be positioned proximate to a target site of internal body tissue;   a counter electrode in electrical communication with the source electrode, the counter electrode being configured to cooperate with the source electrode to form a localized electric field proximate to the target site; and   a reservoir capable of interacting with the localized electric field, the reservoir being configured to carry a cargo capable of being delivered to the target site when exposed to the localized electric field formed between the source electrode and the counter electrode.   
     
     
         2 . A delivery system according to  claim 1 , further comprising an electrode deployment device configured to insert at least one of the source electrode and the counter electrode proximate to the target site of internal body tissue in vivo. 
     
     
         3 . A delivery system according to  claim 2  further comprising a control system in communication with the electrode deployment device, the control system being configured to guide the electrode deployment device with placement of the source electrode and the counter electrode. 
     
     
         4 . A delivery system according to  claim 2  wherein the electrode deployment device comprises one of a catheter device, an endoscopic device, a laparoscopic device, an implantable device, and combinations thereof. 
     
     
         5 . A delivery system according to  claim 4  wherein the catheter device comprises a first and second expandable member serially disposed along a longitudinal axis of the catheter device, the source electrode being axially disposed between the first and second expandable members such that, upon inflation of the first and second expandable members to occlude the target site, the target site is isolated and the delivery of the cargo is contained to the target site. 
     
     
         6 . A delivery system according to  claim 4  wherein the catheter device comprises a perforated polymer sheath, the cargo being capable of exiting the catheter device through a plurality of perforations defined by the perforated polymer sheath, and the source electrode comprising an array of probes terminating at different lengths and being independently powered such that the probes are capable of being variably controlled, the source electrode further comprising a plurality of insulating members disposed about and between the probes so as to form cargo delivery zones substantially aligned with the perforations of the perforated polymer sheath. 
     
     
         7 . A delivery system according to  claim 4  wherein the endoscopic device comprises a proximal end and a distal end having the source electrode disposed thereabout for positioning proximate to the target site, the source electrode comprising a hollow needle member forming the reservoir, the proximal end having a port to fluidly connect the proximal and distal ends such that the reservoir is capable of being remotely filled with the cargo. 
     
     
         8 . A delivery system according to  claim 1  wherein the cargo comprises at least one of small ionic molecules, nucleic acids, proteins, organic nanoparticles, therapeutic agents, and imaging agents. 
     
     
         9 . A delivery system according to  claim 1  wherein the source electrode includes an array of probes comprising one of thin wires, foil, mesh, pellets, disks, stents, clamps, prongs, clips, needles, hollow tubes, and combinations thereof. 
     
     
         10 . A delivery system according to  claim 1  wherein the source electrode and the counter electrode are comprised of one of a metallic material, a conductive polymer material, and combinations thereof. 
     
     
         11 . A delivery system according to  claim 1  further comprising at least one insulating member at least partially disposed about the source electrode, the at least one insulating member being configured to confer directionality to the transport profile of the cargo released from the reservoir. 
     
     
         12 .- 25 . (canceled) 
     
     
         26 . A method of delivering a cargo to a target site of internal body tissue, the method comprising:
 disposing a source electrode proximate to a target site of internal body tissue in vivo;   disposing a counter electrode in electrical communication with the source electrode, the counter electrode being configured to cooperate with the source electrode to form a localized electric field proximate to the target site;   disposing a reservoir such that the reservoir is capable of interacting with the localized electric field, the reservoir being configured to carry a cargo capable of being delivered to the target site when exposed to the localized electric field formed between the source electrode and the counter electrode; and   applying a voltage potential across the source and counter electrodes to form an electric field, thereby delivering at least a portion of the cargo to the target site.   
     
     
         27 . A method according to  claim 26 , wherein disposing the source electrode comprises disposing the source electrode proximate to the target site of internal body tissue in vivo using an electrode deployment device. 
     
     
         28 . A method according to  claim 27  further comprising guiding the electrode deployment device with a control system in communication therewith, the control system being configured to guide the electrode deployment device for positioning of the source electrode and the counter electrode. 
     
     
         29 . A method according to  claim 27  wherein disposing a source electrode further comprises disposing a source electrode with an electrode deployment device comprising one of a catheter device, an endoscopic device, a laparoscopic device, an implantable device, and combinations thereof. 
     
     
         30 . A method according to  claim 29  wherein disposing a source electrode further comprises disposing a source electrode with an electrode deployment device comprising a catheter device having a first and second expandable member serially disposed along a longitudinal axis of the catheter device, the source electrode being axially disposed between the first and second expandable members such that, upon inflation of the first and second expandable members to occlude the target site, the target site is isolated and the delivery of the cargo is contained to the target site. 
     
     
         31 . A method according to  claim 29  wherein disposing a source electrode further comprises disposing a source electrode with an electrode deployment device comprising a catheter device having a perforated polymer sheath, the cargo being capable of exiting the catheter device through a plurality of perforations defined by the perforated polymer sheath, and the source electrode comprising an array of probes terminating at different lengths and being independently powered such that the probes are capable of being variably controlled, the source electrode further comprising a plurality of insulating members disposed about and between the probes so as to form cargo delivery zones substantially aligned with the perforations of the perforated polymer sheath. 
     
     
         32 .- 48 . (canceled) 
     
     
         49 . A method of treating a target site of body tissue, the method comprising:
 delivering a therapeutic agent to a body cavity of a patient for storage thereof;   positioning a first electrode proximate to a target site of internal body tissue;   positioning a second electrode such that the second electrode is in electrical communication with the first electrode; and   applying a voltage potential across the first and second electrodes to drive the therapeutic agent from the body cavity to the target site.   
     
     
         50 . A method according to  claim 49  wherein delivering a therapeutic agent to a body cavity further comprises implanting a device within the body cavity, the device being configured to carry and release the therapeutic agent upon the voltage potential being applied between the first and second electrodes. 
     
     
         51 . A method according to  claim 49  wherein delivering a therapeutic agent to a body cavity further comprises delivering a therapeutic agent to one of a peritoneal cavity, a cranial cavity, an oral cavity, a pleural cavity, an abdominopelvic cavity, and a pelvic cavity. 
     
     
         52 .- 53 . (canceled)