Radio-Frequency Electrical Membrane Breakdown for the Treatment of High Risk and Recurrent Prostate Cancer, Unresectable Pancreatic Cancer, Tumors of the Breast, Melanoma or Other Skin Malignancies, Sarcoma, Soft Tissue Tumors, Ductal Carcinoma, Neoplasia, and Intra and Extra Luminal Abnormal Tissue

Abstract

An imaging, guidance, planning and treatment system integrated into a single unit or assembly of components, and a method for using same, that can be safely and effectively deployed to treat prostate cancer, unresectable pancreatic cancer, tumors of the breast or soft tissue, including those located in the head, neck, central nervous system or brain, melanoma, ductal carcinoma, neoplasia, or intra and extra luminal abnormal tissue. The system utilizes the novel process of Radio-Frequency Electrical Membrane Breakdown (“EMB” or “RFEMB”) to destroy the cellular membranes of unwanted or cancerous tissue without denaturing the intra-cellular contents of the cells comprising the tissue, thereby ablating it and exposing tumor antigens and other intra-cellular components which can have an immunologic effect on local or distant cancerous tissue, with or without the addition of immunologic adjuvant drugs, agents, or materials. The system preferably comprises at least one EMB treatment probe 20, at least one trackable biopsy needle 200, at least one trackable anesthesia needle 300, and at least one controller unit for at least partially automating the treatment process.

1 . (canceled) 
     
     
         2 . A system for ablating soft tissue in a living subject, the system comprising:
 an electric pulse generator configured to produce a bi-polar pulse;   a probe comprising an electrode connected to said electric pulse generator, in which the probe and electric pulse generator are configured to cause application, to the soft tissue, of an electric field in a range of 1,500 V/cm to 10,000 V/cm,   in which the applied electric field in the range of 1,500 V/cm to 10,000 V/cm and the bi-polar pulse produced by the electric pulse generator are sufficient to cause immediate destruction of cell membranes of cells of the soft tissue and immediate spillage of non-denatured intracellular components and antigens into an extracellular space;   one or more needles configured to administer one or more immunologic response enhancing drugs intratumorally to the soft tissue; and   a controller connected to the electric pulse generator and therapeutic probe.   
     
     
         3 . The system of  claim 2 , wherein the probe comprises:
 a core electrode comprising an electrically conductive material;   an outer electrode at least partially covering the core; and   an insulating sheath comprising an electrically insulating material and disposed between the core electrode and the outer electrode.   
     
     
         4 . The system of  claim 3 , in which the outer electrode is mounted on the insulating sheath, and in which the outer electrode and the insulating sheath are movable as a unit laterally relative to the core to enable adjustment of the lateral distance between a distal end of the core electrode and the outer electrode. 
     
     
         5 . The system of  claim 2 , in which the probe defines a lumen configured to receive a surgical tool. 
     
     
         6 . The system of  claim 5 ,
 in which the electrode comprises an outer electrode disposed on an outer surface of the probe, and   in which the system comprises:
 a needle sized to fit within the lumen of said the probe, and 
 a needle electrode disposed on a distal end of the needle, wherein a polarity of the needle electrode is different than a polarity of the outer electrode. 
   
     
     
         7 . The system of  claim 2 , in which the probe comprises an expandable balloon and a stent. 
     
     
         8 . The system of  claim 2 , in which the probe comprises:
 a positive electrode disposed at a first location on an outer surface of the probe; and   a negative electrode disposed at a second location on the outer surface of the probe, in which the first location and the second location are separated along a length of the probe.   
     
     
         9 . The system of  claim 2 , in which the probe is flexible. 
     
     
         10 . The system of  claim 2 , in which the probe is curved. 
     
     
         11 . The system of  claim 2 , in which the electric pulse generator is configured to produce a bi-polar pulse characterized by an instant charge reversal between a positive and a negative polarity. 
     
     
         12 . A method for ablating soft tissue in a living subject, the method comprising:
 delivering, by an electric pulse generator to the electrode of a probe inserted into the soft tissue of the living subject, a bi-polar pulse, in which delivery of the bi-polar pulse causes the electrode of the probe to apply, to the soft tissue, an electric field in the range of 1,500 V/cm to 10,000 V/cm and sufficient to cause immediate destruction of cell membranes of cells of the soft tissue and immediate spillage of non-denatured intracellular components and antigens into an extracellular space; and   administering, by one or more needles, one or more immunologic response enhancing drugs intratumorally to the soft tissue.   
     
     
         13 . The method of  claim 12 , in which administering the one or more immunologic response enhancing drugs comprises administering a combination of at least two immune checkpoint inhibitors and an immunomodulatory agent, each being present in a therapeutically effective amount. 
     
     
         14 . The method of  claim 13 , in which the at least two immune checkpoint inhibitors comprise a CTLA-4 inhibitor and a PD-1 inhibitor. 
     
     
         15 . The method of  claim 14 , in which the at least two immune checkpoint inhibitors comprise a PD-L1 inhibitor. 
     
     
         16 . The method of  claim 13 , in which the immunomodulatory agent comprises an agent capable of modulating myeloid cell functions. 
     
     
         17 . The method of  claim 16 , in which the immunomodulatory agent comprises Tasquinimod. 
     
     
         18 . The method of  claim 12 , in which the probe is inserted into a tumor in a prostate, breast, pancreas, skin, brain, or central nervous system. 
     
     
         19 . The method of  claim 12 , in which the probe is inserted into a bile duct, pancreatic duct, or bowel. 
     
     
         20 . The method of  claim 12 , in which the probe is a curved probe, and in which the method comprises inserting the curved probe into breast tissue through a scope. 
     
     
         21 . The method of  claim 12 , comprising inserting the probe endoscopically into the soft tissue. 
     
     
         22 . The method of  claim 12 , comprising inserting the probe into the soft tissue using guidance from endoscopic ultrasound. 
     
     
         23 . The method of  claim 12 , comprising inserting the probe through a posterior stomach or duodenal wall into a tumor in a pancreas. 
     
     
         24 . The method of  claim 12 , in which the probe comprises an expandable balloon and a stent, and in which the method comprises:
 inserting the probe into a duct of the soft tissue;   expanding the balloon; and   following application of the electric field to the soft tissue, removing the balloon and leaving the stent to remain in the duct of the soft tissue.