Methods for delivery of therapeutic materials to treat cancer

Abstract

Disclosed is a localized method for treatment of cancer including the steps of providing a drug delivery catheter; navigating the catheter to the bile duct; and delivering a therapeutic agent into the bile duct. According to one aspect of the method, the drug delivery catheter is a multi-occlusion balloon catheter. The multi-occlusion balloon catheter may include at least two balloons. The multi-occlusion balloon catheter may optionally include a pressure transducer between the balloons to optimize delivery technique.

1 . (canceled) 
     
     
         2 . A method of treatment, the method comprising:
 inserting a catheter into a bile duct;   occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder, to isolate a region of the bile duct;   delivering a therapeutic agent into the isolated region of the bile duct; and   maintaining a pressure in the isolated region of the bile duct to diffuse the therapeutic agent into a tissue around the bile duct.   
     
     
         3 . The method of  claim 2 , wherein maintaining the pressure of the isolated region of the bile duct comprises delivering the therapeutic agent into the isolated region of the bile duct under pressure. 
     
     
         4 . The method of  claim 2 , further comprising increasing or decreasing the pressure in the isolated region of the bile duct to change a penetration depth of the therapeutic agent into the tissue around the bile duct. 
     
     
         5 . The method of  claim 2 , wherein the tissue around the bile duct comprises a tumor. 
     
     
         6 . The method of  claim 2 , wherein the tissue around the bile duct comprises one or more of: a pancreatic tumor, a liver tumor and a cholangiocarcinoma. 
     
     
         7 . The method of  claim 2 , wherein inserting the catheter comprises advancing the catheter over a guidewire within the bile duct. 
     
     
         8 . The method of  claim 2 , wherein inserting the catheter comprises inserting the catheter into the bile duct to a region of the bile duct that adjacent to a tumor. 
     
     
         9 . The method of  claim 2 , wherein inserting the catheter comprises inserting the catheter through an endoscopic retrograde cholangiopancreatogram (ERCP) catheter. 
     
     
         10 . The method of  claim 2 , wherein inserting the catheter comprises inserting the catheter percutaneously. 
     
     
         11 . The method of  claim 2 , wherein inserting comprises adjusting the distance between the first occluder and the second occluder by advancing the first occluder distally, wherein the first occluder is on an inner catheter slidably disposed within a lumen of the catheter. 
     
     
         12 . The method of  claim 2 , wherein occluding the bile duct comprises inflating the first occluder and the second occluder. 
     
     
         13 . The method of  claim 2 , wherein the therapeutic agent is selected from the group of: (5-fluorouracil (5-FU), Aldesleukin, Axitinib, Bleomycin, Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, doxorubicin liposomal non-pegylated (un-coated), doxorubicin liposomal pegylated (PEG coated), Floxuridine, Gemcitabine Hydrochloride, Irinotecan Hydrochloride Liposome, Lanreotide Acetate, leucovorin (antidote to folic acid antagonist used with 5FU), Methotrexate, Mitomycin, Mitoxantrone, Nivolumab, Olaparib, Oxaliplatin, Sorafenib Tosylate, Temsirolimus, Thiotepa, Topotecan Hydrochloride, Vinblastine Sulfate, vincristine sulfate). 
     
     
         14 . A method of treatment, the method comprising:
 inserting a catheter into a bile duct to a region of the bile duct that adjacent to a tumor;   isolating a region of the bile duct adjacent to the tumor by occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder;   introducing a therapeutic agent into the isolated region of the bile duct from out of an opening in a side wall of the catheter between the first occluder and the second occluder; and   diffusing the therapeutic agent into a tissue around the bile duct by maintaining the pressure in the isolated region of the bile duct at greater than an interstitial tissue pressure in the tissue around the bile duct.   
     
     
         15 . The method of  claim 14 , further comprising increasing or decreasing the pressure in the isolated region of the bile duct to change a penetration depth of the therapeutic agent into the tissue around the bile duct. 
     
     
         16 . The method of  claim 14 , wherein the tumor comprises one or more of: a pancreatic tumor, a liver tumor and a cholangiocarcinoma. 
     
     
         17 . The method of  claim 14 , wherein inserting the catheter comprises advancing the catheter over a guidewire within the bile duct. 
     
     
         18 . The method of  claim 14 , wherein inserting the catheter comprises inserting the catheter through an endoscopic retrograde cholangiopancreatogram (ERCP) catheter. 
     
     
         19 . The method of  claim 14 , wherein inserting comprises adjusting the distance between the first occluder and the second occluder by advancing the first occluder distally, wherein the first occluder is on an inner catheter slidably disposed within a lumen of the catheter. 
     
     
         20 . The method of  claim 14 , wherein the therapeutic agent is selected from the group of: (5-fluorouracil (5-FU), Aldesleukin, Axitinib, Bleomycin, Carboplatin, Cetuximab, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, doxorubicin liposomal non-pegylated (un-coated), doxorubicin liposomal pegylated (PEG coated), Floxuridine, Gemcitabine Hydrochloride, Irinotecan Hydrochloride Liposome, Lanreotide Acetate, leucovorin (antidote to folic acid antagonist used with 5FU), Methotrexate, Mitomycin, Mitoxantrone, Nivolumab, Olaparib, Oxaliplatin, Sorafenib Tosylate, Temsirolimus, Thiotepa, Topotecan Hydrochloride, Vinblastine Sulfate, vincristine sulfate). 
     
     
         21 . A method of treatment, the method comprising:
 inserting a catheter into a bile duct to a region of the bile duct that adjacent to a tumor;   isolating a region of the bile duct adjacent to the tumor by occluding the bile duct with a first occluder on a distal end region of the catheter and a second occluder on the distal end region of the catheter proximal to the first occluder;   injecting a therapeutic agent into the isolated region of the bile duct from out of an opening in a side wall of the catheter between the first occluder and the second occluder so that the pressure in the isolated region of the bile duct is greater than an interstitial tissue pressure in a tissue around the bile duct, whereby the therapeutic agent diffuses into the tissue around the bile duct.