Device and method for ablative treatment of targeted areas within a body lumen

Abstract

Disclosed is a cryotherapy device comprising at least one inflow channel, at least one outflow channel, control means for controlling the evacuation of expanded cryo-fluid from a body lumen, wherein the control means receive data from at least one sensor that gathers data regarding at least one parameter of the body lumen and wherein the cryotherapy device is introduced into the body lumen via an endoscope.

What is claimed is: 
     
         1 . A method of treating tissue within an organ having a lumen, said method comprising:
 introducing a cryotherapy device into a lumen of an organ via an endoscope;   injecting expandable cryo-fluid through at least one inflow channel of the cryotherapy device, directly or indirectly, into the organ lumen, such that the expandable cryo-fluid exits from said inflow channel and expands, directly or indirectly, in the organ lumen thereby freezing at least part of the treated tissue;   detecting an indication with regard to at least one parameter of said organ lumen, and/or at least one parameter of at least one outflow channel of the cryotherapy device, and/or at least one parameter of said at least one inflow channel and   evacuating said expanded cryo-fluid, directly or indirectly, through said at least one outflow channel of the cryotherapy device according to said detected indication, from the organ lumen.   
     
     
         2 . The method according to  claim 1 , wherein said at least one parameter of said organ lumen comprises pressure accumulation in said organ lumen, and wherein said evacuating comprises evacuating said expanded cryo-fluid according to said detected indication of said pressure accumulation. 
     
     
         3 . The method according to  claim 1 , wherein said at least one parameter of said at least one outflow channel and/or said at least one inflow channel comprises flow speed, flow direction, temperature and/or pressure. 
     
     
         4 . The method according to  claim 1 , wherein said injecting comprises providing said expandable cryo-fluid to at least one element at a distal end of the device, wherein said at least one element defines a channel between said inflow channel and said organ lumen and selectively directs said expandable cryo-fluid from the distal end of the device to at least one targeted area within the organ lumen, such that the expandable cryo-fluid exits from said inflow channel through said at least one element and expands, directly or indirectly, in the organ lumen thereby freezing at least part of the treated tissue. 
     
     
         5 . The method according to  claim 2 , comprising controlling said injecting and/or said evacuating by a controller receiving data from at least one sensor that gathers data regarding pressure in said organ lumen. 
     
     
         6 . The method according to  claim 5 , wherein said controlling comprises controlling said injecting and/or said evacuating to maintain pressure levels in said organ lumen between 10 mBar and 100 mBar. 
     
     
         7 . The method according to  claim 1 , comprising controlling said injecting and/or said evacuating by a controller receiving data from at least one sensor that gathers data with regard to at least one of, pressure in said treated organ lumen, a temperature of the treated organ lumen, flow rate, and flow time, or any combination thereof. 
     
     
         8 . The method according to  claim 1 , wherein said detecting comprises detecting an indication with regard to temperature within said organ lumen; and wherein said method comprising stopping said injecting if a temperature within said organ lumen is below 10 degrees Celsius. 
     
     
         9 . The method according to  claim 1 , wherein said detecting comprises detecting blockage of said at least one outflow channel, and wherein said method comprising controlling said injecting according to the detected blockage. 
     
     
         10 . The method according to  claim 1 , wherein said organ comprises the bladder, and wherein said introducing comprises introducing said device into the bladder, via a urethra. 
     
     
         11 . The method according to  claim 1 , wherein said evacuating comprises evacuating body fluids from the bladder through at least one outflow channel. 
     
     
         12 . The method according to  claim 1 , wherein the cryo-fluid is selected from liquid nitrogen, carbon dioxide (CO2), nitrous oxide (N2O), or any combination thereof. 
     
     
         13 . The method according to  claim 1 , wherein said introducing comprises bending said cryotherapy device within said organ in sharp angular movements larger than 90 degrees. 
     
     
         14 . The method according to  claim 1 , wherein said organ lumen comprises a cervix, a prostate, a urethra, a ureter or a uterus. 
     
     
         15 . The method according to  claim 1 , wherein at least one inflow channel and at least one outflow channel are the same channel, wherein the direction of flow therethrough is controlled by a controller. 
     
     
         16 . The method according to  claim 1 , wherein said injecting comprises injecting said expandable cryo-fluid through at least one frontal inflow opening of the cryotherapy device into said organ lumen, and wherein said evacuating comprises evacuating said expanded cryofluid through at least one frontal outflow opening of the inflow channel. 
     
     
         17 . The method according to  claim 1 , wherein said evacuating comprises evacuating said expanded cryofluid through at least one side outflow opening of the outflow channel. 
     
     
         18 . The method according to  claim 1 , wherein said injecting comprises injecting said expandable cryo-fluid through a plurality of side inflow openings of said inflow channel, into said organ lumen. 
     
     
         19 . The method according to  claim 1 , wherein said method is a method for treating bladder cancer, comprising diagnosing a patient with bladder cancer, wherein said introducing comprises introducing said cryotherapy device into a bladder of said patient, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said bladder, thereby freezing at least part of said cancerous tumor. 
     
     
         20 . The method according to  claim 1 , wherein said method is a method for treating cervix cancer, wherein said introducing comprises introducing said cryotherapy device into a cervix of a patient diagnosed with cervix cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said cervix, thereby freezing at least part of said cancerous tumor. 
     
     
         21 . The method according to  claim 1 , wherein said method is a method for treating prostate cancer, wherein said introducing comprises introducing said cryotherapy device into a prostate of a patient diagnosed with prostate cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said prostate, thereby freezing at least part of said cancerous tumor. 
     
     
         22 . The method according to claim I, wherein said method is a method for treating urethral cancer, wherein said introducing comprises introducing said cryotherapy device into a urethra of a patient diagnosed with urethral cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said urethra, thereby freezing at least part of said cancerous tumor. 
     
     
         23 . The method according to claim wherein said method is a method for treating ureteral cancer, wherein said introducing comprises introducing said cryotherapy device into a ureter of a patient diagnosed with ureteral cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said ureter, thereby freezing at least part of said cancerous tumor. 
     
     
         24 . The method according to  claim 1 , wherein said method is a method for treating uterus cancer, wherein said introducing comprises introducing said cryotherapy device into a uterus of a patient diagnosed with uterus cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said uterus, thereby freezing at least part of said cancerous tumor. 
     
     
         25 . The method according to  claim 1 , wherein said method is a method for treating upper tract urothelial cancer, wherein said introducing comprises introducing said cryotherapy device into a ureter or kidney of a patient diagnosed with upper tract urothelial cancer, and wherein said injecting comprises directing said expandable cryo-fluid at a cancerous tumor in said ureter or kidney, thereby freezing at least part of said cancerous tumor.