Thermal Ablation System

Abstract

A thermal ablation system comprises a fluid handling unit receiving fluid from a fluid source at a first pressure, the fluid handling unit including a heater heating the fluid to a desired temperature and a pump and an introducer including a sheath which, when in an operative position, is received within a hollow organ, the sheath including a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ and returning the withdrawn fluid to the console via a return lumen, wherein the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer.

1 . A thermal ablation system comprising:
 a fluid handling unit receiving fluid from a fluid source at a first pressure, the fluid handling unit including a heater heating the fluid to a desired temperature and a pump; and   an introducer including a sheath which, when in an operative position, is received within a hollow organ, the sheath including a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ and returning the withdrawn fluid to the console via a return lumens wherein the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer.   
   
   
       2 . The system according to  claim 1 , wherein the fluid handling unit includes a reusable console and a disposable cartridge. 
   
   
       3 . The system according to  claim 1 , wherein the pump increases the pressure of the fluid by a substantially constant amount. 
   
   
       4 . The system according to  claim 2 , wherein a motor of the pump is located in the console and an impeller of the pump is located within the cartridge. 
   
   
       5 . The system according to  claim 4 , wherein the motor drives the impeller via a magnetic coupling. 
   
   
       6 . The system according to  claim 2 , wherein no fluid passes through the console. 
   
   
       7 . The system according to  claim 1  wherein the fluid handling unit is mounted on a variable height base. 
   
   
       8 . The system according to  claim 3 , wherein the console includes a fluid bag mounting pole for mounting the fluid source a predetermined height above a fluid inlet of the fluid handling unit to achieve a desired substantially constant fluid pressure within the hollow organ. 
   
   
       9 . The system according to  claim 1 , wherein the fluid handling unit includes a user interface including at least one of a display screen, a touch screen, a keypad and a speaker. 
   
   
       10 . The system according to  claim 1 , wherein the fluid handling unit includes a height determining mechanism ensuring a desired height differential between the fluid source and the hollow organ. 
   
   
       11 . The system according to  claim 10 , wherein the height determining mechanism provides a visual indication of a reference height relative to the hollow organ. 
   
   
       12 . The system according to  claim 11 , wherein the height determining mechanism includes a light beam port projecting a light beam substantially horizontally. 
   
   
       13 . The system according to  claim 2 , wherein the console includes a valve arrangement selectively opening and closing fluid circulation lumens in the cartridge. 
   
   
       14 . The system according to  claim 14 , wherein the valve arrangement includes at least one pincher valve. 
   
   
       15 . The system according to  claim 2 , wherein the cartridge includes a filter arrangement filtering the fluid from the return lumen. 
   
   
       16 . The system according to  claim 2 , wherein the cassette includes a reservoir storing the fluid and a level sensor outputting a signal corresponding to a level of the fluid within the reservoir. 
   
   
       17 . The system according to  claim 16 , wherein the console includes a controller determining a fluid volume as a function of the signal. 
   
   
       18 . The system according to  claim 2 , wherein the cartridge includes a drainage lumen emptying fluid from the return lumen into a drainage bag. 
   
   
       19 . The system according to  claim 1 , wherein the introducer includes a grip having a sheath extending distally therefrom and a scope connector extending proximally therefrom. 
   
   
       20 . The system according to  claim 19 , wherein the grip is sized and shaped for single-handed use. 
   
   
       21 . The system according to  claim 19 , wherein the scope connector includes a lock for detachably coupling a visualization device to the introducer and a scope adapter adjusting a length of the introducer. 
   
   
       22 . The system according to  claim 19 , wherein the sheath includes a seal disposed proximally of a distal end of the sheath. 
   
   
       23 . The system according to  claim 22 , wherein the seal is radially expandable from the sheath. 
   
   
       24 . The system according to  claim 22 , wherein a distance between the distal end of the sheath and a distal end of the seal is selected so that, when the distal end of the sheath is in a desired position within the hollow organ, the seal is located within a lumen through which the sheath is introduced into the hollow organ. 
   
   
       25 . The system according to  claim 24 , wherein the hollow organ is a uterus and the distance is between 0 cm and 1.5 cm so that, when the distal end of the sheath is in a desired position within the uterus, the seal is located within a cervix. 
   
   
       26 . The system according to  claim 1 , wherein the introducer includes a tenaculum stabilizer. 
   
   
       27 . A method, comprising:
 aligning a fluid handling unit of a thermal ablation system to a desired height relative to a hollow organ to be treated;   heating a fluid in the fluid handling unit to a predetermined temperature;   pumping the fluid from the fluid handling unit via a fluid delivery lumen into an introducer inserted into the hollow organ; and   after the fluid has been circulated through the hollow organ, withdrawing the fluid from the tissue structure to the fluid handling unit via a fluid return lumen in the introducer.   
   
   
       28 . The method according to  claim 27 , further comprising:
 filtering the fluid received from the fluid return lumen; and   pumping the fluid back into the introducer via the fluid delivery lumen.   
   
   
       29 . The method according to  claim 27 , further comprising:
 monitoring a volume of the fluid circulating through the hollow organ; and   when the volume is outside a predetermined range, executing a safety procedure.