Systems and methods for treating tissue regions of the body

Abstract

Systems and methods deploy a therapeutic or diagnostic element into contact with a body tissue region. The systems and methods can sense position of the therapeutic or diagnostic element relative to a targeted tissue region without direct or indirect visualization, by sensing fluid pressure in a fluid path having an outlet located at or near the therapeutic or diagnostic element. The systems and methods can also inflate the therapeutic or diagnostic element during use, while taking steps to avoid over-inflation and/or while dynamically monitoring the pressure conditions within the expanded element.

1 - 11 . (canceled) 
     
     
         12 . A method for sensing position of a device relative to a body region based on fluid pressure detection, the method comprising the steps of:
 a) providing a device having an operative or diagnostic element, a fluid path to convey fluid, and a fluid outlet to body tissue located at or near the operative or diagnostic element, the fluid outlet communicating with the fluid path to output fluid to the body region;   b) inserting the device into the body region of a patient;   c) providing pressurized fluid through the fluid path of the device to exit the fluid outlet at or near the operative or diagnostic element so the fluid comes into contact with body tissue as the device is moved;   d) sensing fluid pressure in the fluid path to detect impeding of fluid from the fluid outlet to sense a position of the device as increased tissue pressure generates a back pressure in the fluid path from the fluid outlet detectable by the sensor;   e) indicating to a user the sensed fluid pressure or changes in the sensed fluid pressure to provide an indication of the position of the device relative to the body region; and   f) subsequent to step (e) operating the operative or diagnostic element of the device.   
     
     
         13 . The method of  claim 12 , further comprising the step of expanding an expandable basket of the device after sensing fluid pressure, the fluid pressure sensed when the basket is in a collapsed condition. 
     
     
         14 . The method of  claim 12 , wherein the step of sensing fluid pressure provides a marker for a high pressure zone created by the lower esophageal sphincter. 
     
     
         15 . The method of  claim 13 , wherein the step of providing pressurized fluid includes the step of providing pressurized fluid through ports in arms of the expandable basket. 
     
     
         15 . The method of  claim 12 , further comprising the step of displaying on a graphical user interface the sensed fluid pressure or changes in the sensed fluid pressure. 
     
     
         16 . The method of  claim 12 , wherein the source of fluid conveys air under pressure, and the fluid pressure is sensed using a manometer. 
     
     
         17 . The method of  claim 12 , wherein the operative element is adapted to make tissue contact and the outlet is located at or near a surface of the operative element. 
     
     
         18 . The method of  claim 12 , wherein the step of sensing fluid pressure detects changes in a high pressure zone. 
     
     
         19 . The method of  claim 18 , wherein the high pressure zone is in the lower esophageal sphincter. 
     
     
         20 . The method of  claim 18 , further comprising the step of withdrawing the device from the high pressure zone after sensing positioning in the high pressure zone. 
     
     
         21 . The method of  claim 12 , further comprising the step of generating a visual output when a threshold pressure is sensed. 
     
     
         22 . The method of  claim 12 , further comprising the step of generating an audible output when a threshold pressure is sensed. 
     
     
         23 . The method of  claim 12 , wherein the position of the device is determined without visualization. 
     
     
         24 . The method of  claim 12 , wherein the device includes a valve, and further comprising the step of selectively opening or closing the valve to selectively convey or impede fluid through the outlet and into contact with the tissue as the device is moved. 
     
     
         25 . The method of  claim 24 , wherein the device includes a basket having arms and the valve enables fluid flow through the arms. 
     
     
         26 . The method of  claim 12 , wherein the device is inserted beyond the target tissue, and further comprising the step of withdrawing the device toward the target tissue.