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 high pressure zone within a body lumen of a patient based on fluid pressure detection for treating GERD, the method comprising the steps of:
 a) providing a device having an operative or diagnostic element for treating the lower esophageal sphincter for treating GERD, an inflatable balloon, a an irrigation lumen forming a fluid path positioned external of the balloon to convey fluid to an internal circumferential region of a sphincter at a plurality of radially spaced regions, and a fluid outlet to body tissue located at or near the operative or diagnostic element, the operative or diagnostic element includes a basket structure having a plurality of arms and an electrode element movable within the plurality of arms, the fluid outlet communicating with the fluid path to output fluid to a body region where tissue contact by the basket structure is intended, the irrigation lumen forming the fluid path extending through the arms of the basket structure;   b) inserting the device into the body region of the patient;   c) while the balloon is in a collapsed condition, 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, the fluid outlet including a plurality of radially spaced and axially aligned outlets to provide fluid at radially spaced regions of the sphincter;   d) while the balloon is in the collapsed condition moving the device axially within a body lumen while sensing fluid pressure in the fluid path to detect impeding of fluid from the fluid outlet to sense an axial position of the device as increased tissue pressure sensed over time generates a back pressure in the fluid path from the fluid outlet detectable by a sensor;   e) indicating to a user the sensed fluid pressure or changes in the sensed fluid pressure to provide an indication of the axial position of the device relative to the body region;   f) ceasing application of pressurized fluid and marking the position of the device using reference marks on the device in response to the sensed fluid pressure;   g) subsequent to step (f), inflating the balloon and operating the operative or diagnostic element of the device to deliver energy to the lower esophageal sphincter for treating GERD.   
     
     
         13 . The method of  claim 12 , further comprising the step of expanding the basket structure of the device after sensing fluid pressure. 
     
     
         14 . The method of  claim 12 , wherein the step of sensing fluid pressure provides a marker for the 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 the arms of the expandable basket structure. 
     
     
         16 . 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. 
     
     
         17 . The method of  claim 12 , wherein a source of fluid conveys air under pressure, and the fluid pressure is sensed using a manometer. 
     
     
         18 . The method of  claim 12 , wherein the fluid outlet is located at or near a surface of the operative element. 
     
     
         19 . The method of  claim 12 , wherein the step of sensing fluid pressure detects changes in the high pressure zone. 
     
     
         20 . The method of  claim 19 , wherein the high pressure zone is in the lower esophageal sphincter. 
     
     
         21 . The method of  claim 19 , further comprising the step of withdrawing the device from the high pressure zone after sensing positioning in the high pressure zone. 
     
     
         22 . The method of  claim 12 , further comprising the step of generating a visual output when a threshold pressure is sensed. 
     
     
         23 . The method of  claim 12 , further comprising the step of generating an audible output when a threshold pressure is sensed. 
     
     
         24 . The method of  claim 12 , wherein the position of the device is determined without visualization. 
     
     
         25 . 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 fluid outlet and into contact with the tissue as the device is moved. 
     
     
         26 . The method of  claim 25 , wherein the valve enables fluid flow through the arms. 
     
     
         27 . 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.