Method for measuring esophageal sphincter compliance

Abstract

An apparatus and method are disclosed for measuring the compliance of the lower esophageal sphincter (LES), the apparatus comprises a catheter having a plurality of extendable members disposed therealong for both measuring the compliance of the LES and stimulating the esophagus which relaxes the LES to obtain a more clinically relevant measurement of LES compliance. In one embodiment, the plurality of extendable members include a first balloon which is located and inflated within the esophagus to trigger esophageal motility, a second, non-elastic balloon that is positioned within the LES, and a third balloon which is inflated within the stomach to help align the second balloon with LES. Incrementally increasing volumes of air are introduced into the second balloon, with the resulting pressures exerted by the LES calculated and compared to normative values to assess the condition of the LES.

1 . A method measuring the compliance of the lower esophageal sphincter of a human patient, comprising the steps of: 
 a. providing a manometry catheter having at least a first extendable member and a second extendable member located distal thereto;    b. inserting the manometry catheter into the gastrointestinal tract of the patient and positioning the second extendable member such that it traverses the lower esophageal sphincter;    c. expanding the first extendable member to contact the walls of the esophagus and cause the esophagus to enter a transient state of relaxation;    d. expanding the second extendable member to a first volume within the lower esophageal sphincter;    e. measuring force exerted by the lower esophageal sphincter against the second extendable member; and    f. expanding the second extendable member to at least a second volume that is greater than the first volume to obtain at least one additional measurement of the force being exerted by the lower esophageal sphincter against the second expandable member such that a plurality of measurements can be obtained that are efficacious for assessing the compliance of the lower esophageal sphincter.    
   
   
       2 . The method of  claim 1 , wherein the first expandable member comprises a first balloon and the second expandable member comprises a second a balloon.  
   
   
       3 . The method of measuring the compliance of the lower esophageal sphincter of a human patient, wherein the first balloon comprises an compliant material and the second balloon comprises a substantially non-elastic material.  
   
   
       4 . The method of  claim 3 , wherein the measurement of force exerted by the lower esophageal sphincter against the second balloon comprises a pressure reading measured within the second balloon, the method further including the step of obtaining a plurality of pressure readings from within the second balloon during a progressive series of inflations thereof, the inflations occurring at increasing volumes relative to the first volume.  
   
   
       5 . The method of  claim 4 , further comprising the steps of calculating a compliance curve by plotting the plurality of pressure readings taken at each of the progressive series of inflations and analyzing the compliance curve intraoperatively to assess the relative compliance of the lower esophageal sphincter.  
   
   
       6 . The method of  claim 3 , further including the step of inflating the second balloon within the lower esophageal sphincter while the fist balloon is deflated to establish a baseline measurement of the compliance of the lower esophageal sphincter.  
   
   
       7 . The method of  claim 1 , wherein the manometry catheter further includes a third extendable member located distal to the second expandable member, the method further comprising the steps of expanding the third extendable member within the stomach, pulling back the manometry catheter until the third extendable member abuts the lower esophageal sphincter such that the second expandable member is positioned thereacross.  
   
   
       8 . The method of  claim 1 , wherein the manometry catheter includes at least one manometric port distributed therealong, the method further comprising the steps of obtaining a pressure reading within the gastrointestinal tract; and analyzing the pressure reading to ascertain whether the second expandable member is correctly positioned within the lower esophageal sphincter.  
   
   
       9 . A method for using a compliance measuring catheter having a first, a second, and a third extendable member to measure the compliance of the lower esophageal sphincter of a human patient, comprising the steps of: 
 a. inserting at least the distal portion of the compliance measuring catheter via one of a nasal passage or the mouth of the patient;    b. deploying the third extending member within the stomach of the patient and partially withdrawing the compliance measuring catheter until it abuts the stomach wall;    c. deploying the first extending member to contact the inner surface of the esophagus of the patient; and    d. deploying the second extending member within the lower esophageal sphincter in a stepwise manner, contacting the lower esophageal sphincter with incrementally increasing force against the inner surface thereof to establish a series of data points used to calculate the compliance of the lower esophageal sphincter.    
   
   
       10 . The method of  claim 9 , wherein the first, second, and third extendable members comprise balloons, wherein deployment of the first, second, and third balloons includes the steps of inflating each via at least one of a syringe or a pump.  
   
   
       11 . The method of  claim 10 , including the step of inflating the second balloon within the lower esophageal sphincter while the fist balloon is deflated to establish a baseline measurement of the compliance of the lower esophageal sphincter.