System for treating gastric reflux by tightening a lower esophageal sphincter

Abstract

A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus. Bioelectric activity causing a relaxation of the sphincter is detected and energy is delivered from either the mapping electrode or the treatment electrode to treat the bioelectric activity. A method of treating a sphincter provides a sphincter electropotential mapping device with at least one of a mapping electrode or a treatment electrode. The sphincter electropotential mapping device is introduced into at least a portion of the sphincter, the lower esophageal sphincter, stomach, the cardia or the fundus. Bioelectric activity causing a relaxation of the sphincter is detected and energy is delivered from either the mapping electrode or the treatment electrode to treat the bioelectric activity.

1 - 3 . (canceled) 
     
     
         4 . A system for regulating temperature at a tissue site during treatment of gastroesophageal reflux disease, the system comprising:
 a device having a plurality of electrodes, a tissue temperature measuring device attached to the electrodes for producing a signal representative of a measured tissue temperature at an interface between the electrodes and tissue, the electrodes advanceable from a retracted position within the device to an extended position extending from the device to apply energy to the lower esophageal sphincter to form lesions to tighten the sphincter to treat gastroesophageal reflux disease;   a power source to apply energy to the plurality of electrodes, the power source having multiple channels to deliver separately modulated power to the plurality of electrodes such that individual electrodes of the plurality of electrodes generate an independent output, the tissue temperature measuring device coupled to the power source, and power supplied is modified in response to tissue temperature measurement;   a tissue impedance monitor, the tissue impedance monitor measuring tissue impedance based on energy delivered to tissue, the measured impedance compared to a preset value and if the measured impedance exceeds the preset value a disabling signal is generated to cease delivery of energy;   an electronically controlled pump for delivering fluid at an appropriate flow rate and duration to control temperature at the interface between the electrodes and tissue; and   a comparator receiving the signal representative of the measured tissue temperature and comparing the measured tissue temperature value to a pre-set desired tissue temperature, if the measured tissue temperature exceeds such pre-set desired tissue temperature, a signal is sent to a flow regulator electronically connected to a fluid pump to increase flow of cooling solution to the tissue, and the existing flow rate of cooling solution to the tissue site is maintained if the measured tissue temperature does not exceed the desired temperature.   
     
     
         5 . The system of  claim 4 , wherein the device includes a basket assembly and the electrodes are deployed by expansion of the basket assembly. 
     
     
         6 . The system of  claim 4 , wherein the device includes a basket assembly comprising a plurality of arms, the arms having an aperture and the electrodes advanceable through the apertures in the arms. 
     
     
         7 . The system of  claim 6 , wherein the apertures are structured to limit the depth of penetration of the electrodes. 
     
     
         8 . The system of  claim 4 , further comprising a basket assembly and a pull wire to expand the basket assembly. 
     
     
         9 . The system of  claim 4 , wherein when the electrodes are moved to the extended position the temperature measuring device is located further radially from a longitudinal axis of the device. 
     
     
         10 . The system of  claim 4 , further comprising a basket assembly and an inflatable balloon to expand the basket assembly. 
     
     
         11 . The system of  claim 4 , wherein the device is configured for insertion through a mouth of a patient. 
     
     
         12 . The system of claim  1 , wherein increasing and maintaining existing flow rate of cooling solution maintains the tissue at a desired temperature for a selected period of time. 
     
     
         13 . A system for regulating temperature at a tissue site during treatment of gastroesophageal reflux disease, the system comprising:
 a device having a basket assembly at a distal portion and a plurality of electrodes, the basket assembly having a plurality of arms and expandable to an expanded configuration, the arms having an aperture for passage of an electrode of the plurality of electrodes, a tissue temperature measuring device attached to the electrodes for producing a signal representative of a measured tissue temperature at the interface between the electrodes and tissue, the electrodes advanceable from a retracted position within the device to an extended position extending from the apertures in the arms of the basket assembly to apply energy to the lower esophageal sphincter to form lesions to tighten the sphincter to treat gastroesophageal reflux disease, the tissue temperature measuring device movable with advancement of the electrodes;   a power source to apply energy to the plurality of electrodes, the power source having multiple channels to deliver separately modulated power to each of the plurality of electrodes such that each of the plurality of electrodes generates an independent output;   a feedback system coupling the tissue temperature measuring device to the power source, the power supplied responsive to tissue temperature measurement to regulate delivery of energy in response to tissue temperature;   an electronically controlled pump for delivering fluid at an appropriate flow rate and duration to control temperature at the interface between the electrodes and tissue; and   a comparator receiving the signal representative of the measured tissue temperature and comparing the measured temperature value to a pre-set desired tissue temperature, if the measured tissue temperature exceeds such pre-set desired tissue temperature, a signal is sent to a flow regulator electronically connected to a fluid pump to increase flow of cooling solution to the tissue, and the existing flow rate of the cooling solution to the tissue site is maintained if the measured tissue temperature does not exceed the desired temperature.   
     
     
         14 . The system of  claim 13 , further comprising a tissue impedance monitor, the tissue impedance monitor measuring tissue impedance based on energy delivered to tissue, the measured impedance compared to a preset value and if the measured impedance exceeds a preset value a disabling signal is generated to cease delivery of energy. 
     
     
         15 . The system of  claim 13 , wherein the electrodes in the advanced position curve radially outwardly away from a longitudinal axis of the device. 
     
     
         16 . The system of  claim 14 , wherein the electrodes in the advanced position curve radially outwardly away from a longitudinal axis of the device. 
     
     
         17 . The system of  claim 13 , further comprising an inflatable balloon to expand the basket assembly. 
     
     
         18 . The system of  claim 13 , wherein the electrodes have penetrating tips. 
     
     
         19 . The system of  claim 13 , further comprising a user interface to display the measured tissue temperature.