Systems and methods for treating tissue with radiofrequency energy

Abstract

A device for applying radiofrequency energy for sphincter treatment comprising a flexible outer tube, an expandable basket having a plurality of arms movable from a collapsed position to an expanded position, and a plurality of electrodes movable with respect to the arms from a retracted position to an extended position. An advancer is slidably disposed within the outer tube to move the plurality of electrodes to the extended position. An actuator moves the advancer from a first position to a second position to advance the plurality of electrodes. An aspiration tube extends within the outer tube. An assembly includes an aspiration disabler having a first position to enable aspiration from a distal portion of the aspiration tube to a proximal portion and a second position to disable aspiration.

1 - 16 . (canceled) 
     
     
         17 . A method of treating gastrointestinal reflux disease comprising:
 providing a treatment device having a plurality of electrodes and an assembly having a disabler for disabling aspiration through an aspiration tube extending within the device, the disabler having a first position to enable aspiration from a distal portion of the aspiration tube to a proximal portion of the aspiration tube, the disabler movable to a second position to disable aspiration to facilitate axial and rotational movement of the treatment device within tissue and to limit undesired movement of tissue which can cause overtreatment of tissue and tissue ablation;   applying radiofrequency energy to the plurality of electrodes to thermally treat tissue below a tissue ablation threshold and create a plurality of tissue lesions along axially spaced tissue levels within the upper gastrointestinal tract;   monitoring tissue temperature throughout the applying of radiofrequency energy; and   regulating power ensuring in response to the monitoring of tissue temperature that the tissue temperature does not exceed a predetermined value which would cause tissue ablation and/or tissue necrosis.   
     
     
         18 . The method for  claim 17 , further comprising the step of sliding a mechanism to selectively cover and uncover an opening in a sidewall of the aspiration tube. 
     
     
         19 . The method of  claim 17 , further comprising the step of moving a mechanism radially inwardly to deform a wall of the aspiration tube. 
     
     
         20 . The method of  claim 17 , wherein the plurality of electrodes each have a non-penetrating tip substantially conical in configuration to deform the tissue when advanced into contact with tissue. 
     
     
         21 . The method of  claim 17 , wherein in the first position an opening in the aspiration tube is closed to enable aspiration and in the second position the opening in the aspiration tube is open to disable aspiration. 
     
     
         22 . The method of  claim 21 , wherein the opening is in a sidewall of the aspiration tube. 
     
     
         23 . The method of  claim 17 , wherein the plurality of electrodes are maintained in axial alignment when advanced from the treatment device. 
     
     
         24 . The method of  claim 23 , wherein tips of the plurality of electrodes are maintained at equidistant radial spacing when advanced from the treatment device. 
     
     
         25 . The method of  claim 17 , wherein aspiration is disabled without having to shut off a vacuum. 
     
     
         26 . The method of  claim 17 , wherein aspiration is disabled at a handle section of the treatment device. 
     
     
         27 . A method of treating gastrointestinal reflux disease in a patient comprising:
 providing a treatment device having an expandable basket assembly, a plurality of electrodes movable from a retracted position within the basket assembly to an extended position extending from the basket assembly and an assembly having a disabler for disabling aspiration through an aspiration tube, the disabler having a first position to enable aspiration from a distal portion of the aspiration tube to a proximal portion of the aspiration tube, the disabler movable to a second position to disable aspiration to facilitate axial and rotational movement of the treatment device within tissue and to limit undesired movement of tissue to prevent overtreatment and tissue ablation;   advancing the plurality of electrodes from the basket assembly;   applying radiofrequency energy to the plurality of electrodes to thermally treat tissue below a tissue ablation threshold and create a plurality of tissue lesions at a first tissue level of a plurality of axially spaced tissue levels within an upper gastrointestinal tract of the patient;   monitoring tissue temperature throughout the application of radiofrequency energy;   regulating power ensuring in response to the monitoring of tissue temperature that the tissue temperature does not exceed a predetermined value which would cause tissue ablation and/or tissue necrosis;   disabling aspiration while the vacuum remains on and subsequently moving the treatment device axially to a second tissue level of the axially spaced tissue levels, the disabling of aspiration releasing tissue which could otherwise be pulled to the second tissue level,   advancing the plurality of electrodes at the second tissue level; and   applying radiofrequency energy to the plurality of electrodes to thermally treat tissue at the second tissue level below a tissue ablation threshold and create a plurality of tissue lesions at the second tissue level within the upper gastrointestinal tract of the patient.   
     
     
         28 . The method of  claim 27 , wherein the user can disable and enable aspiration at a handle region of the treatment device. 
     
     
         29 . The method of  claim 27 , wherein disabling suction releases any tissue hugging the treatment device to avoid unwanted movement of tissue during axial movement of the device to treat a next axially spaced tissue level. 
     
     
         30 . The method of  claim 27 , further comprising the step of locking the disabler in position. 
     
     
         31 . The method of  claim 27 , wherein the plurality of electrodes are maintained in axial alignment by a spacer within the treatment device. 
     
     
         32 . The method of  claim 27 , wherein the basket assembly includes a balloon collapsible for movement of the treatment device. 
     
     
         33 . The method of  claim 32 , wherein aspiration is disabled at a handle section of the treatment device.