Esophageal ablation technology

Abstract

An esophageal ablation system including a positioner, an elongated, flexible shaft extending from the positioner, and a microwave emitter assembly disposed near the distal end of the shaft. The emitter assembly includes one or more microwave antennae and a balloon tor spacing the antennae relative to target tissue. The device may have an inner balloon for deploying the antenna. The systems, devices and methods disclosed are useful for treating Barrett's Esophagus, Esophageal Adenocarcinoma, and Squamous Cell Carcinoma.

The invention claimed is: 
     
         1 . An microwave thermal ablation system for human medical therapy, comprising:
 a microwave generator;   at least one microwave emitter communicatively connected to the microwave generator, the microwave emitter being adapted to being inserted into the body of a patient;   a medical balloon inflation means; and   a positioning balloon connected to the balloon inflation means and to the at least one microwave emitter for holding the at least one microwave emitter in a desired position relative to a target tissue or tissues within the body of a patient.   
     
     
         2 . The microwave thermal ablation system of  claim 1 , wherein the microwave generator provides 17-18 GHz frequency power to the at least one microwave emitter via a power line. 
     
     
         3 . The microwave thermal ablation system of  claim 1 , wherein the at least one microwave emitter is selected from the group of emitters consisting of coaxial antenna, planar antenna, patch type, tri-axial antenna, slot antenna, helical antenna, bow-tie antenna, dipole antenna, broad band antennas and narrow band antennas. 
     
     
         4 . The microwave thermal ablation system of  claim 3 , wherein the at least one emitter is constructed, and arranged of a plurality of individual emitters in an array. 
     
     
         5 . The microwave thermal ablation system of  claim 3 , wherein the at least one emitter is single, direct fed, patch type antenna that has a radius curved surface. 
     
     
         6 . The microwave thermal ablation system of  claim 3  wherein the balloon inflation means provides a one way or reversible gas or liquid fluid to the positioning balloon via a fluid conduit. 
     
     
         7 . The microwave thermal ablation system of  claim 1 , wherein the positioning balloon is disposed on a catheter having at least one lumen for power connection between the microwave generator and the at least one microwave emitter, and fluid communication between the balloon inflation means and the positioning balloon. 
     
     
         8 . The microwave thermal ablation system of  claim 7 , wherein the positioning balloon is disposed around the at least one microwave emitter. 
     
     
         9 . The microwave thermal ablation system of  claim 8 , whereby, in use, (a) the catheter is inserted into a patient's body with the balloon in an uninflated state, (b) the at least one microwave emitter and surrounding positioning balloon are moved to a desired position near target tissue that is to be thermally ablated, (c) the positioning balloon is inflated to a desired diameter, (d) the at least one microwave emitter is held in a fixed position near the target tissue by the positioning balloon, and (e) microwave power is delivered from the microwave generator to the at least one microwave for a predetermined period of time, at a predetermined frequency and at a predetermined phase. 
     
     
         10 . The microwave thermal ablation system of  claim 9 , wherein the predetermined time, frequency, and/or phase is modulated. 
     
     
         11 . The microwave thermal ablation system of  claim 8 , wherein the at least one microwave antenna is disposed in a fixed position on the catheter, whereby the at least one microwave antenna is at least generally centrally disposed within the positioning balloon. 
     
     
         12 . The microwave thermal ablation system of  claim 8 , wherein the at least one microwave antenna is movable away from the catheter when, in use, the positioning balloon is in an inflated state. 
     
     
         13 . The microwave thermal ablation system of  claim 12 , wherein the system further comprises an emitter deployment balloon connected to the catheter and disposed within the positioning balloon, the emitter deployment balloon being constructed and arranged to be inflatable to move the at least one microwave emitter a predetermined distance away from the catheter, whereby the at least one microwave emitter is disposed off center relative to a central axis of the catheter/positioning balloon assembly, and thereby closer to one portion of the circumferential wall of the inflated positioning balloon. 
     
     
         14 . The microwave thermal ablation system of  claim 13 , wherein the catheter includes an emitter deployment balloon inflation fluid lumen communicatively extending from the emitter deployment balloon to the balloon inflation means. 
     
     
         15 . The microwave thermal ablation system of  claim 12 , wherein the system further comprises an extendable scaffolding assembly connected to the catheter and to the at least one microwave emitter, and disposed within the positioning balloon, the scaffolding system having a low profile, non-extended state where the at least one microwave emitter is disposed near the center axis of the catheter and an extended state to move the at least one microwave emitter a predetermined distance away from the catheter, whereby the at least one microwave emitter is disposed off center relative to a central axis of the catheter/positioning balloon assembly, and thereby closer to one portion of the circumferential wall of the inflated positioning balloon. 
     
     
         16 . The microwave thermal ablation system of  claim 15 , wherein the scaffolding assembly comprises a centering bottom link connected to the catheter, a mandrel connected to the centering bottom link, a pull link connected to the mandrel, a pair of pivotable expansion links connected at their lower ends to the centering bottom link and the pull link, and an antenna mount connected to the upper ends of the expansion link. 
     
     
         17 . The microwave thermal ablation system of  claim 16 , wherein the catheter includes (a) a tip extending distally away from the positioning balloon, (b) the tip having a central lumen open to the distal end of the system, and (c) a telescoping slide shaft is disposed on the central lumen of the distal tip and connecting the distal end of the centering bottom link. 
     
     
         18 . The microwave thermal ablation system of  claim 1 , further comprising a catheter shaft including (a) at least power line electrically connecting the microwave generator and the at least one microwave generator, and (b) at least one lumen communicatively fluidly connecting the balloon inflation means and the positioning balloon, the at least one microwave emitter and the positioning balloon being coupled to the catheter shaft at a predetermined position, the catheter shaft being adapted to being inserted into the body of a patient and for translating the at least one microwave emitter and the positioning balloon within and through the patient's body. 
     
     
         19 . The microwave thermal ablation system of  claim 18 , further comprising a handle connected to a proximal, end of the catheter shaft. 
     
     
         20 . The microwave thermal ablation system of  claim 8 , further comprising means to visually track the position of the at least one microwave emitter in the patient's body during use of the system. 
     
     
         21 . The microwave thermal ablation system of  claim 20 , wherein the means to visually track includes the positioning balloon being at least partially constructed of material that is transparent to users during radiographic and/or endoscopic visualization. 
     
     
         22 . The microwave thermal ablation system of  claim 1 , wherein at least a portion of the positioning balloon is constructed of material that shields microwave radiation. 
     
     
         23 . The microwave thermal ablation system of  claim 1  further comprising at least one sensor selected from the group consisting of thermocouples, temperature sensors, and thermistors. 
     
     
         24 . The microwave thermal ablation system of  claim 1  for use to treat Barrett's Esophageal cells via non-contact dielectric heating. 
     
     
         25 . An microwave thermal ablation system for use in treating Barrett's Esophageal ceils via non-contact dielectric heating, comprising:
 a. a microwave generator for providing 915 MHz to 20 GHz microwave energy;   b. at least one microwave emitter communicatively connected to the microwave generator, the microwave emitter being adapted to being inserted into the body of a patient;   c. a medical balloon inflation means;   d. a positioning balloon connected to the balloon inflation means and to the at least one microwave emitter for holding the at least one microwave emitter in a desired position relative to a target tissue or tissues within the body of a patient, the positioning balloon being disposed around the at least one microwave emitter; and   e. a catheter shaft including:
 ii) at least power line electrically connecting the microwave generator and the at least one microwave generator, and 
 (ii) at least one lumen communicatively fluidly connecting the balloon inflation means and the positioning balloon, 
   
       the at least one microwave emitter and the positioning balloon being coupled to the catheter shaft at a predetermined position, the catheter shaft being adapted to being inserted into the body of a patient and for translating the at least one microwave emitter and the positioning balloon within and through the patient's body. 
     
     
         26 . A microwave thermal ablation method for human medical therapy, comprising the steps of:
 a. providing a system including
 i. a microwave generator; 
 ii. at least one microwave emitter communicatively connected to the microwave generator, the microwave emitter being adapted to being inserted into the body of a patient; 
 iii. a medical balloon inflation means; 
 iv. a positioning balloon connected to the balloon inflation means and to the at least one microwave emitter for holding the at least one microwave emitter in a desired position relative to a target tissue or tissues within the body of a patient; and 
 v. wherein the positioning balloon is disposed on a catheter having at least one lumen for power connection between the microwave generator and the at least one microwave emitter, and fluid communication between the balloon inflation means and the positioning balloon; 
   b. inserting the catheter into a patient's body with the balloon in an uninflated state,   c. moving the at least one microwave emitter and surrounding positioning balloon to a desired position near target tissue that is to be thermally ablated,   d. inflating the positioning balloon to a desired diameter, thereby holding the at least one microwave emitter in a fixed position near the target tissue by the positioning balloon, and   e. delivering microwave power from the microwave generator to the at least one microwave for a predetermined period of time, at a predetermined frequency and at a predetermined phase.