| CPC A61B 18/04 (2013.01) [A61B 2018/0072 (2013.01); A61B 2018/00261 (2013.01); A61B 2018/00345 (2013.01); A61B 2018/00488 (2013.01); A61B 2018/00494 (2013.01); A61B 2018/00541 (2013.01); A61B 2018/00577 (2013.01); A61B 2018/00744 (2013.01); A61B 2018/00982 (2013.01); A61B 2018/048 (2013.01)] | 19 Claims |
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1. A multi-stage method for treating at least one of excess weight, obesity, eating disorders, metabolic syndrome, dyslipidemia, diabetes, polycystic ovarian disease, fatty liver disease, non-alcoholic fatty liver disease, or non-alcoholic steatohepatitis disease by ablating duodenal tissue using a vapor ablation system, wherein the vapor ablation system comprises a controller having at least one processor in data communication with at least one pump and a catheter connection port in fluid communication with the at least one pump, the multi-stage method comprising:
connecting a proximal end of a first catheter to the catheter connection port to place the first catheter in fluid communication with the at least one pump, wherein the first catheter comprises at least first and second positioning elements positioned at first and second attachment points, respectively, on the catheter and separated along a length of the first catheter and at least two ports positioned between the at least first and second positioning elements, wherein each of the at least first and second positioning elements are of wire mesh cone or disc, and wherein each of the at least first and second positioning elements has a first configuration and a second configuration, and wherein, in the first configuration, each of the at least first and second positioning elements is compressed within the first catheter and in the second configuration, each of the at least first and second positioning elements is expanded to be at least partially outside the first catheter;
positioning the first catheter inside a patient such that, upon being expanded into the second configuration, a distal one of the at least first and second positioning elements is positioned within in the patient's small intestine and a proximal one of the at least first and second positioning elements is proximally positioned more than 1 cm from the distal one of the at least first and second positioning elements;
expanding each of the at least first and second positioning elements into their second configurations;
activating the controller, wherein, upon activation, the controller is configured to cause the at least one pump to deliver saline into at least one lumen in the first catheter and, wherein, upon activation, the controller is configured to cause an electrical current to be delivered to at least one electrode positioned within the at least one lumen of the first catheter at a place different from said attachment points of the at least first and second positioning elements to the first catheter;
delivering vapor through ports positioned in the first catheter between the at least first and second positioning elements, wherein said delivering vapor comprises delivering a first amount of vapor for less than a therapeutic time, waiting a period of time to permit an edema to form, and, after said edema is formed, delivering a second amount of vapor for the therapeutic time to ablate duodenal tissue;
using the controller, shutting off the delivery of saline and electrical current;
removing the first catheter from the patient to complete a first stage of treating;
waiting for at least six weeks;
determining an efficacy of the first phase of treatment;
depending on the determined efficacy, connecting a proximal end of a second catheter to the catheter connection port to place the second catheter in fluid communication with the at least one pump, wherein the second catheter comprises at least third and fourth positioning elements positioned at third and fourth attachment points, respectively, on the catheter and separated along a length of the second catheter and at least two ports positioned between the at least third and fourth positioning elements, wherein each of the at least third and fourth positioning elements are of wire mesh cone or disc, and wherein each of the at least third and fourth positioning elements has a first configuration and a second configuration, and wherein, in the first configuration, each of the at least third and fourth positioning elements is compressed within the second catheter and in the second configuration, each of the at least third and fourth positioning elements is expanded to be at least partially outside the second catheter;
positioning the second catheter inside a patient such that, upon being expanded into the second configuration, a distal one of the at least third and fourth positioning elements is positioned within in the patient's small intestine and a proximal one of the at least third and fourth positioning elements is proximally positioned more than 1 cm from the distal one of the at least third and fourth positioning elements;
expanding each of the at least third and fourth positioning elements into their second configurations;
activating the controller, wherein, upon activation, the controller is configured to cause the at least one pump to deliver saline into at least one lumen in the second catheter and, wherein, upon activation, the controller is configured to cause an electrical current to be delivered to at least one electrode positioned within the at least one lumen of the second catheter at a place different from said attachment points of the at least third and fourth positioning elements to the second catheter;
delivering vapor through ports positioned in the second catheter between the at least third and fourth positioning elements;
using the controller, shutting off the delivery of saline and electrical current; and
removing the second catheter from the patient to complete a second stage of treatment.
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