Endoscopic Lead Implantation Method

Abstract

A method of implanting electrically conductive leads in the gastrointestinal musculature for stimulation of target tissues involves an endoscopic approach through the esophagus. An endoscope is inserted into the esophagus of a patient. The mucosal surface of the anterior esophagus is punctured in the region encompassing the lower esophageal sphincter (LES). A tunnel is created through the submucosa and exits at the muscularis propria, adventitia, or serosal side of the stomach. The lead is navigated further to the anterior abdominal wall. A first end of the lead remains within the gastrointestinal musculature while a second end of the lead is positioned just outside the anterior abdominal wall. The first end of the lead comprises at least one electrode. An implantable pulse generator (IPG) is implanted and operably connected to the second end of the lead to provide electrical stimulation to target tissues.

1 . A method of implanting electrically conductive leads proximal to a gastrointestinal musculature of a patient utilizing an endoscopic approach, comprising the steps of:
 inserting an endoscope into a gastrointestinal tract of a patient;   identifying a gastrointestinal structure comprising said gastrointestinal musculature;   entering a gastrointestinal (GI) wall with an electrically conductive lead from a mucosal side by puncturing a mucosa of an anterior segment of a region proximal to the gastrointestinal structure;   creating a tunnel in a submucosa of the anterior segment of the region encompassing the gastrointestinal structure, the tunnel exiting the GI wall through a muscularis propria, adventitia, or serosal side of the gastrointestinal tract of the patient;   navigating the lead through the tunnel to an anterior abdominal wall; and   exiting a second end of the lead through the anterior abdominal wall while leaving a first end of the lead proximal to the gastrointestinal musculature of the patient within the tunnel, wherein the region encompassing the gastrointestinal structure comprises an area 3 cm above and 3 cm below the gastrointestinal structure.   
     
     
         2 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , wherein said tunnel created in the submucosa of the anterior segment of the gastrointestinal structure is less than 5 cm in length. 
     
     
         3 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , wherein said tunnel created in the submucosa of the anterior segment of the gastrointestinal structure is within the range of 1 cm to 5 cm in length. 
     
     
         4 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , wherein said first end of said lead is not anchored to a gastrointestinal tissue. 
     
     
         5 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , wherein said first end of said lead is anchored to a gastrointestinal tissue. 
     
     
         6 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , wherein said leads are adapted to electrically stimulate the gastrointestinal musculature in an amount effective to treat any one or combination of obesity and gastroesophageal reflux disease (GERD). 
     
     
         7 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , further comprising using magnetic, ultrasound, radiologic, or fluoroscopic imaging, or physical indicators, mechanical indicators, or auditory indicators, in addition to visual imaging to assist in lead navigation. 
     
     
         8 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 1 , further comprising subcutaneously implanting an implantable pulse generator (IPG) proximate the lead exit point in the anterior abdominal wall. 
     
     
         9 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 8 , further comprising attaching said second end of said lead with said IPG so that said lead can receive pulse signals from said IPG. 
     
     
         10 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 8 , further comprising using wireless communication to transmit pulse signals from said IPG to said lead. 
     
     
         11 . A method of implanting electrically conductive leads proximal to a gastrointestinal musculature of a patient utilizing an endoscopic approach, comprising the steps of:
 inserting an endoscope into a gastrointestinal tract of a patient;   identifying a gastrointestinal structure comprising said gastrointestinal musculature;   entering the gastrointestinal (GI) wall with an electrically conductive lead from a mucosal side by puncturing the mucosa of an anterior segment of a region proximal to the gastrointestinal structure;   creating a tunnel in the submucosa of the anterior segment of the region encompassing the gastrointestinal structure, the tunnel exiting the GI wall through the serosal side of the gastrointestinal tract of the patient;   navigating the lead through the tunnel to the anterior abdominal wall; and   exiting a second end of the lead through the anterior abdominal wall while leaving a first end of the lead proximal to the gastrointestinal musculature of the patient within the tunnel, wherein the region encompassing the gastrointestinal structure comprises an area 3 cm above and 3 cm below the gastrointestinal structure.   
     
     
         12 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , wherein the tunnel created in the submucosa of the anterior segment of the gastrointestinal structure is equal to or greater than 5 cm in length. 
     
     
         13 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , wherein said first end of said lead is not anchored to a gastrointestinal tissue. 
     
     
         14 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , wherein said first end of said lead is anchored to a gastrointestinal tissue. 
     
     
         15 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , further comprising a step of insufflating the stomach. 
     
     
         16 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , further comprising the steps of:
 finding a site where the stomach is in cross-approximation with the anterior abdominal wall;   securing the stomach with one or more anchors;   exiting the serosal surface of the stomach proximate said site; and   entering an anterior abdominal wall proximate said site.   
     
     
         17 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , wherein said leads are used to electrically stimulate the gastrointestinal musculature in a therapeutically effective amount to treat any one or combination of obesity and gastroesophageal reflux disease (GERD). 
     
     
         18 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , further comprising using magnetic, ultrasound, radiologic, or fluoroscopic imaging, or physical indicators, mechanical indicators, or auditory indicators, in addition to visual imaging to assist in lead navigation. 
     
     
         19 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 11 , further comprising subcutaneously implanting an implantable pulse generator (IPG) proximate the lead exit point in the anterior abdominal wall. 
     
     
         20 . The method of implanting electrically conductive leads in a gastrointestinal musculature utilizing an endoscopic approach of  claim 19 , further comprising attaching said second end of said lead with said IPG so that said lead can receive pulse signals from said IPG. 
     
     
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