Devices and methods for endolumenal gastrointestinal bypass

Abstract

The present invention provides devices and methods for attachment of an endolumenal gastrointestinal device, such as an artificial stoma device, a gastrointestinal bypass sleeve or other therapeutic or diagnostic device, within a patient's digestive tract. In one application of the invention, an endolumenal bypass sleeve is removably attached in the vicinity of the gastroesophageal junction to treat obesity and/or its comorbidities, such as diabetes. The bypass sleeve may be at least partially deployed by eversion.

What is claimed is: 
     
         1 . A method of treating a patient, comprising the steps of:
 providing a gastrointestinal sleeve device having an elongate tubular body, with a proximal end and a distal end;   positioning the gastrointestinal sleeve device in the patient's digestive tract such that the proximal end of the tubular body is positioned in the vicinity of the gastroesophageal junction to receive ingested material from the patient's esophagus and the distal end of the tubular body is positioned in the patient's intestine; and   securing the proximal end in the vicinity of the gastroesophageal junction, and   everting the sleeve to position the distal end within the intestine   
     
     
         2 . A method of treating a patient as in  claim 1 , wherein the securing step comprises advancing at least four tissue anchors through the tissue wall and positioning a retention surface on each tissue anchor in contact with the serosal surface 
     
     
         3 . A method of treating a patient as in  claim 2 , wherein the tissue anchor comprises a connecting element for connecting the retention surface to the sleeve device, and the length of the connecting element is at least about 75% of the uncompressed wall thickness. 
     
     
         4 . A method of treating a patient as in  claim 3 , wherein the length of the connecting element is at least about 95% of the uncompressed wall thickness. 
     
     
         5 . A method of treating a patient as in  claim 3 , wherein the length of the connecting element is at least about 125% of the uncompressed wall thickness. 
     
     
         6 . A method of treating a patient as in  claim 1 , wherein the tubular body is impermeable such that the tubular body acts as an internal intestinal bypass. 
     
     
         7 . A method of treating a patient as in  claim 1 , wherein the providing step comprises providing the tubular body with a stoma in the vicinity of the proximal end. 
     
     
         8 . A method of treating a patient as in  claim 1 , wherein the everting step comprises everting the tubular body such that the distal end is positioned at least as far as the patient's jejunum. 
     
     
         9 . A method of treating a patient as in  claim 1 , wherein the everting step comprises everting the tubular body such that the distal end is positioned at least about 100 cm past the pylorus. 
     
     
         10 . A method of treating a patient as in  claim 1 , wherein the providing step comprises providing a sleeve having a substantially constant diameter throughout its length. 
     
     
         11 . A method of treating a patient as in  claim 1 , wherein the providing step comprises providing a sleeve having a funnel-shaped entry on the proximal end. 
     
     
         12 . A system for treating a patient, comprising:
 a gastrointestinal attachment cuff having a tubular body, a proximal end and a distal end; and   a gastrointestinal bypass sleeve at least partially inverted within itself, and adapted for eversion within the gastrointestinal tract.   
     
     
         13 . An endolumenal gastric bypass system, comprising:
 an elongate, flexible filler tube, having a proximal end and a distal end; and   an elongate, flexible gastric bypass sleeve, having a proximal end and a distal end;   wherein the proximal end of the bypass sleeve is removably attached to the distal end of the filler tube.   
     
     
         14 . An endolumenal gastric bypass system as in  claim 13 , wherein the filler tube is at least about 30 cm long. 
     
     
         15 . An endolumenal gastric bypass system as in  claim 13 , wherein the filler tube is at least about 50 cm long. 
     
     
         16 . An endolumenal gastric bypass system as in  claim 14 , wherein the bypass sleeve is at least about 75 cm long. 
     
     
         17 . An endolumenal gastric bypass system as in  claim 13 , wherein the distal end of the bypass sleeve is proximally retracted into the filler tube. 
     
     
         18 . An endolumenal gastric bypass system as in  claim 17 , further comprising a source of media for everting the distal end of the bypass sleeve out of the filler tube. 
     
     
         19 . An endolumenal gastric bypass system as in  claim 18 , further comprising an attachment cuff, configured for attachment in the vicinity of the gastroesophageal junction. 
     
     
         20 . An endolumenal gastric bypass system as in  claim 19 , wherein the attachment cuff comprises a first connector and the bypass sleeve comprises a second connector for facilitating connection between the bypass sleeve and the cuff.