Methods and devices for intragastric support of functional or prosthetic gastrointestinal devices

Abstract

Disclosed herein are systems and methods for attaching or maintaining the position of a therapeutic or diagnostic device in a body lumen, such as the GI tract without necessarily requiring any penetrating attachments through any body walls. The system can include at least two elements: a proximal orientation element and a distal support element. The proximal orientation element can be configured to reside at least partially within the esophageal lumen and the distal support element can be configured to reside in the stomach, such as along the greater curve of the stomach.

1 . An intragastric support system comprising:
 a proximal orientation element having a proximal end and a distal end, wherein the proximal orientation element has a diameter sized to fit within the lumen of an esophagus; wherein the long axis of the proximal orientation element is configured to be substantially parallel with the long axis of the esophagus; and   a distal support element configured to reside non-circumferentially against only a portion of the stomach cavity; wherein the distal support element is transformable from a first configuration where a long axis of the distal support element is configured to be substantially parallel with the long axis of the proximal orientation element during delivery to a second configuration where the long axis of the distal support element is configured to be not substantially parallel with the long axis of the proximal orientation element when implanted in the body, wherein the support system is configured such that the proximal end of the proximal orientation element is in the esophagus and the distal end of the proximal orientation element is in the stomach when implanted in the body, wherein a longitudinal dimension of the distal support element is no more than about a longitudinal dimension of the proximal orientation element.   
     
     
         2 . The intragastric support system of  claim 1 , wherein the longitudinal dimension of the distal support element is no more than about 70% of the longitudinal dimension of the proximal orientation element. 
     
     
         3 . The intragastric support system of  claim 1 , wherein the longitudinal dimension of the distal support element is no more than about 60% of the longitudinal dimension of the proximal orientation element. 
     
     
         4 . The intragastric support system of  claim 1 , wherein the longitudinal dimension of the distal support element is no more than about 50% of the longitudinal dimension of the proximal orientation element. 
     
     
         5 . The intragastric support system of  claim 1 , further comprising a gastrointestinal bypass sleeve. 
     
     
         6 . The intragastric support system of  claim 1 , wherein the distal support element comprises a drug reservoir. 
     
     
         7 . The intragastric support system of  claim 1 , wherein the proximal orientation element comprises a rounded proximal head to prevent esophageal trauma. 
     
     
         8 . The intragastric support system of  claim 1 , wherein the proximal orientation element has a variable-length cross section. 
     
     
         9 . The intragastric support system of  claim 1 , wherein the proximal orientation element comprises a plurality of strut members. 
     
     
         10 . The intragastric support system of  claim 1 , wherein the distal support element is transformable between a first reduced configuration and a second expanded configuration. 
     
     
         11 . An intragastric support system comprising:
 a proximal orientation element having a proximal end and a distal end, wherein the proximal orientation element has a diameter sized to fit within the lumen of an esophagus; wherein the long axis of the proximal orientation element is configured to be substantially parallel with the long axis of the esophagus;   a distal support element configured to reside non-circumferentially against only a portion of the stomach cavity; and   a joint configured to pivotably couple the proximal orientation element to the distal support element,   wherein the distal support element is transformable from a first configuration where a long axis of the distal support element is configured to be substantially parallel with the long axis of the proximal orientation element during delivery to a second configuration where the long axis of the distal support element is configured to be not substantially parallel with the long axis of the proximal orientation element when implanted in the body, wherein the support system is configured such that the proximal end of the proximal orientation element is in the esophagus and the distal end of the proximal orientation element is in the stomach when implanted in the body.   
     
     
         12 . The intragastric support system of  claim 11 , wherein the joint comprises a ball-and-socket joint. 
     
     
         13 . The intragastric support system of  claim 11 , wherein the joint comprises a hinged joint. 
     
     
         14 . The intragastric support system of  claim 11 , wherein the joint is a uniaxial joint. 
     
     
         15 . A method for treating a patient, comprising:
 providing an intragastric support system, the system comprising a proximal orientation element having a proximal end and a distal end, a distal support element, and a food collecting ring;   inserting the proximal orientation element and the distal support element into a gastrointestinal tract lumen, wherein a long axis of the proximal orientation element is substantially parallel to a long axis of the distal support element;   positioning the system such that the proximal end of the proximal orientation element is within the esophagus of a patient and the distal support element is within the stomach of a patient; and   transforming the distal support element such that the long axis of the distal support element is not substantially parallel to the long axis of the proximal orientation element, wherein after the transforming step the distal support element resides non-circumferentially along less than the entirety of the wall of the stomach and a longitudinal dimension of the distal support element is no more than about a longitudinal dimension of the proximal orientation element.   
     
     
         16 . The method of  claim 15 , wherein transforming the distal support element is such that the long axis of the distal support element is substantially perpendicular to the long axis of the proximal orientation element. 
     
     
         17 . The method of  claim 15 , wherein the intragastric support system further comprises a joint configured to pivotably couple the distal support element to the proximal orientation element, the joint having a locked state to prevent movement of the distal support element with respect to the proximal orientation element. 
     
     
         18 . The method of  claim 15 , further comprising the step of:
 locking the joint at a position wherein a long axis of the proximal orientation element is at least substantially coaxial with a long axis of the distal support element during delivery; and   unlocking the joint to allow the distal support element to pivot within a range of motion with respect to the proximal orientation element when the distal support element is implanted in the stomach.