Gastrointestinal implant delivery systems and methods

Abstract

The present invention provides delivery systems for positioning a gastrointestinal implant in a patient, for example, for treatment of a metabolic disease. Also provided are methods for assembling the delivery systems, methods of positioning a gastrointestinal implant, and methods of treatment of metabolic diseases, such as type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), obesity, and related comorbidities thereof.

1 . A delivery system for placing a gastrointestinal implant in a gastrointestinal tract of a patient, the delivery system comprising:
 (a) a delivery catheter comprising a lumen;   (b) a container assembly at the distal portion of the delivery catheter, the container assembly comprising a proximal capsule and a distal cap removably attachable thereto; and   (c) a gastrointestinal implant comprising: (i) a sleeve configured to carry fluid from its proximal end to its distal end; and (ii) an anchor connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract;   wherein the gastrointestinal implant is configured to fit within the container assembly such that the anchor fits within the proximal capsule and a portion of the sleeve fits within the distal cap.   
     
     
         2 - 6 . (canceled) 
     
     
         7 . The delivery system of  claim 1 , wherein the distal cap is an atraumatic material. 
     
     
         8 . The delivery system of  claim 7 , wherein the atraumatic material is silicone. 
     
     
         9 - 15 . (canceled) 
     
     
         16 . The delivery system of  claim 1 , wherein the container assembly further comprises an ejection mechanism. 
     
     
         17 . The delivery system of  claim 16 , wherein the ejection mechanism is a plunger. 
     
     
         18 - 38 . (canceled) 
     
     
         39 . A method of positioning a gastrointestinal implant in a patient, the method comprising the steps of:
 (a) providing a container assembly containing a gastrointestinal implant, the gastrointestinal implant comprising a proximal anchor and an elongate distal portion, wherein the container assembly comprises:
 (i) a proximal capsule containing the proximal portion of the gastrointestinal implant, and 
 (ii) a distal cap containing all or part of the elongate distal portion; 
   (b) directing the container assembly into the patient's gastrointestinal tract;   (c) securing the proximal anchor to a luminal wall of the gastrointestinal tract; and   (d) allowing peristalsis to extend the elongate distal portion;   thereby positioning the gastrointestinal implant.   
     
     
         40 . The method of  claim 39 , wherein step (c) is initiated by ejecting the gastrointestinal implant and the distal cap from the proximal capsule. 
     
     
         41 . A method of positioning a gastrointestinal implant in a patient, the method comprising the steps of:
 (a) providing a container assembly containing a gastrointestinal implant, the gastrointestinal implant comprising a proximal anchor and an elongate distal portion, wherein the container assembly comprises:
 (i) a proximal capsule containing the proximal portion of the gastrointestinal implant, and 
 (ii) a distal cap containing all or part of the elongate distal portion; 
   (b) directing the container assembly into the patient's gastrointestinal tract;   (c) ejecting the proximal anchor from the proximal capsule while the elongate distal portion is retained within the distal cap; and   (d) allowing:
 (i) the proximal anchor to secure to a luminal wall of the gastrointestinal tract; and 
 (ii) peristalsis to extend the elongate distal portion; 
   thereby positioning the gastrointestinal implant in the patient.   
     
     
         42 - 52 . (canceled) 
     
     
         53 . The method of  claim 39 , wherein the distal cap is an atraumatic material. 
     
     
         54 . The method of  claim 53 , wherein the atraumatic material is silicone. 
     
     
         55 - 61 . (canceled) 
     
     
         62 . The method of  claim 39 , wherein the container assembly further comprises an ejection mechanism. 
     
     
         63 . The method of  claim 62 , wherein the ejection mechanism is a plunger. 
     
     
         64 - 84 . (canceled) 
     
     
         85 . A method of assembling a delivery system, the method comprising the steps of:
 (a) providing a gastrointestinal implant comprising: (i) a sleeve configured to carry fluid from its proximal end to its distal end; and (ii) an anchor connected to the sleeve at or near its proximal end, the anchor configured to secure the proximal end of the sleeve within the gastrointestinal tract;   (b) inserting the anchor within a proximal capsule, the proximal capsule connected to a distal portion of a delivery catheter;   (c) inserting a portion of the sleeve within a distal cap; and   (d) attaching the proximal end of the distal cap to the distal end of the proximal capsule;   thereby assembling the delivery system.   
     
     
         86 - 89 . (canceled) 
     
     
         90 . The method of  claim 85 , wherein the distal cap is an atraumatic material. 
     
     
         91 . The method of  claim 90 , wherein the atraumatic material is silicone. 
     
     
         92 - 121 . (canceled) 
     
     
         122 . A method of treating a metabolic disorder, the method comprising positioning a gastrointestinal implant using the methods of  claim 39 . 
     
     
         123 . The method of  claim 122 , wherein the metabolic disorder is type 2 diabetes. 
     
     
         124 . The method of  claim 122 , wherein the metabolic disorder is non-alcoholic steatohepatitis (NASH). 
     
     
         125 . The method of  claim 122 , wherein the metabolic disorder is obesity.