GASTROINTESTINAL IMPLANT DELIVERY SYSTEMS AND METHODS
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.