Gastrointestinal implant delivery systems and methods
Inventors
Cote, Nicholas • Hanlon, Ryan • Lamport, Ronald B. • Maxwell, Barry • Panek, John • Parker, Ian K. • Schorer, Scott • Williams, Nicholas
Assignees
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Publication Number
US-11318008-B2
Publication Date
2022-05-03
Expiration Date
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.
Core Innovation
The invention relates to a delivery system for placing a gastrointestinal implant in a gastrointestinal tract of a patient. The delivery system includes a delivery catheter having a lumen and a container assembly at a distal portion of the delivery catheter, the container assembly including a proximal capsule and a distal cap removably attachable to the proximal capsule.
The gastrointestinal implant includes a sleeve configured to carry fluid from its proximal end to its distal end, and an anchor connected to the sleeve at or near its proximal end. The implant is sized and 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.
The container assembly further comprises an anchor locking mechanism within the proximal capsule. The described positioning allows the container assembly to be directed into the gastrointestinal tract, the proximal anchor to be secured to a luminal wall, and peristalsis to extend an elongate distal portion, with the distal cap containing all or part of the elongate distal portion after the proximal anchor is secured.
Claims Coverage
The partial content includes three independent claims, covering a delivery system and methods of positioning the gastrointestinal implant. Across these independent claims, the inventive features focus on the configured fit of the implant within the proximal capsule and distal cap, an anchor locking mechanism, and peristalsis-driven extension of an elongate distal portion after securing the proximal anchor.
Proximal capsule and distal cap container assembly fit
A delivery system where a container assembly at a distal portion of a delivery catheter includes a proximal capsule and a distal cap removably attachable thereto, and the gastrointestinal implant fits within the container assembly such that the anchor fits within the proximal capsule and a portion of the sleeve fits within the distal cap.
Anchor locking mechanism in the proximal capsule
The container assembly further comprises an anchor locking mechanism within the proximal capsule.
Peristalsis-driven extension after luminal anchoring
A method where a container assembly containing a gastrointestinal implant is directed into the patient’s gastrointestinal tract, the proximal anchor is secured to a luminal wall of the gastrointestinal tract, and peristalsis is allowed to extend an elongate distal portion, thereby positioning the gastrointestinal implant.
Proximal anchor ejected while distal portion retained in distal cap
A method where, after directing the container assembly into the gastrointestinal tract, the proximal anchor is ejected from the proximal capsule while the elongate distal portion is retained within the distal cap, then allowing the proximal anchor to secure to a luminal wall and peristalsis to extend the elongate distal portion.
Overall, the independent claims establish a delivery system using a proximal capsule and distal cap container assembly with an anchor locking mechanism, and methods that position the implant by anchoring the proximal anchor to a luminal wall and using peristalsis to extend an elongate distal portion, including an ejection and retention variant.
Stated Advantages
Reduced procedure time.
Fewer adverse effects.
No need for manual distal catheter extension of the sleeve.
Potentially reduced fluoroscopy.
Documented Applications
Treating metabolic diseases including type 2 diabetes, NASH, NAFLD, and obesity using a gastrointestinal implant delivery system.
Modulating incretin effect, including GLP-1 and GIP, and producing effects related to appetite and fat digestion, including PYY, CCK, and ghrelin, in the treatment context described.
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