Gi Dynamics, Inc.

Barry Maxwell

David A Melanson

Andy H Levine

Richard A Gambale

Peter J Shank

Andres Chamorro, Iii

John Panek

Ian K Parker

Christopher Nutting

Ronald B Lamport

Andres Chamorro

James H Loper

Scott Schorer

Ryan Hanlon

Nicholas Williams

Nicholas Cote

Sean K Holmes

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.

Gastrointestinal implant delivery systems and methods

A gastrointestinal implant device () comprises a planar proximal element () configured to reside in a stomach to resist distal migration, a distal element () configured to reside in an intestine to resist proximal migration and one or more tethers () coupling the planar proximal element to the distal element.

Transpyloric anchoring

An implant includes a collapsible anchor to be deployed within a lumen and a protrusion coupled to the anchor. The protrusion, in a constrained state, extends a distance from an exterior surface of the anchor and, in an unconstrained state, extends further from the exterior surface of the anchor. Also included is a biodegradable constraint, such as a biodegradable tube or suture, configured to maintain the protrusion in the constrained state until the constraint releases. The implant may include additional biodegradable constraints, each constraint configured to maintain the protrusion in a different constrained state and to degrade over a different predetermined period after the implant has been deployed within the lumen. The protrusion may include a bi-directional barb or an open loop. The protrusion may be configured to penetrate a wall of the lumen and to allow tissue to grow about the protrusion. The implant may also include an unsupported, thin-walled sleeve coupled to the anchor and configured to extend into the lumen upon deployment of the collapsible anchor.

Anchors with biodegradable constraints

A gastrointestinal implant device comprises a planar proximal element configured to reside in a stomach to resist distal migration, a distal element configured to reside in an intestine to resist proximal migration and one or more tethers coupling the planar proximal element to the distal element.

An implant () includes a protrusion () with an open or rounded loop () (or open head) connected to a collapsible anchor. The protrusion may include a straight length of wire () or a helical length wire, with one or more wire loops () at the end of the length forming the loop. Upon deployment within the gastrointestinal tract, the protrusion expands from a collapsed state, alongside the anchor, to a relaxed state, in which the protrusion extends outward from the anchor. As the protrusion expands to its relaxed state, it pushes the loop into the wall of the duodenum, causing the loop to penetrate the duodenal wall. A pocket of scar tissue forms about the head and possibly through an opening in the head, securing the anchor within the duodenum. The implant may also include a thin-walled sleeve that is coupled to the anchor and extended from the anchor into the intestine.

Anchors with open heads

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Spencer, MA, United States of America

Barry Maxwell