Flanged gastrointestinal devices and methods of use thereof

Inventors

DiCesare, Paul • Radziunas, Jeffrey P. • Green, Ronald L. • Mastri, Dominick L. • Schorer, Scott • Williams, Nicholas

Assignees

Morphic Medical Inc

Abstract

The present invention provides gastrointestinal devices for limiting transfer and contact of material across luminal walls along a segment of the gastrointestinal tract (e.g., at the duodenum and/or upper jejunum). Devices of the invention include a gastrointestinal sleeve, an anchor, and a flange for attachment to a luminal wall proximal to the pyloric orifice. The invention also provides methods of use associated with such gastrointestinal devices, including methods for delivery, removal, and treatment of metabolic disorders, such as type 2 diabetes, non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, obesity, and related comorbidities thereof by implanting gastrointestinal devices.

Core Innovation

The invention relates to flanged gastrointestinal implant devices and associated coupling structures configured to deliver fluid from a stomach proximal end to a duodenal distal end. A sleeve has a proximal end configured to be at or proximal to a pyloric orifice and a distal end configured to be at or distal to a duodenum. The device includes an anchor connected to the sleeve, wherein the anchor is configured to be retained within a duodenal bulb.

A flange is positioned proximal to the anchor and is configured to resist distal migration of the gastrointestinal device. The anchor is connected to the sleeve at a sleeve-coupling interface by a coupling liner. The coupling between the anchor and sleeve is configured either by a relaxed diameter of the anchor greater than a maximum diameter of the sleeve at the sleeve-coupling interface, or by an anchor exerting an outward radial force on the sleeve at the sleeve-coupling interface.

The outward radial force is configured to maintain the sleeve in an open configuration at the sleeve-coupling interface, with the sleeve-coupling interface positioned at or distal to the distal-most end of the anchor or positioned from 1-6 inches distal to the flange. The described design provides pyloric opening functionality by short duodenal-bulb anchoring while limiting distal migration and material transfer across luminal walls.

From the background and summary context, the problem is to alter gut hormone signaling and digestion/absorption by delivering stomach chyme and digestive secretions from the stomach proximal to the pyloric orifice to the duodenum/upper jejunum. The device is positioned to target metabolic disorders including type 2 diabetes, non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), and obesity and related comorbidities by mechanisms including delayed digestion/carbohydrate absorption and reduced bile mixing.

Claims Coverage

Independent claim coverage centers on a gastrointestinal device combining a sleeve, a duodenal bulb-retained anchor, and a proximal flange that resists distal migration, with an anchor-to-sleeve coupling liner that either uses a relaxed-diameter relationship or uses outward radial force to maintain an open sleeve configuration at a defined sleeve-coupling interface location. One independent claim is identified from the provided content.

Across the independent claim, the core inventive coverage is the combination of pyloric-proximal sleeve delivery, duodenal-bulb retention by an anchor, and a proximal flange that resists distal migration, with anchor-to-sleeve coupling via a coupling liner that maintains an open sleeve configuration either through a relaxed-diameter relationship or through outward radial force at a defined sleeve-coupling interface location.

Stated Advantages

Documented Applications