Segmented gastrointestinal devices and methods of use thereof
Inventors
Schorer, Scott • Thompson, Chris
Assignees
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Publication Number
US-11684502-B2
Publication Date
2023-06-27
Expiration Date
Abstract
A gastrointestinal device and methods of use thereof for the treatment of metabolic disorders is provided. The gastrointestinal device features disintegrable sleeve configured to fit within a patient's duodenum and to carry fluid (e.g., liquid or semisolid material, for example, chyme and digestive secretions) from its proximal end to its distal end.
Core Innovation
The invention relates to a gastrointestinal device that includes a disintegrable sleeve having a proximal end and a distal end. The disintegrable sleeve is configured to fit within the patient’s duodenum and carry fluid from the proximal end to the distal end, and it is designed to disintegrate in situ to produce segment separation as it erodes.
The disintegrable sleeve includes a plurality of non-erodible segments connected by one or more erodible portions. As erosion occurs at the erodible portion(s) and/or the connected structure, the non-erodible segments separate, and the one or more erodible portions and/or the plurality of non-erodible segments are polygonal.
The described geometry and materials support controlled separation, including non-erodible segment materials formed from fluoropolymer options and erodible portions formed from biodegradable polymers and related copolymers. The sleeve can include additional device features such as an anchoring system and an eversion resistant element, and the patent associates this segmented, delayed-separation architecture with metabolic-disorder treatment by modulating fluid movement and contact within the gut, including an incretin effect and modulation of gut hormones such as PYY, CCK, and ghrelin.
Claims Coverage
The document contains one independent claim defining the disintegrable, segmented gastrointestinal sleeve for duodenum placement and controlled separation via erosion, plus dependent claims that further specify polygonal form, segment connectivity, material selections, proportional geometry constraints, and optional anchoring/securement features. The independent claim includes inventive features centered on the duodenum-sized sleeve carrying fluid with non-erodible polygonal segments connected by erodible portions whose erosion causes separation.
Duodenum fit disintegrable sleeve carrying fluid
A gastrointestinal device comprising a disintegrable sleeve comprising a proximal end and a distal end, the disintegrable sleeve configured to fit within the patient's duodenum and carry fluid from the proximal end to the distal end.
Non-erodible segments connected by erodible portions
The disintegrable sleeve comprises a plurality of non-erodible segments connected by one or more erodible portions, wherein erosion of the one or more erodible portions causes the plurality of non-erodible segments to separate.
Polygonal erodible and/or non-erodible features
The one or more erodible portions and/or the plurality of non-erodible segments are polygonal.
Non-erodible fluoropolymer segment material selection
The gastrointestinal device includes erodible portions made from a material selected from PLA, PGA, diolamine, trimethylene carbonate, caprolactone, or copolymers thereof and the non-erodible segments are selected from PTFE, ePTFE, FEP, PFA, EFTE, or PVDF.
Erodible portion dimensional constraints relative to non-erodible segments
The gastrointestinal device is configured so that the erodible portions have a longitudinal width that is no more than 10% of the width of the non-erodible segments and the erodible portions have a thickness that is at least 5% less than the non-erodible segments.
Anchoring system to secure the sleeve
The gastrointestinal device further includes an anchoring system that secures the sleeve to a patient's gastrointestinal tract.
Overall, the claims focus on a duodenum-fitted disintegrable sleeve carrying fluid, where non-erodible segments connected by erodible portions separate upon erosion, including polygonal segment/portion configurations. Dependent claim refinements specify fluoropolymer and biodegradable polymer material selections, proportional width and thickness constraints between erodible and non-erodible parts, and optional securement via an anchoring system.
Stated Advantages
Erosion of erodible portions causes separation of non-erodible segments.
Device is configured to fit within the patient’s duodenum and carry fluid from the proximal end to the distal end.
Documented Applications
Treatment of metabolic disorders including type 2 diabetes, NASH, NAFLD, and obesity via a segmented gastrointestinal device configured for placement in the duodenum/upper small intestine.
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