# US 11,026,826 B2 · Flanged gastrointestinal devices and methods of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,826 B2 - Document ID: US11026826B2 - Status: Granted - Kind: B2 - Application number: 16/073,661 - Filed: 2017-01-30 - Published: 2019-01-31 - Granted: 2021-06-08 - Earliest claimed: 2016-01-29 - Assignees: GI Dynamics, Inc. - Applicants: GI Dynamics, Inc. - Inventors: Paul Dicesare; Jeffrey P. Radziunas; Ronald L. Green; Dominick L. Mastri; Scott Schorer; Nicholas Williams - Web page: https://patentgrep.com/patent/US11026826B2 ## CPC - A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves} - A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95) - A61F 5/00: Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices (bandages, dressings or absorbent pads A61F13/00) {; Anti-rape devices} - A61F 5/0089: {Instruments for placement or removal} - A61M 29/00: Dilators with or without means for introducing media, e.g. remedies - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - A61F 2002/045: {Stomach, intestines} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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. ## Claims ### Claim 1 A gastrointestinal device comprising: (a) a sleeve configured to carry fluid from its proximal end to its distal end, wherein its proximal end is configured to be at or proximal to a subject's pyloric orifice and its distal end is configured to be at or distal to the subject's duodenum; (b) an anchor connected to the sleeve, the anchor configured to be retained within a duodenal bulb; and (c) a flange positioned proximal to the anchor, the flange configured to resist distal migration of the gastrointestinal device, wherein a coupling liner connects the anchor to the sleeve at a sleeve-coupling interface, wherein a relaxed diameter of the anchor is greater than a maximum diameter of the sleeve at the sleeve-coupling interface; or wherein the anchor is configured to exert an outward radial force on the sleeve at the sleeve-coupling interface, wherein the outward radial force on the sleeve at the sleeve-coupling interface is configured to maintain the sleeve in an open configuration at the sleeve-coupling interface, wherein the sleeve-coupling interface is at or distal to the distal-most end of the anchor or wherein the sleeve-coupling interface is from 1-6 inches distal to the flange. ### Claim 2 (depends on 1) The gastrointestinal device of claim 1, wherein the anchor is a wave anchor. ### Claim 3 (depends on 2) The gastrointestinal device of claim 2, further comprising a drawstring attached to the wave anchor, the drawstring configured to exert an inward radial force on a proximal end of the wave anchor when pulled proximally. ### Claim 4 (depends on 1) The gastrointestinal device of claim 1, wherein the flange is directly connected to the proximal end of the sleeve or the flange and the sleeve are made from a polymeric liner, wherein all or a portion of the sleeve is thinner than the polymeric liner of the flange. ### Claim 5 (depends on 4) The gastrointestinal device of claim 4, wherein the polymeric liner is selected from the group consisting of polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), fluorinated ethylene propylene (FEP), perfluoroalkoxy (PFA), ethylene tetrafluoroethylene (ETFE), and polyvinylidene fluoride (PVDF). ### Claim 6 (depends on 1) The gastrointestinal device of claim 1, wherein the flange is a circular flange having a maximum outer diameter that is at least 100% greater than a diameter of the sleeve. ### Claim 7 (depends on 1) A method of implanting the gastrointestinal device of claim 1, the method comprising attaching the flange to a proximally oriented luminal surface proximal to the pyloric orifice. ### Claim 8 (depends on 1) A method of treating a metabolic disorder, the method comprising implanting the gastrointestinal device of claim 1 by attaching the flange to a proximally oriented luminal surface proximal to the pyloric orifice. ### Claim 9 (depends on 8) The method of claim 8, wherein the metabolic disorder is type 2 diabetes or wherein the metabolic disorder is non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), or obesity. ### Claim 10 (depends on 8) The method of claim 8, wherein the proximally oriented luminal surface is a proximal surface of the pyloric sphincter or an antral surface of a stomach. ### Claim 11 (depends on 8) The method of claim 8, wherein the attaching is performed endoscopically or comprises transmission of a distal force from an attachment element to the proximally oriented luminal surface. ### Claim 12 (depends on 11) The method of claim 11, wherein the attaching comprises puncturing a gastrointestinal wall. ### Claim 13 (depends on 11) The method of claim 11, wherein the attachment element comprises a suture or a staple. ### Claim 14 (depends on 1) A method of removing the gastrointestinal device of claim 1, the method comprising: (a) disengaging the flange from a proximally oriented luminal surface proximal to the pyloric orifice; (b) pulling a drawstring attached to the anchor, the drawstring configured to exert an inward radial force on a proximal portion of the anchor when pulled proximally; and (c) retracting the anchor into a retrieval catheter.