# US 7,347,875 B2 · Methods of treatment using a bariatric sleeve > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,347,875 B2 - Document ID: US7347875B2 - Status: Granted - Kind: B2 - Application number: 11/001,794 - Filed: 2004-11-30 - Published: 2005-04-14 - Granted: 2008-03-25 - Earliest claimed: 2002-12-02 - Assignees: GI Dynamics, Inc. - Inventors: Andy H. Levine; John Cvinar - Web page: https://patentgrep.com/patent/US7347875B2 ## CPC - A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves} - A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)} - A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery} - A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)} - A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus} - 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 2/07: Stent-grafts - A61F 2/848: having means for fixation to the vessel wall, e.g. barbs - A61F 2/90: characterised by a net-like or mesh-like structure - A61F 5/0089: {Instruments for placement or removal} - A61B 2017/00238: {Type of minimally invasive operation (A61B2017/00805 takes precedence)} - A61B 2017/0084: {low friction (A61B2017/00853 takes precedence)} - A61B 2017/00867: {shape memory effect} - A61B 2017/0419: {H-fasteners} - A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle} - A61B 2017/061: {hollow or tubular} - A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes - A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts - A61F 2002/044: {Oesophagi or esophagi or gullets} - A61F 2002/045: {Stomach, intestines} - A61F 2002/075: {the stent being loosely attached to the graft material, e.g. by stitching} - A61F 2002/8483: {Barbs} - A61F 2002/8486: {provided on at least one of the ends} - A61F 2002/9528: {for retrieval of stents} - A61F 2210/0076: multilayered, e.g. laminated structures - A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes - A61F 2250/0039: differing in diameter - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal. ## Claims ### Claim 1 A method of treatment comprising the steps of: anchoring a stent within the digestive system, the stent comprising a network of struts and coupled to a proximal portion of a flexible, floppy sleeve, open at both ends, the stent comprising barbs that are inserted into muscle as the sleeve anchor expands to anchor the proximal portion of the sleeve; and extending the flexible, floppy sleeve within the intestine, a distal portion of the flexible, floppy sleeve extending beyond the stent and being unsupported; wherein the flexible sleeve is anchored distal to or within the pylorus; and wherein the sleeve is thin and conformable so that it collapses in the intestine to a small volume. ### Claim 2 (depends on 1) The method of treatment of claim 1, wherein the flexible sleeve is anchored distal to the pylorus. ### Claim 3 (depends on 1) The method of treatment of claim 1, wherein the anchoring step comprises anchoring the stent within the pyloric orifice. ### Claim 4 (depends on 1) The method of treatment of claim 1, wherein the stent is collapsible. ### Claim 5 (depends on 1) The method of treatment of claim 1, wherein the stent is covered by a proximal portion of the sleeve. ### Claim 6 (depends on 5) The method of treatment of claim 5, wherein the stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve. ### Claim 7 (depends on 1) The method of treatment of claim 1, wherein the sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of Treitz. ### Claim 8 (depends on 1) The method of treatment of claim 1, wherein the sleeve is formed of a fluoropolymer. ### Claim 9 (depends on 1) The method of treatment of claim 1, wherein the sleeve is formed of expanded polytetrafluoroethylene. ### Claim 10 (depends on 9) The method of treatment of claim 9, wherein the sleeve is coated with a coat of silicone. ### Claim 11 (depends on 9) The method of treatment of claim 9, wherein the sleeve is coated with a coat of polyurethane. ### Claim 12 (depends on 1) The method of treatment of claim 1, wherein the sleeve is formed of polyethylene. ### Claim 13 (depends on 1) The method of treatment of claim 1, wherein the distal end of the sleeve is directionally textured. ### Claim 14 (depends on 1) The treatment of claim 1, further comprising anchoring the proximal portion of the sleeve with barbs extending from the exterior surface of the stent into tissue. ### Claim 15 (depends on 14) The method of treatment of claim 14, wherein the barbs comprise pairs of barbs that are outwardly directed and in opposite, axial directions. ### Claim 16 (depends on 15) The method of treatment of claim 15, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach. ### Claim 17 (depends on 15) The method of claim 15, wherein the barbs are at a proximal end of the stent. ### Claim 18 (depends on 14) The method of treatment of claim 14, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction. ### Claim 19 (depends on 1) The method of treatment of claim 1, further comprising coupling an anti-buckling device to the sleeve to reduce buckling of the sleeve. ### Claim 20 (depends on 19) The method of claim 19, wherein the anti-buckling device extends from below the stent to the distal end of the flexible sleeve. ### Claim 21 (depends on 19) The method of claim 19, wherein the anti-buckling device reduces twisting of the sleeve. ### Claim 22 (depends on 1) The method of treatment of claim 1, further comprising causing enzymes secreted in the duodenum to pass through the duodenum outside of the extended sleeve. ### Claim 23 (depends on 1) The method of treatment of claim 1, wherein the flexible sleeve and stent are delivered to the intestine using an esophageal catheter. ### Claim 24 (depends on 1) The method of treatment of claim 1, wherein the flexible sleeve and stent are removed through the esophagus. ### Claim 25 (depends on 1) The method of treatment of claim 1, wherein the flexible sleeve extends into the duodenum. ### Claim 26 (depends on 1) The method of treatment of claim 1, wherein the sleeve has a coefficient of friction of less than 0.2. ### Claim 27 (depends on 1) The method of treatment of claim 1, wherein the anchoring step further comprises: placing the stent within the pyloric orifice; and holding the pylorus open using the stent. ### Claim 28 (depends on 27) The method of treatment of claim 27, further comprising coupling an anti-buckling device to the sleeve to reduce buckling of the sleeve. ### Claim 29 (depends on 28) The method of treatment of claim 28, wherein the anti-buckling device extends from below the sleeve anchor to the distal end of the flexible sleeve. ### Claim 30 (depends on 28) The method of claim 28, wherein the anti-buckling device reduces twisting of the sleeve. ### Claim 31 (depends on 1) The method of claim 1, wherein the sleeve is at least one foot in length. ### Claim 32 A method of treatment comprising the steps of: anchoring within the digestive system a proximal portion of a flexible, floppy, sleeve, open at both ends, and coupled to a collapsible sleeve anchor, the sleeve anchor comprising barbs that are inserted into muscle as the sleeve anchor expands to anchor the proximal portion of the sleeve; and extending the flexible, floppy sleeve within the intestine, a distal portion of the flexible floppy sleeve extending beyond the sleeve anchor and being unsupported; wherein the sleeve anchor is a stent; wherein the sleeve is anchored distal to or within the pylorus; and the sleeve is thin and conformable so that it collapses in the intestine to a small volume. ### Claim 33 (depends on 32) The method of treatment of claim 32, wherein the flexible sleeve is anchored distal to the pylorus. ### Claim 34 (depends on 32) The method of treatment of claim 32, wherein the anchoring step further comprises: placing the collapsible sleeve anchor within the pyloric orifice; and holding the pylorus open using the collapsible sleeve anchor. ### Claim 35 (depends on 32) The method of treatment of claim 32, wherein the sleeve anchor is covered by a proximal portion of the sleeve. ### Claim 36 (depends on 35) The method of treatment of claim 35, wherein the sleeve anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve. ### Claim 37 (depends on 32) The method of treatment of claim 32, wherein the sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of Treitz. ### Claim 38 (depends on 32) The method of treatment of claim 32, wherein the sleeve material has a coefficient of friction of less than 0.2. ### Claim 39 (depends on 32) The method of treatment of claim 32, wherein the sleeve is formed of a fluoropolymer. ### Claim 40 (depends on 32) The method of treatment of claim 32, wherein the sleeve is formed of expanded polytetrafluoroethylene. ### Claim 41 (depends on 40) The method of treatment of claim 40, wherein the sleeve is coated with a coat of silicone. ### Claim 42 (depends on 40) The method of treatment of claim 40, wherein the sleeve is coated with a coat of polyurethane. ### Claim 43 (depends on 32) The method of treatment of claim 32, wherein the sleeve is formed of polyethylene. ### Claim 44 (depends on 32) The method of treatment of claim 32, wherein the distal end of the sleeve is directionally textured. ### Claim 45 (depends on 32) The method of treatment of claim 32, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach. ### Claim 46 (depends on 32) The method of treatment of claim 32, wherein the barbs comprise pairs of barbs that are outwardly directed and in opposite, axial directions. ### Claim 47 (depends on 46) The method of claim 46, wherein the barbs are at a proximal end of the anchor. ### Claim 48 (depends on 32) The method of treatment of claim 32, wherein a first plurality of barbs are oriented in a proximal direction and a second plurality of barbs are oriented in a distal direction. ### Claim 49 (depends on 32) The method of treatment of claim 32, wherein the sleeve causes enzymes secreted in the duodenum to pass through the duodenum outside the sleeve. ### Claim 50 (depends on 32) The method of treatment of claim 32, wherein the flexible sleeve and sleeve anchor are delivered to the intestine using an esophageal catheter. ### Claim 51 (depends on 32) The method of treatment of claim 32, wherein the flexible sleeve and sleeve anchor are removed through the esophagus. ### Claim 52 (depends on 32) The method of treatment of claim 32, wherein the flexible sleeve extends into the duodenum. ### Claim 53 (depends on 32) The method of claim 32, wherein the sleeve is at least one foot in length. ### Claim 54 A method of treatment comprising the steps of: anchoring with an anchoring mechanism within the gastrointestinal tract a flexible, floppy, sleeve, open at both ends, the anchoring mechanism being a stent and the stent comprising barbs that are inserted into muscle as the stent expands to anchor a proximal portion of the sleeve; and extending the flexible, floppy sleeve into the intestine, the sleeve having a coefficient of friction of less than about 0.2, a distal portion of the flexible floppy sleeve extending beyond the anchoring mechanism and being unsupported; wherein the sleeve is anchored distal to or within the pylorus; and the sleeve is thin and conformable so that it collapses in the intestine to a small volume. ### Claim 55 (depends on 54) The method of claim 54, wherein the extended sleeve limits absorption of nutrients in the duodenum. ### Claim 56 (depends on 54) The method of treatment of claim 54, wherein the stent comprises a network of struts that is anchored within the pyloric orifice. ### Claim 57 (depends on 54) The method of treatment of claim 54, wherein the sleeve is formed of a fluoropolymer. ### Claim 58 (depends on 54) The method of treatment of claim 54, wherein the fluoropolymer is expanded polytetrafluoroethylene. ### Claim 59 (depends on 58) The method of claim 58 wherein the sleeve is anchored distal to the pylorus. ### Claim 60 (depends on 54) The method of claim 54, wherein the sleeve is at least one foot in length. ### Claim 61 (depends on 54) The method of claim 54 wherein the sleeve is anchored distal to the pylorus.