# US 10,864,352 B2 · Systems, devices and methods for the creation of a therapeutic restriction in the gastrointestinal tract > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,352 B2 - Document ID: US10864352B2 - Status: Granted - Kind: B2 - Application number: 16/267,771 - Filed: 2019-02-05 - Published: 2020-01-02 - Granted: 2020-12-15 - Earliest claimed: 2013-11-22 - Assignees: Fractyl Laboratories, Inc. - Applicants: Fractyl Laboratories Inc. - Inventors: Harith Rajagopalan; Jay Caplan; R. Maxwell Flaherty; J. Christopher Flaherty - Web page: https://patentgrep.com/patent/US10864352B2 ## CPC - A61M 25/0084: {being one or more injection needles} - A61F 5/0013: {Implantable devices or invasive measures} - A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves} - A61K 31/728: Hyaluronic acid - A61K 33/42: Phosphorus; Compounds thereof - A61K 35/33: Fibroblasts - A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39) - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61L 31/043: {Proteins; Polypeptides; Degradation products thereof} - A61L 31/048: {obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence)} - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/145: {Hydrogels or hydrocolloids} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 25/0082: {Catheter tip comprising a tool} - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - A61F 2005/0016: {comprising measuring means} - A61M 2025/0089: {Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip} - A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres} - A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body} - 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)} - 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) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A system for treating a patient comprises a delivery device and injectate. The delivery device comprises an elongate shaft with a distal portion and at least one delivery element positioned on the elongate shaft distal portion. The delivery device is constructed and arranged to deliver the injectate through the at least one delivery element and into tissue to create a therapeutic restriction in the gastrointestinal tract. Methods of creating a therapeutic restriction are also provided. ## Claims ### Claim 1 A method of reducing a patient's weight, said method comprising: advancing a fluid delivery element to a location proximate a luminal segment of the gastrointestinal tract of the patient; and delivering an injectate through the delivery element and into tissue proximate the luminal segment to create a therapeutic restriction in the luminal segment; wherein the luminal segment is located in the patient's proximal or distal small intestine; wherein the patient experiences a loss of weight in response to the therapeutic restriction. ### Claim 2 (depends on 1) The method of claim 1, wherein the therapeutic restriction is constructed and arranged to restrict the passage of food through a portion of the gastrointestinal tract of the patient. ### Claim 3 (depends on 1) The method of claim 1, wherein the therapeutic restriction is constructed and arranged to cause at least one of: early satiety; premature satiety; or satiety. ### Claim 4 (depends on 1) The method of claim 1, wherein the therapeutic restriction is constructed and arranged to alter an absorptive property and/or a secretive property of the gastrointestinal tract of the patient. ### Claim 5 (depends on 1) The method of claim 1, wherein the therapeutic restriction is created by injecting a volume of injectate of at least 1.0 mL. ### Claim 6 (depends on 5) The method of claim 5, wherein the therapeutic restriction is created by injecting a volume of injectate of at least 3.0 mL. ### Claim 7 (depends on 1) The method of claim 1, wherein the therapeutic restriction is created by injecting a volume of injectate of no more than 20.0 mL. ### Claim 8 (depends on 7) The method of claim 7, wherein the therapeutic restriction is created by injecting a volume of injectate of no more than 10.0 mL. ### Claim 9 (depends on 1) The method of claim 1, wherein at least 50% of the injectate remains in the patient at least one month after being delivered into tissue. ### Claim 10 (depends on 9) The method of claim 9, wherein at least 50% of the injectate remains in the patient at least three months after being delivered into tissue. ### Claim 11 (depends on 10) The method of claim 10, wherein at least 50% of the injectate remains in the patient at least six months after being delivered into tissue. ### Claim 12 (depends on 11) The method of claim 11, wherein at least 50% of the injectate remains in the patient at least one year after being delivered into tissue. ### Claim 13 (depends on 1) The method of claim 1, wherein the injectate comprises ethylene vinyl alcohol. ### Claim 14 (depends on 13) The method of claim 13, wherein the injectate further comprises dimethyl sulfoxide. ### Claim 15 (depends on 13) The method of claim 13, wherein the injectate further comprises a second material constructed and arranged to polymerize the ethylene vinyl alcohol. ### Claim 16 (depends on 13) The method of claim 13, wherein the injectate further comprises saline. ### Claim 17 (depends on 1) The method of claim 1, wherein the injectate comprises a peptide polymer. ### Claim 18 (depends on 1) The method of claim 1, wherein the injectate comprises polylactic acid. ### Claim 19 (depends on 1) The method of claim 1, wherein the injectate comprises polymethylmethacrylate. ### Claim 20 (depends on 1) The method of claim 1, wherein the injectate comprises a hydrogel. ### Claim 21 (depends on 1) The method of claim 1, wherein the therapeutic restriction comprises an inner diameter less than or equal to 10 mm. ### Claim 22 (depends on 21) The method of claim 21, wherein the therapeutic restriction comprises an inner diameter less than or equal to 5 mm. ### Claim 23 (depends on 21) The method of claim 21, wherein the therapeutic restriction comprises an inner diameter less than or equal to 4 mm. ### Claim 24 (depends on 21) The method of claim 21, wherein the therapeutic restriction comprises an inner diameter less than or equal to 2 mm. ### Claim 25 (depends on 21) The method of claim 21, wherein the therapeutic restriction comprises an inner diameter less than or equal to 1 mm. ### Claim 26 (depends on 1) The method of claim 1, wherein the therapeutic restriction comprises an inner diameter that is between 1% and 50% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction. ### Claim 27 (depends on 26) The method of claim 26, wherein the therapeutic restriction comprises an inner diameter that is between 1% and 20% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction. ### Claim 28 (depends on 26) The method of claim 26, wherein the therapeutic restriction comprises an inner diameter that is between 1% and 10% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction. ### Claim 29 (depends on 26) The method of claim 26, wherein the therapeutic restriction comprises an inner diameter that is between 1% and 5% of the inner diameter of the luminal segment prior to creation of the therapeutic restriction. ### Claim 30 (depends on 1) The method of claim 1, wherein the delivery element comprises multiple delivery elements positioned on an expandable element. ### Claim 31 (depends on 30) The method of claim 30, wherein the multiple delivery elements are circumferentially spaced. ### Claim 32 (depends on 1) The method of claim 1, wherein the delivery element comprises a first delivery element advanced toward a first luminal segment of the gastrointestinal tract of the patient and wherein the injectate comprises a first injectate delivered through the first delivery element and into tissue proximate the first luminal segment to create a first therapeutic restriction in the first lumen segment, the method further comprising: advancing a second delivery element to a location proximate a second luminal segment of the gastrointestinal tract of the patient; and delivering a second injectate through the second delivery element and into tissue proximate the second luminal segment to create a second therapeutic restriction in the second luminal segment. ### Claim 33 (depends on 32) The method of claim 32, wherein the second therapeutic restriction and the first therapeutic restriction are created on the same day. ### Claim 34 (depends on 32) The method of claim 32, wherein the second therapeutic restriction is created at least one week after the creation of the first therapeutic restriction. ### Claim 35 (depends on 32) The method of claim 32, wherein the second therapeutic restriction is positioned at least 5 mm from the first therapeutic restriction. ### Claim 36 (depends on 1) The method of claim 1, wherein the luminal segment is located in at least one of the patient's duodenum and proximal jejunum. ### Claim 37 (depends on 1) The method of claim 1, wherein the luminal segment is located in at least one of the patient's distal jejunum and ileum.