WO2004049982B1 - Bariatric sleeve - Google Patents

Bariatric sleeve

Info

Publication number
WO2004049982B1
WO2004049982B1 PCT/US2003/038238 US0338238W WO2004049982B1 WO 2004049982 B1 WO2004049982 B1 WO 2004049982B1 US 0338238 W US0338238 W US 0338238W WO 2004049982 B1 WO2004049982 B1 WO 2004049982B1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
implant device
gastrointestinal implant
anchor
treatment
Prior art date
Application number
PCT/US2003/038238
Other languages
French (fr)
Other versions
WO2004049982A3 (en
WO2004049982A2 (en
WO2004049982A9 (en
Inventor
Andy H Levine
John F Cvinar
Dave Melanson
John C Meade
Original Assignee
Gi Dynamics Inc
Andy H Levine
John F Cvinar
Dave Melanson
John C Meade
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32475346&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2004049982(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US10/339,786 external-priority patent/US7025791B2/en
Application filed by Gi Dynamics Inc, Andy H Levine, John F Cvinar, Dave Melanson, John C Meade filed Critical Gi Dynamics Inc
Priority to JP2004570987A priority Critical patent/JP4980569B2/en
Priority to EP03796559.7A priority patent/EP1569582B1/en
Priority to BR0316956-1A priority patent/BR0316956A/en
Priority to AU2003298801A priority patent/AU2003298801B9/en
Priority to CA2512203A priority patent/CA2512203C/en
Publication of WO2004049982A2 publication Critical patent/WO2004049982A2/en
Publication of WO2004049982A9 publication Critical patent/WO2004049982A9/en
Publication of WO2004049982A3 publication Critical patent/WO2004049982A3/en
Publication of WO2004049982B1 publication Critical patent/WO2004049982B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089—Instruments for placement or removal
    • A—HUMAN NECESSITIES
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    • A61B2017/00238—Type of minimally invasive operation
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    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/061—Needles, e.g. needle tip configurations hollow or tubular
    • A—HUMAN NECESSITIES
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    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044—Oesophagi or esophagi or gullets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045—Stomach, intestines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8483—Barbs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract

Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device (200) 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 (208) for anchoring the device to the stomach and a flexible sleeve (202) to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Claims

AMENDED CLAIMS
[Received by the International Bureau on 20 October 2004 (20.10.04): original claims 1-126 replaced by amended/new claims 1-132; (16 pages)]
A gastrointestinal implant device comprising: a flexible sleeve, open at both ends, and adapted to extend into the intestine lo limit absorption of nutrients in the intestine and a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to anchor the sleeve.
2. The gastrointestinal implant device of claim 1 , wherein the stent is retained within the pyloric orifice to hold the pylorus open,
3. The gastrointestinal implant device of claim 1, wherein the stent is collapsible,
4. The gastrointestinal implant device of claim 1 , wherein the stent is covered by a proximal portion of the sleeve.
5. The gastrointestinal implant device of claim 4, wherein the stent is sandwiched between a first inner laye of the sleeve and a second outer layer of the sleeve.
6, The gastrointestinal implant device 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 diistal end below the ligament of Treite.
7. The sastrointesti ial implant device of claim 1, wherein the sleeve material has a coefficient of friction of less than 0.2.
& The gastrointestinal implant device of claim 1, wherein the sleeve is formed of expanded polytetra hioroethyleπie,
9. The gastrointestinal implant device of claim 1, wherein the sleeve is formed of polyethylene.
JO, The gastrointestinal implant device of claim 8, wherein the sleeve is coated with silicons, 0
1 The gastrointestinal implant device of claim 8, wherein the sleeve js coated with polyurethane,
12. The gastrointestinal implant device of claim 1, wherein the distal end of the S sleeve is directionally textured.
13 , The gastrointestinal implant device of claim 1 further comprising barbs extending from the exterior surface of the stent adapted to anchor the proximal portion of the sleeve to muscle. 0
1 , The gastrointestinal implant device of claim 13, wherein the barbs are bidirectional.
15, The gaslrointcslmal implant device of claim 14, wherein the barbs are 5 adapted to anchor tho flexible sleeve to the pyloric muscle in the stomach.
16. The gastrointestinal implant device of claim 1 further comprising: an anti-buckling device coupled to the sleeve and extending from below the ste to the distal end of tho flexible sleeve to reduce buckling of 0 the sleeve.
17. The gastrointestinal implant device of claim 1 , wherein the sleeve allqws enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.
18. The gastrointestinal implant device of claim 1 in combmatlon with a catheter to insert the flexible sleeve.
ϊ 9. The gastrointestinal implant device of claim 1 in combination with a removal device to remove the flexible sleeve,
20, A gastrointestinal implant device comprising; a flexible sleeve, open at both ends, and adapted to extend into the intestine to limit absolution of nutrients in the intestine; and a collapsible anchor coupled to a proximal end of the sleeve, the anchor comprising barbs adapted for insertion into tissue as the anchor expands to anchor the proximal portion of the sleeve in the digestive tract.
21. The gastrointestinal implant device of claim 20, wherein the anchor is retained within the pylαric orifice to hold the pylorus open.
22, The gastrointestinal implant device of claim 20, wherein the anchor is covered by a proximal portion of the sleeve,
23. The gastrointestinal implant device of claim 22, wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.
24, The gastrointestinal implant device of claim 20, 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,
25. The gastrointestinal implant device of claim 20, wherein the sleeve material has a coefficient of friction of less than 0.2. 26, The gastrointestinal implant device of claim 20, wherein the sleeve is formed of expanded polytetrafluoroethylene,
27. The gastrointestinal implant evice of claim 20, wherein the sleeve is formed of polyethylene.
28. The gastrointestinal implant device of claim 26, wherein the sleeve is coated with silicone,
29. The gastrointestinal implant device of claim 26, wherein the sleeve is coated with polyurethane,
30. The gastrointestinal implant device of claim 20, wherein the distal end of the sleeve is dircctiϋnally textured.
31. The gastrointestinal implant device of claim 20, wherein the barbs are bidirectional.
32. The gastrointestinal implant device of claim 20, wherein the bnrbs arc adapted to anehor the flexible sleeve to muscle.
33. The gastrointestinal implant device of claim 20 further comprising; an anti-buckling device coupled to the sleeve and extending from below the anchor to the distal end of ihe flexible sleeve to reduce twisting of the sleeve,
34. The gastrointestinal implant device of claim 20, wherein the sleeve is adapted to allow enzymes secreted in the duodenum to pass through the duodenum outside the sleeve. 5, The gastrointestinal implant device of claim 20 in combination with a catheter to insert the flexible sleeve.
36. The gastrointestinal implant device of claim 20 in combination with a removal device to remove the flexible sleeve,
37. A method of treatment comprising the steps of: anchoring a stent in the digestive tract, the stent comprising a network of struts and coupled to a proximal portion of a flexible sleeve, open at both ends; and extending the flexible sleeve into the intestine to limit absorption of nutrients.
38. The method of treatment of claim 37, wherein the stent is retained within the pylorie orifice to hold the pylorus open,
39, The method of treatment of claim 37, wherein the stent is collapsible.
40, The method of treatment of claim 37, wherein the stent is covered by a proximal portion of the sleeve.
41 , The method of treatment of claim 40, wherein the Stent is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.
42, The method of treatment of claim 37, wherein the sleeve is of a length that chyme exiling the stomach funneled through the proximal end of lh© sleeve exits the sleeve through the distal end below the ligament of Treitz.
43. The method o f treatment of claim 37, wherein the sleeve is formed of expanded polytetrafluoroethylenc.
4. The method of treatment of claim 37, wherein the sleeve is formed of polyethylene,
45. Tho method of treatment of claim 43, wherein the sleeve is coated with siliconc.
46, The method of treatment of claim 43, wherein the sleeve is coated with pc-lyurethaπe.
47. The method of treatment of claim 37, wherein the distal end of the sleeve is directionally textured.
48 , The method of treatment of claim 37 further comprising: anchoring the proximal portion of the sleeve to the stomach with barbs extending from the exterior surface of the stent.
49. The method of treatment of claim 48, wherein the barbs are bi-directional.
50. The method of treatment of claim 49, wherein the barbs anchor the flexible sleeve to the pyloric muscle in the stomach.
51. The method of ircarmeri. of claim 37 further comprising: coupling an anti-buckHng device to the sleeve, the anti-buckling device extending from below the stent to the distal end of the flexible sleeve to reduce twisting of the sleeve.
52. The method of treatment of claim 37, wherein the sleeve allows enz es secreted in the duodenum to pass through the duodenum outside the sleeve. 3, The method of treatment of claim 37, wherein the flexible sleeve and anchor are applied to the stomach and taken from an esophageal cathcteT,
54. The method of treatment of claim 37, wherein the flexible sleeve and stent are removed through the esophogus.
55. A method of treatment comprising the steps of; anchoring a proximal portion of a flexible sleeve, open at both ends, and coupled to a collapsible anchor, the anchor comprising barbs for insertion into tissue as the anchor expands to anchor the proximal portion of the sleeve in the digestive tract; and extending the flexible sleeve into the intestine to limit absorption of nutrients.
56. The method of treatment of claim 55, wherein the anchor is retained within Ihe pyloric orifice to hold the pylorus open.
57. The method of treatment of claim 55, wherein the anchor is covered by a proximal portion of the sleeve.
58. The method of treatment of claim 57, wherein the anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleevςs.
59, The method of treatment of claim 55, wherein the sleeve is of a length that chyme exiting the stomach Tunneled through the proximal end of the sleeve exits the sleeve through the distal end below the ligament of TreiU,
60- The method of treatment of claim 55, wherein the sleeve material has a coefficient of friction of less than 0.2.
61. The method of treatment orclaim 55, wherein the sleeve is formed of expanded polytetrafluoroethylene.
62. The method of treatment of claim 55, wherein the sleeve is formed of polyethylene.
63. The method of treatment of claim 1 , wherein the sleeve is coated with silicons,
64. The method of treatment of claim 61 , wherein the sleeve is coated with polyurcthane,
65. The method of treatment of claim 55, wherein the distal end ofthc sleeve is directioπally textured.
66. The method of treatment of claim 20, wherein the barbs anchor the flexible sleeve to muscle,
67, The method of treatment of claim 55, wherein the barbs are bi-directional,
68 , The method of treatment of claim 55 further comprising: coupling an anti-buekling device to the sleeve, the sπti-buckling device extending from below the anchor to the distal end ofthc flexible sleeve to reduce twisting of the sleeve.
69, The method of troabnent of claim 55, wherein the sleeve allows enzymes secreted in tho duodenum to ass through the duodenum outside the sleeve.
70, The method of treatment of claim 55, wherein the flexible sleeve and anchor are applied to the stomach and broken from an esophageal catheter. 71 , The method of treatment of claim 55, wherein the flexible sleeve and stent are removed through the esσphogus,
72. A method of treating type 2 diabetes comprising: anchoring a flexible sleeve, open at both ends; and extending the flexible sleeve into the duodenum to limit absorption of nutrients in the duodenum.
73. The method of claim 72, wherein the sleeve is of a length that chyme exiting the stomach funneled through the proximal end of the slaavo oxits the sleeve through the distal end below the ligament of Treitz.
74. The method of claim 72, wherein the sleeve is formed of expanded pόlytolrafluoroethy ne.
75 , The method of claim 72, wherein the sleeve is foπned of polyethylene.
76, The method of claim 74, wherein the sleeve is coated with silicone.
77, The method of claim 74, wherein the sleeve i s coated with polyurcihanc.
78, Tho method of claim 72, wherein the distal end of the βleeve is direciioπally textured.
79, The method of claim 72 further comprising: coupling barbs to a collapsible anchor, the barbs extending from the exterior surface of the sleeve for anchoring the proximal portion of the sleeve to the stomach.
80, The method of claim 79, wherein the barbs arc bi-directional. 70
81. The method of claim 80, wherein the barbs anchor he flexible sleeve to the pyloric muscle in the stomach.
82. The method of claim 72 further comprising coupling an anti-buckling device to the sleeve, the anti-buckling device extending to the distal end o thc flexible sleeve to reduce twisting of the Sleeve,
S3. The method of claim 72, wherein the sleeve allows enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.
84. The method of claim 72 in combination with a catheter to insert the flexible sleeve.
85. The method of claim 72 in combination with a removal device to remove the flexible sleeve,
86. A delivery system for placing a gastrointestinal implant device in a body comprising: an outer sheath in the proximal portion of tho delivery system Tor storing a proximal portion of the gastrointestinal implant device, the proximal portion of the gastrointestinal implant device including an anchoring device adapted to anchor the device; an inner sheath within the uter sheath, the inner sheath extending beyond the outer sheath toward the distal end of the delivery system, a first lumen within the inner sheath for passing the outer sheath over a guidewirc and a seco d lumen within the inner sheath for moving a moyeable clement to secure the distal end of a sleeve coupled to the anchoring devico to the inner sheaili; a release mechanism to release the anchoring device from the outer sheath; and 71
a sleeve release mechanism coupled to the moveable element for releasing the distal end of the sleeve,
87. The delivery system of claim 86, wherein the moveable clement is a Sleeve retention wire, which exits the second lumen and pierces the distal end of the sleeve.
88, The dolivery system of claim 86, wherein the moveable element is a snare wire which captures the distal en of the sleeve.
89, Tho delivery system of claim 86, wherein the release mechanism pulls the outer sheath toward the proximal end of the delivery system to remove the outer sheath from the anchoring device,
90, The delivery system of claim 89, wherein the sleeve release m echanis pulls the moveable element toward the proximal end of tihe delivery system to release the distal end of the sleeve after the anchoring device has been released.
91. The delivery system of claim 86, wherein a distal portion of the sleeve stored In a pill for delivery and the distal portion of the sleeve is released from the pill by peristalsis,
92. The delivery system of claim 86, wherein a distal portion of the sleeve is stored in a dissolvable pill for delivery.
93, The delivery system of claim 86 further comprising: a spherical shaped element al the distal end of the delivery system, the spherical shaped clement held by the moveable element.
94. The delivery system of claim 93 wherein the element is remotely rclcasable. 72
S 95. The delivery system of claim 94, wherein the spherical shaped clement is attached to an element retention wire which is held by the moveable element.
96. The delivery system of claim 94, wherein the moveable element is looped through the spherical shaped element. 0
97. The delivery system of claim 94, wherein the distal end of the moveable clement is coiled and stored within the spherical shaped element,
98. The delivery system of claim 94, wherein the moveable element is held in an 5 S-shapcd track within the spherical shaped element.
99. The delivery system o f claim 86 further comprising: an expandable balloon at the distal end of the delivery system.
0 100, The delivery system of claim 86, wherein the inner sheath includes a third lumen through which a fluid is passed to release the sleeve from the distal end of the delivery device,
101. The delivery system of claim 94, wherein the sleeve release mechanism pulls 5 the moveable element toward the proximal end o thc delivery system to release the spherical shaped clement after tho anchoring device has been released,
102. A removal device for removing a gastrointestinal implant e ice from' the 0 body comprising: an outer sheath for storing a proximal portion o thc gastrointestinal implant device, the proximal portion o thc gastrointestinal implant dwicc including a self-expanding anchoring device adapted to anchor the implant device; and 35 an inner sheath within the outer sheath, a plurality of fingers extending from the distal end of the inner sheath, the fingers collapsing the 73
proximal end ofthc anchoring device to allow the anchoring device to be drawn into the outer sheath,
103. The removal device of claim 101, wherein the fingers collapse the slcnt by engaging the stent and pulling radially inward on the proximal end of the slcnt
104, The removal dovi e of claim 102, wherein the fingers pull radially inward as the inner sheath is moved over the fingers,
105, A gastrointestinal implant device comprising; a flexible sleeve, open at both ends, and adapted to extend into the intestine to limit absorption of nutrients in the intestine; and a collapsible anchor coupled to a proximal end o hc sleeve, the anchor comprising two spaced apart rings of differing diameters to anchor the proximal portion of the sleeve in the digestive tract.
106. The gastrointestinal implant device of claim 105 wherein the rings arc made fro Nitinol,
107. The gastrointestinal implant device of claim 105, wherein each ofthc rings includes at least two stabilizing ears.
108. The gastrointestinal implant device of claim 105, wherein the ring is formed by loosely intertwined wires.
109. The gastrointestinal implant device of claim 105, wherein the rings are linked with a connecting bar.
110. The gastrointestinal implant device of claim 108, wherein the connecting bar includes extensions extending from the exterior surface of the bar adapted io anchor the proximal portion ofthc sleeve in the digestive tract. 74
111. The gastrointestinal implant device of claim 110, wherein extensions extending from the exterior surface of a proximal ring and extensions extending from the exterior surface of a distal ring arc angled towards each other.
112. The gastrointestinal implant device of claim 105, wherein the anchor is covered by a proxi al portion of the sleeve
113, The gastrointestinal implant device of claim 105, wherein the interior surface of the ring is covered by the sleeve and the exterior surface of the ring is coated with a polymer,
114. The gastrointestinal implant device of claim 105 in combination with a catheter to insert the flexible sleeve,
115. The gastrointestinal implant device of claim 114, wherein the rings are folded in a u-shapo stored in a delivery tube to insert the flexible sleeve.
116. The gastrointestinal implant device of claim 105, wherein the sleeve is impregnated with an anti-hunger hormone.
117. The gastrointestinal implant device of claim 11 , wherein the anti-hunger hormone is peptidc-YY.
118, The gastrointestinal implant device of claim 105, wherein the sleeve is impregnated with a drug that reduces inflammation.
119, The gastrointestinal implant device of claim 10S, wherein the distance between the rings is selected to hold the pylorus open,
1 0. A method of treating intestinal bowel disease comprising the steps of; 75
anchoring a flexible sleeve, the sleeve open at both en s and impregnated with a drug that reduces inflammation; and extending the flexible sleeve into the intestine,
121. A method of treating obesity comprising the steps of: anchoring a flexible slccVe, the sleeve open at both ends and enhanced with anti-hunger hormones; and extending the flexible sleeve into the intestine,
1 2 , A gastrointes tinal itnpl ant device comprising: a collapsible sleeve, open at both ends, and adapted to extend into the intestine to limit absorption of nutrients in the intestine; and a stent, comprising a network of struts, coupled to a proximal portion of the sleeve, and adapted to anchor the sleeve in the digestive tract.
123. Λ gastrointestinal implant device comprising: a collapsible sleeve, open at both ends, and adapted to extend into the intestine to limit absorption of nutrients in the intestine, the sleeve material having a coefficient of friction of less than 0-2; and an anchoring device, coupled to a proximal portion of the sleeve, arid adapted to anchor the sleeve in the digestive tract,
324. Λ gastrointestinal implant device comprising: a collapsible sleeve formed of expanded polytctrailuoroethyicne, open at both ends, and adapted to extend within the intestine to limit absorption of nutrients in t e intestine; and an anchoring device, coupled to a proximal portion of the sleeve, and adapted to anchor the sleeve in the digestive tract.
125, Λ delivery apparatus comprising: a catheter for passage through tho intestines; and a spherically shaped element coupled to the distal end of the catheter. 76
126. The delivery apparatus of claim 125 wherein the spherically shaped element is remotely relcasable,
127, The method of claim 72 wherein the flexible sleeve is thin and floppy,
128, The gastrointestinal implant device of claim 1, wherein the sleeve is formed of pσlytetmfhioroethylcne,
129. The gastrointestinal implant device of claim 20, wherein the sleeve is formed of polytetrafluoroethylene.
130. The method of treatment of claim 37, wherein the sleeve is formed of polyletrafluor oethylenc ,
131. The method of treatment of claim 55, wherein the sleeve is formed of polytetrafluoroethylene,
132. The method of claim 72, wherein the sleeve is formed of polytetrafluoroethylene,
PCT/US2003/038238 2002-12-02 2003-12-02 Bariatric sleeve WO2004049982A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2004570987A JP4980569B2 (en) 2002-12-02 2003-12-02 Gastrointestinal implant device and delivery system for placing the device in the body
EP03796559.7A EP1569582B1 (en) 2002-12-02 2003-12-02 Bariatric sleeve
BR0316956-1A BR0316956A (en) 2002-12-02 2003-12-02 Gastrointestinal implant device; treatment method; method of treating type 2 diabetes; delivery system for placing a gastrointestinal implant device in a body; removal device for removing a gastrointestinal implant device from the body; and delivery appliance
AU2003298801A AU2003298801B9 (en) 2002-12-02 2003-12-02 Bariatric sleeve
CA2512203A CA2512203C (en) 2002-12-02 2003-12-02 Bariatric sleeve

Applications Claiming Priority (6)

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US43032102P 2002-12-02 2002-12-02
US60/430,321 2002-12-02
US10/339,786 US7025791B2 (en) 2002-12-02 2003-01-09 Bariatric sleeve
US10/339,786 2003-01-09
US51214503P 2003-10-17 2003-10-17
US60/512,145 2003-10-17

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JP (4) JP4980569B2 (en)
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