# US 9,750,596 B2 · Bariatric sleeve

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- Number: US 9,750,596 B2
- Document ID: US9750596B2
- Status: Granted
- Kind: B2
- Application number: 14/842,254
- Filed: 2015-09-01
- Published: 2016-03-03
- Granted: 2017-09-05
- Earliest claimed: 2002-12-02
- Assignees: GI Dynamics, Inc.
- Applicants: GI Dynamics, Inc.
- Inventors: Andy H. Levine; John F. Cvinar; David A. Melanson; John C. Meade
- Web page: https://patentgrep.com/patent/US9750596B2

## CPC

- 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)
- 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 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61F 2/07: Stent-grafts
- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- A61F 5/0089: {Instruments for placement or removal}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 2017/00238: {Type of minimally invasive operation (A61B2017/00805 takes precedence)}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/061: {hollow or tubular}
- 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 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 2220/0008: Fixation appliances for connecting prostheses to the body
- 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. When implanted within the intestine, the sleeve can limit the absorption of nutrients, delay the mixing of chyme with digestive enzymes, altering hormonal triggers, providing negative feedback, and combinations thereof. The anchor is collapsible for endoscopic delivery and removal.

## Claims

### Claim 1

A gastrointestinal implant device comprising:
a sleeve at least 12 inches in length, open at both ends, unsupported at its distal end, and adapted to extend within the intestine;
a collapsible sleeve anchor coupled to a proximal portion of the sleeve and adapted to anchor the sleeve within the digestive system; and
bi-directional barbs extending from the exterior surface of the sleeve anchor, each barb comprising two tines directed in opposite directions from each other and outwardly from the anchor, wherein one tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a first direction and another tine is so oriented at an oblique angle as to prevent longitudinal movement of the device in a second direction substantially opposite to the first direction.

### Claim 2 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor comprises a compliant wave anchor.

### Claim 3 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor has a relaxed diameter greater than 40 millimeters.

### Claim 4 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor is adapted to be retained within the pyloric orifice.

### Claim 5 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor is adapted to anchor the sleeve distal to the pylorus.

### Claim 6 (depends on 5)

The gastrointestinal implant device of claim 5, wherein the collapsible sleeve anchor is configured to be retained within the duodenal bulb.

### Claim 7 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor comprises barbs for insertion into tissue.

### Claim 8 (depends on 7)

The gastrointestinal implant device of claim 7, wherein the barb is bi-directional.

### Claim 9 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor comprises a drawstring configured to facilitate removal of the anchor.

### Claim 10 (depends on 9)

The gastrointestinal implant device of claim 9, wherein the drawstring resides along a proximal portion of the anchor, reducing the proximal diameter of the anchor when drawn.

### Claim 11 (depends on 9)

The gastrointestinal implant device of claim 9, wherein the drawstring is woven around the proximal portion of the anchor through openings.

### Claim 12 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the collapsible sleeve anchor is sandwiched between a first inner layer of the sleeve and a second outer layer of the sleeve.

### Claim 13 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the sleeve comprises an anchoring ring bonded to the proximal end of the sleeve.

### Claim 14 (depends on 1)

The gastrointestinal implant device of claim 1, wherein an anti-buckling device is coupled to the sleeve and extends from below the anchor to the distal end of the flexible sleeve to reduce buckling of the sleeve.

### Claim 15 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the sleeve material has a coefficient of friction of less than 0.2.

### Claim 16 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the sleeve is formed of a fluoropolymer.

### Claim 17 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the sleeve comprises markings to detect the position and orientation of the sleeve on a fluoroscopic image.
