# US 7,608,114 B2 · Bariatric sleeve

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- Number: US 7,608,114 B2
- Document ID: US7608114B2
- Status: Granted
- Kind: B2
- Application number: 11/302,944
- Filed: 2005-12-13
- Published: 2006-07-20
- Granted: 2009-10-27
- Earliest claimed: 2002-12-02
- Assignees: GI Dynamics, Inc.
- Inventors: Andy H. Levine; John F. Cvinar; David A. Melanson; John C. Meade
- Web page: https://patentgrep.com/patent/US7608114B2

## 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 floppy sleeve, open at both ends, and adapted to extend within the intestine, the sleeve being unsupported at a distal end, and being at least one foot in length, the sleeve being noncompliant and having a coefficient of friction less than about 0.2, the sleeve having a wall thickness of less than 0.001 inches and being conformable to collapse in the intestine to a small volume;
a collapsible sleeve anchor coupled to a proximal portion of the sleeve and adapted to anchor the sleeve-at or distal to the pylorus, in the intestine; and
barbs extending from the collapsible sleeve anchor, the barbs being at the proximal end of the anchor, the barbs being bi-directional and having two tines directed in opposite directions from each other and outwardly from the anchor, of which 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 is adapted to be retained distal to the pylorus.

### Claim 3 (depends on 2)

The gastrointestinal implant device of claim 2, wherein the collapsible sleeve anchor is adapted to be retained proximal to the ampulla of Vater.

### 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 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 6 (depends on 1)

The gastrointestinal implant device of claim 1, wherein each bidirectional barb is formed as a unitary piece.

### Claim 7 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the sleeve is adapted to cause enzymes secreted in the duodenum to pass through the duodenum outside the sleeve.

### Claim 8 (depends on 1)

The gastrointestinal implant device of claim 1, wherein the device is removable.

### Claim 9 (depends on 1)

The implant of claim 1, wherein the barbs are adapted to anchor the proximal portion of the sleeve to muscle.

### Claim 10

A gastrointestinal implant device comprising:
a flexible, floppy sleeve means open at both ends and adapted to extend within the intestine for altering normal digestion along at least that portion of the intestine containing the sleeve, the sleeve being unsupported at a distal end and the sleeve being at least one foot in length, the sleeve being noncompliant and having a coefficient of friction less than about 0.2, the sleeve having a wall thickness of less than 0.001 inches and being conformable to collapse in the intestine to a small volume;
means coupled to a proximal portion of the sleeve for anchoring the sleeve within the digestive system, the means for anchoring being adapted to anchor the sleeve at or distal to the pylorus, in the digestive system; and
barb means extending from the exterior surface of the anchoring means, the barb means being adapted to anchor the proximal portion of the sleeve to muscle, the barb means being bi-directional barbs, the bi-directional barbs comprising two tines directed in opposite directions from each other and outwardly from the anchor, of which 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 11 (depends on 10)

The gastrointestinal implant device of claim 10, wherein the sleeve means blocks absorption of nutrients.

### Claim 12 (depends on 10)

The gastrointestinal implant device of claim 10, wherein the sleeve means delays the mixing of chyme and digestive enzymes.

### Claim 13 (depends on 10)

The gastrointestinal implant device of claim 10, wherein the sleeve means blocks hormonal release within the gastrointestinal tract.

### Claim 14 (depends on 10)

The gastrointestinal implant of claim 10, wherein the collapsible sleeve anchor is adapted to be retained within the pyloric orifice.

### Claim 15 (depends on 10)

The gastrointestinal implant of claim 10, wherein the collapsible sleeve anchor is adapted to anchor the sleeve distal to the pylorus.

### Claim 16 (depends on 10)

The gastrointestinal implant device of claim 10, wherein the barbs are adapted to anchor the sleeve to muscle.
