# US 9,517,153 B2 · Bypass device, support frame for bypass device, and method

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- Number: US 9,517,153 B2
- Document ID: US9517153B2
- Status: Granted
- Kind: B2
- Application number: 14/155,825
- Filed: 2014-01-15
- Published: 2015-07-16
- Granted: 2016-12-13
- Earliest claimed: 2014-01-15
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Brian Roselauf; Jonathan Phan; Naoki Aramaki
- Web page: https://patentgrep.com/patent/US9517153B2

## CPC

- A61F 5/0079: {Pyloric or esophageal obstructions}
- A61F 5/0076: {preventing normal digestion, e.g. Bariatric or gastric sleeves}
- 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)

## Abstract

A liner support frame is configured to be positioned in a gastrointestinal tract of a human and to support a liner which inhibits nutrient absorption and anchor the liner in place in the gastrointestinal tract, the liner support frame includes a plurality of frame members connected to one another so that the liner support frame possesses a plurality of openings. The liner support frame includes a plurality of frame portions arranged axially and possessing different tapers.

## Claims

### Claim 1

A bypass device implantable in a gastrointestinal tract of a human, which includes small intestines, to inhibit absorption of nutrients, the bypass device comprising:
a support frame positionable in the gastrointestinal tract in an implanted condition of the bypass device, the support frame possessing a central axis and extending over an axial extent between opposite axial ends of the support frame;
a liner fixed to the support frame so that in the implanted condition of the bypass device the liner is supported by the support frame and anchored in place in the gastrointestinal tract which includes small intestines, the liner being made of a material different from the support frame and being configured to extend away from the support frame and along at least a portion of the small intestines when the support frame is positioned in the gastrointestinal tract in the implanted condition of the bypass device;
the support frame comprising a plurality of frame members connected to one another so that the support frame possesses an axially central frame portion, one frame portion on one axial end side of the axially central frame portion, and an other frame portion on an opposite axial end side of the axially central frame portion;
the frame members in the one frame portion being configured and connected to one another so that the frame members in the one frame portion define a plurality of spaced-apart diamond-shaped openings arranged axially and circumferentially;
the frame members in the other frame portion being configured and connected to one another so that the frame members in the other frame portion define a plurality of spaced apart diamond-shaped openings arranged axially and circumferentially; and
the frame members forming the axially central portion of the support frame defining openings in the axially central portion of the support frame that are other than diamond-shaped;
the axially central frame portion possessing a cross-section perpendicular to the central axis that is smallest relative to the cross-section perpendicular to the central axis of all other portions of the support frame;
the axially central frame portion possessing the smallest cross-section, inclusive of an axial center of the axially central frame portion, being comprised of a plurality of the frame members that are circumferentially spaced from one another to define the openings in the axially central frame portion of the support frame;
the axially central frame portion being a part of an axially central frame section of the support frame, the frame members forming the axially central frame section including a first straight part and two second straight parts, the two straight parts being angled at an angle other than zero degrees and other than 180 degrees with the first straight part;
the first straight part being positioned axially between two second straight parts so that one of the second straight parts is proximal of the first straight part and the other second straight part is distal of the first straight part; and
each of the second straight parts including first and second end portions, the first end portion of each second straight part being located adjacent the first straight part, the second end portion of one second straight part being located adjacent the one frame portion, and the second end portion of the other second straight part being located adjacent the other frame portion.

### Claim 2 (depends on 1)

The bypass device according to claim 1, wherein each of the frame members forming the axially central portion of the support frame is an axially extending frame member.

### Claim 3 (depends on 2)

The bypass device according to claim 2, wherein each of the frame members forming the one frame portion and the other frame portion is a wavy-shaped annular frame member, with axially adjacent wavy-shaped annular frame members in the one frame portion being connected to one another, and with axially adjacent wavy-shaped annular frame members in the other frame portion being connected to one another.

### Claim 4 (depends on 1)

The bypass device according to claim 1, wherein each of the frame members forming the one frame portion and the other frame portion is a wavy-shaped annular frame member, with axially adjacent wavy-shaped annular frame members in the one frame portion being connected to one another, and with axially adjacent wavy-shaped annular frame members in the other frame portion being connected to one another.

### Claim 5 (depends on 1)

The bypass device according to claim 1, wherein all of the openings in the axially central portion of the support frame possess a common shape other than diamond-shaped.

### Claim 6

A liner support frame configured to be positioned in a gastrointestinal tract of a human and to support a nutrient absorption-inhibiting liner to anchor the liner in place in the gastrointestinal tract, the liner support frame comprising:
a plurality of frame members connected to one another so that the support frame possesses an axially central frame portion, one frame portion on one axial end side of the axially central frame portion, and an other frame portion on an opposite axial end side of the axially central frame portion;
the frame members in the one frame portion being configured and connected to one another so that the frame members in the one frame portion define a plurality of spaced apart diamond-shaped openings arranged axially and circumferentially;
the frame members in the other frame portion being configured and connected to one another so that the frame members in the other frame portion define a plurality of spaced apart diamond-shaped openings arranged axially and circumferentially;
the frame members forming the axially central portion of the support frame being configured to define openings in the axially central portion of the support frame, inclusive of an axial center of the axially central frame portion, that possess a shape other than diamond-shaped;
the axially central frame portion being a part of an axially central frame section of the support frame, the frame members forming the axially central frame section including a first straight part and two second straight parts, the two straight parts being angled at an angle other than zero degrees and other than 180 degrees with the first straight part;
the first straight part being positioned axially between two second straight parts so that one of the second straight parts is proximal of the first straight part and the other second straight part is distal of the first straight part; and
each of the second straight parts including first and second end portions, the first end portion of each second straight part being located adjacent the first straight part, the second end portion of one second straight part being located adjacent the one frame portion, and the second end portion of the other second straight part being located adjacent the other frame portion.

### Claim 7 (depends on 6)

The liner support frame according to claim 6, wherein each of the frame members forming the axially central portion of the support frame is an axially extending frame member.

### Claim 8 (depends on 7)

The liner support frame according to claim 7, wherein each of the frame members forming the one frame portion and the other frame portion is a wavy-shaped annular member, with axially adjacent wavy-shaped frame members in the one frame portion being connected to one another and axially adjacent wavy-shaped frame members in the other frame portion being connected to one another.

### Claim 9 (depends on 6)

The liner support frame according to claim 6, wherein each of the frame members forming the one frame portion and the other frame portion is a wavy-shaped annular member, with axially adjacent wavy-shaped frame members in the one frame portion being connected to one another and axially adjacent wavy-shaped frame members in the other frame portion being connected to one another.

### Claim 10 (depends on 6)

The liner support frame according to claim 6, wherein all of the openings in the axially central portion of the support frame possess a common shape other than diamond-shaped.

### Claim 11

A method comprising:
introducing a bypass device into a human body, the bypass device comprising a support frame possessing a central axis and a liner fixed to the support frame, wherein the liner is made of a material different from the support frame, the support frame comprising: a plurality of frame members connected to one another so that the support frame possesses an axially central frame portion, one frame portion on one axial end side of the axially central frame portion, and an other frame portion on an opposite axial end side of the axially central frame portion; the frame members in the one frame portion being configured and connected to one another so that the frame members in the one frame portion define a plurality of spaced apart diamond-shaped openings arranged axially and circumferentially; the frame members in the other frame portion being configured and connected to one another so that the frame members in the other frame portion define a plurality of spaced apart diamond-shaped openings arranged axially and circumferentially; and the frame members forming the axially central portion of the support frame defining openings in the axially central portion of the support frame, inclusive of an axial center of the axially central frame portion, that possess a shape other than diamond-shaped; the axially central frame portion being a part of an axially central frame section of the support frame, the frame members forming the axially central frame section including a first straight part and two second straight parts, the two straight parts being angled at an angle other than zero degrees and other than 180 degrees with the first straight part; the first straight part being positioned axially between two second straight parts so that one of the second straight parts is proximal of the first straight part and the other second straight part is distal of the first straight part; and each of the second straight parts including first and second end portions, the first end portion of each second straight part being located adjacent the first straight part, the second end portion of one second straight part being located adjacent the one frame portion, and the second end portion of the other second straight part being located adjacent the other frame portion; and
positioning the bypass device in a gastrointestinal tract of the human body which includes a pyloric sphincter so that the axially central portion of the support frame is positioned in the pyloric sphincter while the liner extends away from the support frame and along at least a portion of the small intestines of the gastrointestinal tract to inhibit absorption of nutrients across the portion of the small intestines.

### Claim 12 (depends on 6)

The bypass device according to claim 6, wherein the axially central frame portion possesses a cross-section perpendicular to the central axis that is smallest relative to the cross-section perpendicular to the central axis of all other portions of the support frame, and the axially central frame portion possessing the smallest cross-section, including the axial center of the axially central frame portion, being comprised of a plurality of the frame members that are circumferentially spaced from one another so that one of the openings in the axially central frame portion of the support frame is located between each circumferentially adjacent pair of the frame members in the axially central frame portion.

### Claim 13 (depends on 1)

The bypass device according to claim 1, wherein an axial end portion of each opening in the axially central frame portion is bounded by a connecting portion connecting the second straight part of one frame member with the second straight part of a circumferentially adjacent frame member.

### Claim 14 (depends on 13)

The bypass device according to claim 13, wherein the axial end portion of each opening is axially farther from the central portion than the first straight part.
