# US 10,945,735 B2 · Luminal structure anchoring devices and methods

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- Number: US 10,945,735 B2
- Document ID: US10945735B2
- Status: Granted
- Kind: B2
- Application number: 13/865,098
- Filed: 2013-04-17
- Published: 2013-09-05
- Granted: 2021-03-16
- Earliest claimed: 2004-04-12
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Xlumena, Inc.
- Inventors: Kenneth F. Binmoeller; Corbett W. Stone
- Web page: https://patentgrep.com/patent/US10945735B2

## CPC

- A61B 1/00148: {using anchoring means}
- A61B 1/0014: {Fastening element for attaching accessories to the outside of an endoscope, e.g. clips, clamps or bands}
- A61B 1/041: {Capsule endoscopes for imaging}
- 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 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/0408: {Rivets}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0414: {having a suture-receiving opening, e.g. lateral opening}
- A61B 2017/0454: {the anchor being crimped or clamped on the suture}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/3601: {of respiratory organs}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

The present invention relates to a device for endoscopy or endosonography-guided transluminal interventions whereby two luminal structures in the body may be drawn toward each other and a fluid conduit formed in between. The device may have a hollow central member to which is coupled a distal retention member and in one embodiment a proximal retention member. The retention members may each be positioned inside one of the luminal structures and expanded from a first condition to an expanded second condition having an increased radius. The length of the central member may be shortened and its diameter expanded to approximate the two retention members and thereby the luminal structures.

## Claims

### Claim 1

A system to form a fluid pathway between adjacent tissue layers of a first luminal body and a second body comprising:
a penetrating member;
a central member forming a lumen and having a middle portion, distal and proximal end portions, and a lumen diameter; and
the middle portion, the distal end portion and the proximal end portion configured to move from a first configuration to a second configuration,
whereby, in the second configuration, a length of the middle portion between the distal and proximal end portions decreases and the lumen diameter of the central member along the middle portion increases and respective non-overlapping distal and proximal retention members separated by a distance along the middle portion are formed, the distal and proximal retention members comprising bent portions forming curves to present an atraumatic interface to appose the adjacent tissue layers of the first luminal body and second body, and terminal ends of the bent portions extend away from the adjacent tissue layers and are free of contact with the adjacent tissue layers.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first luminal body and second body are selected from the group consisting of the: esophagus, stomach, small intestine, colon, bladder, gallbladder, uterus, or bronchotracheal tree.

### Claim 3 (depends on 1)

The system of claim 1, further comprising: a sheath configured to provide a radial restraint on the central member in the first configuration.

### Claim 4 (depends on 1)

The system of claim 1, wherein the central member is configured to be removed after formation of an anastomosis between the first luminal body and second body.

### Claim 5 (depends on 1)

The system of claim 1, wherein the penetrating member comprises a needle.

### Claim 6 (depends on 1)

The system of claim 1, wherein at least a portion of the central member includes a covering or membrane.

### Claim 7 (depends on 1)

The system of claim 1, wherein the central member includes a self-expanding mesh.

### Claim 8 (depends on 1)

The system of claim 1, wherein the central member, including the middle portion, distal retention member and proximal retention member, in the second configuration, are a stent.

### Claim 9 (depends on 1)

The system of claim 1, wherein the first luminal body and second body are segments of the bowel.

### Claim 10 (depends on 1)

The system of claim 1, wherein the second body is a ductal structure.

### Claim 11 (depends on 1)

The system of claim 1, wherein the first luminal body is the stomach and the second body is the bowel.

### Claim 12 (depends on 1)

The system of claim 1, wherein the first luminal body is the stomach and the second body is the gallbladder.

### Claim 13 (depends on 1)

The system of claim 1, wherein the distal and proximal retention members form radially expanded flanges when in the second configuration.

### Claim 14 (depends on 13)

The system of claim 13, wherein the first luminal body is a stomach.

### Claim 15 (depends on 14)

The system of claim 14, wherein the second body is a neighboring tissue structure to the stomach.

### Claim 16 (depends on 1)

The system of claim 1, whereby, in the second configuration, at least a portion of the distal retention member bends back over the middle portion, and at least a portion of the proximal retention member bends back over the middle portion.

### Claim 17

A medical device to form a fluid pathway between adjacent tissue layers of a first luminal body and a second body, comprising:
a central member defining a lumen for the fluid pathway, the central member having a middle portion, a lumen diameter, a distal end portion and a proximal end portion; and
the distal end portion including a distal retention member and the proximal end portion including a proximal retention member, in an expanded configuration,
whereby, in the expanded configuration, the distal retention member and the proximal retention member are separated and non-overlapping along the middle portion, a length of the middle portion is decreased and the lumen diameter of the central member along the middle portion is increased, the distal and proximal retention members comprising bent portions forming curves to present an atraumatic interface to appose the adjacent tissue layers of the first luminal body and second body, and terminal ends of the bent portions extend away from the adjacent tissue layers and are free of contact with the adjacent tissue layers.

### Claim 18 (depends on 17)

The device of claim 17, whereby, in the expanded configuration, at least a portion of the distal retention member bends back over the middle portion, and at least a portion of the proximal retention member bends back over the middle portion.

### Claim 19

A drainage device to form a fluid pathway between adjacent tissue layers of a first luminal body and a second body, comprising:
a central member forming a lumen for the fluid pathway and having a middle portion, a lumen diameter, a distal end portion and a proximal end portion;
the distal end portion configured to move from a first configuration to a second configuration to form a distal retention member; and
the proximal end portion configured to move from a first configuration to a second configuration to form a proximal retention member,
whereby, in the second configuration of the distal retention member and the proximal retention member, the distal and proximal retention members are non-overlapping and separated by a distance along the middle portion, a length of the middle portion is decreased and the lumen diameter of the central member along the middle portion is increased, the distal and proximal retention members comprising bent portions forming curves to present an atraumatic interface to appose the adjacent tissue layers of the first luminal body and second body, and terminal ends of the bent portions extend away from the adjacent tissue layers and are free of contact with the adjacent tissue layers.

### Claim 20 (depends on 19)

The device of claim 19, whereby, in the second configuration of the distal retention member and the proximal retention member, at least a portion of the distal retention member bends back over the middle portion, and at least a portion of the proximal retention member bends back over the middle portion.