# US 10,245,026 B2 · Methods and devices for folding and securing tissue

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- Number: US 10,245,026 B2
- Document ID: US10245026B2
- Status: Granted
- Kind: B2
- Application number: 14/840,561
- Filed: 2015-08-31
- Published: 2016-02-25
- Granted: 2019-04-02
- Earliest claimed: 2000-09-22
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Marc O. Schurr; Kurt Geitz; Robert Sakal; Gerhard F. Buess; Daniel Kalanovic
- Web page: https://patentgrep.com/patent/US10245026B2

## CPC

- A61B 17/0644: {penetrating the tissue, deformable to closed position}
- A61B 17/0643: {with separate closing member, e.g. for interlocking with staple}
- A61B 17/068: Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00})
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 17/1285: {for minimally invasive surgery}
- A61B 2017/00827: {Treatment of gastro-esophageal reflux}
- A61B 2017/0641: {having at least three legs as part of one single body}
- A61B 2017/0647: {having one single leg, e.g. tacks}
- A61B 2017/081: {Tissue approximator (A61B2017/1103, A61B17/8866 take precedence)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

The present invention relates to devices, and methods for using the devices, to create and secure a tissue fold during an endoluminal medical procedure. The devices and methods may be used for folding and securing, for example, a fundus wall onto an esophagus wall or esophageal tissue in the region of the lower esophageal sphincter (LES) to reduce the diameter of the esophagus opening in that region. One aspect of the invention includes forming the tissue fold by closing a grasping arm that is pivotably connected to an overtube that has been positioned at the juncture of the fundus wall and esophagus wall. A further aspect of the invention includes tissue clips configured to be inserted and positioned through an endoluminal device.

## Claims

### Claim 1

A method of securing tissue comprising:
inserting an endoscope, a tube, and a rotatable arm through an esophagus, the tube disposed radially outward and around the endoscope, and the rotatable arm movably mounted to the tube;
rotating the rotatable arm toward the tube;
engaging tissue between the rotatable arm and a portion of the tube;
inserting a tissue fastener through a lumen of the tube, wherein an entirety of the tissue fastener is passed through a single opening in the tube adjacent a distal end of the tube, and wherein the tissue fastener includes a first arm configured to contact and extend along a first side of the tissue and a second arm configured to contact and extend along a second side of the tissue; and
securing the tissue with the tissue fastener, a first end of the tissue fastener engaging a first outer surface of the tissue and having a free end positioned on the first side of the tissue, and a second end of the tissue fastener engaging a second outer surface of the tissue and having a free end positioned on the second side of the tissue opposite the first side of the tissue.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
prior to engaging tissue between the rotatable arm and the portion of the tube, pulling the tissue between the rotatable arm and the portion of the tube.

### Claim 3 (depends on 1)

The method of claim 1, wherein, prior to securing the tissue, the tissue fastener is at least partially disposed in the tube.

### Claim 4 (depends on 1)

The method of claim 1, wherein the tissue fastener is a clip.

### Claim 5 (depends on 1)

The method of claim 1, furthering comprising:
after securing the tissue with the tissue fastener, rotating the rotatable arm away from the tube.

### Claim 6 (depends on 1)

The method of claim 1, furthering comprising:
rotating the tube about a longitudinal axis of the tube.

### Claim 7 (depends on 1)

The method of claim 1, wherein the tissue is at least partially formed by at least one of a fundus wall and an esophagus wall.

### Claim 8 (depends on 1)

The method of claim 1, wherein the rotatable arm is rotated by a cable.

### Claim 9 (depends on 1)

The method of claim 1, wherein, prior to securing the tissue, the tissue fastener is held by a deployment device.

### Claim 10 (depends on 9)

The method of claim 9, wherein the deployment device is at least partially disposed within the tube.

### Claim 11 (depends on 9)

The method of claim 9, wherein the tissue secured by the tissue fastener is a tissue fold.

### Claim 12

A method of securing tissue comprising:
inserting an endoscope, a tube and a rotatable arm through an esophagus, the tube disposed radially outward and around the endoscope, and the rotatable arm in a first position movably mounted to the tube, wherein the first position is substantially along a longitudinal axis of the tube;
pivoting the rotatable arm from the first position to a second position to form an acute angle between the rotatable arm and the tube;
engaging tissue between the rotatable arm and the tube;
inserting a tissue fastener through a lumen of the tube, wherein an entirety of the tissue fastener is passed through a single opening in the tube adjacent a distal end of the tube; and
securing the tissue with the tissue fastener, a first end of the tissue fastener engaging a first outer surface of the tissue and having a free end positioned on a first side of the tissue, and a second end of the tissue fastener engaging a second outer surface of the tissue and having a free end positioned on a second side of the tissue opposite the first side of the tissue, wherein the tissue fastener is an integral, one-piece fastener, and wherein the tissue fastener includes a first arm configured to contact and extend along the first side of the tissue and a second arm configured to contact and extend along the second side of the tissue.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
prior to engaging tissue between the rotatable arm and the tube, pulling the tissue between the rotatable arm and the tube.

### Claim 14 (depends on 12)

The method of claim 12, wherein prior to securing the tissue, the tissue fastener is at least partially disposed in the tube.

### Claim 15 (depends on 12)

The method of claim 12, furthering comprising:
after securing the tissue with the tissue fastener, rotating the rotatable arm away from the tube.

### Claim 16 (depends on 12)

The method of claim 12, furthering comprising:
rotating the tube about the longitudinal axis of the tube.

### Claim 17 (depends on 12)

The method of claim 12, wherein the tissue is at least partially formed by at least one of a fundus wall and an esophagus wall.

### Claim 18 (depends on 12)

The method of claim 12, wherein, prior to securing the tissue, the tissue fastener is held by a deployment device at least partially disposed within the tube.

### Claim 19 (depends on 12)

The method of claim 12, wherein the tissue secured by the tissue fastener is a tissue fold.

### Claim 20

A method of securing tissue comprising:
positioning an endoscope and a tube in an esophagus so that the tube is disposed radially outward and around the endoscope, and positioning a rotatable arm in a stomach so that the rotatable arm is in a first position movably mounted to the tube, wherein the first position is substantially along a longitudinal axis of the tube;
moving the rotatable arm from the first position to a second position to form an acute angle between the rotatable arm and the tube;
engaging tissue between the rotatable arm and the tube;
inserting a tissue fastener through a lumen of the tube and through a single opening in a wall of the tube, wherein the tissue fastener includes a first arm configured to contact and extend along a first side of the tissue and a second arm configured to contact and extend along a second side of the tissue; and
securing the tissue with the tissue fastener, a first end of the tissue fastener engaging a first outer surface of the tissue and having a free end positioned on the first side of the tissue, and a second end of the tissue fastener engaging a second outer surface of the tissue and having a free end positioned on the second side of the tissue opposite the first side of the tissue.
