# US 11,896,235 B2 · Hemostasis clip deployment

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- Number: US 11,896,235 B2
- Document ID: US11896235B2
- Status: Granted
- Kind: B2
- Application number: 17/815,413
- Filed: 2022-07-27
- Published: 2022-11-17
- Granted: 2024-02-13
- Earliest claimed: 2019-05-28
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Daniel Congdon; Laurie A. Lehtinen; Alex Roberts
- Web page: https://patentgrep.com/patent/US11896235B2

## CPC

- A61B 17/1227: {Spring clips}
- A61B 17/1285: {for minimally invasive surgery}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 2017/0034: {adapted to be inserted through a working channel of an endoscope}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00818: {Treatment of the gastro-intestinal system}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/12004: {for haemostasis, for prevention of bleeding}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A device includes a clip including a capsule and a pair of clip arms, proximal ends of which are slidably received within a channel of the capsule to move the clip arms between an open configuration and a closed configuration. The clip arms are aligned relative to one another via a pin received within openings extending through proximal ends of the clip arms. A proximal portion includes a flexible shaft extending from a proximal end to a distal end including a bushing releasably coupled to the capsule. A control member extends longitudinally through the flexible shaft from a proximal end to a distal end releasably coupled to the proximal ends of the clip arms, the distal end of the control member including a pair of holding jaws, each of which include a pair of fingers extending about the pin along opposing sides thereof to grip the pin therebetween.

## Claims

### Claim 1

A clipping system, comprising:
an applicator including a flexible shaft extending from a proximal end which, in an operative configuration, remains outside a living body to a bushing at a distal end thereof which, in the operative configuration, is inserted into the living body to a site adjacent to target tissue to be clipped;
a clip releasably coupled to the bushing, the clip including a capsule having a channel extending therethrough, and a pair of clip anus, proximal ends of which are slidably received within the channel to move the clip arms between an open configuration and a closed configuration, the clip arms being aligned relative to one another via a pin received within openings extending through proximal ends of the clip arms; and
a control member extending longitudinally through the flexible shaft from a proximal end to a distal end releasably coupled to the proximal ends of the clip arms to move the clip arms between the open and closed configurations, the distal end of the control member including a first holding jaw including a pair of fingers extending about opposing sides of the pin and gripping the pin.

### Claim 2 (depends on 1)

The system of claim 1, wherein the control member includes a second holding jaw including a pair of fingers extending about opposing sides of the pin and gripping the pin, the first and second holding jaws being located on opposite sides of a longitudinal axis of the capsule from one another.

### Claim 3 (depends on 1)

The system of claim 1, wherein a proximal end of the capsule includes tabs biased radially inward to engage a corresponding structure of the bushing.

### Claim 4 (depends on 3)

The system of claim 3, wherein the distal end of the control member includes a pair of spacing jaws configured to extend between the proximal ends of the clip arms along opposing sides of the pin, the pair of spacing jaws sized and shaped so the spacing jaws move the tabs radially outward as the distal end of the control member is moved proximally past the proximal end of the capsule to deploy the clip from the applicator.

### Claim 5 (depends on 2)

The system of claim 2, wherein the proximal ends of the clip arms are biased radially outward.

### Claim 6 (depends on 5)

The system of claim 5, wherein each of the first and second holding jaws extends over an exterior surface along a proximal end of a corresponding one of the clip arms to constrain the clip awls in an unlocked configuration in which locking structures at the proximal ends of the clip arms are held in a radially inward position and prevented from engaging corresponding locking features of the capsule.

### Claim 7 (depends on 6)

The system of claim 6, wherein the locking structures include locking tabs extending from proximal ends of the clip arms and the locking features of the capsule including windows extending laterally through a wall thereof so that, when the proximal ends of the clip are released from the distal end of the control member, the locking tabs are received within the locking windows to lock the clip in the closed configuration.

### Claim 8 (depends on 1)

The system of claim 1, wherein the clip arms are biased toward the open configuration so that the clip arms are constrained toward the closed configuration via an interior surface of the capsule and revert to the biased open configuration when the clip arms are moved distally so that distal portions of the clip arms project distally out of the capsule.

### Claim 9 (depends on 1)

The system of claim 1, wherein each of the clip arms includes an engaging feature configured to engage a corresponding portion of the capsule such that, when the engaging features engage the corresponding portion of the capsule, the clip arms are prevented from moving further proximally relative to capsule.

### Claim 10

A clipping system, comprising:
an applicator including a flexible shall extending from a proximal end which, in an operative configuration, remains outside a living body to a distal end which, in the operative configuration, is inserted into the living body to a site adjacent to target tissue to be clipped;
a clip releasably coupled to the applicator via a bushing at the distal end of the flexible shaft, the clip including:
a capsule including a channel extending therethrough; and
a pair of clip arms, proximal ends of which are slidably received within the channel of the capsule to move the clip arms between an open configuration, in which distal ends thereof are separated from one another, and a closed configuration, in which the distal end of the clip arms are drawn toward one another; and
a control member extending through the flexible shaft from a proximal end to a distal end releasably coupled to the proximal ends of the clip arms to move the clip arms between the open and the closed configurations, the distal end including a middle portion received between the proximal ends of the clip arms, a first portion of a pin and a second portion of the pin extending away from opposing surfaces of the middle portion to be received in openings extending through proximal ends of the clip arms to maintain an alignment of the clip arms relative to one another, the first and second portions being pulled proximally out of the openings of the clip arms and past a proximal edge thereof when a predetermined force is exerted on the clip arms via the distal end.

### Claim 11 (depends on 10)

The system of claim 10, wherein each of the first and second portions of the pin includes an overhang extending therefrom over a portion of an exterior surface along the proximal end of a corresponding one of the clip arms to constrain outwardly biased proximal ends of the clip arms radially inward in an unlocked configuration in which locking structures along the proximal ends of the clip arms are prevented from engaging corresponding locking features of the capsule.

### Claim 12 (depends on 11)

The system of claim 11, wherein each of the clip arms includes a slot extending proximally from the opening to a proximal edge thereof to define two fingers which flex apart from one another to release the pin therefrom when the predetermined force is exerted thereon.

### Claim 13 (depends on 12)

The system of claim 12, wherein each of the clip arms includes a relief along a longitudinal edge thereof immediately distal of the opening to facilitate flexing of the two fingers away from one another when the predetermined force is exerted thereon.

### Claim 14 (depends on 11)

The system of claim 11, wherein each of the clip arms includes a notch extending along a surface thereof from the opening to a proximal edge thereof so that, when the predetermined force is exerted thereon via the pin, the clip arms separate along the notches to release the pin from the openings.

### Claim 15 (depends on 14)

The system of claim 14, wherein first and second portions of the pin taper toward a proximal end thereof to split each of the clip alms along the notch.

### Claim 16 (depends on 11)

The system of claim 11, wherein a proximal end of the capsule includes tabs biased radially inward to engage a corresponding structure of the bushing, the middle portion being sized and shaped to move the tabs radially outward as the distal end of the control member is moved proximally past the proximal end of the capsule to deploy the clip from the applicator.

### Claim 17

A method for treating a target tissue, comprising:
inserting a clip device through a working channel of a flexible insertion device to a target site within a body until a clip of the clip device extends distally past a distal end of the working channel, the clip device including an applicator including a flexible shaft extending from a proximal end to a distal end, a capsule and a pair of clip arms slidably received therein, the pair of clip arms being aligned relative to one another via a pin extending through openings extending through proximal ends of the clip arms;
moving the clip device between an open configuration, in which distal ends of the clip arms are separated from one another, and a closed configuration, in which the distal ends of the clip arms are drawn toward one another, via a control member coupled to the clip anus, until target tissue is received between the distal ends of the clip arms, a distal end of the control member being coupled to the proximal ends of the clip arms via first and second holding jaws, each of which includes a pair of fingers extending about and gripping the pin along opposing sides;
drawing the clip arms proximally into the capsule to move the clip toward the closed configuration to grip the target tissue between the clip arms; and
deploying the clip by drawing the control member proximally relative to the capsule until a predetermined force is exerted on the distal end of the control member to spread the fingers apart from one another releasing the pin from therebetween and separating the clip from the applicator.

### Claim 18 (depends on 17)

The method of claim 17, wherein the distal end of the control member includes a pair of spacing jaws extending between the proximal ends of the clip arms along opposing sides of the pin.

### Claim 19 (depends on 18)

The method of claim 18, wherein deploying the clip includes moving the distal end of the control member proximally past a proximal end of the capsule connected to a bushing at the distal end of the flexible shaft so that the spacing jaws engage radially inwardly crimped tabs of the capsule moving the tabs radially outward out of engagement with the applicator.

### Claim 20 (depends on 17)

The method of claim 17, wherein each of the first and second holding jaws extends along an exterior surface of a corresponding one of the clip arms to constrain the proximal ends of the clip arms radially inward toward an unlocked configuration, in which locking structures along the proximal ends of the clip arms are prevented from engaging corresponding locking features of the capsule.
