# US 11,304,726 B2 · Tissue-fastening tool indwelling system and method for indwelling tissue-fastening tool

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- Number: US 11,304,726 B2
- Document ID: US11304726B2
- Status: Granted
- Kind: B2
- Application number: 16/668,030
- Filed: 2019-10-30
- Published: 2020-02-27
- Granted: 2022-04-19
- Earliest claimed: 2017-05-16
- Assignees: Olympus Corporation
- Applicants: Olympus Corporation
- Inventors: Masatoshi Sato
- Web page: https://patentgrep.com/patent/US11304726B2

## CPC

- 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 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 17/0644: {penetrating the tissue, deformable to closed position}
- A61B 17/083: {Clips, e.g. resilient}
- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00336: {with a protective sleeve, e.g. retractable or slidable}
- A61B 2017/0034: {adapted to be inserted through a working channel of an endoscope}
- A61B 2017/0046: {with a releasable handle; with handle and operating part separable}
- A61B 2017/0645: {being elastically deformed for insertion}
- A61B 2017/0649: {Coils or spirals}
- A61B 2017/1117: {adapted for discharge after necrotisation, e.g. by evacuation, expulsion or excretion}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/3405: {using mechanical guide means}
- A61B 2090/034: {abutting on parts of the device itself}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A tissue-fastening tool indwelling system includes: a sheath; a needle tube disposed in the sheath; a tissue-fastening tool including a wire having a coil region disposable in the needle tube in a stretched state and restorable to a coil shape with the same winding diameter outside the needle tube; a stylet connected to the wire; and a manipulation part for manipulating the stylet to advance the wire and rotate the sheath in a first direction. In a state where a distal end of the needle tube is proximal of the distal end of the sheath, the manipulation part is designed to operate such that the wire is delivered from the sheath by a length of one winding of the coil region per rotation of the sheath by less than one turn, and the protruding coil region biased to have a diameter larger than the winding diameter.

## Claims

### Claim 1

A tissue-fastening tool indwelling system comprising:
a sheath extending from a distal end to a proximal end;
a needle tube disposed in the sheath so as to be projectable and retractable from the distal end of the sheath;
a tissue-fastening tool comprising an element wire including a coil region capable of being:
in a stretched state inside the needle tube, and
restored to a coil shape in which a plurality of windings have an identical winding diameter when delivered outside the needle tube;
a stylet connected to an end portion of the tissue-fastening tool inside the needle tube; and
a manipulation part configured to advance the stylet and rotate the sheath in a first direction around a longitudinal axis when the stylet is advanced,
wherein:
the sheath includes a slit at its distal end, the slit includes a proximal portion and a distal portion, the distal portion includes two protrusions, and a width between the two protrusions of the distal portion of the slit is smaller than a width of the proximal portion of the slit, and
in a state in which the tissue-fastening tool is at least partially disposed inside the needle tube and a distal end of the needle tube is located at a proximal side of the distal end of the sheath:
the manipulation part is configured to operate such that the coil region of the tissue-fastening tool is deployed from the sheath by a length of one winding of the coil region per rotation of the sheath by an amount of less than one turn, and
a portion of the tissue-fastening tool protruding from the sheath is biased to have a diameter larger than the winding diameter of the coil region.

### Claim 2 (depends on 1)

The tissue-fastening tool indwelling system according to claim 1, wherein the manipulation part includes:
a cam tube including a guide groove formed in a wall of the cam tube, the guide groove having a helical shape at a pitch longer than the length of one winding of the coil region; and
a guide part which includes a slit formed linearly along a longitudinal axis and is capable of transmitting a rotational torque to the sheath,
wherein:
the stylet includes a guided part which protrudes in a radial direction from an outer circumferential surface of a proximal end region of the stylet, and is slidably fitted into the guide groove and the slit of the guide part, and
the manipulation part is configured to operate such that the stylet is advanced while rotating with respect to the needle tube, and the sheath is rotated in the first direction when the guided part of the stylet moves along the guide groove and rotates the guide part while being engaged in the slit of the guide part.

### Claim 3 (depends on 1)

The tissue-fastening tool indwelling system according to claim 1, wherein:
the slit has a first circumferential edge and a second circumferential edge opposite to each other in the first direction,
the first circumferential edge is located on a downstream side of the second circumferential edge in the first direction, and a first protrusion of the two protrusions protrudes from the first circumferential edge towards an upstream side in the first direction,
and
the portion of the tissue-fastening tool protruding from the sheath is configured to contact the first circumferential edge such that deviation of the protruding portion of the tissue-fastening tool from the slit of the sheath is minimized by the first protrusion.

### Claim 4 (depends on 3)

The tissue-fastening tool indwelling system according to claim 3, wherein:
the tissue-fastening tool further includes:
a coupling part which is connected to a proximal end side of the coil region and is capable of being restored to a shape that helically extends from the proximal end side of the coil region toward a distal end side of the coil region while extending outward in a radial direction from the coil region when delivered outside the needle tube; and
an outer circumferential loop which is connected to a proximal end side of the coupling part and capable of being restored to a closed loop shape surrounding the coil region when deployed outside the needle tube,
the second circumferential edge is located on an upstream side of the first circumferential edge in the first direction, and a second protrusion of the two protrusions protrudes from the second circumferential edge towards a downstream side in the first direction,
and
the manipulation part is configured to operate such that the tissue-fastening tool is advanced while being rotated, and the element wire constituting the coupling part is delivered from the sheath by a length of one turn of the coupling part per rotation of the sheath in the first direction by an amount of more than one turn, and
a portion of the coupling part protruding from the sheath is biased to have a radius of curvature smaller than a radius of a helical curvature of the coupling part fully delivered from the sheath, and is configured to contact the second circumferential edge such that deviation of the protruding portion of the coupling part from the slit of the sheath is minimized by the second protrusion.

### Claim 5 (depends on 1)

The tissue-fastening tool indwelling system according to claim 1, wherein:
the tissue-fastening tool further includes:
a coupling part connected to a proximal end of the element wire of the coil region, and capable of being restored to a shape that helically extends from a proximal end side of the coil region toward a distal end side of the coil region and extends outward in a radial direction from the coil region when deployed outside the needle tube, and
an outer loop which is connected to a proximal end of the element wire of the coupling part, and is capable of being restored to a helical shape that is positioned outward in the radial direction from the coil region and has a helical diameter larger than the winding diameter of the coil region when deployed outside the needle tube,
wherein in a state in which the tissue-fastening tool is partially disposed inside the needle tube and the distal end of the needle tube is located on the proximal side of the distal end of the sheath, the manipulation part is configured to operate such that:
the tissue-fastening tool is delivered from the sheath by a length of one winding of the coupling part and the outer loop per rotation of the sheath in the first direction by an amount of one turn or more, and
the element wire of the coupling part and the outer loop delivered from the sheath is biased to form a circular arc having a diameter smaller than the helical diameter.

### Claim 6 (depends on 5)

The tissue-fastening tool indwelling system according to claim 5, wherein
the manipulation part includes a cam tube including a guide groove formed in a wall of the cam tube, the guide groove having a helical shape at a pitch longer than the length of one winding of the coil region; and
the pitch of the guide groove is set such that the tissue-fastening tool is delivered from the sheath by a length of one turn of the coupling part and the outer loop and the sheath is rotated by a rotation amount of one turn or more.

### Claim 7 (depends on 6)

The tissue-fastening tool indwelling system according to claim 6, wherein the pitch of the guide groove is set to be:
longer than the length of one winding of the coil region, and
shorter than at least one of a length of one winding of the coupling part and a length of one winding of the outer loop.

### Claim 8

A method for indwelling a tissue-fastening tool via a tissue-fastening tool indwelling system,
the method comprising:
operating a manipulation part to advance a stylet connected to an end portion of the tissue-fastening tool with respect to a needle tube in which the tissue-fastening tool and the stylet are disposed so as to protrude the tissue-fastening tool from a distal end of the needle tube, and indwelling a distal end side region of the tissue-fastening tool in a first luminal organ, the needle tube being projectably and retractably disposed in a sheath, where the sheath being rotated in a first direction around a longitudinal axis when the manipulation part is operated to advance the stylet, the tissue-fastening tool comprising an element wire including a coil region that is capable of being restored from a stretched state inside the needle tube to a coil shape in which a plurality of windings have an identical winding diameter when delivered outside the needle tube;
pulling the needle tube out of a wall of the first luminal organ and a wall of a second luminal organ while a distal end opening portion of the sheath is brought into contact with the wall of the second luminal organ in a state in which a distal end side region of the coil region of the tissue-fastening tool is indwelled in the first luminal organ and storing the needle tube in the sheath; and
indwelling a proximal end side region of the tissue-fastening tool in the second luminal organ by delivering the proximal end side region of the tissue-fastening tool from the sheath while biasing the proximal end side region to have a diameter larger than the winding diameter of the coil region,
wherein the sheath includes a slit at its distal end, the slit includes a proximal portion and a distal portion, the distal portion includes two protrusions, and a width between the two protrusions of the distal portion of the slit is smaller than a width of the proximal portion of the slit.

### Claim 9 (depends on 8)

The method according to claim 8, wherein
the coil region is deployed from the sheath by a length of one winding of the coil region per rotation of the sheath by an amount of less than one turn.

### Claim 10 (depends on 8)

The method according to claim 8, wherein:
the tissue-fastening tool further includes:
a coupling part which is connected to a proximal end of the element wire of the proximal end side region, and has a shape that helically extends from the proximal end side region toward the distal end side region of the coil region and extends outward in a radial direction from the coil region when delivered outside the needle tube, and
an outer loop which is connected to a proximal end of the element wire of the coupling part, and has a helical shape that is positioned outward in the radial direction from the coil region and has a helical diameter larger than the winding diameter of the coil region when delivered outside the needle tube,
the tissue-fastening tool is further indwelled into the second luminal organ by biasing the coupling part and the outer loop of the tissue-fastening tool so as to form a circular arc having a diameter smaller than the helical diameter after protruding the coil region from the sheath.

### Claim 11 (depends on 10)

The method according to claim 10, wherein
when delivering the tissue-fastening tool from the sheath while biasing the coupling portion and the outer loop to form the circular arc having a diameter smaller than the helical diameter, the tissue-fastening tool is deployed from the sheath by a length of one winding of the coupling part and the outer loop per rotation of the sheath by an amount of one turn or more.