# US 2021/0275162 A1 · Surgical fastener deployment system

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- Number: US 2021/0275162 A1
- Document ID: US20210275162A1
- Status: Published application
- Kind: A1
- Application number: 17/192,029
- Filed: 2021-03-04
- Published: 2021-09-09
- Earliest claimed: 2020-03-05
- Assignees: Apollo Endosurgery US, Inc.
- Applicants: Apollo Endosurgery US, Inc.
- Inventors: Vladimir Mitelberg; Donald K. Jones; Brian Szymczak
- Web page: https://patentgrep.com/patent/US20210275162A1

## CPC

- 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 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- A61B 17/0487: {Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks (suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122)}
- A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)}
- A61B 2017/00115: {with audible or visual output}
- A61B 2017/00309: {Cut-outs or slits}
- A61B 2017/00349: {Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue (A61B17/06066 takes precedence)}
- A61B 2017/00407: {Ratchet means}
- A61B 2017/00862: {elastic or resilient}
- A61B 2017/0409: {Instruments for applying suture anchors}
- A61B 2017/0412: {having anchoring barbs or pins extending outwardly from suture anchor body}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/042: {plastically deformed during insertion}
- A61B 2017/0427: {having anchoring barbs or pins extending outwardly from the anchor body}
- A61B 2017/0441: {the shaft being a rigid coil or spiral}
- A61B 2017/0448: {Additional elements on or within the anchor}
- A61B 2017/0464: {for soft tissue}
- A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61F 5/0086: {using clamps, folding means or the like}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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 system includes a first tube, a sharp coil at a distal end of the first tube, a second tube displaceable within the first tube, and a sharp housing at a distal of the second tube for storing fasteners. The housing can be positioned at a first tissue, and the coil rotated to advance the coil into engagement with the first tissue. The first tube is retracted to retract the first tissue, and then a first fastener is deployed at the first tissue location. Then, without removing the system from the patient, the distal end of the system is moved adjacent a second tissue location, and the process is repeated for a second fastener at the second tissue location. A suture extends between the first and second fasteners, and tension is applied to the suture to draw the first and second tissues toward each other to reconfigure the tissue.

## Claims

### Claim 1

A tissue fastener deployment system, comprising:
a) a handle;
b) a first tubular member having a proximal end and a distal end and defining a longitudinal axis, the proximal end rotatably coupled to the handle;
c) a coil having a tissue-piercing distal tip, the coil rotationally fixed relative to the first tubular member, such that rotation of the first tubular member relative to the handle results in rotation of the coil, wherein when the distal tip of the coil is rotated against tissue the distal tip of the coil is adapted to pierce and engage the tissue;
d) at least one fastener axially displaceable relative to the distal end of the first tubular member and through the coil, the fastener having a first configuration when in the deployment system, and a second configuration when deployed in tissue, wherein in the second configuration portions of the fastener are displaced apart from each other relative to the first configuration;
e) a push member longitudinally displaceable relative to the first tubular member and adapted to apply an axial displacement force against the at least one fastener; and
f) an actuator movably coupled relative to the handle, wherein actuating the actuator results in longitudinal displacement of the push member relative to the first tubular member and to apply an axial displacement force against the at least one fastener to deploy one of the at least one fastener from the deployment system.

### Claim 2 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the first configuration is a constrained configuration that constrains the portions against an inherent spring bias, and in the second configuration the portions displace in accord with the inherent spring bias.

### Claim 3 (depends on 2)

The tissue fastener deployment system according to claim 2, wherein:
the portions are jaw arms that are biased outwardly from each other.

### Claim 4 (depends on 3)

The tissue fastener deployment system according to claim 3, wherein:
the jaw arms have teeth.

### Claim 5 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the distal end of the fastener is sharpened, and the proximal end is blunt.

### Claim 6 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the at least one fastener includes proximal and distal ends, a side wall, an axial bore from the proximal end to the distal end, a longitudinal slot extending through the side wall along a portion of the length of the axial bore, and a crossbar bridging across the longitudinal slot to the side wall on opposite sides of the longitudinal slot at a location between the proximal and distal ends.

### Claim 7 (depends on 6)

The tissue fastener deployment system according to claim 6, wherein:
the distal end of the at least one fastener is sharpened, and the proximal end is blunt.

### Claim 8 (depends on 6)

The tissue fastener deployment system according to claim 6, further comprising:
a suture,
wherein the at least one fastener includes a plurality of fasteners, and the suture is retained relative to the crossbar of a distalmost fastener of the plurality of fasteners, and extends completely through the axial bore of each relatively proximal fastener of the plurality of fasteners.

### Claim 9 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the first tubular member and the push member are sufficiently flexible to be positioned through a tortuous path.

### Claim 10 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the first tubular member comprises a flat-wound coil.

### Claim 11 (depends on 1)

The tissue fastener deployment system according to claim 1, wherein:
the coil is a tapered helix.

### Claim 12

A tissue fastener for use in an endoscopic deployment system, comprising:
a tubular structure defining a proximal end, a distal end, a side wall extending from the proximal end to the distal end, an axial bore extending from the proximal end to the distal end, a longitudinal slot extending through the side wall along a portion of the length of the axial bore, and a crossbar bridging across the longitudinal slot,
a distal portion of the tubular structure defining a plurality of jaw arms that are resiliently biased outwardly relative to each other.

### Claim 13 (depends on 12)

The tissue fastener according to claim 12, wherein:
the distal end is sharp, and the proximal end is blunt.

### Claim 14 (depends on 12)

The tissue fastener according to claim 12, wherein:
the jaw arms have teeth.

### Claim 15 (depends on 14)

The tissue fastener according to claim 14, wherein:
the teeth on the jaw arms face each other.

### Claim 16

A tissue fastener deployable from a surgical fastener deployment system in conjunction with suture, consisting of:
a unitary element having a blunt proximal end and a sharp distal end, a peripheral side wall between the proximal and distal ends, a longitudinal axial bore extending between the proximal and distal ends and sized to receive the suture, a longitudinal slot from the bore through the side wall, and a suture retainer at a longitudinally proximal location along the side wall.

### Claim 17 (depends on 16)

The tissue fastener of claim 16, wherein:
the suture retainer is a crossbar extending across the longitudinal slot and joining opposing portions of the side wall.

### Claim 18 (depends on 16)

The tissue fastener of claim 16, wherein:
the unitary element is a portion of a hypotube.

### Claim 19 (depends on 16)

The tissue fastener of claim 16, wherein:
the fastener includes jaw arms positioned distal to said suture retainer, sad jaw arms being resiliently biased outwardly from the longitudinal axis.

### Claim 20 (depends on 16)

The tissue fastener of claim 16, wherein:
the distal end of the fastener is adapted to mate against a proximal end of a like fastener.

### Claim 21

A train of tissue fasteners deployable from a surgical fastener deployment system in conjunction with suture, the train of fasteners comprising:
a plurality of like fasteners arranged end to end, the fasteners including a distalmost fastener and relatively proximal fasteners,
each fastener consisting of a unitary element having proximal and distal ends, a peripheral side wall between the proximal and distal ends, a longitudinal axial bore extending between the proximal and distal ends and sized to receive the suture, a longitudinal slot from the bore through the side wall, and a suture retainer at a longitudinally proximal location bridging the longitudinal slot,
a suture having a distal end retained relative to the suture retainer of the distalmost fastener, and a length extending through the axial bore at the proximal end of the distalmost fastener and through the axial bores of each of the relatively proximal fasteners.

### Claim 22 (depends on 21)

The train of tissue fasteners of claim 21, wherein:
the distal end of the suture is retained relative to the suture retainer with a knot, bead, or tie.

### Claim 23 (depends on 21)

The train of tissue fasteners of claim 21, wherein:
the suture can be drawn at a perpendicular angle relative to each fastener at its suture retainer.

### Claim 24 (depends on 21)

The train of tissue fasteners of claim 21, wherein:
the proximal and distal ends of each fastener are blunt.

### Claim 25 (depends on 21)

The train of tissue fasteners of claim 21, wherein:
the proximal end of the distalmost fastener is adapted to mate against the distal end of a relatively proximal fastener, and the proximal and distal ends of the fasteners are oriented non-orthogonal relative to the axial bore.

### Claim 26 (depends on 21)

The train of tissue fasteners of claim 21, wherein:
the proximal and distal ends are obliquely angled relative to the axial bore.

### Claim 27

A method of deploying a fastener into tissue, comprising:
a) providing a fastener deployment system having a proximal end and distal end, the deployment system including,
i) a handle,
ii) a first tubular member having a proximal end and a distal end and defining a longitudinal axis, the proximal end rotatably coupled to the handle,
iii) a coil having a tissue-piercing distal tip, the coil rotationally fixed relative to the first tubular member, such that rotation of the first tubular member relative to the handle results in rotation of the coil, wherein when the distal tip of the coil is rotated against tissue the distal tip of the coil is adapted to pierce and engage the tissue, and
iv) a fastener axially displaceable relative to the distal end of the first tubular member and through the coil, the fastener having a first configuration when in the deployment system, and a second configuration when deployed in tissue, wherein in the second configuration portions of the fastener are displaced apart from each other relative to the first configuration;
b) positioning the distal end of the deployment system adjacent a first tissue location;
c) rotating the coil about the longitudinal axis to advance the coil into engagement with the first tissue location;
d) retracting the first tubular member to retract the first tissue location engaged by the coil; and
e) advancing the fastener at least partially through the coil and into the first tissue location, wherein the fastener in the first tissue location is provided in the second configuration.

### Claim 28 (depends on 27)

The method according to claim 27, wherein:
the fastener deployment system houses a plurality of fasteners, and further comprising, for each fastener to be deployed,
positioning the distal end of the deployment system adjacent a respective tissue location
rotating the coil about the longitudinal axis to advance the coil into engagement with the respective tissue location;
retracting the first tubular member to retract the respective tissue location engaged by the coil; and
advancing the fastener at least partially through the coil and into the respective tissue location, wherein the fastener in the respective tissue location is provided in the second configuration.

### Claim 29 (depends on 28)

The method according to claim 28, wherein:
the plurality of fasteners are coupled to a common suture, and applying tension on the suture between the deployed fasteners to reconfigure the first and respective tissue locations relative to each other, and then retaining the applied tension to the suture.

### Claim 30 (depends on 29)

The method according to claim 29, further comprising:
providing an endoscope having a working channel, and the first tubular member and coil of the deployment system are advanced through the working channel prior to the engagement between the coil with the first tissue location piercing.

### Claim 31 (depends on 30)

The method according to claim 30, wherein:
the endoscope is positioned within a natural body orifice.