# US 11,998,190 B2 · Method and apparatus for serial deployment of multiple tissue fasteners

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- Number: US 11,998,190 B2
- Document ID: US11998190B2
- Status: Granted
- Kind: B2
- Application number: 15/447,747
- Filed: 2017-03-02
- Published: 2017-07-20
- Granted: 2024-06-04
- Earliest claimed: 2012-01-11
- Assignees: Amsel Medical Corporation
- Applicants: Arnold Miller; Raanan Miller
- Inventors: Arnold Miller; Raanan Miller
- Web page: https://patentgrep.com/patent/US11998190B2

## CPC

- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/00008: {Vein tendon strippers (tube strippers A61M1/83)}
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61B 17/12: for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B 17/12009: {Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot}
- A61B 17/12013: {for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/12022: {Occluding by internal devices, e.g. balloons or releasable wires (plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20)}
- A61B 17/12027: {Type of occlusion (A61B17/12113 takes precedence)}
- A61B 17/12031: {complete occlusion}
- A61B 17/12036: {partial occlusion}
- A61B 17/1214: {Coils or wires}
- A61B 17/12145: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)}
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 17/128: for applying or removing clamps or clips
- A61B 17/1285: {for minimally invasive surgery}
- A61B 17/0643: {with separate closing member, e.g. for interlocking with staple}
- A61B 2017/00668: {the implement being a tack or a staple}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts}
- A61B 2017/0419: {H-fasteners}
- A61B 2017/0641: {having at least three legs as part of one single body}
- A61B 2017/0645: {being elastically deformed for insertion}
- A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device}
- A61B 2017/12095: {Threaded connection}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

One-piece tissue fasteners are provided for securing two or more tissue layers to each other. Delivery devices are described by which a tandem array of such fasteners can be delivered and deployed to secure tissue layers in a number of locations without requiring removal or reloading of the removal tool.

## Claims

### Claim 1

A system for delivering and deploying a plurality of tissue fasteners to multiple locations of tissue layers to be secured to each other comprising:
a delivery tube having proximal and distal ends and having a lumen and a distal outlet opening at the distal end; a plurality of tissue fasteners disposed in a tandem array in the lumen of the delivery tube, each of the tissue fasteners comprising a tubular body having proximal and distal ends and an inner lumen
a shuttle mechanism extending through the delivery tube and through bodies of the tandem fasteners, the shuttle mechanism being movable longitudinally within the delivery tube, the shuttle mechanism having at its distal end, a a fastener-engaging mechanism for selectively engaging a fastener body within the lumen of the fastener sufficiently to slide the fastener within the lumen of the delivery tube in a distal or proximal direction;
whereby the shuttle mechanism may selectively eject the most distal of the fasteners in the array within the delivery tube toward and out of the distal outlet or retract a partially ejected fastener back into the delivery tube.

### Claim 2 (depends on 1)

The system as defined in claim 1 in which the shuttle mechanism is retractable within the delivery tube to selectively engage the next leading fastener in the tandem array.

### Claim 3 (depends on 1)

The system as defined in claim 1 wherein the delivery tube comprises a needle having a sharp tip.

### Claim 4 (depends on 1)

The system as defined in claim 1 wherein the shuttle mechanism comprises an elongate shaft and where the fastener-engaging mechanism for selectively engaging a fastener comprises a radially expandable member selectively expandable to engage a luminal portion of a fastener body to enable movement of the fastener within and out of the delivery tube.

### Claim 5 (depends on 4)

The system as defined in claim 4 where the radially expandable member comprises a balloon.

### Claim 6 (depends on 4)

The system as defined in claim 4 wherein each of the fasteners has a detent element formed in its body and the fastener-engaging mechanism comprises a detent element disposed at the distal end of the shaft and being selectively engageable with the detent elements on the fastener bodies; and an actuator rod extending through the shaft and operatively engaged with the detent elements of the shaft for selectively operating the shaft detent element.

### Claim 7 (depends on 4)

The system as defined in claim 4 where the expandable member comprises: the shaft having an outer tube an inner actuator rod that extends distally of the distal end of the outer tube, the distal end of the outer tube having a plurality of longitudinal slits that define a plurality of radially expandable legs, the actuator rod having an enlarged distal end that can selectively engage the distal ends of the legs to expand or contract the effective diameter.

### Claim 8 (depends on 1)

The system as defined in claim 1 wherein the fasteners are disposed in the delivery tube in a column in end-to-end engagement with each other and further comprising: a pushing member disposed within the delivery tube in engagement with the most trailing fastener in the column.

### Claim 9 (depends on 1)

The system as defined in claim 1 wherein each of the fasteners is a one-piece tissue fastener comprising:
a tubular body having proximal and distal ends; a plurality of proximal legs extending from the proximal end of the body and a plurality of distal legs extending from the distal end of the body, the body and the legs being formed from a shape memory material, the legs having an unstressed deployed configuration in which they extend radially outward from the body, the legs being bendable from their unstressed configuration to a low profile, stressed configuration in which the legs extend in a more longitudinally oriented direction so that they can be contained within a tubular delivery device; the fastener being adapted to engage and secure together multiple layers of tissue with the tubular body transfixing the tissue layers and the tissue layers contained between the deployed proximal legs and the deployed distal legs.
