# US 2013/0158554 A1 · Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue

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- Number: US 2013/0158554 A1
- Document ID: US20130158554A1
- Status: Published application
- Kind: A1
- Application number: 13/717,515
- Filed: 2012-12-17
- Published: 2013-06-20
- Earliest claimed: 2011-12-19
- Assignees: Rotation Medical, Inc.
- Inventors: Charles L. EUTENEUER; Rebecca McCARVILLE
- Web page: https://patentgrep.com/patent/US20130158554A1

## CPC

- A61B 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone}
- A61B 17/064: Surgical staples, {i.e. penetrating the tissue}
- A61B 17/0644: {penetrating the tissue, deformable to closed position}
- A61B 17/08: Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound}
- A61B 17/56: Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B 17/84: Fasteners therefor {or fasteners being internal fixation devices}
- A61B 17/844: {with expandable anchors or anchors having movable parts}
- A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)}
- A61B 17/0643: {with separate closing member, e.g. for interlocking with staple}
- A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil}
- A61B 2017/0403: {Dowels}
- A61B 2017/0432: {the separate member staying in the anchor after placement}
- A61B 2017/081: {Tissue approximator (A61B2017/1103, A61B17/8866 take precedence)}
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2218/00: Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A fastener for attaching a sheet-like implant to tissue or bone. The fastener includes a first arm having a proximal end and a distal end, a second arm having a proximal end and a distal end, and a bridge extending therebetween. Each of the first and second arms include a trunk portion defining at least a portion thereof, the trunk portion having a cavity therein and an aperture through a wall thereof. A claw is disposed in the cavity which is moveable from a first delivery position to a second deployed position. A pull member engages each claw to move the claw from the delivery position to the deployed position.

## Claims

### Claim 1

A fastener for attachment to bone comprising:
a first arm having a proximal end and a distal end, a second arm having a proximal end and a distal end, and a bridge connecting the first arm and second arm, wherein each of the first and second arms include a trunk portion extending over at least a portion of the length thereof, each trunk having a cavity therein and an aperture through a wall of each trunk to the cavity;
a claw disposed in each cavity of each trunk wherein each of the claws is moveable from a first retracted position for delivery of the staple to a second deployed position having a portion of the claw extending through the aperture in active engagement with bone when implanted therein; and,
a pull member releasably engaging each of the claws to move the claw from the first to the second position.

### Claim 2 (depends on 1)

The fastener of claim 1, wherein each of the claws includes a head, the head including an anterior edge opposite a posterior edge, a tail of the first claw abutting the posterior edge of the head, wherein the head of each claw is disposed completely within the cavity of the trunk in the delivery position.

### Claim 3 (depends on 2)

The fastener of claim 2, wherein each of the cavities is a lumen defined by a wall of each trunk having an inner surface defining the lumen extending along a longitudinal axis with the aperture extending through this wall.

### Claim 4 (depends on 3)

The fastener of claim 3, wherein each claw extends across the lumen of its respective trunk with the anterior edge of the head extending into the aperture and the tail extending through the aperture when the staple is in the deployed configuration.

### Claim 5 (depends on 4)

The fastener of claim 4, wherein the head is shaped and dimensioned such that camming forces applied to the wall by the anterior edge of the head as the claw moves between the delivery position and the deployed position urge a portion of the wall toward an elastically deflected shape.

### Claim 6 (depends on 2)

The fastener of claim 2, wherein the head of each claw has a major axis and a minor axis that is perpendicular to the major axis, the head having a length measured along the major axis and a width measured along the minor axis, the length being greater than the width.

### Claim 7 (depends on 6)

The fastener of claim 6, wherein the length of the head is greater than a diameter of the lumen and the width of the head is less than the diameter of the lumen.

### Claim 8 (depends on 6)

The fastener of claim 6, wherein the major axis of the head is generally parallel to the longitudinal axis of the lumen when each claw is in the delivery position; and
the major axis of the head extends in a direction transverse to the longitudinal axis of the lumen when each claw is in the deployed position.

### Claim 9 (depends on 9)

The fastener of claim 9, wherein the minor axis of the head extends in a direction transverse to the longitudinal axis of the lumen when each claw is in the delivery position; and
the minor axis of the head is generally parallel to the longitudinal axis of the lumen when each claw is in the deployed position.

### Claim 10 (depends on 1)

The fastener of claim 1, wherein the pull member is a rod releasable connected to a notch in each claw.

### Claim 11 (depends on 1)

The fastener of claim 1, wherein the pull member is a suture extending through a hole defined by each claw such that the suture can be disconnected from the first claw by pulling one end of the suture through the hole.

### Claim 12

A fastener for fastening a sheet-like implant to tissue, comprising:
a first trunk having a proximal end and a distal end, a second trunk having a proximal end and a distal end, and a bridge having a first end abutting the proximal end of the first trunk and the second end abutting the proximal end of the second trunk such that the bridge extends from the proximal end of the first trunk to the proximal end of the second trunk;
the first trunk including a wall having an inner surface defining a lumen extending along a longitudinal axis, the wall defining an aperture fluidly communicating with the lumen, the aperture being defined by one or more edge surfaces of the wall, edge surfaces including a proximal aperture edge and a distal aperture edge;
a first claw at least partially disposed within the lumen of the first trunk, the first claw configured for actuation between a delivery position and a deployed position in which a distal portion of the first claw extends in a direction transverse to the longitudinal axis of the first trunk to retain the first trunk in the tissue;
a first pull member slidably disposed in the lumen of the first trunk, the first pull member and the first claw engaging each other to form a connection, the connection being configured such that a proximally directed force applied to the first pull member is transferred to the first claw to urge movement of the first claw between the delivery position and the deployed position;
the first claw including a body having an upper surface opposite a lower surface, the body defining a curvilinear axis extending between first and second ends of the body, the upper surface of the body engaging the proximal aperture edge of the wall so that the upper surface slides along the proximal aperture edge as the first claw moves between the delivery position and the deployed position;
the upper surface and the lower surface being separated by a height of the body, the height varying along the curvilinear axis such that, when the first claw reaches the deployed position, an intermediate portion of the first claw becomes wedged between the proximal aperture edge and the distal aperture edge forming an interference fit with the upper surface of the body contacting the proximal aperture edge and the lower surface of the body contacting the distal aperture edge.

### Claim 13 (depends on 12)

The fastener of claim 12, wherein the first claw includes a proximal knife edge that penetrates at least a portion of the inner surface of the wall when the first claw assumes the deployed position.

### Claim 14 (depends on 12)

The fastener of claim 12, wherein the upper surface of the claw comprises a convex surface so that first claw simultaneously rotates and translates as the upper surface slides along the proximal aperture edge as the first claw moves between the delivery position and the deployed position.

### Claim 15 (depends on 14)

The fastener of claim 14, wherein the lower surface of the claw comprises a concave surface.

### Claim 16 (depends on 11)

The fastener of claim 11, wherein the pull member is a rod and the connection comprises a rod engaging feature formed in the body of the first claw that cooperates with a claw engaging feature formed proximate the distal end of the pull member.

### Claim 17 (depends on 16)

The fastener of claim 16, wherein the claw engaging feature comprises a tab and the rod engaging feature comprises a slot dimensioned to receive the tab.

### Claim 18 (depends on 17)

The fastener of claim 17, wherein the tab and the slot provide a detachable mechanical coupling between the first claw and the pull member.