Surgical fastener assemblies and methods

Patent metadata

Field	Value
Publication number	US-12447004-B2
Application number	US-202217663651-A
Country	US
Kind code	B2
Filing date	May 16, 2022
Priority date	May 17, 2021
Publication date	Oct 21, 2025
Grant date	Oct 21, 2025

Abstract

This disclosure includes fasteners for coupling an implant to tissue (e.g., soft-tissue and/or bone), fabric-like implants, and assemblies with fasteners pre-loaded with implants. The present implants generally comprise at least one flexible, fibrous layer that is substantially planar in a flattened state. In some embodiments of the present assemblies for delivery of a fastener, the assembly comprises fastener cartridge, a fibrous implant wrapped around a portion of the cartridge, a fastener extending through the implant, and an elongated shield disposed around the implant and the cartridge such that the implant is retained between the cartridge and the shield. Kits comprise a plurality of fasteners pre-loaded with implants. Some of the present kits also include one or more of the present fastener-delivery apparatuses or tools; for example, a plurality of pre-loaded fasteners with a single, reloadable tool; a plurality of tools each pre-loaded with a fastener that is pre-loaded with an implant; and/or a plurality of cartridges each pre-loaded with a fastener that is pre-loaded with an implant, and a common tool for use with the cartridges.

First claim

The invention claimed is:

1. An assembly for delivery of a fastener, the assembly comprising:
a fastener cartridge having a body with a proximal end, and a distal end, the proximal end configured to be removably coupled to a distal end of an apparatus to deliver a fastener coupled to the cartridge, the cartridge comprising:
a spike having a spike proximal end coupled to the distal end of the cartridge, and a spike distal end extending from the distal end of the cartridge, the spike proximal end having a transverse dimension that is smaller than a transverse dimension of the distal end of the cartridge such that a shoulder is defined at the spike proximal end, the shoulder configured to abut a head of a fastener received over the spike;

a fastener received over the spike, the fastener comprising:
an elongated shaft having a shaft length extending from a shaft proximal end to a shaft distal end, and defining an internal passage extending along the shaft length;
an enlarged head coupled to the proximal end of the shaft and abutting the shoulder of the cartridge;
a plurality of outriggers extending from the enlarged head in a direction away from the internal passage; and
a plurality of first barbs each extending along a portion of the shaft length, each first barb having a leading edge and trailing edge spaced from the proximal end of the shaft, the leading edge of each first barb being disposed between the trailing edge of that first barb and the distal end of the shaft; and
where the shaft, head, outriggers, and first and second barbs are defined by a unitary piece of polymer; and

a flexible, fibrous implant having a first end edge, a second end edge, and a pair of lateral edges extending between the first and second end edges, where the implant is substantially planar when in a flattened state in which the first end edge is separated from the second end edge under a first tension of 5 Newtons (N) applied perpendicular to each of the end edges, and in which the lateral edges are separated from each other under a tension of 5 N applied perpendicular to each of the lateral edges;
an elongated, tubular shield disposed over the implant, at least a portion of the fastener, and at least a portion of the cartridge;
where the shaft extends through the implant at a point that is closer to the first end edge than to the second end edge, a first portion of the implant extends proximally around at least a portion of the cartridge, and the first portion of the implant is disposed between the cartridge and the shield.

2. The assembly of claim 1 , where the fastener further comprises:
a plurality of second barbs that are unitary with the shaft, each of the second barbs extending along a portion of the shaft length, each of the second barbs having a leading edge and a trailing edge disposed between the head and the trailing edges of the first barbs, the leading edge of each second barb being disposed between the trailing edge of that second barb and the distal end of the shaft.

3. The assembly of claim 1 , where the implant comprises a woven layer and a nonwoven layer coupled to the woven layer.

4. The assembly of claim 1 , where the implant further comprises at least one suture leg coupled to the implant at a point that is closer to the second end edge than to the first end edge, the suture leg having a free portion that is configured to extend beyond the second end edge.

5. The assembly of claim 4 , where the implant comprises:
a first suture leg coupled to the implant at a first point that is closer to the second edge than to the first end edge, the first point being closer to a first one of the lateral edges than to a second one of the lateral edges, the first suture leg having a first free portion that is configured to extend beyond the second end edge; and
a second suture leg coupled to the implant at a second point that is closer to the second edge than to the first end edge, the second point being closer to the second one of the lateral edges than to the first one of the lateral edges, the second suture leg having a second free portion that is configured to extend beyond the second end edge.

6. An assembly for delivery of a fastener, the assembly comprising:
a fastener cartridge having a body with a proximal end, and a distal end, the proximal end configured to be removably coupled to a distal end of an apparatus to deliver a fastener coupled to the cartridge, the cartridge comprising:
a pair of spikes each having a spike proximal end coupled to the distal end of the cartridge, and a spike distal end extending from the distal end of the cartridge, the spike proximal end having a transverse dimension that is smaller than a corresponding transverse dimension of the distal end of the cartridge body such that a shoulder is defined at the spike proximal end, the shoulder configured to abut a head of a fastener received over the spikes;

a fastener received over the spikes, the fastener comprising:
a first elongated shaft having a first shaft length extending from a first shaft proximal end to a first shaft distal end, and defining an internal first passage extending along the first shaft length;
a second elongated shaft having a second shaft length extending from a second shaft proximal end to a second shaft distal end, and defining an internal second passage extending along the second shaft length;
an enlarged head coupled to the proximal ends of the first shaft and the second shaft, the had abutting the shoulder of the cartridge;
a plurality of first barbs each extending along a portion of the first shaft length, each first barb having a leading edge and trailing edge spaced from the proximal end of the first shaft, the leading edge of each first barb being disposed between the trailing edge of that first barb and the first shaft distal end;
a plurality of second barbs each extending along a portion of the second shaft length, each second barb having a leading edge and trailing edge spaced from the proximal end of the second shaft, the leading edge of each second barb being disposed between the trailing edge of that second barb and the second shaft distal end; and
where the shafts, head, and barbs are defined by a unitary piece of polymer,

a flexible, fibrous implant having a first end edge, a second end edge, and a pair of lateral edges extending between the first and second end edges, where the implant is substantially planar when in a flattened state in which the first end edge is separated from the second end edge under a first tension of 5 Newtons (N) applied perpendicular to each of the end edges, and in which the lateral edges are separated from each other under a tension of 5 N applied perpendicular to each of the lateral edges;
an elongated, tubular shield disposed over the implant, at least a portion of the fastener, and at least a portion of the cartridge;
where the at least one of the first and second shafts of the fastener extends through the implant at a point that is closer to the first end edge than to the second end edge, a first portion of the implant extends proximally around at least a portion of the cartridge, and the first portion of the implant is disposed between the cartridge and the shield.

7. The assembly of claim 6 , where each of the first and second shafts of the fastener extends through the implant at a point that is closer to the first end edge than to the second end edge, a first portion of the implant extends proximally around at least a portion of the cartridge, and the first portion of the implant is disposed between the cartridge and the shield.

8. The assembly of claim 6 , where the fastener further comprises:
a plurality of third barbs each extending along a portion of the first shaft length, each of the th

Assignees

• Arthrosurface Inc

Inventors

• Chao Nam
• Ek Steven W
• Baker Chris
• Brightman Tim
• Leduc Dan

Classifications

• A61F2002/0888

  Anchor in or on a blind hole or on the bone surface without formation of a tunnel · CPC title

• A61F2002/0841

  Longitudinal channel for insertion tool running through the whole tendon anchor, e.g. for accommodating bone drill, guidewire · CPC title

• A61F2002/0858

  Fixation of tendon or ligament between anchor and bone, e.g. interference screws, wedges · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/0805

  Implements for inserting tendons or ligaments · CPC title