# US 2013/0153628 A1 · Fasteners and fastener delivery devices for affixing sheet-like materials to bone or tissue > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0153628 A1 - Document ID: US20130153628A1 - Status: Published application - Kind: A1 - Application number: 13/717,530 - Filed: 2012-12-17 - Published: 2013-06-20 - Earliest claimed: 2011-12-19 - Assignees: Rotation Medical, Inc. - Inventors: Charles L. EUTENEUER - Web page: https://patentgrep.com/patent/US20130153628A1 ## 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 17/0642: {for bones, e.g. for osteosynthesis or connecting tendon to bone} - A61B 17/0682: {for applying U-shaped staples or clamps, e.g. without a forming anvil} - A61B 17/17: Guides {or aligning means} for drills {, mills, pins or wires} - A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)} - A61B 17/072: for applying a row of staples in a single action, e.g. the staples being applied simultaneously - A61B 17/07207: {the staples being applied sequentially} - 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 2017/00407: {Ratchet means} - A61B 2017/00668: {the implement being a tack or a staple} - A61B 2017/07214: {Stapler heads} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A fastener for attaching a sheet-like implant to tissue or bone may be provided with a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm. Each of the first and second arms can include at least a partial loop member having a lumen therethrough slidably receiving the other arm, each arm further including a tissue retention member on a distal portion having a projection extending therefrom for engagement of bone or tissue when inserted therein. The staple can also include a one-way position retention assembly for allowing distal movement of each at least partial loop member relative to the other arm therethrough to tension the fastener and maintain a desired configuration. ## Claims ### Claim 1 A fastener for attachment to bone or tissue comprising: a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm, wherein each of the first and second arms include at least a partial loop member having a lumen therethrough slidably receiving the other arm, each arm further including a tissue retention member on a distal portion having a projection extending therefrom; and, a one-way position retention assembly for allowing distal movement of each at least partial loop member relative to the other arm therethrough to tension the fastener and maintain a desired configuration. ### Claim 2 (depends on 1) The fastener of claim 1, wherein each tissue retention member has a lateral extent larger than the arm proximal thereto to provide a change in lateral stiffness to allow flexing of each arm adjacent the tissue retention member in response to a pullout force. ### Claim 3 (depends on 1) The fastener of claim 1, wherein each projection extends proximally and laterally away from its respective arm. ### Claim 4 (depends on 2) The fastener of claim 2, wherein each of the tissue retention members have a lumen extending longitudinally therethrough. ### Claim 5 (depends on 4) The fastener of claim 4, wherein the one-way position retention assembly comprises a generally U-shaped strap having a toothed surface along at least a portion of the length thereof that passes through the lumen of the tissue retention members and engages a surface therein that allows distal movement of the U-shaped strap while preventing proximal movement. ### Claim 6 (depends on 4) The fastener of claim 4, wherein the one-way position retention assembly comprises a projection within the at least partial loop of each arm wherein the projection engages a toothed surface on the arm extending therethrough to allow distal movement of the loop along the arm while preventing proximal movement. ### Claim 7 (depends on 1) The fastener of claim 1, wherein the first arm, the second arm and the bridge are each formed of a polymeric material. ### Claim 8 (depends on 7) The fastener of claim 7, wherein the polymeric material comprises a polyether ether ketone (PEEK) material. ### Claim 9 A staple for insertion and retention in bone or tissue comprising: a first arm having a proximal portion and a distal portion, a second arm having a proximal portion and a distal portion, and a bridge formed at least in part by the proximal portion of the first arm overlapping the proximal portion of the second arm, wherein each of the first and second arms include a laterally extending loop having a lumen slidably receiving a portion of the other arm therethrough, each arm further including a tissue retention member on a distal portion thereof; and, a generally U-shaped strap having a toothed surface along at least a portion of the length thereof that engages a surface of each arm and allows distal movement of the U-shaped strap while preventing proximal movement. ### Claim 10 (depends on 9) The fastener of claim 9, wherein each tissue retention member has a lateral extent larger than the arm proximal thereto to provide a change in lateral stiffness to allow flexing of each arm adjacent the tissue retention member in response to a pullout force. ### Claim 11 (depends on 9) The fastener of claim 9, wherein each projection extends proximally and laterally away from its respective arm. ### Claim 12 (depends on 9) The fastener of claim 9, wherein each of the tissue retention members has a lumen extending longitudinally therethrough. ### Claim 13 (depends on 12) The fastener of claim 12, wherein the generally U-shaped strap toothed surface passes through the lumen of each of the tissue retention members and engages a surface therein that allows distal movement of the U-shaped strap while preventing proximal movement. ### Claim 14 A fastener delivery tool comprising: a barrel assembly having an outer sheath with a staple delivery assembly disposed therein, the staple delivery assembly including a shaft having a distal surface for the engagement of a bridge portion of a staple when mounted on the delivery tool; the staple delivery assembly further including a pair of staple setting rods extending along the length of the shaft each having stake portions extending distally beyond the distal surface, wherein each stake portion includes a distal portion sized for sliding engagement of a tissue retention member and a proximal portion having a surface abutting a loop member on a staple arm for applying distally directed force to the loop to achieve a desired configuration of the staple retained in tissue when the stakes are moved distally relative to the surface; and, a handle assembly fixed to the outer sheath of the barrel in operative relationship with the staple delivery assembly. ### Claim 15 (depends on 14) The fastener delivery tool of claim 14, wherein the staple delivery assembly is longitudinally extendable from a first position enclosed within the sheath to a second position wherein at least a portion of the staple delivery assembly extends distally from the sheath. ### Claim 16 (depends on 14) The fastener delivery tool of claim 14, wherein the staple delivery assembly includes a proximal shaft portion having a proximal portion of the staple setting rods fixed thereto and a distal portion with a spring therebetween to allow relative longitudinal movement between the distal surface and the staple setting rods in response to increased force on the proximal end of the staple delivery assembly. ### Claim 17 (depends on 16) The fastener delivery tool of claim 16, wherein at least a portion of the staple setting rods have a cross sectional shape that slidingly engages a channel of like cross sectional shape on the staple delivery assembly to restrict relative motion of the surface and staple setting rods in the longitudinal direction.