Medical device for joining materials

Abstract

To provide a medical device for joining materials.SOLUTION: This device comprises a piercing element configured to penetrate materials to be joined. The piercing element is sufficiently sharp to penetrate the materials to be joined and comprises a hollow interior along at least a portion of its length, configured to allow distal advancement of a fastener therethrough, and includes an open tip through which the fastener can be pushed. The device can be used for fastening materials including tissue, synthetic mesh, and biologic mesh (e.g., ADM).SELECTED DRAWING: Figure 9

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 926,273, filed October 25, 2019, and U.S. Provisional Patent Application No. 63 / 022,286, filed May 8, 2020.

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] FIELD OF THE DISCLOSURE This application relates to the field of surgical fixation devices. [Background technology]

[0004] The attachment of soft tissue to materials (such as synthetic, biological, or absorbable meshes) is performed in many surgical procedures and is typically accomplished using sutures, staples, or tacks. However, these fixation methods have trade-offs. It takes a lot of time to apply multiple sutures. Stapling or tacking can be relatively fast, but may be undesirable when metal or hard, sharp-tipped fasteners present issues (e.g., pain, imaging, puncture of structures, retention). Furthermore, most existing staplers and tackers are not suitable for tougher materials such as acellular dermal matrix (also known as ADM, biological mesh), which requires time-consuming suturing.

[0005] Acellular dermal matrix (ADM) is a material that is typically made from donor skin of human or porcine origin, and is processed to remove cellular content and retain a collagen and elastin fiber matrix. ADM is used to treat a variety of conditions where intact skin scaffolding is required, and can be attached to tissue using sutures. Examples of surgical procedures that use ADM include breast reconstruction, cosmetic breast procedures, abdominal wall repair (e.g., abdominal wall / incisional hernia repair, wall reinforcement / prophylaxis), burns and wounds (e.g., diabetic foot ulcers), and orthopedic procedures (e.g., quadriceps tendon strengthening, Achilles tendon repair, and augmentation in the shoulder, hip, and knee).

[0006] Currently, there are no staplers that can penetrate the ADM, so physicians secure the ADM to the tissue with sutures, which is a time-consuming procedure. In procedures using other materials that can be stapled (e.g., mesh), physicians use significant force to drive the stapler into the tissue to ensure a good connection. However, the driving carries the risk of damaging the underlying tissue or organs as the tissue being stapled comes into contact with the underlying tissue during stapling.

[0007] For example, in ventral and incisional hernia repair, mesh is used to reinforce midline closure and prevent hernia recurrence. When using an ADM in an open onlay approach, as shown in Figure 1, the ADM 2 is placed over the abdominal muscle 4 and sutured in place. Multiple sutures 6 are carefully placed to secure the ADM 2 to the muscle 4, ensuring that the ADM 2 is taut, flat, and has sufficient fixation points. Suturing is not only time consuming, but is relatively difficult and skill dependent, which may adversely affect clinical outcomes. Summary of the Invention [Problem to be solved by the invention]

[0008] A fast, easy-to-use fixation device that can puncture the ADM or other mesh, aid in positioning and tensioning the ADM (or other mesh), secure the ADM (or other mesh) to soft tissue using non-metallic (polymeric or absorbable) fasteners, and work with an onlay procedure would be an advantageous tool to reduce surgeon workload / procedure time and provide a reproducible fixation construct. [Means for solving the problem]

[0009] In a first aspect, a fixation device is provided comprising a shaft, a handle, and a needle extending from the shaft, the needle comprising a slot extending along at least a portion of the needle, the device may be configured to receive a fastener comprising a first bar and a second bar connected by a bar connector, the first bar being positioned within the needle and the second bar being positioned outside the needle.

[0010] The device may further include at least one fastener having a first bar and a second bar connected by a bar connector, the first bar being disposed within the needle and the second bar being disposed outside the needle, and a push member configured to push the fastener out of the needle.

[0011] The device may further comprise a pushing member configured to push the fastener out of the needle.

[0012] In some embodiments, the device further comprises a fastener reservoir within the shaft. The second bar may be disposed within the shaft. In some embodiments, the device comprises at least one ramp near a distal end of the device, the ramp configured to redirect the second bar while the fastener is pushed distally. The device may comprise a shoulder disposed at a fixed or adjustable distance proximate the distal end of the needle. In some embodiments, the device comprises a trigger configured to deploy the fastener by engaging with the push member. The shaft may include one or more of an articulating end and a rotating end. In some embodiments, the shaft comprises a bending end.

[0013] The shaft may include a replaceable cartridge, which may include the entire shaft or a distal portion of the shaft.

[0014] In some embodiments, the needle can be retracted and / or advanced relative to the shaft, and a distal portion of the shaft can be retracted and / or advanced relative to the needle.

[0015] In some embodiments, the needle comprises one or more barbs. The barbs may be ejectable / retractable. In some embodiments, the needle comprises one or more bumps. The needle may comprise one or more notches. In some embodiments, the needle comprises an enlarged region adjacent the end of the needle.

[0016] The needle may comprise one or more blades. The one or more blades may be retractable. The one or more blades may be actuable. In some embodiments, the device comprises one or more auxiliary needles.

[0017] The one or more auxiliary needles may include one or more auxiliary needle barbs. In some embodiments, the one or more auxiliary needle barbs are ejectable / retractable.

[0018] The device may include a first ramp extending from a surface proximate to the needle, the first ramp extending away from the surface and configured to lift the bar connector and the second bar over the needle when the fastener is pushed distally. In some embodiments, the device may include a ramp extending from a sidewall, the ramp extending away from the sidewall and configured to rotate the second bar when the fastener is pushed distally such that the second bar is moved toward a direction generally parallel to the material being fastened. The device may include a surface or sidewall configured to maintain the rotated position of the second bar.

[0019] In some embodiments, at least a portion of the needle slot is helical.The device may include a support configured to provide counter-traction to a material to be secured while the needle is withdrawn from the material.

[0020] The device may include a support configured to provide counter-traction to the secured material while the needle is withdrawn from the material.

[0021] In some embodiments, the needle is bent or curved.

[0022] The width of the needle slot may be greater than the width of the bar connector or the fastener. In some embodiments, the edges of the needle slot include rounded, broken, ground, or other non-sharp edge configurations.

[0023] The size of the inner diameter of the needle and the size of the outer diameter of the needle can be selected to provide a passage of sufficient size through the materials to be joined such that the bar and bar connector of the fastener pass through the materials to be joined with minimal force, hi some embodiments, the size of the inner diameter and the outer diameter of the needle are selected to provide a minimal insertion force into the materials to be joined.

[0024] The bevel angle of the needle tip may be configured to provide a minimal insertion force into the material to be bonded, hi some embodiments, the bevel angle of the needle tip is configured to withstand repeated use.

[0025] The length of the needle may be selected to minimize trauma to the tissue and structures surrounding the repair site, hi some embodiments, the length of the needle is selected to be suitable for placing one or more ends of the fastener within tissue.

[0026] In another aspect, a tissue fastener configured to attach tissue to another material or tissue is provided, the fastener comprising a first bar, a second bar, and a connector joining the first bar to the second bar, the connector configured to have sufficient strength to withstand deployment of the first bar.

[0027] In some embodiments, at least one of the first and second bars has one or more blunt ends. At least one of the height, length, or width of the second bar may differ from the corresponding dimension of the first bar. In some embodiments, the second bar is configured to flex. At least one of the first and second bars may be curved.

[0028] In some embodiments, at least one of the second bar and the first bar may include downward and / or upward protrusions. At least one of the first bar, the second bar, and the connector bar may include one or more barbs. In some embodiments, at least one of the first bar and the second bar may include an extending wing. At least one of the first bar and the second bar may include a curling arm.

[0029] In some embodiments, the first bar comprises a circular cross-section. At least one of the first bar, the second bar, and the connector may have a circular, oval, square, or rectangular cross-section.

[0030] In some embodiments, the thickness or diameter of the connector is less than the thickness or diameter of the first bar or the second bar.

[0031] In some embodiments, the connector material is stretched or pre-stretched. The first arm and the second arm may extend in different directions. In some embodiments, at least one of the first bar and the second bar includes an end feature. At least one of the first bar and the second bar may include a bend. In some embodiments, the length of the connector is adjustable. The connector may be positioned at an angle other than perpendicular to the first bar and the second bar. In some embodiments, at least one of the first bar, the second bar, and the connector bar includes one or more materials. The connector bar may be bent or curved.

[0032] In some embodiments, the length of the tissue fastener is sized to embed one or more ends of the fastener within tissue, and the one or more ends of the fastener embedded within tissue may include one or more features configured to resist extraction from tissue.

[0033] In some embodiments, one or more ends of the fastener that are not embedded in tissue include one or more features configured to retain an onlay material.

[0034] In some embodiments, a method is provided for securing an onlay material to tissue, the method including the steps of piercing the onlay material and tissue with a needle including a slot, the needle forming part of a fixation device, and advancing a fastener having a first bar disposed within the needle, the first bar being connected to a second bar by a connector.

[0035] The method may include controlling the insertion depth of the needle using a stop.

[0036] In some embodiments, the method includes withdrawing the needle from tissue from a first location within the tissue, positioning or tensioning the material on the needle, and puncturing the tissue at a second location.

[0037] In some embodiments, the method includes redirecting the second bar.

[0038] The method may include advancing the fasteners including by actuating a trigger on the fixation device, hi some embodiments, the method includes maintaining / stabilizing the position of the needles within the onlay material and tissue while deploying the fasteners.

[0039] The method may include redirecting the second bar using one or more ramps located near a distal end of the device. In some embodiments, redirecting the second bar includes moving or lifting the second bar to avoid engagement of the needle with the slot. Redirecting the second bar may include moving the second bar toward a position parallel to a surface of the onlay material. In some embodiments, redirecting the second bar includes rotating the second bar such that the second bar moves toward being parallel to a surface of the onlay material.

[0040] In some embodiments, the method includes deploying a first bar within the tissue. The method may include deploying the second bar so that it is disposed adjacent to the onlay material. In some embodiments, the method may include deploying the fasteners so that the tissue and the onlay material are joined and secured together by the fasteners. The method may include withdrawing the needles from the onlay material and tissue after the fasteners are deployed. In some embodiments, the method may include supporting the onlay material and tissue while withdrawing the needles. The method may include holding the onlay material and tissue away from underlying structures while the fasteners are deployed.

[0041] In another aspect, a fixation device is provided comprising: two needles extending therefrom, each needle comprising a slot extending along at least a portion of the needle; at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar positioned within one needle and the second bar positioned within the other needle; and a push member configured to push the bars distally into and out of the needles.

[0042] In yet another aspect, a method is provided for securing an onlay material to tissue, the method comprising the steps of piercing the onlay material and tissue with two needles, each needle having a slot, the needles forming part of a fixation device, advancing a fastener comprising a first bar positioned within one needle and a second bar positioned within the other needle, the first bar connected to the second bar by a connector, and deploying the first and second bars within the tissue such that the tissue and onlay material are secured together by the fasteners.

[0043] In yet another aspect, a fixation device is provided comprising: a needle extending therefrom, the needle comprising a slot extending along at least a portion of the needle, at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar and the second bar disposed within the needle, and a push member configured to push the bars distally inward and outward of the needle.

[0044] In another aspect, a method is provided for securing an onlay material to tissue, the method including the steps of piercing the onlay material and tissue with a slotted needle, the needle forming part of a securement device, advancing a fastener including a first bar and a second bar positioned within the needle, the first bar connected to the second bar by a connector, deploying the first bar into tissue at a first location, removing the needle from the onlay material and tissue at the first location, and deploying the second bar into tissue at a second location such that the tissue and onlay material are secured together by the fastener.

[0045] In yet another aspect, a fixation device is provided that includes a first jaw including a slotted needle and a second jaw opposing the first jaw.

[0046] The device may include an opening configured to receive the needle when the first and second jaws are moved toward one another.

[0047] In a further aspect, a method is provided for fastening tissue or materials, the method including the steps of piercing a first tissue or material with a slotted needle, the needle forming part of a fastening device, piercing the first tissue or material comprising moving opposing jaws of the fastening device toward one another, piercing a second tissue or material with the needle to join the first and second tissues or materials, piercing the second tissue or material comprising moving the opposing jaws toward one another, and advancing a fastener with a first bar disposed within the needle and connecting the first bar to a second bar with a connector.

[0048] In some embodiments, the method includes deploying the first bar through the tissue or material such that the first bar rests on one surface of the tissue or material and the second bar rests on another surface of another tissue or material. The method may include deploying the fasteners such that the tissues or materials are secured together by the fasteners.

[0049] In another aspect, a method is provided for fastening tissue or material comprising the steps of piercing a first tissue or material with a first needle having a slot, the first needle forming a part of a fastening device, piercing a second tissue or material with a second needle having a slot, the second needle forming a part of the fastening device, joining the first and second tissues or materials and joining the tissues or materials comprises moving the first tissue or material with the first needle and piercing the second tissue or material with the second needle, advancing the fastener comprising a first bar positioned within the first needle and a second bar positioned within the second needle, the first bar connected to the second bar by a connector, and deploying the first bar and the second bar through the tissue or material such that the tissues or materials are joined and secured together by the fastener.

[0050] In yet another aspect, a method is provided for securing an onlay material to tissue, the method including the steps of placing an onlay material adjacent tissue, embedding a first bar of fasteners within the tissue, and positioning a second bar of the fasteners adjacent the onlay material, thereby securing the onlay material to the tissue, the fasteners including a connector connecting the first bar to the second bar.

[0051] In another aspect, a method for fastening a material to tissue is provided, the method including the steps of placing a material adjacent to tissue, placing a first bar of a fastener adjacent to the tissue, and placing a second bar of the fastener adjacent to the material, thereby fastening the material to the tissue, the fastener comprising a connector connecting the first bar and the second bar.

[0052] In a first aspect, a surgical device for joining materials is provided, the device comprising a head portion, first and second fangs having sharp ends and a hollow or partially hollow interior, and a deployment member configured to expel staples from the head portion.

[0053] The first fang may be configured to receive a first leg of a staple and the second fang may be configured to receive a second leg of a staple. The device may further comprise a retractable backstop configured to actuate toward the first and second fangs, the backstop comprising a first hole or partial perimeter configured to receive the first fang, a second hole or partial perimeter configured to receive the second fang, and a joint connecting the head portion and the retractable backstop and configured to allow the retractable backstop to actuate toward the head portion.

[0054] In some embodiments, at least one of the first and second fangs includes an open side shaped to allow passage of a staple leg. The open side may include a slot. The deployment member may include two outer dies configured to be moved downwardly toward a central die. In some embodiments, the deployment member includes a central die and two outer dies configured to be moved downwardly toward the central die. At least one of the first and second fangs may include an angled or sharp tip.

[0055] In some embodiments, the fangs may be mounted on a retractable shuttle. The device may include a staple disposed in a retractable shuttle having a first staple leg disposed in the first fang and a second staple leg disposed in the second fang. In some embodiments, the retractable shuttle is configured to retract the fangs.

[0056] In some embodiments, the device comprises a staple disposed within a retractable head having a first leg disposed within the first fang and a second leg disposed within the second fang. The retractable head can be configured to be retracted while the head portion maintains its position. The head portion can be configured to hold a plurality of staples. In some embodiments, the head portion comprises a staple cartridge configured to hold a plurality of staples.

[0057] In some embodiments, the head portion is at one end of a shaft. The head portion may be configured to rotate or articulate.

[0058] One or more fangs may include an attached blade. In some embodiments, one or more fangs include an actuatable blade. The blade may be tapered from a base of the fang to an end of the fang. In some embodiments, the one or more fangs are configured to articulate. One or more fangs may include an internal feature shaped to guide a staple into a closed position. In some embodiments, the one or more fangs are adjustable. The one or more fangs may include a thread. In some embodiments, the one or more fangs include at least one of a barb, a notch, or a neck. The fangs may be replaceable. In some embodiments, the fangs are covered by an actuatable shroud or backstop.

[0059] In another aspect, a surgical device for joining materials is provided, the device comprising a head portion with fangs and a deployment member configured to expel staples from the head portion.

[0060] The fangs may be configured to receive the staple legs.

[0061] The device may comprise a retractable backstop configured to be actuated towards the fangs, the retractable backstop including a first aperture or partial perimeter configured to receive the fangs and a joint connecting the head portion and the retractable backstop and configured to actuate the retractable backstop towards the fangs.

[0062] In some embodiments, the head portion is configured to rotate at least 180.degree.. In some embodiments, the fangs include an open side shaped to allow passage of a staple leg.

[0063] The head portion may be configured to articulate. In some embodiments, the first fang includes an attached blade. The blade may be tapered from a base of the fang to an end of the fang. In some embodiments, the fang is configured to articulate. The fang may include an internal feature shaped to guide the staple into a closed position. In some embodiments, a position of the first fang is adjustable. The first fang may be threaded. In some embodiments, the fang includes at least one of a barb, a notch, and a neck. The fang may be replaceable. In some embodiments, the fang is configured to flip down from the head portion.

[0064] In yet another aspect, a method for joining materials is provided, the method including piercing a first material and a second material with a fang, the fang forming a portion of a fixation device, and deploying a staple through the fang.

[0065] The method may include initially piercing the first material with the fang. The method may include initially piercing only the first material with the fang by positioning the first material between the fang and a backstop and moving the backstop toward the fang, thereby forcing the first material against the fang. In some embodiments, the method may include moving the backstop away from the fang to retract the backstop. The method may include positioning the first material against the second material with the fang with the first material attached. The method may include piercing the second material with the fang. In some embodiments, the method may include retracting the first and second materials using one or more of the fang or partially deployed staples. The method may include deploying the staples to bond the first material to the second material. In some embodiments, the method may include detaching the fang from the first and second materials. The method may include deploying the staples by expelling the staples from the head portion. In some embodiments, the method may include deploying the staples by forming the staples around a central die. The method may include deploying the staples using an outer die to form the staples around a central die. The first material may include an onlay material. The second material may include tissue.

[0066] In another aspect, a surgical device for joining materials is provided comprising a head portion with a first staple exit configured to permit passage of a first staple leg and a second staple exit configured to permit passage of a second staple leg, and a deployment member configured to expel staples from the head portion.

[0067] The device may further comprise a retractable backstop configured to be actuated toward the staple legs, the retractable backstop comprising a first hole or partial perimeter configured to receive the first staple leg, a second hole or partial perimeter configured to receive the second staple leg, and a joint connecting the head portion and the retractable backstop and configured to allow the retractable backstop to be actuated toward the staple legs.

[0068] In some embodiments, the deployment member comprises a central die and two outer dies configured to be moved downwardly towards the central die.

[0069] In some embodiments, the first and second staple legs include angled or sharp tips.

[0070] The device may comprise a staple that may be positioned within a retractable shuttle. In some embodiments, the device comprises a staple disposed within a retractable shuttle, with the first staple leg disposed at or within the first staple exit and the second staple leg disposed at or within the second staple exit. The retractable shuttle may be configured to retract the staple legs.

[0071] The head portion may comprise a staple cartridge configured to hold a plurality of staples. The head portion may comprise a staple cartridge configured to hold a plurality of staples. The head portion may be at an end of a shaft. The head portion may be configured to rotate or articulate. The head portion may include one or more attached blades. The head portion may include one or more actuatable blades. The blades may be tapered from a base of the head portion toward the ends of the staple legs. The staple legs may be configured to flip down from the head. The staple legs may be covered by an actuatable shroud or backstop.

[0072] In another aspect, a surgical device for joining materials is provided, the device comprising a first arm having a channel configured to hold a staple, an opening in the channel to allow passage of the staple during staple deployment, and a push member configured to advance the staple through the first hole, the device further comprising a second arm having a second hole or partial circumference, and a hinge connecting the first and second arms and configured to allow the first and second arms to move away from and toward each other.

[0073] The first arm may include a stop configured to interact with a shaped feature of the staple to inhibit movement of the staple. The stop may be configured to disengage.

[0074] In some embodiments, the first arm comprises a first forming member configured to form the staple. In some embodiments, the first arm comprises a moveable second forming element configured to advance and cooperate with the first forming element to form the staple. In some embodiments, the second arm comprises a hole or a portion of a perimeter (such as a slot) that moves toward the first arm to receive the pierced end of the staple. In some embodiments, the first arm comprises a push member configured to push the staple. The first arm may include a push member configured to push the staple through a forming element to form the staple. In some embodiments, the staple has a first preformed end configured to penetrate the material to be bonded. The staple may have a second preformed end configured to interact with the stop and retain the material to be bonded.

[0075] In another aspect, a method for joining materials is provided that includes the steps of moving opposing arms or jaws toward one another to pierce the materials to be joined with an end of a staple, securing the materials to be joined between the opposing arms or jaws, and deploying and forming the staple to secure the materials to be joined.

[0076] The method may include advancing a first end of the staple through a channel opening of the first arm or jaw. In some embodiments, the method may include advancing a second forming element to form the first end of the staple to pierce the material to be bonded. The method may include using a stop to interact with a formed feature of the staple to inhibit movement of the staple during advancement of the second forming feature.

[0077] In some embodiments, the method includes positioning a first one of the materials between the opposing arms or jaws. The method may include moving the opposing arms or jaws toward one another to pierce the first material on the staple. The method may include moving the opposing arms away from one another. The method may further include positioning a second one of the materials between the opposing arms or jaws. The method may include moving the opposing arms or jaws toward one another to pierce the second material on the staple. The method may include securing the materials to be joined between the opposing arms or jaws. In some embodiments, the method includes pushing the staple through one or more forming members to fully form and close the staple and secure the materials together. The method may include releasing the staple from the first arm or jaw to hold the materials secured together by the staple. The method may include moving the opposing arms or jaws away from each other to release the material.

[0078] In another aspect, a tissue fastener or staple configured to attach tissue to another material or tissue is provided. The fastener or staple includes a first leg, a second leg, and a span connecting the first leg and the second leg. The first leg and the second leg can be approximately perpendicular to the span. In some embodiments, the first leg and the second leg have an acute angle to the span. In some embodiments, the bend between the span and the leg includes a bend radius of about 0.005 to 0.020 inches. In some embodiments, the bend between the span and the leg includes a bend radius of about 0.021 to 0.100 inches. In some embodiments, the ends of the closed staple legs lie in the same plane above and below each other relative to one another. In some embodiments, the span is configured with a bump or hump on an outer surface of the span. The fastener can include a metal, a polymer, and / or an absorbent material.

[0079] In another aspect, a tissue fastener or staple configured to join tissue and / or materials is provided. The staple comprises one or more preformed bends at a first end of the staple and a sharp tip at a second end of the staple. In some embodiments, the one or more preformed bends on the first end of the staple are configured to hold the material to be joined. In some embodiments, the sharp tip on the second end of the staple is configured to pierce the material to be joined. In some embodiments, the second end of the staple comprises one or more preformed bends. The fastener may comprise a metal, a polymer, and / or an absorbent material.

[0080] In another aspect, a tissue fastener or staple configured for joining tissue and / or materials is provided, the fastener comprising one or more heads at a first end of the staple and a sharpened tip at a second end of the staple, the fastener may comprise a metal, a polymer, and / or an absorbent material.

[0081] In another aspect, a surgical device for joining materials is provided, the device comprising a moveable housing including a track, a push member configured to be advanced along the track, a first linkage connected to the housing and a first articulating fang, and a second linkage connected to the housing and a second articulating fang.

[0082] In some embodiments, the fangs have sharp tips configured to pierce the material to be bonded. The articulating fangs may be configured to rotate the tips of the fangs relative to one another. The fangs may have internal grooves configured to guide the staple or fastener to be formed. The fangs may have internal grooves configured to form the staple. In some embodiments, the fangs have internal grooves configured to shield the staple from surrounding tissue and body structures. The push member may be configured with end features to push the staple or fastener to be formed. In some embodiments, the articulating fangs are disposed at the end of a shaft.

[0083] In another aspect, a surgical device for joining materials is provided, the device comprising a first jaw and a second jaw, the first jaw and / or the second jaw configured to be actuated toward one another, the device further comprising a hook positioned in the first jaw, an end of the hook extending toward the second jaw, the end of the hook configured to be deployed from the first jaw, and one or more staples positioned in the second jaw and configured to be deployed in a direction toward the first jaw.

[0084] In some embodiments, the second jaw comprises a window having a frame at least partially surrounding the window on a side of the second jaw facing the first jaw. The hook may be rigid or flexible.

[0085] In another aspect, a method for joining materials is provided that includes clamping a first material between a first jaw and a second jaw of a device, deploying a hook from the first jaw to capture and stabilize the first material to the first jaw, unclamping the first jaw and the second jaw, positioning a second material adjacent to the first material and between the first jaw and the second jaw, clamping the material between the first jaw and the second jaw, and deploying a staple from the second jaw to join the first material and the second material.

[0086] In some embodiments, the step of deploying a staple or fastener comprises deploying a staple or fastener from the second jaw. In some embodiments, the step of deploying a staple or fastener comprises deploying a staple or fastener from the first jaw. The method may include retracting the hook from the first material.

[0087] In yet another aspect, a device for stabilizing a material is provided, the device comprising a first jaw having one or more piercing elements and a second jaw having one or more openings or recesses, the first jaw and the second jaw configured to move toward one another.

[0088] In some embodiments, the one or more piercing elements disposed on the first jaw and extending toward the second jaw are configured to interact with the one or more openings or recesses on the second jaw when the first jaw and the second jaw are moved sufficiently toward one another. In some embodiments, the one or more piercing elements disposed on the first jaw and extending toward the second jaw are configured to enter the one or more openings or recesses on the second jaw when the first jaw and the second jaw are moved sufficiently toward one another.

[0089] In another aspect, a method for stabilizing materials to be bonded is provided, the method including the steps of positioning a first material between a first jaw and a second jaw of a device, moving the first jaw and the second jaw toward one another such that one or more piercing elements positioned on the first jaw pierce the first material, separating the first jaw and the second jaw, positioning a second material between the first jaw and the second jaw, and moving the first jaw and the second jaw toward one another such that the one or more piercing elements positioned on the first jaw pierce the second material.

[0090] In some embodiments, the method includes moving the first jaw and the second jaw toward each other such that one or more piercing elements disposed on the first jaw enter the one or more openings or recesses on the second jaw to pierce a material.

[0091] The method may include moving or retracting the device to move or retract the first and second materials. The method may include joining a stapling mechanism to the stabilized material. The method may include stapling the first and second materials together. The method may include joining the first and second materials together using other joining means such as sutures, tacks, fasteners, adhesives, etc.

[0092] In another aspect, a device for stabilizing surgically stapled material is provided, the device comprising a first jaw having a sharpened tip and a second jaw having a sharpened tip, the first jaw and / or the second jaw configured to be moved toward the other jaw.

[0093] In another aspect, a method is provided for stabilizing a material to be bonded, the method including the steps of positioning a first material between first and second jaws of a device, the first and second jaws each including a sharp tip, and moving the first and second jaws toward each other to pierce the first material with the sharp tips.

[0094] The method may include separating the first and second jaws while holding the first material at the sharpened tip, and moving the first and second jaws toward each other to pierce the second material with the sharpened tip. The method may include moving or retracting the device to increase or retract the first and second materials. The method may include joining a stapling mechanism to the stabilized material. The method may include joining the first and second materials with other joining means such as sutures, tacks, fasteners, adhesives, etc. In some embodiments, the method includes stapling the first material to the second material.

[0095] In another aspect, a surgical device for joining materials is provided, the device comprising an elongate shaft and a curved staple disposed at a distal end of the elongate shaft.

[0096] The staples may be positioned in a plane perpendicular to the elongate shaft. In some embodiments, the staples are positioned in a plane oriented at an angle other than perpendicular to the elongate shaft. A second arm or shaft may support the material and include a slot or opening at its end configured to receive an end of the staple. The second arm or shaft may be configured to actuate or rotate to form or close the staple.

[0097] In another aspect, a method for joining materials is provided that includes advancing a device to a surgical site including an elongate shaft and curved staples disposed on a distal end of the elongate shaft, the staples being disposed in a plane perpendicular to the elongate shaft, placing the first material onto a second material, rotating the elongate shaft such that piercing ends of the curved staples pierce the first and second materials, and closing the staples.

[0098] In some embodiments, an edge of the first material is bonded to the second material. The method may include positioning a second arm or shaft including a slot or opening at an end to support the material and receive the piercing end of a staple. The method may include actuating or rotating a second arm or shaft to form or close the staple. The method may include releasing the staple from the device. The method may include actuating or rotating the elongate shaft to form or close the staple. At least one of the first and second materials may include an ADM.

[0099] In another aspect, a device for joining materials is provided comprising a first elongate shaft configured to hold a first leg of a staple and a second elongate shaft configured to hold a second leg of a staple, the first and second elongate shafts positioned adjacent one another substantially parallel, and rotation of the elongate shafts causes the staple legs to move toward one another.

[0100] In some embodiments, the first and second staple legs are curved toward each other.

[0101] In another aspect, a method of surgically stapling material is provided, the method including the steps of advancing a device to a surgical site, the device including a first elongate shaft including a first leg of a staple and a second elongate shaft including a second leg of a staple, and further including the steps of positioning a first material over a second material and rotating the first and second elongate shafts relative to one another such that the first and second legs pierce the first and second materials to close the staple.

[0102] In some embodiments, the method includes releasing the staples from the device.In some embodiments, at least one of the first material and the second material comprises an ADM.

[0103] In another aspect, a surgical device for joining materials is provided, the device comprising a first jaw configured to hold a first end of a staple, the first end of the staple including a preformed feature and a second end configured to pierce a material, the device further comprising a second jaw having a slot or opening, the first jaw and the second jaw configured to move toward one another.

[0104] In some embodiments, the preformed feature comprises a loop or hook shape. In some embodiments, the slot or opening in the second jaw is configured to receive the second end of the staple when the first jaw and the second jaw are moved toward one another. In some embodiments, the second jaw is configured to actuate or rotate to form or close the staple. In some embodiments, the second jaw is advanceable and retractable relative to the first jaw. The second jaw may comprise an anvil. The first jaw may comprise an actuator configured to advance the staple into an anvil on the second jaw. The second end of the staple may comprise a bend. The first jaw may comprise a piercing shroud or fang configured to cover the staple tip.

[0105] In another aspect, a method for joining materials is provided that includes the steps of advancing a device having a first jaw and a second jaw, the first jaw holding a first end of a staple including a preformed feature, positioning a first material between the first jaw and the second jaw, moving the first jaw and the second jaw toward one another such that the second end of the staple pierces the first material and enters a slot or opening on the second jaw, moving the first jaw and the second jaw away from one another, positioning a second material between the first jaw and the second jaw, and moving the first jaw and the second jaw toward one another such that the second end of the staple pierces the second material.

[0106] The method may include transferring the first material to a preformed feature on the staple.The method may include moving or retracting the device to move or retract the first and second materials.

[0107] The method may include actuating or rotating the second jaw to close the staple. In some embodiments, the method may include sliding the second jaw to align the staple tip with an anvil on the second jaw prior to positioning the second material. The method may include moving the jaws toward one another such that a second end of the staple pierces the second material and enters the anvil to curl, form, or close the staple. The method may include releasing the staple from the device.

[0108] In another aspect, there is provided a staple configured for use with any of the devices or methods disclosed herein, the staple comprising a central portion, a first leg extending from a first end of the central portion at a first bend, and a second leg extending from a second end of the central portion at a second bend, the first bend and the second bend each comprising a hump.

[0109] In yet another aspect, there is provided a staple configured for use with any of the devices or methods disclosed herein, the staple comprising a first leg extending from a first end of the central portion at a first intersection and a second leg extending from a second end of the central portion at a second intersection, the central portion comprising at least one hump proximate the intersection.

[0110] In another aspect, a device for bonding materials is provided, the device comprising a first arm with a first fang and a first hole, and a second arm with a second fang and a second hole, the first arm connected to the second arm at a joint, the first arm and the second arm configured to rotate relative to one another about the joint, such that upon rotation, the first fang is configured to enter the second hole and the second fang is configured to enter the first hole. The fangs may include one or more of notches, barbs, necks, or the like for retaining the first material on the fangs. The fangs may include a lubricious coating to allow the opposing fang to be detached from the first material.

[0111] In another aspect, a method for joining materials is provided, the method including the steps of advancing a device comprising a first arm with a first fang and a first hole and a second arm with a second fang and a second hole, the first arm and the second arm being connected at a joint and configured to rotate about the joint, positioning the device over a first material, the device in an open position, piercing the first material with the first and second fangs, rotating the first arm and the second arm about the joint such that the first fang enters the second hole and the second fang enters the first hole, rotating the first arm and the second arm away from each other, positioning the device and the attached first material over a second material, and piercing the second material with the first fang and the second fang.

[0112] The method may include deploying a staple to join the first and second materials.The method may include moving or retracting the device to move or retract the first and second materials.

[0113] In another aspect, a device for joining materials is provided, the device comprising: a carrier configured to extend from a head, the head configured to deploy staples; and sharpened elements configured to extend from the carrier, tips of the sharpened elements configured to move toward one another to grasp a target material, and the carrier configured to retract with the sharpened elements extended to join the head to the target material.

[0114] The tips of the sharpened elements can be configured to overlap to grasp and / or pierce the target material, and the sharpened elements can be configured to have a surface that prevents the staple ends from protruding beyond the sharpened elements.

[0115] In another aspect, a prosthetic material is provided with a plurality or array of holes, which may be configured to be sized to allow a staple or fastener, or a portion of a staple or fastener, to pass through the material.

[0116] In another aspect, a device for joining materials is provided, the device comprising a body including a feature for fastening to bone and a wire extending from the body, the wire forming an exposed end of the wire.

[0117] The exposed end of the wire may include a tip.

[0118] The wires may be configured to bend to hold material or tissue.

[0119] In another aspect, a method for joining materials is provided, the method including the steps of inserting into bone one or more devices for joining materials to bone, the device having a body with features for fastening to bone and a wire extending from the body, piercing one or more materials to be joined to bone with the wire, and shaping or closing the wire to fasten the one or more materials to the bone.

[0120] In another aspect, a device for joining materials is provided, the device comprising a fastener or staple in the form of a loop with at least one sharp end and a shaft configured to expand the loop of one or more staples, the shaft being in an inner diameter of the loop of the one or more staples and rotating and compressing the end of the one or more staples.

[0121] The staple may be disposed at an end of the shaft and configured to pierce the materials to be bonded with the sharp end when the staple is rotated by the shaft, hi some embodiments, the diameter of the loop of the staple returns or contracts to secure the materials to be bonded.

[0122] In another aspect, a device for joining materials is provided, the device comprising a polymer strand with a series of openings configured to receive ends of the polymer strand and configured to melt and fuse joints between the openings and the strand passing through the openings to form fixation loops.

[0123] The device may further comprise a guide tube having a tip configured to pierce the material to be bonded and form a loop shape, and a slot running the length or a portion of the length of the tube, the slotted lumen of the guide tube being sized to allow the polymer strand having an opening to pass therethrough.

[0124] In another aspect, a device for joining materials is provided, the device comprising a first curved tubular lumen having a distal end and a second curved tubular lumen having a distal end, the first and second curved tubular lumens articulating to pierce the first and second materials to be joined and to mate the opposed distal ends of both lumens.

[0125] In some embodiments, the mated tips of both lumens form a continuous lumen configured to receive a material, the continuous lumen forming a loop shape, and the lumens can be configured to be removed leaving a polymer loop that joins and secures the material.

[0126] In yet another aspect, a device for joining materials is provided. The device includes a curved cannula having a tip on one end configured to pierce the materials to be joined and form a passage through the materials to allow a suture or strand to pass through the materials. In some embodiments, the curved cannula can be removed leaving the suture or strand in the materials to be joined. In some embodiments, a fastening element can fasten a loop with the suture or strand to join the materials to be joined. In some embodiments, the fastening element or a separate element can fuse the loop. In some embodiments, an excess length of the suture or strand can be removed leaving a loop that secures the materials together.

[0127] In yet another aspect, a device for stabilizing materials is provided, the device comprising an inner tube with an angled barb at one end and an outer tube with an angled barb at the same end, the angled barb on the inner tube and the angled barb on the outer tube facing each other to form a pair, and further comprising one or more pairs of barbs that sandwich or secure one or more materials to be joined when the inner or outer tube is rotated in a direction that brings the tips of the one or more pairs of barbs together.

[0128] The inner tube may have a lumen through which instruments can be passed, hi some embodiments, the walls of the inner and outer tubes include windows to provide visibility and access to the working area of ​​the stabilized tissue.

[0129] In another aspect, a device for stabilizing a material is provided, the device comprising at least two pincers, with tips of the pincers facing one another, a portion of each pincer having an outer contour, and a tube surrounding the pincers and configured to advance the tips of the pincers to meet, in some embodiments, the tips of the pincers are configured to grasp the material when the tips of the pincers are moved toward one another.

[0130] In yet another aspect, a fixation device is provided comprising a shaft and a needle extending from the shaft, the needle comprising a slot extending along at least a portion of the needle, the device configured to receive at least one fastener comprising a first bar and a second bar connected by a bar connector, the first bar configured to be positioned within the needle and the second bar configured to be positioned outside of the needle, a push member configured to push the fastener out of the needle, and one or more control rods comprising a connector, the connector configured to connect to a surgical robot.

[0131] In some embodiments, the shaft is configured to rotate and / or articulate. In some embodiments, at least one control rod provides motion to move fasteners from a transfer zone through a transition zone. In some embodiments, at least one control rod is configured to provide motion to move fasteners from a transition zone through an operation zone and deploy the fasteners. One or more control rod connectors may be configured to connect to one or more control rods of the surgical robot. In some embodiments, the one or more control rod connectors include a connection clamp or union configured to interact with a ball or end feature of the surgical robot. In some embodiments, the connection clamp or union includes a first location in the device for receiving a ball or end feature on the surgical robot. In some embodiments, the connection clamp or union includes a second location on the device for securing the control rod connection to the surgical robot. In some embodiments, the connector on the fixation device includes a collar that attaches to the surgical robot. In some embodiments, the connector on the fixation device is threaded into the surgical robot. In some embodiments, the device is configured to receive a fastener cartridge including one or more fasteners. The fastener cartridge may be replaceable. The fastener cartridge may be configured to be replaceable while the device is connected to the surgical robot. In some embodiments, the fastener cartridge includes features to secure the cartridge to the device. The fastener cartridge may include spring loaded features to secure the cartridge to the device. In some embodiments, the fastener cartridge includes features to align the cartridge to a transition zone of the device. In some embodiments, the fastener cartridge includes features to align the cartridge to the control rod or push rod of the device. The fastener cartridge may be flexible.In some embodiments, the needle of the device is configured to be replaceable while the device is connected to the surgical robot.

[0132] In another aspect, a fixation device configured for fixation in soft tissue is provided, the device comprising one or more piercing elements having a sharpened tip and a hollow or partially hollow interior in communication with an opening near or through the tip, the hollow or partially hollow interior configured to permit advancement of the fastener.

[0133] The device may include a push member configured to advance a fastener. In some embodiments, the device includes a fastener configured to advance from the opening along the interior of the piercing element near or through the tip. The length of the fastener may be sized to allow one or more ends of the fastener to be embedded in tissue. In some embodiments, the one or more ends of the fastener configured to be embedded in tissue include one or more features configured to resist withdrawal from tissue. The one or more ends of the fastener not embedded in tissue may include one or more features configured to retain an onlay material. In some embodiments, the length of the piercing element is selected to minimize trauma to tissue and structures surrounding the repair site. In some embodiments, the length of the piercing element is selected to be suitable for placing one or more ends of the fastener in tissue.

[0134] In another aspect, a method of fastening in soft tissue is provided, the method including piercing a material to be bonded with one or more piercing elements of a fastening device, advancing fasteners along an interior of the piercing elements, and expelling the fasteners from an opening near or through a distal end of the piercing elements.

[0135] The method may include using a stop, shoulder, etc. to control the insertion depth of the piercing element(s). The method may include placing one end or more than one end of the fastener into tissue.

[0136] In another aspect, a method of fixation in soft tissue is provided, the method comprising piercing materials to be joined with one or more piercing elements of a fixation device, the piercing elements forming one or more openings or passages through the materials to be joined.

[0137] The method may include forcing a fastener through the opening(s) or passage(s) formed by the one or more piercing elements in the material to be bonded. The method may include placing one end or more ends of the fastener into tissue.

[0138] In another aspect, a device for fastening a material is provided comprising a piercing element configured to penetrate a material to be joined, the piercing element being sufficiently sharp to penetrate the material, the piercing element comprising a hollow interior along at least a portion of its length, the hollow interior configured to have a fastener advanced distally therethrough, and further comprising an open tip through which the fastener can be expelled.

[0139] The device may include a push member for advancing the fastener distally into and out of the piercing element. In some embodiments, the length of the piercing element may be selected to minimize and / or avoid trauma to surrounding structures. In some embodiments, the length of the piercing element may be selected to be suitable for placing one end of the fastener in tissue. In some embodiments, the length of the piercing element is about 0.100 to 0.380 inches. The piercing element may comprise a needle or fangs.

[0140] In another aspect, a method for joining materials is provided that includes inserting a piercing element of a fixation device into or through a material, advancing a fastener along an interior of the piercing element, and extruding the fastener, or a portion of the fastener, through the material and out a distal tip of the piercing element.

[0141] In another aspect, a method for joining materials is provided that includes inserting a piercing element of a fastening device into materials forming one or more openings or passages through the materials, and threading a fastener through the openings or passages formed by the piercing element.

[0142] The materials may include synthetic mesh, biological mesh (eg, ADM), and / or tissue.

[0143] In another aspect, a method for joining materials is provided that includes inserting a piercing element of a fixation device into a mesh, advancing a fastener along an interior of the piercing element, and extruding the fastener, or a portion of the fastener, through the material and out a distal tip of the piercing element.

[0144] In another aspect, a method for joining materials is provided that includes inserting piercing elements of a fixation device into or through a mesh to form one or more openings or passages through the materials and threading a fastener through the openings or passages formed by the piercing elements.

[0145] The mesh may include a synthetic mesh and / or a biological mesh.

[0146] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0147] [Figure 1] FIG. 1 is a schematic diagram of an onlay procedure. [Diagram 2] FIG. 1 illustrates an embodiment of a fixation device. [Figure 4] ~ [Figure 9] 3 illustrates one embodiment of a method for using the device of FIG. 2 in an onlay procedure. [Figure 10] FIG. 1 illustrates one embodiment of a fastener. [Figure 11] 13A-13C show an embodiment of a fastener positioned within a needle of a fixation device. [Figure 12] ~ [Figure 15] 12A-12C illustrate an embodiment of a method for using the fixation device of FIG. 11 in an onlay procedure, including an embodiment of a deflector that interacts with the filaments of the fastener. [Figure 16] ~ [Figure 19] 12 illustrates one embodiment of a method for using the fixation device of FIG. 11 in a sole procedure using a transparent material to allow visualization. [Figure 20] FIG. 1 illustrates an embodiment of a fastener with a blunt end. [Figure 21] FIG. 1 illustrates an embodiment of a fastener in which the second bar has a shorter length L and a different height H than the first bar. [Figure 22] 13A-13C show an embodiment of a fixation device with a needle at the distal end of the shaft. [Figure 23] ~ [Figure 26] 13A-13D illustrate an embodiment of a fixation device with features that may help maintain the onlay material on the needles of the fixation device and reduce / eliminate the amount of stabilizing force required during fastener deployment. [Figure 27A] ~ [Diagram 31]13A-13D illustrate additional embodiments of fixation devices that include features that can reduce / eliminate the amount of stabilizing force required during fastener deployment. [Diagram 32] ~ [Diagram 35] FIG. 13 illustrates an embodiment in which the fastener is deployed and the second bar is misaligned. [Diagram 36] ~ [Figure 37] 13A-13C illustrate an embodiment of a fastener having a flexible second bar deployed from a fixation device. [Figure 38] ~ [Figure 39] FIG. 13 illustrates an embodiment of a deflector interacting with a second bar of a fastener. [Diagram 40] ~ [Fig.42O] 13A-13C illustrate another embodiment of a fastener deflector configured to interact with a filament of a fastener and a second bar to redirect the second bar. [Figure 43A] ~ [Fig. 43D] FIG. 1 illustrates an embodiment of a needle with a helical slot. [Diagram 44] ~ [Diagram 45] FIG. 1 depicts the withdrawal force generated on a needle. [Figure 46] ~ [Figure 48] 1 shows an embodiment of a support for a fixation device. [Figure 49A] ~ [Figure 51C] FIG. 1 shows an embodiment of a needle with one or more blades. [Figure 52] FIG. 1 illustrates an embodiment of a fastener having one or more curved bars. [Diagram 53] FIG. 1 illustrates an embodiment of a fastener having one or more protrusions. [Figure 54] FIG. 1 illustrates an embodiment of a fastener with barbs. [Figure 55] ~ [Figure 56B]1 illustrates an embodiment of a fastener with extended wings. [Figure 57] FIG. 1 shows an embodiment of a fastener with curling arms. [Figure 58A] ~ [Figure 59C] 1A-1C show various views of two embodiments of a fastener with different cross-sectional shapes. [Figure 60] 13 illustrates an embodiment of a first bar of a fastener positioned within a needle. [Figure 61A] ~ [Figure 61B] 1 illustrates an embodiment of a fastener that is manufactured in multiple steps. [Figure 62A] ~ [Figure 62C] 1A-1C show an embodiment of a fastener having bars extending in different directions. [Figure 63] FIG. 1 illustrates an embodiment of a fastener having a bar with end features. [Figure 64] FIG. 1 illustrates an embodiment of a fastener having a bar with a bend. [Figure 65] 1A-1C show an embodiment of a fastener with an adjustable connector or filament. [Figure 66] ~ [Figure 70] FIG. 1 illustrates an embodiment of a fastener with a connector or filament disposed at an oblique angle relative to the bar of the fastener. [Figure 71] FIG. 1 illustrates an embodiment of a fastener comprising two or more materials. [Fig. 72A] ~ [Fig. 72C] 13A-13C show embodiments of shafts having articulating and / or rotating ends. [Figure 73] FIG. 1 shows an embodiment of a shaft having a bend at its distal end. [Fig. 74A] ~ [Fig. 74B] FIG. 1 illustrates an embodiment of a fixturing device having a replaceable cartridge. [Fig. 75A] ~ [Fig. 75B] FIG. 13 illustrates an embodiment of a shaft having a needle that can be retracted and / or advanced relative to the shaft. [Figure 76A] ~ [Figure 76B] FIG. 13 illustrates an embodiment of a shaft having a sheath that can be retracted and / or advanced relative to the needle / shaft. [Figure 77] ~ [Figure 79] FIG. 1 illustrates one embodiment of a fixation device. [Figure 80] ~ [Figure 83] 13A-13C show another embodiment of a fixation device. [Figure 84] ~ [Figure 89] FIG. 1 illustrates an embodiment of a fixation device with opposing jaws. [Figure 90] ~ [Figure 94B] 13A-13C show another embodiment of a fixation device. [Figure 95A] ~ [Fig. 96F] 1 illustrates an embodiment of a fastener. [Figure 97A] ~ [Figure 97C] 1A-1C show embodiments of fasteners with bent filaments or connectors. [Figure 98A] ~ [Figure 98B] FIG. 1 illustrates an embodiment of a slotted needle. [Figure 99A] ~ [Figure 99B] FIG. 1 illustrates an embodiment of a curved slotted needle. [Figure 100A] ~ [Figure 100B] FIG. 1 illustrates an embodiment of a slotted needle. [Figure 101A] ~ [Figure 101G] 1 illustrates an embodiment of a device configured to grasp and staple material. [Figure 102A] ~ [Fig. 102F] 1 illustrates an embodiment of a device configured to grasp and staple material. [Figure 103A] ~ [Figure 10H] 1 illustrates an embodiment of a device configured to clamp and staple material. [Figure 104] FIG. 1 illustrates an embodiment of an upper jaw of a device configured to clamp material. [Figure 105A] ~ [Figure 105G] FIG. 13 shows an embodiment of a lower jaw with a hook. [Figure 106A] ~ [Figure 106B] 1A-1C illustrate one embodiment of a device for grasping and positioning material to be stapled. [Figure 107A] ~ [Fig. 107H] 106A-106B depict an embodiment of a method of using the device of FIG. [Figure 8A] ~ [Figure 8D] 1A-1C illustrate one embodiment of a device for grasping and positioning material to be stapled. [Figure 109A] ~ [Figure 109B] 1 illustrates one embodiment of a stapling device. [Figure 110A] ~ [Figure 110L] FIG. 10 illustrates an embodiment using the device of FIGS. 9A-9B. [Fig. 111A] ~ [Fig. 111D] 1 illustrates one embodiment of a stapling device. [Fig. 112A] ~ [Fig. 112B] 13A-13C illustrate one embodiment of a staple closure mechanism. [Fig. 113A] ~ [Fig. 113J]14A-14C illustrate an embodiment of a stapling device that uses staples having preformed features. [Fig. 114A] ~ [Fig. 114C] 13A-13C show another embodiment of a stapling device that uses staples having preformed features. [Fig. 115A] ~ [Fig. 115F] FIG. 114A illustrates an embodiment using the device of FIGS. 114A-114C. [Fig. 116A] ~ [Fig. 116B] 13A-13C show another embodiment for closing the staples. [Figure 117] 1A-1C show an embodiment of a staple having preformed features and a pre-bent tip. [Fig. 118A] ~ [Fig. 118C] 1A-1C show an embodiment of a staple having preformed features and a pre-bent tip. [Fig. 119A] ~ [Figure 119C] 13A-13C show an embodiment of a staple having multiple pre-bends. [Figure 120] FIG. 13 illustrates an embodiment of a jaw with a shroud configured to cover the staples. [Fig. 121A] ~ [Fig. 121C] 1 illustrates one embodiment of a stapling device. [Fig. 122A] ~ [Figure 122M] FIG. 121A illustrates an embodiment using the device of FIGS. 121A-121C. [Fig. 123A] ~ [Fig. 123B] 1 illustrates one embodiment of a stapling device. [Fig. 124A] ~ [Figure 124K] FIG. 123B illustrates an embodiment using the device of FIGS. 123A and 123B. [Fig. 125]FIG. 13 illustrates one embodiment of a staple reservoir. [Fig. 126] A diagram showing one embodiment of a device 12700 with a stapler head 12702 similar in structure to that shown in FIG. 125. [Fig. 127A] ~ [Fig. 127B] FIG. 123C shows an embodiment of a device including a stapler head similar to the structure shown in FIGS. 123A and 123B. [Fig. 128A] ~ [Fig. 128C] 1A-1C show an embodiment of a stapling device having an articulating head. [Fig. 129A] ~ [Fig. 129B] 13A-13C illustrate an embodiment of fangs and staples stretching holes in a target material. [Fig. 130A] ~ [Fig. 130C] FIG. 1 illustrates an embodiment of a device with retractable fangs. [Fig. 131A] ~ [Fig. 131C] FIG. 1 illustrates an embodiment of a fang with blades. [Fig. 132] FIG. 1 illustrates an embodiment of an articulating fang. [Fig. 133A] ~ [Fig. 133B] 13A-13D illustrate an embodiment of a fang with internal features configured to close a staple. [Fig. 134A] ~ [Fig. 134C] FIG. 13 illustrates an embodiment of fangs with adjustable position. [Fig. 135] FIG. 13 shows an embodiment of a fang with external threads. [Fig. 136A] ~ [Figure 136C] 1A-1D illustrate various embodiments of fangs. [Fig. 137] FIG. 1 illustrates an embodiment of a fang configured for everting downwards. [Figure 138] FIG. 1 illustrates an embodiment of a fang covered by a shroud. [Figure 139] FIG. 13 illustrates one embodiment of fangs hidden within holes in the backstop. [Fig. 140A] ~ [Fig. 140B] 1A-1D show embodiments of staples having various shapes. [Fig. 141A] ~ [Fig. 141B] 1A-1C illustrate an embodiment of a closed staple shape. [Fig. 142A] ~ [Fig. 142D] FIG. 13 illustrates an embodiment in which the staples are spring-loaded open. [Fig. 143A] ~ [Fig. 143C] 1A-1C illustrate an embodiment of a staple with legs configured to remain in a closed position. [Fig. 144] 1A-1C illustrate an embodiment of a staple with legs configured to remain in a closed position. [Fig. 145A] ~ [Fig. 145D] FIG. 1 illustrates one embodiment of the stapling device disclosed herein being used by a single user. [Fig. 146A] ~ [Fig. 146D] 11A-11C illustrate one embodiment of a method for forming staple legs at different times using a stapler. [Fig. 147A] ~ [Fig. 147E] 1 illustrates one embodiment of a stapling mechanism. [Fig. 148A] ~ [Fig. 148D] FIG. 1 illustrates an embodiment of a fang. [Figure 149] FIG. 1 illustrates one embodiment of a material with a number of fabricated holes. [Fig. 150A] ~ [Fig. 150D] 1A-1C show an embodiment of a bone anchor staple. [Fig. 151A] ~ [Fig. 151C]1 illustrates one embodiment of a stapling device. [Fig. 152A] ~ [Fig. 152C] FIG. 1 illustrates an embodiment of a device configured to join materials. [Fig. 153A] ~ [Fig. 153C] FIG. 1 illustrates an embodiment in which polymer strands are used to bond materials. [Fig. 154A] ~ [Fig. 154E] FIG. 1 illustrates an embodiment of a device configured to bond materials. [Fig. 155A] ~ [Fig. 155E] FIG. 1 illustrates an embodiment of a device configured to bond materials. [Fig. 156] FIG. 1 illustrates an embodiment of a device configured to grip a material. [Fig. 157A] ~ [Fig. 157D] FIG. 1 illustrates an embodiment of a device configured to grip a material. [Fig. 158] FIG. 1 illustrates one embodiment of a surgical robot effector end with a fixation device as described herein. [Fig. 159] 1A-1C illustrate a comparison of an embodiment of a robot end effector fixation device and an embodiment of a fixation device with a handle. [Fig. 160] ~ [Fig. 162] FIG. 1 illustrates one embodiment of a connection between a fixation device and a surgical robot. [Fig. 163] ~ [Fig. 165] FIG. 13 is a detailed view of one embodiment of a connection between a fixation device and a surgical robot. [Fig. 166] ~ [Fig. 168] 13A-13C illustrate one embodiment of inserting a delivery cartridge into a stationary device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0148] Disclosed herein are embodiments of fastener devices that can puncture ADMs or other materials (e.g., synthetic mesh, absorbable mesh, tissue), facilitate positioning and tensioning of ADMs (or other materials), and secure ADMs (or other materials) to soft tissues using (polymeric, absorbable, or metallic) fasteners, and work in onlay procedures. The tool can also be used in any other procedure that joins soft tissues together or soft tissues to materials. The device can include a stapler. The device requires minimal pressure on the tissue during deployment and can be compatible for use in multiple procedures. Such a device is a unique tool that reduces the surgeon's workload and procedure time, and prevents damage to underlying tissues and organs.

[0149] The devices disclosed herein can advantageously provide the ability to access confined locations. Device embodiments can also conceal sharp features during insertion and removal of the device. The devices can penetrate the toughness of the material (e.g., ADM). The devices can be used to target / control the location of the stapled material (e.g., ADM). The devices can be configured to be used during onlay procedures. The devices can be configured to grasp the desired tissue or material (e.g., ADM) and retract the tissue or material to avoid underlying structures. Some of the devices can be configured to shield / protect underlying structures. Device embodiments can also be configured to retract tissue and close the staples. The concepts described herein can be applied to many procedures (e.g., pelvic slings, dural closure) that may benefit from the above advantages. It will be understood that the devices disclosed herein can be used to manipulate materials such as ADM, but can also be used to manipulate other materials such as other meshes, membranes, etc.

[0150] Some examples of procedures utilizing meshes (e.g., ADMs) in which the devices disclosed herein may be used include breast reconstruction, abdominal wall procedures, treatment of diabetic foot ulcers, and orthopedic procedures (e.g., augmentation of quadriceps tendon repairs, augmentation of Achilles tendon repairs, and augmentation of rotator cuff repairs). Breast reconstruction after mastectomy has traditionally been performed in two stages: a tissue expansion phase and an implant phase. The introduction of the ADM has provided the option to convert the two-stage process to a one-stage (also known as primary one-stage breast reconstruction). The following describes two techniques used in primary one-stage breast reconstruction: In the subpectoral technique, the pectoralis major muscle is transected from the chest wall at the inframammary fossa. The ADM is sutured to the chest wall at the inframammary fossa. The implant is inserted into a pocket under the pectoralis major muscle. The ADM is attached to the pectoralis major muscle and the implant pocket is closed. In the prepectoral technique, the implant is encased in the ADM. The implant / ADM is placed into the mastectomy pocket overlying the pectoralis major muscle. The ADM is secured to the chest wall.

[0151] In abdominal wall surgery, ADMs are used to repair abdominal wall / incisional hernias and to prophylactically reinforce the abdominal wall to prevent incisional hernias. ADMs can be placed in multiple locations to repair the abdominal wall, and the devices disclosed herein can facilitate ADM onlay procedures.

[0152] When treating diabetic foot ulcers, after the wound has been debonded, the ADM is secured in place over the wound to allow dermal integration and healing to occur. To reinforce a quadriceps tendon repair, the ADM is placed over the repair and secured in place. To reinforce an Achilles tendon repair, the ADM is wrapped around the repaired tendon and secured in place. As noted in the previous examples, there are numerous procedures in which devices and methods for puncturing, manipulating, and joining materials, including ADM, are highly useful.

[0153] Throughout this disclosure, the term "target material(s)" is used to refer to materials that can be joined or otherwise manipulated by the devices and using the methods described herein. Target materials can include mesh (e.g., ADM, synthetic mesh), tissue, membrane, etc. In some embodiments, a first target material comprises an ADM joined to a second target material with tissue. In some embodiments, a first target material comprises tissue joined to a second target material with tissue. Other combinations are possible.

[0154] Throughout this disclosure, the terms "fang" and "needle" may be used to refer to sharp elements that may or may not have a hollow region along at least a portion of their interior.

[0155] Described herein are embodiments of fixation devices (e.g., staplers, etc.) capable of fastening materials and tissues (e.g., tissue to tissue, material to tissue), including synthetic meshes and tough biological meshes such as acellular dermal matrix (ADM). As described herein, tough materials (such as ADM) are not amenable to traditional fixation devices and generally require time-consuming suturing.

[0156] The fixation devices described herein utilize one or more sharp piercing elements (e.g., needles or fangs) to penetrate material and then deploy fasteners (e.g., staples) therethrough. The piercing elements are sharp enough to penetrate material (e.g., synthetic mesh, ADM). The piercing elements have a hollow interior along at least a portion of their length. The fasteners, or portions of the fasteners, can be advanced distally within the hollow portion. The piercing elements have an open tip through which the fasteners, or portions of the fasteners, can be pushed through the material to be bonded. A push member can be used to advance the fasteners distally into and out of the piercing elements.

[0157] In some embodiments, the length of the piercing element may be selected to minimize / avoid trauma to surrounding structures. For example, in an onlay procedure, the length of the piercing element may be selected to minimize or avoid contact with the tissue and structures underlying the repair site. The length of the piercing element may also be selected to be suitable for placing one end of a fastener at a depth within tissue.

[0158] For example, the length of the piercing element can be about 0.240 inches (or about 0.100-0.380 inches, or about 0.140-0.340 inches, or about 0.190-0.290 inches, or about 0.220-0.260 inches, or about 0.230-0.250 inches, or about 0.235-0.245 inches, etc.).

[0159] Devices that deliver fasteners through hollow needles are known. An example of such a device is taught in U.S. Pat. No. 4,006,747. However, such devices are taught as having a long needle that is used to pass through the tissue to be joined, with the needle exiting the tissue on the opposite side of the wound to be closed. These needles may be poorly suited to prevent trauma to the underlying structures (e.g., in an onlay procedure). Furthermore, such devices are generally configured for use by multiple operators. The fixation devices described herein can be used by a single person to perform the repair.

[0160] The fixation device may include designs including, but not limited to, those shown in any one or combination of Figures 2-9, 11-19, 22-51C, 72A-84B, 98A-101G, 103A-107H, 121A-148D.

[0161] A method of using such a fixation device includes inserting one or more piercing elements of the fixation device into or through a material (e.g., synthetic mesh, ADM, or tissue). The method further includes advancing a fastener (e.g., a stapler, other fastener, etc.) along the interior of the piercing element. The method includes pushing the fastener, or a portion of the fastener, out the distal tip of the piercing element through the material.

[0162] The method may include forming one or more openings or passages through the material by inserting a piercing element(s) into or through the material. The method may include passing a fastener or a portion of a fastener through the openings or passages formed by the piercing elements.

[0163] As mentioned above, the devices disclosed herein may be particularly advantageous in onlay procedures such as abdominal wall repair. The devices and methods disclosed herein provide many advantages over those currently available. Currently, other options for securing onlay meshes in open abdominal wall repair include sutures, metal staples or tacks, and fibrin glue. If a surgeon uses an ADM, they will likely have to use sutures (with needles) to penetrate the toughness of the ADM. However, suturing significantly increases procedure time and is relatively difficult and skill-dependent, which may affect clinical outcomes. Stapling and tacking are not suitable for penetrating the toughness of the ADM, and fibrin glue is expensive. The devices disclosed herein provide a solution to these problems, advantageously penetrating the toughness of the ADM or other meshes and rapidly deploying reproducible fasteners.

[0164] In intraperitoneal onlay mesh repair (IPOM repair), devices including barbed tacks and spiral metal tacks may be used. In such repairs, the mesh is generally introduced into the abdominal cavity and covers the hernia defect on the peritoneal side of the peritoneum. The tacks are deployed outward and embedded in the abdominal muscles, which generally causes pain to the patient. If absorbable tacks are used, the pain is said to decrease as the tacks are absorbed. If metal tacks are used, the patient may have to undergo a second surgery to remove the tacks and relieve the pain. The devices disclosed herein may advantageously secure the material to be attached (e.g., mesh) by securing one end of the fastener against the fascia. This eliminates the need to embed a portion of the fastener into the muscle, which increases patient comfort.

[0165] 2 illustrates one embodiment of a fastener device 100 including a needle 102, a shaft / fastener reservoir 104, a handle 106, a deployment trigger 108, and a fastener 118 (FIG. 8). The needle 102 can be configured to be sharp enough to penetrate tough materials such as ADM and allow the fastener to pass therethrough.

[0166] Figure 3 shows an onlay material (e.g., ADM) 110 and tissue 112 to be joined. Figures 4-9 show the basic steps for fastening material 110 (e.g., ADM) to tissue 112 using fastener device 100. In Figure 4, the user applies distal force via the handle to pierce material 110 and tissue 112 with needle 102.

[0167] 5-7, the user has the option to withdraw the needle from the tissue from a first position 114 (FIG. 5), position or tension the material (e.g., ADM) as needed (FIG. 6), and then puncture the tissue at a second position 116 (FIG. 7).

[0168] Because there is friction / compression between the material (e.g., ADM) and the needle, the material can remain on the needle as the user withdraws the needle from the tissue. Below (e.g., with respect to Figures 23-26), several mechanisms are described that facilitate repositioning.

[0169] In Figure 8, a user applies a stabilizing force to the material (e.g., ADM) and tissue and simultaneously actuates deployment trigger 108, which deploys fasteners 118 and secures material 110 to tissue 112. Below (e.g., with respect to Figures 23-31), several methods for reducing / eliminating the required stabilizing force are described in more detail.

[0170] In Figure 9, the user applies a proximal force via the handle to withdraw the needle from the material (e.g., ADM) and tissue. Below (e.g., with respect to Figures 44-51), several mechanisms that assist in needle withdrawal are described in more detail.

[0171] FIG. 10 illustrates an embodiment of a fastener implant 200 made of a polymer or absorbable material, or metal. For example, the implant may include nylon, polyethylene, polypropylene, various absorbable polymers, or nitinol. The fastener has a first bar 202 and a second bar 204 on either end of a connector 206 (e.g., a filament). In FIG. 11, the first bar resides in a lumen 208 of a slotted delivery needle 210. The fastener may have a rectangular cross-section as shown in FIG. 10. The rectangular cross-section of the first bar includes flat sides to improve the resistance of the fastener to being pulled out of the tissue. Other shaped cross-sections are possible (e.g., circular, oval, etc.). In some embodiments, different portions of the fastener may include the same or different cross-sections. In some embodiments, different portions of the fastener may include the same or different dimensions. The filament 206 of the fastener exits the delivery needle slot 212, while the second bar 204 resides on the outside of the needle. The length of the filament is sized to bond and / or compress the tissue and mesh to be bonded. For example, in an open onlay repair, the length of the filament may be selected so that the burr is embedded in the muscle. Examples of suitable dimensions are described with respect to Figures 95A-96C. In a laparoscopic IPOM repair, the length of the filament may be selected so that the burr is deployed on the opposite side of the peritoneum / fascia and is not embedded in the muscle to avoid pain to the patient.

[0172] 12 shows a shoulder 214 that controls and limits the insertion depth of the needle. The shoulder can have a fixed or adjustable distance from the needle tip 216. The shoulder can control the deployment depth of the first bar of the fastener and control the amount of bonding and / or compression between the onlay material and the tissue. In embodiments including a fixed distance shoulder, the distance can be about 0.235 inches (or about 0.17-0.30 inches or about 0.185-0.285 inches or about 0.20-0.27 inches, etc.).

[0173] 13, needle 216 pierces onlay material 218 (e.g., ADM or other mesh) and tissue 220 until shoulder 214 contacts material 218 (e.g., ADM). The user advantageously has the option to withdraw the needle from tissue 220 (with material remaining in the needle) before deploying the fasteners in order to position or tension onlay material 218, if desired.

[0174] In Figure 14, as a push rod (not shown, within the needle lumen) advances the first bar down the needle lumen, a deflector 222 acts on the fastener filaments. This action redirects the second bar 204 and prepares it to seat on the surface of the onlay material (e.g., ADM). Below (e.g., Figures 32-43D), several other embodiments for optimizing the placement of the second bar 204 and the attachment and / or compression of the onlay material / tissue are described in more detail.

[0175] 15, the first bar and filament are delivered through the onlay material 218 (e.g., ADM) and embedded in the tissue 220 by moving through the hole in the material 218 created by the slotted needle. At the same time, the second bar 204 seats on the surface of the onlay material 218 (e.g., ADM). During this step, the user applies a stabilizing force to the onlay material 218 and tissue 220 to keep the material from being pushed out of the needle.

[0176] 16 and 17, push rod 224 deploys first bar 202 into tissue 220 (shown as transparent to allow visualization).

[0177] 18 and 19, the push rod is retracted and the needle is withdrawn from the tissue 220 and the onlay material 218 (eg, ADM), leaving the onlay material and tissue joined and / or compressed and secured together by the fasteners.

[0178] In some embodiments, the bar of the fastener has a blunt end 226, as shown in FIG. 20. The blunt end can advantageously prevent the bar from unintentionally penetrating any fascia that may be underneath the target muscle tissue. Since the needle handles the puncture of the onlay material (e.g., ADM), it is not necessary for the fastener to have a sharp end. The blunt end can have a square or rectangular end, as shown in FIG. 20. The blunt end can be rounded in some embodiments.

[0179] FIG. 21 shows an embodiment of a fastener in which the second bar has a different (in this example, shorter) length L and a different (in this example, higher) height H than the first bar. The shorter length allows the fastener to be positioned closer to the edge of the onlay material (e.g., ADM) without the end of the bar protruding too far beyond the end of the material. The higher height increases the stiffness and strength of the bar. In another embodiment, a lower height reduces the profile of the bar on the onlay material (e.g., ADM), which may benefit the repair. In some embodiments, a larger width of the second bar may be used to increase the contact surface area of ​​the bar.

[0180] 22 shows an embodiment of a needle 228 at the end of a shaft 230. The shaft (e.g., diameter and length) is sized to allow access for performing open or laparoscopic surgery.

[0181] Embodiments of a mechanism for facilitating relocation FIG. 23 shows an embodiment of a needle with one or more barbs 300 that help maintain the onlay material 302 (e.g., ADM) on the needle to (re)position and / or tension the material 302. The needle pierces the onlay material 302 and the barbs 300 maintain the onlay material 302 on the needle. The user withdraws the needle from the tissue from the first position while the barbs maintain the onlay material on the needle. The user repositions the needle to (re)position or tension the onlay material and then inserts the needle into the tissue at the second position. To enable withdrawal of the needle from the ADM, a support (e.g., FIGS. 46-48) can be used to withdraw the barbed needle from the ADM. Alternatively, the barbs can be retracted to facilitate needle withdrawal.

[0182] FIG. 24 illustrates an embodiment that includes one or more raised bumps 304 that help maintain (re)positioning and / or tensioning the onlay material (eg, ADM) on the needle.

[0183] FIG. 25 shows an embodiment with one or more notches 306 that maintain the onlay material (eg, ADM) on the needle to aid in (re)positioning and / or tensioning the onlay material.

[0184] 26 shows an embodiment in which the needle includes an enlarged portion 308. The enlarged portion increases the compression force 310 of the onlay material (e.g., ADM) on the needle. The increased compression force helps to keep the onlay material on the needle and (re)position and / or tension the onlay material.

[0185] Feature embodiments for reducing or eliminating the amount of stabilizing force required during fastener deployment When the first bar and filament pass through the hole made by the needle in the onlay material (e.g., ADM), the amount of interference the first bar and filament encounter with the onlay material depends on the size of the passage made by the needle through the onlay material. The amount of interference affects the force required to push the first bar and filament through the passage of the needle in the onlay material. The force that the first bar and filament apply to the onlay material must have a "stabilizing" force against the onlay material so that the first bar and filament can pass through the passage without pushing the onlay material off the needle. One way to keep the onlay material on the needle is for the user to apply a distal force to the device / needle during fastener deployment. Current designs balance the competing needs between 1) reducing the amount of force required for the needle to puncture the ADM and 2) reducing the stabilizing force required. To reduce the stabilizing force required, the inner and outer diameters of the needle are sized to create a passage large enough in the ADM so that the first bar and (folded) filament of the fastener can pass through the ADM with minimal force. By minimizing the force required to drive the fastener through the ADM, the stabilizing force required by the user is also reduced. Using a larger sized needle would create a larger passageway within the ADM, further reducing the force required to drive the fastener through the ADM (and further reducing the stabilizing force required by the user). However, a larger sized needle would also increase the amount of force required for the needle to pierce the ADM. As a result, this needle design achieves a balance between two competing needs by using a tri-bevel tip design with a primary bevel angle that minimizes the force required for the needle to pierce the ADM. The tri-bevel tip also maintains the durability of the needle tip over repeated use. Examples of primary bevel angles include 20-24 degrees, 14-30 degrees, etc. The following concepts describe feature embodiments that may help further minimize the amount of stabilizing force required by the user during fastener deployment.

[0186] The mechanisms shown in Figures 23-26 may also be used to assist in maintaining the onlay material (e.g., ADM) on the needle during fastener deployment. This assistance may reduce or eliminate the amount of stabilizing force the user needs to apply during fastener deployment. To allow for needle withdrawal, supports (e.g., Figures 46-48) may be used to withdraw the needle from the onlay material. Alternatively, referring to Figure 23, the barbs may be retracted to facilitate needle withdrawal.

[0187] Figure 27A shows an embodiment with one or more blades 400 on the needle. The blades cut slits 402 through the onlay material (e.g., ADM) 404 such that when the onlay material flap 406 within the needle lumen breaks as the first bar and filament pass through the onlay material, the taller flap creates more space through the onlay material. As a result, the first bar and filament can pass through the onlay material with less force, allowing the user to apply less force against the onlay material during fastener deployment. Figure 27B shows a comparison with a smaller flap size (no slits).

[0188] As shown in the embodiment of Figure 28, after the fastener delivery needle 408 pierces the onlay material 410 (e.g., ADM) and enters the tissue 412, one or more barbs 414 may be deployed from the fastener delivery needle into the tissue. The user can then lift / hold the onlay material and tissue away from any underlying structures and deploy the fastener without unintentionally fastening the underlying structures, which can sometimes be caused by having to push in the onlay material / tissue during deployment.

[0189] As shown in the embodiment of Figures 29-31, after the fastener delivery needle 416 pierces the onlay material 410 (e.g., ADM) and enters the tissue 412 (Figure 29), one or more barb deployment needles 418 pierce the onlay material and enter the tissue (Figure 30). The barbs 420 then deploy from the barb deployment needle into the tissue. The user can then lift / move the onlay material and tissue away from any underlying structures to deploy the fasteners without unintentionally fastening the underlying structures, which can sometimes be caused by having to push in the onlay material / tissue during deployment.

[0190] Embodiments of a mechanism for optimizing the placement of the second bar Without one or more deflectors (e.g., deflector 222 in FIG. 14), the deployment of the second bar may be blocked, resulting in suboptimal coaptation and / or compression between the onlay material (e.g., ADM) and tissue. FIG. 32 shows the outside of the needle slot 504 as the second bar 506 moves toward the onlay material. As shown in FIGS. 33 and 34, the distal end of the bar 500 seats on the onlay material and the proximal end of the bar 502 can enter the needle slot 504. This configuration prevents the second bar 506 from seating on the onlay material during deployment. As shown in FIG. 35, the resulting gap 508 between the second bar 506 and the onlay material prevents the second bar 506 from coapting and / or compressing the onlay material to the tissue. The deflector 222 solves this problem by deflecting the filaments of the fasteners to redirect the second bar 506 to seat on the onlay material and bond and / or compress the onlay material to the tissue. The following concepts describe alternative methods of optimizing the placement of the second bar and bond and / or compress the onlay material / tissue.

[0191] FIG. 36 shows an embodiment of a fastener with a second bar having a shorter height. The shorter height makes the second bar more flexible such that when the second bar encounters the configuration illustrated in FIG. 34, the bar flexes. The flexed second bar 510 allows the bond 512 between the filament and the second bar to advance to the onlay material. By allowing the bond between the filament and the second bar to advance to the onlay material, there is no gap between the second bar and the onlay material and the fastener can bond and / or compress the onlay material to tissue, as shown in FIG.

[0192] Figures 38 and 39 show an embodiment of a deflector 514 that directly interacts with the second bar 516 of the fastener. The deflector is curved in one or more directions, indicated as a first direction 518 (e.g., upward, shown in the side view of Figure 38) and a second direction 520 (e.g., inward, shown in the top view of Figure 39). Both the curves or directions work together to deflect the second bar. The deflector 514 redirects the second bar 516 to seat on the onlay material (e.g., ADM).

[0193] 40-42O show another embodiment of a fastener deflector configured to interact with the filament and second bar of the fastener to redirect the second bar to seat on the onlay material (e.g., ADM). FIGS. 40 and 41 show a side view and a top view, respectively, of the distal end of a fixation device 4100. FIGS. 40 and 41 show a slotted needle 4102 extending from the distal end of a shaft 4104. Moving distally along the shaft 4104, a first or bottom ramp 4106 extends upward or away from the bottom side 4108 of the shaft. A second ramp or side ramp 4110 protruding from a side wall 4112 is positioned distally from the start of the first ramp 4106.

[0194] Figures 42A-O show one embodiment of a fastener 4200 deployed from a fixation device 4100 as shown in Figures 40 and 41. Figures 42A-C show top, side, and front views, respectively, of a fastener filament 4202 extending from a slotted needle 4102.

[0195] 42D-F show top, side, and front views, respectively, of the fastener 4200 being pushed distally along the slotted needle 4102, with the bottom ramp 4106 lifting the fastener's filament 4202 and raising the fastener's second bar 4204 above the needle 4102.

[0196] 42G-I show top, side, and front views, respectively, of the fastener 4200 continuing to be pushed distally along the needle 4102, the bottom ramp 4106 continuing to lift the filament 4202 and second bar 4204, and causing the side ramp 4110 to rotate the second bar 4204 such that the end 4206 of the second bar rotates toward the needle 4102.

[0197] 42J-L show top, side, and front views, respectively, as the fastener 4200 continues to be pushed distally along the needle 4102, causing the bottom ramps 4106 to continue to lift the second bar 4204 and the side ramps 4110 to continue to rotate the second bar 4204 over the needle 4102. As shown in this series of figures, the second bar 4204 is now approximately parallel to the surface of the onlay material.

[0198] 42M-O show top, side, and front views, respectively, of a side wall 4208, best seen in FIG. 42N, which maintains the position of the second bar 4204 during fastener deployment.

[0199] 43A-43D show one embodiment of a needle with a helical slot 530 in the needle. The helical slot redirects the second bar 532 to seat on the onlay material (e.g., ADM) as the fastener is deployed from the needle. When the end 534 of the second bar 532 contacts the onlay material (e.g., ADM), the rotational motion of the fastener 536 causes the second bar 532 to pivot about the end 534 and seat on the onlay material.

[0200] Redirecting the second bar to move toward a position parallel to the surface of the onlay material provides the benefit of improved coaptation and / or compression of the onlay material and tissue, as discussed above. This also provides the benefit of allowing the surgeon to hold the fixation device at an angle other than perpendicular to the onlay material and tissue. The surgeon can approach the treatment site from any angle while still being assured of positive and consistent positioning of the fasteners.

[0201] Embodiments of a mechanism for assisting needle withdrawal After the needle 600 pierces the onlay material 602 (e.g., ADM), there is a compressive force 604 between the onlay material and the needle that acts to keep the onlay material on the needle. As a result, a "pulling" force 606 is required to pull the needle out of the onlay material (FIG. 44). This pulling force also causes the onlay material 602 to apply a "pulling" force 608 (FIG. 45) that acts to pull the fasteners 610 out of the tissue 612 and / or compromises the retention of the fasteners in the tissue. The following concepts will further assist needle withdrawal when used in conjunction with any features that assist in keeping the onlay material on the needle to (re)position and / or tension the onlay material (such as those described with respect to FIGS. 23-26).

[0202] FIG. 46 shows one embodiment of a support 614 that actuates and contacts the fastener 616 to provide counter traction while the needle 618 is withdrawn from the onlay material 620 (e.g., ADM). The support may include one or more elongated features or shafts that extend beyond the needle and can provide a force to the onlay material while the needle is withdrawn. FIG. 47 shows an alternative embodiment of a support 622 that contacts the onlay material to provide counter traction. The support 622 has a distal feature that extends radially outward such that the support 622 does not contact the fastener 616, but only contacts the onlay material around the fastener. FIG. 48 shows another embodiment of a support 624 that contacts both the fastener and the onlay material to provide counter traction. In FIGS. 46-48, the shoulder 214 (above) may also function as a support. Alternatively, the support may be a separate element. In some embodiments, the support is dual purpose and also functions as a needle protector / cover.

[0203] FIG 49A shows a front view of an embodiment of a needle 626 passing through an onlay material 628 (e.g., an ADM). FIG 49B shows a bottom view of an onlay material hole compressing the outer diameter (OD) of the needle. One or more blades 630 are disposed around the periphery of the needle 626. In the front view of FIG 50A and the bottom view of FIG 50B, the blades 630 are actuated (e.g., advanced distally) to cut a slit through the periphery of the hole, thereby relieving the compression of the onlay material against the OD of the needle. Once the compression is relieved, the needle may be easily withdrawn from the onlay material.

[0204] 51A-51C show an alternative embodiment in which one or more blades 630 are fixed around the periphery of the needle 626. As the needle pierces the onlay material 628 (e.g., ADM), the blades simultaneously cut a slit through the periphery of the hole, thereby relieving compression of the onlay material against the OD of the needle. Once the compression is relieved, the needle can be easily withdrawn from the onlay material.

[0205] Other Fastener Embodiments 52 shows an embodiment of a fastener having a curved first bar 700 to improve retention of the fastener in tissue and a curved second bar 702 to improve retention of the fastener to the onlay material (e.g., ADM). The curved bars may also assist in attaching and / or compressing the onlay material to the tissue. The curved second bar 702 may also prevent the ends of the bars from pointing upward (e.g., away from the onlay material like a "V") and from moving (e.g., rotating) on ​​the onlay material.

[0206] FIG. 53 shows an embodiment of a fastener having one or more downward (e.g., pointing toward the first bar) protrusions 704 on a second bar 706 that prevent the second bar from moving (e.g., rotating) on ​​the onlay material (e.g., ADM).

[0207] 54 illustrates an embodiment of a fastener having multiple barbs 708 on either or both the filament 710 of the fastener and / or the first bar 712 of the fastener. The barbs are oriented to allow the filament and first bar to be easily deployed through the onlay material (e.g., ADM) and tissue, but to make the fastener difficult to withdraw from the tissue and onlay material.

[0208] 55 shows an embodiment of a fastener with a first bar 714 having one or more extending wings 716. The wings are oriented to allow the first bar to be easily deployed into tissue but make it difficult to withdraw the fastener from the tissue. The wings are oriented in the same plane as the fastener.

[0209] 56A and 56B show an embodiment of a fastener with a first bar 718 having one or more extending wings 720. The wings are oriented to allow the first bar to be easily deployed into tissue but make it difficult to pull the fastener out of the tissue. The wings are also oriented to extend out of the plane of the fastener, as shown in FIG. 56B, so that when the first bar 718 is deployed in the same direction as the muscle fibers 722, the wings will extend across the muscle fibers, improving the holding strength of the fastener in the tissue.

[0210] 57 shows an embodiment of a fastener with a first bar 724 having arms 726 that curl when deployed from a needle. The arms curl out of the plane of the fastener across the muscle fibers 728, such that when the first bar is deployed in the same direction as the muscle fibers, the curled arms improve the retention strength of the fastener in tissue.

[0211] 58A-C and 59A-C show front, side and close-up side views, respectively, of two fasteners. FIGS. 58A-C show fastener 730 having a first bar 732 with a circular cross section. The circular cross section has a smaller diameter 734 than the diameter 736 of a circumscribed circle around first bar 738 of fastener 740 having a rectangular / square cross section of comparable stiffness / strength, shown in FIGS. 59A-C. The smaller diameter 734 allows first bar 732 to fit inside a needle having a smaller inside diameter (ID). In other words, a fastener having a rectangular / square cross section will require a larger diameter slotted needle than a fastener having a circular cross section of comparable stiffness / strength. Potential advantages of a needle having a correspondingly smaller outside diameter (OD) include the ability to pierce an onlay material (e.g., ADM) with a needle and the ability to withdraw the needle from the onlay material with a lower force. Another potential advantage of the smaller diameter 734 first bar 732 is the additional space in the needle that is sized for a rectangular / square cross section. The additional space can reduce the amount of stabilizing force required by the user during fastener deployment (e.g., as discussed above with respect to Figures 23-31).

[0212] 58A-C, in some embodiments, the fastener 730 may also have a connector or filament 742 that has a height 744 that is less than the diameter 734 of the first bar 732. As shown in FIG. 60, this allows the needle slot 746 to prevent the first bar 732 from unintentionally exiting the needle lumen 748. The second bar 750 may have a different diameter than the first bar 732 or the same diameter as the first bar 732.

[0213] As shown in FIGS. 61A and B, in some embodiments, the fastener 752 may be manufactured in multiple steps, where in the first step, a preliminary short filament length 754 (FIG. 61A) is manufactured. In a subsequent manufacturing step, the filament may be stretched to a longer length 756 (FIG. 61B). The stretching may serve multiple purposes. First, for polymers that tend to stretch under certain loads, the stretching manufacturing process may reduce / eliminate stretching that may occur after deployment. As a result, the bond and / or compression between the onlay material (e.g., ADM) and tissue achieved at the time of deployment may be better maintained over time to aid in healing. Second, the stretching reduces the cross-sectional shape of the filament. This allows more space in the needle lumen for the first bar 758 and filament 756 to pass through the onlay material. The additional space may reduce the amount of stabilizing force required by the user during fastener deployment (e.g., as described above with respect to FIGS. 23-31). The smaller cross-sectional shape of the filament will also allow for a smaller needle slot width that may prevent the first bar from unintentionally exiting the needle lumen (as shown in FIG. 60). Third, stretching makes the filament more flexible. The additional flexibility of the filament can facilitate redirection of the second bar 760 to optimize placement of the second bar and the attachment and / or compression of the onlay material / tissue (e.g., as described above with respect to FIGS. 32-43D).

[0214] Alternatively, stretching may occur within the device upon deployment to a variable or predetermined length.

[0215] 62A-C show an embodiment of a fastener having a first bar 762 and a second bar 764 extending in different directions. The directions can be different than those shown in FIG. 62. Having the second bar extend in a different direction than the first bar can optimize placement of the second bar and onlay material (e.g., ADM) / tissue attachment and / or compression (e.g., as described above with respect to FIGS. 32-43D). The fastener can be deployed by delivering the shaft / fastener reservoir 104 in an unstressed configuration as shown in FIG. 62. Alternatively, the fastener can be deployed by delivering the shaft / fastener reservoir 104 with the bars deformed / stressed in the same plane (e.g., like an "H" as shown in FIG. 10) and then returning to an unstressed (out-of-plane) configuration for deployment (e.g., as shown in FIG. 62).

[0216] Figure 63 shows an embodiment of a fastener with a second bar 766 having an end feature 768 (such as a chamfer). When the end feature contacts the onlay material (e.g., ADM) during deployment, the end feature slopes the proximal end 770 of the second bar to avoid the needle slot. This may optimize placement of the second bar and onlay material (e.g., ADM) / tissue attachment and / or compression (e.g., as described above with respect to Figures 32-43D).

[0217] Figure 64 shows an embodiment of a fastener with a second bar 772 having a bend 774. As the bent end moves towards the needle slot during deployment, the bend causes the second bar to graze the needle and avoid the needle slot. This may optimize placement of the second bar and onlay material (e.g., ADM) / tissue attachment and / or compression (e.g., as described above with respect to Figures 32-43D).

[0218] To provide additional control over onlay material (e.g., ADM) / tissue attachment and / or compression, the fasteners may incorporate adjustable length filaments. One such embodiment is shown in FIG. 65 with an adjustable length filament 776. After adjusting the filament to the appropriate length (either before or after deployment), excess filament 778 may be trimmed, if desired.

[0219] 66 and 67 show an embodiment of a fastener having filaments 780 at an oblique angle to a first bar 782 and a second bar 784 of the fastener to facilitate a smaller cross section 786 for the shaft / fastener reservoir 104. FIG. 67 shows the smaller cross section 786 as compared to the larger cross section 788 (FIG. 68) of the shaft / fastener reservoir including a fastener having filaments perpendicular to the bars of the fastener (FIG. 69).

[0220] The fasteners may be delivered and deployed in an unstressed configuration, as shown in Figures 66 and 67. Alternatively (as shown in Figure 70), the fasteners may be deformed / stressed from the configuration shown in Figure 69 to the configuration shown in Figure 66 while delivering the shaft / fastener reservoir 104. The fasteners may return to the unstressed configuration (shown in Figure 69) for deployment.

[0221] FIG. 71 shows an embodiment of a fastener that may be constructed or made from multiple materials that 1) have more favorable strain-related properties in the filament direction 790, which may promote elastic benefits in the retention / jointing / compression of the onlay material (e.g., ADM) / tissue, and / or 2) have different properties in the first bar 792 and / or second bar 794 to prevent migration.

[0222] 95A-95C show front perspective, front, and side views, respectively, of one embodiment of a fastener 9500 having a single thickness. The fastener thickness 9520 (FIG. 95C) can be about 0.03 inches (or about 0.01-0.05 inches, about 0.02-0.04 inches, about 0.025-0.035 inches, etc.). In some embodiments, the dimensions of the first and second bars are selected such that the first bar is flexible or rigid enough to curl (or come off the needle) as it is deployed from the fixation device, and the filament or connector connecting the first and second bars is strong enough to withstand the forces exerted on it as it is deployed from the needle. In some embodiments, the length 9508 of the first bar is about 0.33 inches (or about 0.23-0.43 inches, or about 0.325-0.335 inches, etc.). In some embodiments, the height 9510 of the first bar is about 0.03 inches (or about 0.01-0.05 inches, about 0.02-0.04 inches, about 0.025-0.035 inches, etc.). In some embodiments, the width 9512 of the filament or connector is about 0.02 inches (or about 0.01-0.03 inches or about 0.015-0.025 inches, etc.). In some embodiments, the length 9514 of the filament or connector 9506 is about 0.17 inches (or about 0.10-0.24 inches, 0.15-0.19 inches, 0.16-0.18 inches, 0.165-0.175 inches, etc.). In some embodiments, the length 9516 of the second bar is about 0.23 inches (or about 0.13-0.33 inches or about 0.225-0.235 inches, etc.). In some embodiments, the height 9518 of the second bar is about 0.04 inches (or about 0.01-0.07 inches, 0.02-0.06 inches, 0.03-0.05 inches, 0.035-0.045 inches, etc.).

[0223] 96A-C show another embodiment of a fastener 9600 with specific sizes for the first bar 9602, the second bar 9604, and the filament 9606. For example, the first bar 9602 and the second bar 9604 have a circular cross section. As discussed above, the dimensions of the first bar and the second bar are selected such that the first bar is flexible or rigid enough to curl (or come off the needle) as it is deployed from the fixation device, and the filament or connector connecting the first bar and the second bar is strong enough to withstand the forces exerted on the first bar as it is deployed from the needle. In some embodiments, the diameter 9608 of the first bar 9602 is about 0.035 inches (or about 0.02-0.05 inches, 0.025-0.045 inches, or about 0.03-0.04 inches, etc.). In some embodiments, the diameter 9610 of the second bar 9604 is about 0.04 inches (or about 0.01-0.07 inches, 0.02-0.06 inches, 0.03-0.05 inches, 0.035-0.045 inches, etc.). In some embodiments, the thickness 9612 of the filament or connector 9606 is about 0.026 inches (or about 0.016-0.036 inches, or about 0.021-0.031 inches, etc.). In some embodiments, the length 9614 of the first bar 9602 is about 0.33 inches (or about 0.23-0.43 inches, or about 0.325-0.335 inches, etc.). In some embodiments, the length 9616 of the filament or connector 9606 is about 0.17 inches (or about 0.10-0.24 inches, 0.15-0.19 inches, 0.16-0.18 inches, 0.165-0.175 inches, etc.). In some embodiments, the width 9618 of the filament or connector 9606 is about 0.020 inches (or about 0.01-0.03 inches or about 0.015-0.025 inches, etc.). In some embodiments, the length 9620 of the second bar 9604 is about 0.23 inches (or about 0.13-0.33 inches or about 0.225-0.235 inches, etc.).

[0224] 96D-F show another embodiment of a fastener 9630 with specific sizes for the first bar 9632, the second bar 9634, and the filament 9636. For example, the first bar 9632, the second bar 9634, and the filament 9636 have a rectangular cross section. As discussed above, the dimensions of the first bar and the second bar are selected such that the first bar is flexible or rigid enough to curl (or come off the needle) as it is deployed from the fixation device, and the filament or connector connecting the first bar and the second bar is strong enough to withstand the forces exerted on it as it is deployed from the needle. In some embodiments, the thickness 9638 of the first bar (FIG. 96F) can be about 0.039 inches (or about 0.019-0.059 inches, about 0.029-0.049 inches, about 0.034-0.044 inches, etc.), the height 9640 of the first bar (FIG. 96E) can be about 0.033 inches (or about 0.013-0.053 inches, about 0.023-0.043 inches, about 0.028-0.038 inches, etc.), and the length 9642 of the first bar (FIG. 96E) can be about 0.33 inches (or about 0.23-0.43 inches, about 0.325-0.335 inches, etc.). In some embodiments, the thickness 9644 (FIG. 96F) of the filament or connector 9636 can be about 0.030 inches (or about 0.010 inches to 0.050 inches, about 0.020 inches to 0.040 inches, about 0.025 inches to 0.035 inches), the width 9646 (FIG. 96E) of the filament or connector 9636 can be about 0.021 inches (or about 0.011 inches to 0.031 inches, or about 0.016 inches to 0.026 inches, etc.), and the length 9648 (FIG. 96E) of the filament or connector 9636 can be about 0.188 inches (or about 0.118 inches to 0.258 inches, about 0.138 inches to 0.238 inches, about 0.168 inches to 0.208 inches, about 0.178 inches to 0.198 inches, about 0.183 inches to 0.193 inches).In some embodiments, the thickness 9650 of the second bar (FIG. 96F) can be about 0.039 inches (or about 0.019-0.059 inches, about 0.029-0.049 inches, about 0.034-0.044 inches, etc.), the height 9652 of the second bar (FIG. 96E) can be about 0.026 inches (or about 0.016-0.036 inches, about 0.021-0.031 inches), and the length 9654 of the second bar (FIG. 96E) can be about 0.23 inches (or about 0.13-0.33 inches or about 0.225-0.235 inches, etc.).

[0225] 97A-D show another embodiment of a fastener 9700 having a bent filament or connector 9702. The bent filament or connector can facilitate a smaller cross section 9704 for the shaft / fastener reservoir 104. FIG. 97C shows the smaller cross section 9704 compared to the larger cross section 9706 (FIG. 97D) of a fastener having a straight filament or connector 9708. The bent filament can also function to optimize placement of the second bar 9710 and onlay material (e.g., ADM) / tissue attachment and / or compression (e.g., as described above with respect to FIGS. 32-43D).

[0226] Other Delivery Device Embodiments As shown in FIGS. 72A-C, in some embodiments, shaft 800 can have an articulating end 802 (FIGS. 72A & B) and / or a rotating end 804 (FIG. 72C) to facilitate access during open and / or laparoscopic procedures.

[0227] As shown in FIG. 73, the shaft may have a fixed curve 806 at the distal end to facilitate access in an open procedure.

[0228] As shown in Figures 74A and 74B, in some embodiments, the delivery device can have a replaceable cartridge (e.g., if the fasteners deteriorate). The replaceable cartridge can include the entire shaft 808 (Figure 74A) or only the distal portion 810 of the shaft (Figure 74B). If the needle was part of the replaceable cartridge, the user would also benefit from a new needle on the cartridge.

[0229] As shown in Figures 75A and 75B, in some embodiments, the needle 812 can be advanced out of the shaft 814 (Figure 75B) and retracted into the shaft (Figure 75A). With the needle in the retracted position, the sharp needle tip is protected and can prevent trauma while the user inserts the device into the repair site (e.g., via a laparoscopic or open approach). Once the device reaches the repair site, the user advances the needle out of the shaft.

[0230] As shown in FIGS. 76A and 76B, in some embodiments, a sheath 816 can be advanced over needle 818 (FIG. 76A) and retracted to expose the needle (FIG. 76B). With the sheath in the advanced position, the sharp needle tip is protected to prevent trauma while the user inserts the device into the repair site (e.g., via a laparoscopic or open approach). Once the device reaches the repair site, the user retracts the sheath to expose the needle. After fastener deployment, the sheath can also be advanced to apply counter-traction to the onlay material (e.g., ADM) while the user withdraws the needle from the onlay material (e.g., similar to the embodiments to assist with needle withdrawal described with respect to FIGS. 44-51).

[0231] 98A-B show another embodiment of a slotted needle 9800 with a specific outer diameter (OD) 9802, inner diameter (ID) 9804, and slot width 9806. As mentioned above, the ID dimension is selected to allow the bar of the fastener to reside within the ID, and the slot width dimension is selected to allow the bar connector (aka filament) to travel the length of the slot (either with an interference fit or a clearance fit with the slot). In some embodiments, the OD 9802 is about 0.078 inches (or about 0.018-0.148 inches, 0.048-0.108 inches, 0.068-0.088 inches, etc.). In some embodiments, the ID 9804 is about 0.063 inches (or about 0.010-0.140 inches, 0.040-0.100 inches, 0.060-0.080 inches, etc.). In some embodiments, the slot width 9806 is about 0.035 inches (or about 0.020-0.050 inches, 0.025-0.045 inches, 0.030-0.040 inches, etc.) such that the slot width is larger than the filaments to minimize or eliminate deformation and / or indentations on the filaments of the fastener during deployment, but smaller than the bar of the fastener to prevent the bar from inadvertently exiting the lumen of the needle.

[0232] Figure 99A shows another embodiment of a curved (not straight) slotted needle 9900 with the needle tip 9902 on the outside of the curve and the slot 9904 on the inside of the curve. Figure 99B shows another embodiment of a curved slotted needle 9906 with the needle tip 9908 on the inside of the curve and the slot 9910 on the outside of the curve.

[0233] 100A-B show one embodiment of a slotted needle 10000 (FIG. 100A) with blunt edges 10002 (FIG. 100B), such as broken edges, radiused edges, ground edges, etc., along the length of the slot so that the blunt slot edges do not slice, cut, or damage the fastener filaments during deployment.

[0234] Additional embodiments of devices and methods for fastening onlay materials Figure 77 shows an embodiment of a device 900 that includes two deployment needles 902. Both needles pierce the onlay material 904 (e.g., ADM) and tissue 906. Each needle deploys one bar of fasteners 908 into the tissue, as shown in Figure 78. Filaments 910 hold, join and / or compress the onlay material to the tissue, as shown in Figure 79.

[0235] Figure 80 shows an embodiment of a device 912 that includes one deployment needle 914. In Figure 81, the needle pierces the onlay material 904 (e.g., ADM) and tissue 906 at a first location 916, deploying a first bar 918 into the tissue. In Figure 82, the needle is withdrawn from the first location 916 and pierces the onlay material and tissue at a second location 920, deploying a second bar 922 into the tissue. A filament 924 holds the onlay material to adhere and / or compress the tissue, as shown in Figure 83.

[0236] Embodiments of a device and method for enabling interrupted suturing The following concepts demonstrate how fasteners can be used with other device platforms to provide high speed interrupted suturing to join two or more tissues.

[0237] 84 shows one embodiment of a device 1000 having opposing jaws. A first jaw 1002 has a slotted needle 1004 (for deploying fasteners) and a second jaw 1006 has an opening or slot 1008 at the end of the jaw.

[0238] In FIG. 85, a user uses the tip of the needle to aim at a fixed location on a first tissue 1010 (or other material) and then closes the opposing jaws 1002, 1006 so that the needle punctures the first tissue at the targeted fixed location and travels through an opening 1008 at the end of the second jaw 1006.

[0239] In FIG. 86, the user opens the opposing jaws 1002, 1006 to maintain a first tissue 1010 over the needle.

[0240] 87, with a first tissue 1010 on the needle, a user can move the device to join the first tissue 1010 to a second tissue 1012 (or other material). The user uses the tip of the needle to aim a fixed location on the second tissue and then closes the opposing jaws 1002, 1006 so that the needle pierces the second tissue at the targeted fixed location and travels through an opening 1008 at the end of the second jaw 1006.

[0241] In Figures 88 and 89, the user deploys the first bar 1014 and filament 1016 of the fastener through both tissues so that the first bar 1014 and second bar 1018 can hold / fix / join the second tissue 1012 and the first tissue 1010 to each other, respectively.

[0242] In Fig. 89, the user opens the opposing jaws and removes the needle and device from the fixation site, leaving both tissues secured together by the fasteners. The user repeats the process for the next fixation site.

[0243] The advantage of this platform over existing methods is that the user can rapidly join tissues and / or materials and secure them together with intermittent fixation using only one hand or without the need for an assistant.

[0244] The opposing jaws may be joined by a single hinge (e.g., to close like scissors / hemostats). The opposing jaws may also be joined by multiple hinges (e.g., to close like parallel jaw pliers).

[0245] In some embodiments, the device shown in Figures 84-89 includes features described with respect to other embodiments of fixation devices described herein. For example, in some embodiments, the device includes one or more ramps (e.g., as described with respect to Figures 38-42O) configured to redirect a portion of the fastener (e.g., the second bar) as it is being deployed. Examples also include features that can help maintain tissue on the needle (Figures 23-26) and / or features that allow the user to lift tissue away from underlying structures and deploy the fastener without unintentionally fastening the underlying structures (e.g., Figures 28-31).

[0246] FIG. 90 shows one embodiment of a device 1020 including two deployment needles 1022. As shown in FIG. 91, one of the deployment needles pierces a first tissue 1024. In FIGS. 92 and 93, the device is moved to join the first tissue 1024 to a second tissue 1026 by piercing the second tissue with the other deployment needle. In FIG. 94A, each needle deploys one bar 1028 of fasteners through the tissue. In FIG. 94B, filament 1030 holds, joins, and / or compresses the tissue together. The device may also incorporate any of the embodiments described herein to facilitate the procedure. Examples include features that may help maintain the tissue on the needles (e.g., FIGS. 23-26) and / or features that allow the user to lift the tissue away from the underlying structure and deploy the fasteners without unintentionally fastening the underlying structure (e.g., FIGS. 28-31). As another example, in some embodiments, the device includes one or more ramps (e.g., as described with respect to Figures 38-42O) configured to redirect a portion of the fastener (e.g., the second bar) when the fastener is deployed.

[0247] The advantage of this platform over existing methods is that the user can quickly join tissues and / or materials and secure them together with intermittent fixation using only one hand or without the need for an assistant.

[0248] An embodiment of a mechanism enabling robot control In some embodiments, the fixation devices and mechanisms described herein may be configured to function under robotic control, and it will be understood that any embodiment or combination of the embodiments and mechanisms described herein may be utilized in robotic applications.

[0249] In the handled embodiments of the fixation device described above, manipulation and deployment of the fasteners occurs within the distal end of the device, with the proximal handle providing the necessary interface / motion to carry the fasteners within the shaft and transition them to the distal end where they are manipulated into the needles or fangs for deployment.

[0250] In surgical robotic applications, rather than the robot holding the fixation device by a handle and squeezing a trigger like a surgeon, the distal end of the device is transformed into an end effector (which may include transitional elements) and the mechanical action of the handle is replaced by the basic function of a surgical robot arm.

[0251] FIG. 158 shows an end effector 15810 attached to a surgical robot 15812. Using a combination of rotation 15816 and articulation 15818, the surgical robot can position the end effector, optionally in combination with other robotic tools (e.g., forceps), to position and pierce the mesh over the tissue prior to deploying the fasteners (or vice versa).

[0252] FIG. 159 compares embodiments of the paths a fastener takes as it moves from carrier to deployment in the handled and robotic end effector versions of the fixation device. In some embodiments, the end effector functions to transition the fastener from the carrier and manipulate it to prepare it for deployment. As previously described, the carrier has multiple configurations and can hold as few as one fastener or as many fasteners as desired.

[0253] A unique aspect to the robotic interface may be to replicate the cyclical motion of the handle mechanism to deliver and transfer the fastener from the delivery reservoir to the end effector and to provide the fastener to another element that deploys the fastener. In some embodiments, the delivery advancer 15814 advances in increments approximately the same length as the length of the fastener. The increments may be long enough to transfer the fastener from the delivery reservoir to a location in front of the deployment element 15813. The delivery advancer 15814 is held in place before the deployment element 15813 is activated to prevent other fasteners waiting from advancing prematurely and jamming the mechanism. When activated, the deployment element 15813 pushes the fastener through the end effector and manipulates the configuration of the fastener before moving the fastener through the needle / fang, through the onlay material (e.g., mesh) and into tissue and disengaging from the needle / fang. The deployment element 15813 can be started and stopped during deployment, but must be fully extended before retracting to ensure the fastener is fully deployed and the transition zone is clear and ready to repeat the cycle.

[0254] FIG 160 illustrates a quick connection between the proximal end 16024 of the fastener end effector and the distal end of the surgical robot 16020. The distal end of the surgical robot controls the position of the end effector (e.g., move in, move out, rotate and articulate) and the internal push / pull control rod to replicate the fastener handle action to deploy the fastener.

[0255] The proximal end of the fixation device has the necessary features to quickly connect the fixation device to a surgical robot. The internal push / pull rod of the fixation device 16021 is oriented and advanced to capture a mating feature on the push / pull rod 16023 of the surgical robot 16020. The fixation device is then rigidly secured to the robot by advancing the clamp collar 16025 over the device end 16024 and screwing it onto the robot 16020 (FIG. 162). Additional interface / indexing features, such as pins / holes and / or slots / keys, can be used for improved control / rigidity. In some embodiments, hollowing features are utilized to pass other mechanical / electrical / fluid interfaces or supply lines (e.g., additional fasteners).

[0256] Removing the fixation device for quick replacement requires the robot to position the control rod 16023 in the release ("home") orientation, unscrew the threaded collar 16025, and pull the fixation device off the end.

[0257] 163-165 show a more detailed view of one embodiment of the interface between the robotic device and the fixation device push / pull rod 16021. Orienting and mating the fixation device push / pull rod to the robot moves the ball portion of the connecting rod 16023 and expands the connecting clamp 16052 (FIG. 163). As the fixation device is advanced towards the robot, the connecting rod advances into the connecting clamp pivot within a tube in the fixation device 16024, capturing the connecting rod 16023 (FIG. 164). Once connected to the robot, the push rod / clamp assembly is pushed further into the fixation device to establish a control rod connection that the robot can use to replicate the handle mechanical action to advance and deploy fasteners.

[0258] In some embodiments, the robotic transport (which stores multiple fasteners) is equipped with a quick-change interface, allowing the surgeon to replace an empty fastener cartridge with a new, full cartridge.

[0259] In some embodiments, the fastener cartridge is replaceable with or without the need to remove the fastening device from the robot. The transport of the device holds the fasteners where they are moved towards the transition area and deployed. In some embodiments, the transport (e.g., cartridge) is removable. When the fastener supply is exhausted, the transport cartridge can be removed and replaced instead of removing / replacing the fastening device from the robot. As shown in FIG. 166, the transport cartridge 16081 is filled with fasteners. The cartridge can have features to lock the cartridge to the device housing 16080.

[0260] Referring to FIG. 167, the cartridge 16081 is inserted into the device housing. Guides ensure that the cartridge lines up with features of the transition zone of the fixation device. Now referring to FIG. 168, the cartridge interface can be spring loaded to lock the cartridge 16081 in place and ensure that the deployment and delivery push rod (from the proximal end of the fastener) is aligned to move the fastener into the transition zone to deploy the fastener.

[0261] In some embodiments, the delivery reservoir, delivery advancer, and deployment element are flexible. The delivery cartridge can be made of a flexible plastic, such as high and low density polyethylene, allowing it to flex along with the transition and deployment zones within the fastener head as the head articulates.

[0262] Additional Embodiments of the Fixation Device In some of the embodiments disclosed herein, the target material to be joined to another material (e.g., ADM) is held against a backstop or other portion of a component while the fangs or staples are inserted into the target material. Stabilizing the target material in this manner allows staples to be inserted into tough materials such as ADMs. Currently, only sutures are used with tough materials such as ADMs. The devices and mechanisms as described herein allow for the use of a stapling device to join ADMs during a surgical procedure.

[0263] 101A-1G show an embodiment of a device configured to grasp and join materials such as tissue or ADM. As shown in FIG. 101A, the device 10100 includes a housing 10102, a push rod 10104, and a linkage 10106. FIG. 101B shows pincers 10108, each connected to the linkage 10106 by a hinge. As the housing 10102 advances, the pincers 10108 close and grasp a first target material (e.g., ADM), as shown in FIG. 101C. The device 10100 can be used to position materials as needed. The pincers 10108 can be opened, positioned on a second target tissue or material, and actuated to pierce the two target materials. After the pincers 10108 pierce the two materials, the entire device 10100 can be steered to retract the material to avoid underlying structures during staple deployment.

[0264] Advancement of the push rod 10104 then causes the staple legs to track along the pincer grooves 10110 shown in FIGS. 101D and 101E, closing the staples 10112 (FIG. 101F) and securing the target materials together. The pincers 10108 can also act as a guard to prevent the staple legs from grabbing unintended material during staple formation. Additional pincer actuations can be applied to close the staples even tighter, thereby increasing compression against the joined materials, if desired.

[0265] 101G shows another embodiment of the device 10100 where, after actuation, the tips of the pincers 10108 meet. This ability can improve the pincers' grip on material (e.g., when pulling tissue or an ADM away from an underlying structure).

[0266] In some embodiments, the features shown in device 10100 are located at the end of the shaft to facilitate access to localized locations.

[0267] 102A and B show a device 10200 including a head 10202 disposed at the end of a shaft 10201. A carrier 10204 extends (e.g., upon actuation) from the head 10202. As shown in FIG. 102C, tongs 10206 can be actuated and deployed from the carrier 10204 to grasp the target material(s) so that the user can position the material(s) as desired. Once the material is positioned, as shown in FIG. 102D, the tongs 10206 are retracted, the carrier 10204 is positioned against the material, and the tongs 10206 are actuated to pierce the material(s). As shown in FIG. 102E, the carrier 10204 is retracted while the tongs 10206 maintains penetration of the material(s), positioning the material(s) against the head 10202. The device 10200 can be steered to retract the material(s) to avoid underlying structures during staple deployment. The staples 10208 are deployed to secure the materials together as shown in Fig. 102F. The tongs 10206 also act as a guard to prevent the staple legs from grabbing unintended material during staple formation.

[0268] 103A-H show an embodiment using a device 10300 having clamping jaws, hooks 10304 (e.g., flexible hooks, nitinol hooks) configured to deploy from a lower jaw 10308, and staples 10306 deploying from an upper jaw 10310. As shown in FIG. 103A, the hooks 10304 reside in the lower jaw 10308 while the device is inserted into a surgical site. FIG. 103B shows the upper jaw 10310 clamping firmly against a target material 10312 (e.g., an ADM or tissue). FIG. 103C shows the hooks 10304 actuated and the target material secured to the device. FIG. 103D shows the upper jaw 10310 open to allow positioning of a target material against a second target material 10314 (to be joined). In FIG. 103E, two materials are positioned together (e.g., an ADM positioned on tissue). Fig. 103F shows the upper jaw 10310 clamping both materials. The staples 10306 are deployed to secure the materials together as shown in Fig. 103G. The lower jaw 10308 also acts as a guard to prevent the staple legs from grabbing unintended materials during staple formation. Fig. 103H shows the hooks 10304 are retracted to allow for movement or removal of the device 10300.

[0269] 104 shows an embodiment of an upper jaw 10400 with a window 10402. A frame 10404 around the window 10402 serves to clamp the material to be joined (e.g., ADM and tissue) between the upper and lower jaws. Staples 10406 ​​are shown in the upper jaw 10400 near the window 10402. The clamp keeps the material tensioned so that the hooks pass through the material and the window.

[0270] 105A-G show another embodiment of a device 10500 having clamping jaws, rigid hooks 10504 (instead of flexible (e.g., Nitinol) hooks) attached to the lower jaw 10502 by a hinge 10506, and staples 10508 deploying from the upper jaw 10510. FIG. 105B shows the upper jaw 10510 clamping firmly against a target material 10512 (e.g., an ADM or tissue). FIG. 105C shows the rigid hooks 10504 actuated and the target material secured to the device. FIG. 105D shows the upper jaw 10510 open to allow positioning of a target material against a second target material 10514 (to be joined). In FIG. 105E, two materials are positioned together (e.g., an ADM positioned on tissue). Fig. 105F shows the upper jaw 10510 clamping both materials and the staples 10508 deployed to secure the materials together. The lower jaw 10502 also acts as a guard to prevent the staple legs from grabbing unintended material during staple formation. Fig. 105G shows the rigid hooks 10504 retracted, allowing for removal or removal of the device 10500.

[0271] 106A-108B show one embodiment of a device that may be used to secure and stabilize a first and second material to be joined. Such a device may be particularly useful for positioning and stabilizing tough materials (such as ADM) for staple penetration. An integrated or separate (e.g., currently available) stapler or stapling mechanism may be used to perform the stapling to secure the materials together.

[0272] 106A and 106B show a device 10600 with a needle 10602 (or other piercing member) attached to a first jaw 10604. The second jaw 10606 includes an open hole 10608. The needle 10602 and hole 10608 are positioned and configured such that the needle 10602 enters the hole 10608 when the jaws 10604, 10606 are closed, as shown in FIG.

[0273] 107A-H illustrate an embodiment of a method of using the device of FIG. 106A-B to secure a first material 10702 (e.g., ADM) to a second material 10704 (e.g., tissue). FIG. 107A illustrates how the needle tip 10706 is used to target a fixation location on the first material 10702. As shown in FIG. 107B, the jaws 10604, 10606 are closed and the needle 10602 enters a hole in the second jaw (not shown) to pierce the first material. In FIG. 107C, the jaws 10604, 10606 are open. As shown in FIG. 107D, the needle 10602 is used to position the first material 10702 at a desired fixation location on the second material 10704 and the needle tip 10706 is used to target the fixation location on the second material 10704. In FIG. 107E, the jaws 10604, 10606 are closed and the needle 10602 is inserted into the hole in the second jaw, compressing the second material 10704 onto the needle tip 10706. The entire device 10600 can be manipulated to retract the material to avoid underlying structures during staple deployment. FIG. 107F shows the stapling mechanism 10708 extending into the fixation site and deploying the staples 10710 to secure the target materials together. As shown in FIG. 107G, the stapling mechanism 10708 is retracted. As shown in FIG. 107H, the jaws 10604, 10606 are opened and the device 10600 is removed. In some embodiments, the device 10600 is modified such that the needle has a channel through which the staple legs can travel and easily pass through the first material (e.g., tough ADM) and the second material.

[0274] 108A and 108B show an alternative jaw embodiment having two opposing sharp tips 10802. The tips 10802 can be used to position a first target material 10806 to a second target material 10808 and then can be used to pierce the first material and secure the second material as shown in FIGS. 108C and 108D. The entire device 10800 can be steered to retract the target material (e.g., ADM and tissue) to avoid underlying structures during staple deployment. The stapling mechanism retracts to the fixation site and deploys staples to secure the material. This device can be modified so that each sharp tip has a channel through which the corresponding staple leg can travel and easily pass through the first material (e.g., tough ADM) and second material. The tips can also be modified to act as a guard to prevent the staple legs from grabbing unintended materials during staple formation.

[0275] 109A and 109B show an embodiment in which a staple 10902 is attached to the end of a shaft 10904. The staple 10902 may be curved such that one end is attached to the end of the shaft 10904 and a sharp end is free from the shaft. The staple may be curved in a plane perpendicular (or at an angle) to the shaft 10904. This positioning may allow for rotation of the shaft to drive the staple through the adjacent material(s).

[0276] An exemplary application of such a device is shown in FIG. 110A where the staples and shaft are inserted into an incision 11008. In FIG. 110B, the staples and shaft are inserted to where the ADM is to be attached to the tissue. In FIG. 110C, the shaft drives the staples through the ADM and tissue. Prior to closing the staples, the entire device may be manipulated to lift the tissue / ADM and check if underlying structures have been unintentionally grabbed. In FIG. 110D, the forks 11008 advance around the staple tips. In FIG. 110E, the shaft and forks are actuated to bend the staples closed. In FIG. 110F, the device is removed and the closed staples secure the ADM to the tissue.

[0277] A device with this configuration can also be used to place staples away from the edge of a target material (e.g., an ADM). In FIG. 110G, the staple 10902 has pierced the ADM 11002 and tissue 11004. The fork 11008 is used as a backstop on the ADM to allow the staple tip to return up through the ADM 11002 and to apply counter-traction. Prior to closing the staple, the entire device can be manipulated to lift the tissue / ADM to check if underlying structures have been unintentionally grabbed. In FIG. 110H, the shaft and fork are actuated to bend and close the staple 10902, securing the ADM 11002 to the tissue 11004, as shown in FIG. 110I.

[0278] Alternatively, the staple 10902 may pierce the ADM 11002 and tissue 11004 without piercing the ADM 11002 and back up, as shown in FIG. 110J. Before closing the staples, the entire device may be manipulated to lift the tissue / ADM to see if underlying structures have been unintentionally grasped. The legs of the staple 10902 on the ADM 11002 may then be bent to secure the ADM 11002 to the tissue 11004, as shown in FIG. 110K and FIG. 110L.

[0279] 111A and 111B show another embodiment in which a staple 11102 is attached to the end of a shaft 11104. The shaft 11104 can include two rods 11106, each connected to a side of a staple. This architecture can be used to place staples on or away from the edge of the target material (e.g., ADM).

[0280] As shown in Fig. 111C, the staple tips are placed on the ADM / tissue 11108. As shown in Fig. 111D, the rod 11106 of the shaft 11104 is rotated to close the staples 11102. The staples can then be released from the rod. This can be done using a variety of methods (e.g., a push rod that pushes the staples off the shaft, a spring that pushes the staples off the shaft, etc.).

[0281] 112 shows an alternative mechanism for closing the staples 11202. The span of the staple rests on a die 11204. A die 11206 is driven towards the die 11204 causing the staples 11202 to close.

[0282] FIG 113A shows one embodiment of a staple 11302 having a tip 11304 and a preformed feature 11306. FIG 113B shows the staple 11302 being held by a first jaw 11308. FIG 113B also shows a slot 11310 in a second jaw 11312 into which the staple tip 11304 enters when the jaws 11308, 11312 are closed.

[0283] The staple tip 11304 is used to target a fixation location on a target material 11314 (e.g., an ADM). The jaws 11308, 11312 are closed and the staple tip 11304 enters the slot 11310 of the second jaw 11312, thereby piercing the ADM 11314, as shown in FIG. 113C. The ADM 11314 is moved into the preformed staple feature 11306 by sliding the staple until the ADM is positioned within the preformed staple feature, as shown in FIG. 113D. The jaws 11308, 11312 are opened and the ADM 11314 is moved into position, using the staple tip 11304 to target a fixation location on tissue, as shown in FIG. 113D. In FIG. 113E, the jaws 11308, 11312 are closed, thereby allowing the staple tip 11304 to pierce the tissue. As the staple tip 11304 enters the slot 11310 of the second jaw 11312, the tissue 11316 is compressed against the staple 11302. The entire device can be manipulated to lift the tissue / ADM to see if any underlying structure has been unintentionally grasped.

[0284] With the staple legs in the slots of the second jaw 11312, the second jaw 11312 is rotated to close the staple (FIG. 113F) and secure the ADM to the tissue. As shown in FIGS. 113G and 113H, the preformed staple features and the closed staple legs secure the ADM to the tissue. In some embodiments, the preformed staple features can be different than those shown in FIGS. 113A-H, so long as the features help prevent the target material (e.g., the ADM) from dislodging from the staple. Examples can include barbs or barbs (FIG. 113I) or stopper features (FIG. 113J).

[0285] FIG 114A illustrates another embodiment of a staple 11402 having a staple tip 11404 and a preformed feature 11406. As shown in FIG 114A, the staple 11402 is held by a first jaw 11408. A second jaw 11410 includes a hole 11412 and an anvil 11414, as shown in FIG 114B and FIG 114C. As shown in FIG 114B, the hole 11412 can be disposed distally relative to the anvil 11414 in some embodiments. Alternatively, the anvil 11414 can be disposed distally relative to the hole 11412, as shown in FIG 114C.

[0286] 115A-G illustrate one embodiment of a method of using the staple 11402 and jaws 11410, 11408 described with respect to FIGS. 114A-C. The staple tip 11404 is used to target a fixation location on a target material 11502 (e.g., an ADM). As shown in FIG. 115A, the jaws 11408, 11410 are closed and the staple tip 11404 enters the hole 11412 in the second jaw 11410, thereby piercing the ADM 11502. In FIG. 115B, the jaws 11408, 11410 are opened and the second jaw 11410 is actuated to align the anvil 11414 with the staple tip 11404. The ADM 11502 is positioned and the staple tip 11404 is used to target a fixation location on a second target material 11504 (e.g., tissue).

[0287] In Figs. 115C and 115D, the jaws 11408, 11410 are closed, compressing the tissue 11504 against the staple tip 11404 and driving the staple tip 11404 into the anvil 11414 on the second jaw 11410. The entire device can be manipulated to lift the tissue / ADM to see if any underlying structure has been unintentionally gripped. In Fig. 115E, the jaws 11408, 11410 remain closed and the anvil 11414 curls / closes the staple legs 11506, securing the ADM 11502 to the tissue 11504. The anvil 11414 also acts as a guard to prevent the staple legs from gripping unintentional material during staple formation. Fig. 115F shows the staple 11402 in place with the jaws retracted.

[0288] 116A and 116B show an alternative embodiment for closing the staples. In the first jaw 11602, an element 11604 (such as a wedge or other mechanism) is actuated. This advances the staples in the first jaw towards the anvil (if the anvil is in the second jaw) and causes the anvil to curl / close the staple legs and secure the ADM to the tissue. This mechanism can be used alone to close the staples or can be used in combination with closing the jaws as described in FIG. 115.

[0289] FIG. 117 shows an alternative embodiment of a staple 11802 having preformed features 11806 and pre-bent tips 11804 that allow the staple legs to bend in the appropriate direction within the anvil (rather than jamming or buckling within the anvil).

[0290] 118A-C show an alternative embodiment of a staple 11902 having a preformed feature 11904 and a pre-bent tip 11906 that allows the staple legs 11908 to bend in the proper direction within an anvil (not shown). This pre-bent tip 11906 can help prevent jamming or buckling within the anvil. Closing of the staple is accomplished by bending the distal end or leg 11908 within the anvil, as shown in FIG. 118B, and bending the proximal end or leg 11910 with a plunger or other mechanism, as shown in FIG. 118C.

[0291] 119A-C show an alternative embodiment of a staple 12002 including multiple pre-bends 12004 on the distal leg 12006 and multiple pre-bends 12008 on the proximal leg 12010. Closing of the staple is accomplished by bending the distal end or leg in an anvil and bending the proximal end or leg with a plunger or other mechanism. The staple 12002 is shown in its closed configuration in FIG.

[0292] FIG. 120 illustrates a shroud 12102 with sharp tips 12104 attached to the jaws 12106. Staples 12108 reside within the lumen 12110 of the shroud. The sharp shroud tips facilitate penetration of the target material (e.g., ADM). The shroud 12102 provides rigidity to the staples 12108. This design mitigates undesired staple leg bending or deformation resulting from user applied forces (e.g., causing the staple legs to miss the staple forming feature on the second jaw or causing improper staple closure). The shroud slots 12112 allow the staples to close. The staples may or may not have sharp tips. A rigid shroud may also allow for smaller staples since the shroud bears the user applied forces instead of the staples.

[0293] Figures 121A-C show various views of one embodiment of a device 12200 in which a staple 12202 having staple barbs 12204 resides in a first jaw 12206. As shown in Figure 121A, the first end of the staple is bent at an angle and extended toward the exit of the first jaw. The first jaw includes a forming feature 12208. The device also includes a sliding forming member 12210, a push rod 12212, a stop 12214, a cover (clear to allow visualization of the internal features), and a second jaw 12216. Figure 121C shows the hole 12218 and the second jaw 12216.

[0294] Figures 122A-M show one embodiment of a method of using the device 12200 of Figures 121A-C. The device 12200 is inserted into a surgical site with a staple tip present in the lower jaw 12206. As shown in Figure 122A, the push rod 12212 is advanced until the staple barb 12204 contacts the stop 12214, causing the staple tip 12220 to extend from the first jaw 12206.

[0295] 122B and 122C show the sliding forming member 12210 advancing to bend the staple tips by compressing the staples 12202 against the forming features 12208. FIG. 122B shows a schematic of the device 12200 with the internal components visible, and FIG. 122C shows the device used in the procedure with the internal components not visible. Alternatively, the staple tip bending described above may be performed prior to insertion into the surgical site, and the second jaw may be closed to hide the staple tips while the device is inserted into the surgical site.

[0296] 122D and E show that the staple tip 12220 is used to target a fixation location on the target material 12304, in this case an ADM. The jaws 12206, 12216 are then closed and the staple tip 12220 pierces the ADM 12304 by entering the hole 12218 in the second jaw 12216.

[0297] As shown in Figures 122F and G, the stop 12214 (contacting the staple barbs) is disengaged. The jaws 12206, 12216 are then opened. The target material, in this case the ADM, is positioned against a second target material 12306 (e.g., tissue). The staple tip 12220 is used to target a fixation location on the second target material 12306. Figure 122F is a schematic view of the device 12200 and Figure 122G is a view of the device 12200 while it is performing the stapling procedure.

[0298] In Figures 122H and 122I, the jaws 12206, 12216 are closed, compressing the tissue 12306 against the staple tips 12220. The entire device can be steered to retract the tissue / ADM to avoid underlying structures during staple deployment. Figure 122H shows a schematic view of the device 12200, while Figure 122I shows the device 12200 while performing the stapling procedure.

[0299] In Figs. 122J and 122K, the push rod 12212 is advanced. When the sliding forming member 12210 is in its advanced position, it bends the staples by compressing them against the forming feature 12208 of the first jaw 12206. As the push rod 12212 advances the staples, the compression zone (formed by the forming feature 12208 and the sliding forming member 12210) continuously deforms the staples as they advance through the compression zone, causing them to curl. The curled staples secure the ADM 12304 to the tissue 12306. The second jaw 12216 also acts as a guard to prevent the staple legs from grabbing unintended material during staple formation. Fig. 122J shows a schematic of the device 12200, and Fig. 122K shows the device 12200 while performing a stapling procedure.

[0300] Figures 122L and 122M show the staple 12202 after it has been expelled from the device 12200. Figure 122L shows a schematic view of the closed staple 12202, and Figure 122M shows the closed staple 12202 after the stapling procedure has been performed.

[0301] 123A and 123B show a portion of the device 12400 where the staples 12402 reside on the fangs 12404. The fangs 12404 are part of the head 12410 portion of the device. The device 12400 also includes a retractable backstop 12406. The backstop 12406 has holes 12408 shaped to receive the fangs 12404. The backstop 12406 retracts relative to the fangs 12404 of the device. As it retracts, the backstop 12406 moves proximally relative to the fangs 12404 (best seen in FIG. 124E). By using a backstop with holes shaped to receive piercing elements (e.g., fangs), the device can pierce tough materials such as ADM without applying high force or pressure to the tissue. In some embodiments, the staples themselves can function as the piercing elements.

[0302]

[00101] Figures 124A-L show one embodiment of a method of using the device 12400 shown in Figures 123A and 123B. Figures 124A and B show the device 12400 being manipulated such that a target material 12502 to be bonded (e.g., an ADM) is positioned between the fang 12404 and its associated backstop hole 12408. The fang 12404 is used to target a fixed location on the ADM 12502. The backstop 12406 is then actuated to press the ADM 12502 onto the fang 12404. Similar to Figures 122A-L, Figure 124A shows a schematic view of the device 12400 and Figure 124B shows the device while it is performing a stapling procedure.

[0303] 124C and 124D show the backstop 12406 being opened to disengage from the fang 12404 and the hole 12408 being pulled out from the fang 12404. FIG. 124C is a schematic diagram of the device 12400 and FIG. 124D shows the device while performing a stapling procedure.

[0304] Figures 124E and 124F show the backstop 12406 retracted to be moved proximally relative to the fangs 12404, exposing the fangs 12404. Figure 124E shows a schematic view of the device 12400, while Figure 124F shows the device while it is performing a stapling procedure.

[0305] 124G and 124H, the fangs 12404 are used to target and position the ADM 12502 at a fixed location on a second target material, in this case tissue 12504. The fangs 12404 are then inserted into the tissue 12504. The length of the fangs 12404 is sized to penetrate the tissue 12504 to a certain depth. The fangs 12404 prevent the staples 12402 from gripping / damaging underlying structures.

[0306] 124I and 124J show the staple 12402 being formed. The span of the staple 12402 rests on the central die 12510. The outer die 12508 is actuated to bend the staple onto the central die 12510. Actuating the outer die 12508 includes moving the outer die 12508 in the direction shown by the arrows in FIGS. 124I and 124J. The staple legs 12506 bend inwardly to draw, compress and secure the ADM against the tissue.

[0307] The staples may also be deployed in stages. In the first stage, shown in FIG. 124I, the staple 12402 grasps the ADM 12502 and the tissue 12504. To avoid the underlying structure before fully closing the staples, the device can be steered to retract the tissue / ADM before fully closing the staples. While holding the tissue / ADM away from the underlying structure, the staples can be fully closed as shown in FIG. 124J.

[0308] In Fig. 124K, the staples are released from the central die and separated from the stapler. An ejector may assist in pushing the staples out of the central die.

[0309] An alternative method for using the device depicted in Figures 123A-124K is to eliminate the use of a backstop by directly piercing the onlay material and underlying tissue with the fangs so that the fangs pierce the onlay material and penetrate the underlying tissue. The staples can then be fully deployed and closed as depicted in Figures 124I-124J. The staples can also be deployed in stages. In the first stage, shown in Figure 124I, the staple 12402 grasps the ADM 12502 and tissue 12504. To avoid the underlying structures before fully closing the staples, the device can be steered to retract the tissue / ADM before fully closing the staples. While holding the tissue / ADM away from the underlying structures, the staples can be fully closed as shown in Figure 124J.

[0310] In some embodiments, the device 12400 includes a staple reservoir 12600 that is shaped and configured to hold a plurality of staples, as shown in FIG 125. The staple reservoir 12600 can be fixed to the stapler device 12400 or can be a replaceable cartridge.

[0311] FIG 126 illustrates one embodiment of a device 12700 with a stapler head 12702 similar to the structure illustrated in FIG 125. The stapler head 12702 is disposed at the distal end of a shaft 12704, which allows for staple placement in a localized location. The device 12700 includes a handle 12706 and an actuator 12708, which can be used to control the function of the stapling mechanism.

[0312] Figures 127A and 127B show an embodiment of a device 12800 having one fang 12802 on a rotating head 12804, for example, to allow for staple placement on both sides and / or in a localized location of a breast implant. Figure 127A shows the device 12800 with the rotating head positioned such that the fang 12802 is on a first side of the device 12806. Figure 127B shows the device 12800 with the rotating head rotated approximately 180 degrees so that the fang 12802 is on a second side of the device 12806. The head may also be rotated through a range of angles.

[0313] 128A-C show one embodiment of a device 12900 having an articulating head 12902. The articulating head 12902 can allow for staple placement in a localized location. The head 12902 can, in some embodiments, articulate by rotating about a hinge point 12904. FIGS. 128A-C show the head 12902 articulating through first, second, and third positions, respectively.

[0314] In the staple forming embodiments described herein, as shown more clearly in Figures 129A and 129B, the fangs 13004 and staples 13002 stretch holes 13006 in the target material 13008 (e.g., ADM) as the staples 13002 are formed. The stretching holes 13006 resist the staples closing. In some embodiments, the device or mechanism includes additional features to enhance or improve staple formation.

[0315] Figures 130A-C show a device 13100 having retractable fangs 13102. Once the staples 13104 begin to clinch (staple closing die not shown), the fangs 13102 retract, as shown in Figure 130C. With the fangs retracted, the ADM can more easily follow the forming staple legs.

[0316] 131A-B show embodiments of optional features that may be present on the fang or device. In some embodiments, the fang 13202 includes a blade 13204 that forms a slit 13208 in the fang hole 13206 (the hole formed in the target material by the fang). As shown, the blade can extend along the length of the fang (e.g., on its short side) and can include a tapered shape. When the staple is formed, the staple legs 13210 can enter the slit so that the legs can completely close. FIG. 131C shows a top view of an exemplary fang hole 13206 and slit 13208 formed by the combination of the fang 13202 and blade 13204 of FIGS. 131A and 131B.

[0317] FIG. 132 illustrates one embodiment of articulating fangs 13302. The fangs 13302 can act to bend the staple tips 13304 inwardly to aid in staple closure. The articulating fangs can also provide gripping of the two target materials to be joined. The entire device can be steered to retract material to avoid underlying structures during staple deployment. The fangs 13302 can also act as guards to prevent the staple legs from gripping unintended material during staple formation.

[0318] 133A and 133B show an embodiment of a fang 13402 with an internal feature configured to close the staple. The feature also acts as a guard to prevent the staple legs from grabbing unintended material during staple formation. As shown in FIGS. 133A and 133B, the feature can include a beveled edge or surface 13404 configured to bias the staple legs 13406 inwardly as they move toward the edge or surface 13404. The feature can further include another edge or surface 13408 configured to cause the staple legs 13406 to bend when biased toward and adjacent the beveled edge or surface 13404.

[0319] 134A-C show the fangs 13502 having adjustable positions. In a first position, shown in FIG. 134A, the fangs 13502 are hidden during insertion and removal of the device to prevent damage to surrounding structures. In a second position, shown in FIG. 134B, the fangs 13502 are slightly extended and set to penetrate tissue at a shallow depth. In a third position, shown in FIG. 134C, the fangs 13502 are further exposed and set to penetrate tissue at a deeper depth. The staples may be configured not to extend beyond the tip of the fangs, thereby protecting underlying structures. Optional depth markers 13504 on the fangs can assist the user in setting the proper length of the fangs.

[0320] 135 shows one embodiment of a fang 13602 having external threads 13604. Once the fang is placed over a first target material 13606, such as an ADM, and a second target material 13608, such as tissue, the fang 13602 is rotated to screw into the material. The fang 13602 can be rotated to avoid the underlying structures until a desired depth into the material is reached. With the threads engaged with the ADM and tissue, the fangs can be used to pull the ADM and tissue apart to protect the underlying structures during staple deployment.

[0321] 136A-C show various embodiments of the fang 13702. FIG. 136A shows a fang 13702 having a barb 13704 positioned along the length of the fang 13702. FIG. 136B shows a fang 13702 having multiple notches 13706 disposed along the length of the fang 13702. FIG. 136C shows a fang 13702 having multiple necks 13708 disposed along the length of the fang 13702. The barbs, notches, and / or necks grip the target material once the fang(s) is inserted into the target material to a desired depth. The fangs can be used to pull the material(s) apart to protect underlying structures during staple deployment.

[0322] In some embodiments, the tips of the fangs have various sharp tip designs such as a lancet tip, a bed (reverse ground) tip, a trocar tip, etc. These various tip designs can aid in ease of insertion through tough materials such as the ADM.

[0323] In some embodiments, the fangs can be replaceable. For example, the fangs can be part of a replaceable staple cartridge, as described herein. In other embodiments, the fangs are themselves replaceable, independent of use of a cartridge.

[0324] 137 shows one embodiment of fangs 13802 configured to flip down (or rotate, or snap, or articulate, etc.). The fangs may be configured to be hidden within the head portion 13804 of the device to protect surrounding structures. The fangs 13802 may then be configured to flip down when needed, as shown in FIG.

[0325] In some embodiments, as shown in Fig. 138, the fangs 13902 are covered by a shroud 13904 to protect surrounding structures. The shroud 13904 is configured to retract when the fangs are needed.

[0326] In some embodiments, as shown in Fig. 139, the fangs 14002 can be hidden in backstop holes 14004. The backstops 14006 can be configured to activate and retract the fangs 14002 when needed.

[0327] The embodiments described herein in which fangs are used to penetrate the target material may be adapted so that the staple legs perform the function of the fangs, in other words, the staple legs may be configured to penetrate the target material instead of the fangs, thereby eliminating the fangs.

[0328] Figures 140A and 140B show embodiments of staples having various shapes. The staple 14102 in Figure 140A has a more squared shape, whereas the staple 14102 in Figure 140B has a more rounded shape. The radius on the staple 14102 in Figure 140B can allow the target material to slide more easily along the staple legs (e.g., preventing snagging) during staple formation.

[0329] In some embodiments, the stapler or staple is configured such that as a result of staple formation, one staple leg resides on top of the other, as shown in the front view of FIG 141 A. This configuration can help prevent the staple legs from extending out of plane, as shown in the top view of FIG 141B.

[0330] After the staples are formed and the forming die retracts, the staple legs spring open slightly as shown in FIGS. 142A-D. FIGS. 143A-C illustrate staple formation. In FIG. 142A, the forming mechanism 14302 is positioned over the staples 14304 and the central die 14306. In FIG. 142B, the forming mechanism is lowered over the staples, bending the staple legs 14308 around the central die 14306. In FIG. 142C, the forming mechanism 14302 is lifted away from the staples 14304. Removal of the compressive force of the forming mechanism 14302 causes the staple legs 14308 to spring open slightly. FIG. 142D illustrates another embodiment of a staple 14310 with the legs 14312 spring open slightly.

[0331] FIG 143A shows an embodiment of a staple 14402 having features that hold the staple legs 14404 closed after the forming die is retracted. As shown in FIG 143A, the staple 14402 includes a hump 14406 whose shape, size, and position can be altered to adjust the position of the closed staple legs. FIG 143B shows the staple 14402 being compressed into a closed position by a die 14408. FIG 143C shows the staple 14402 with the die removed and the legs 14404 remaining closed.

[0332] 144 illustrates another embodiment of a staple 14502 in which the staple legs remain closed after the forming die is retracted. The staple 14502 includes a bump 14504. The shape, size, and location of the bump can be altered to adjust the position of the closed legs 14506.

[0333] In some embodiments, the staples are made from an absorbent material.

[0334] The embodiment shown in Figures 123A-144 may allow one user to close the incisions and place the staples. Currently, it may take up to two people to close and staple a single incision, i.e., two hands to grasp and close the tissue on either side of the incision, and another hand to deploy the staples (three hands total). The device described with respect to Figures 123A-124K may be operated by a single user to secure tissue on side 1 of the incision with one fang, close tissue on side 2 of the incision with the other fang, and then deploy the staples.

[0335] Figures 145A-D show an embodiment in which such a device is used by a single user. In Figure 145A, a first material 14602 and a second material 14604 to be joined are shown. A fang (not shown) holds the first material 14602 at point 14606. Figure 145B shows the materials as the device is used to join the materials. The first and second materials 14602, 14604 are brought close together. Figure 145C shows the materials next to each other. A second fang (not shown) holds the second material 14604 at point 14608. Figure 145D shows the materials 14602, 14604 after a staple 14610 has been deployed to join the materials 14602, 14604.

[0336] 146A-D illustrate a method of using a stapler (not shown) to form the staple legs 14702, 14704 at different times. FIG. 146A shows two materials 14706, 14708 to be joined. As shown in FIG. 146B, the surgeon can actuate the stapler to close one leg 14702 of the staple in one tissue 14706 (or material). As shown in FIG. 146C, the surgeon can then move the stapler to join the tissues (or materials). FIG. 146D shows the materials 14706, 14708 after a second actuation of the stapler to close the other leg 14704 of the staple in a second tissue 14708 (or material). This approach can be applied to a stapler with fangs or to a stapler without fangs that uses staple legs to perform the function of the fangs.

[0337] Figures 147A-D show another embodiment of a stapling mechanism 14800 as described with respect to Figures 101A-101G. Figure 147A shows a first arm 14802 having a first fang or pincer 14804 and a first backstop hole 14806. The stapling mechanism 14800 also includes a second arm 14808 having a second fang or pincer 14810 and a second backstop hole 14812.

[0338] 147B shows that the fangs 14804, 14810 are placed on a first target material 14814 (e.g., an ADM) and used to target fixed locations on the ADM. The arms 14802, 14808 are actuated to fold the ADM. This causes the fangs 14804 to pierce the folded ADM 14814 into backstop hole 14812 and the fangs 14810 to pierce the folded ADM into backstop hole 14806.

[0339] In FIG. 147C, the arms 14802, 14808 are opened with the fangs 14804 withdrawn from the backstop holes 14812 and corresponding locations on the ADM, and the fangs 14810 withdrawn from the backstop holes 14806 and corresponding locations on the ADM. The ADM adjacent the base of the fangs remains attached to the fangs 14804 and 14810. In FIG. 147D, the ADM 14814 is positioned and the fangs 14804, 14810 are used to target anchoring locations on a second target material 14816 (e.g., tissue) and the fangs 14804, 14810 are inserted into the tissue. If the device has a staple forming die (e.g., as described with respect to FIG. 112 and FIG. 124I-J), the staples can be deployed to approximate, compress, and secure the ADM to the tissue. The staples may be deployed in stages to separate the tissue / ADM and protect the underlying structures before staple closure (as depicted in Figures 124I-J).

[0340] If the device uses the fangs to form the staples (e.g., as described with respect to FIGS. 101A-101G), the arms 14802, 14808 are partially actuated as shown in FIG. 147E. The device is steered to retract the tissue 14816 and ADM 14814 to avoid underlying structures during staple deployment. In some embodiments, to cause staple closure, the push rod is advanced to deploy the staples, the staple legs advance and track along the fang grooves, and the staples close to draw, compress, and secure the ADM against the tissue. The fangs also act as guards to prevent the staple legs from grabbing unintended material during staple formation.

[0341] 148A-D show embodiments of fangs including features configured to enhance the performance of the device of FIG. 147. For example, FIG. 148A shows an embodiment of a fang 14902 with a notch 14904 to better hold a material (e.g., ADM) at the base of the fang. The fang 14902 also includes a taper 14906 to allow the distal end of the fang 14902 to easily pull out of a material such as ADM. FIG. 148B shows an embodiment of a fang 14902 including a lubricious coating 14908 configured to allow the distal end of the fang 14902 to easily pull out of a material such as ADM. The fang 14902 of FIG. 148B also includes a notch 14904. FIG. 148C shows an embodiment of a fang 14902 including a barb 14910 configured to better hold a material such as ADM at the base of the fang. FIG. 148D shows an embodiment of a fang 14902 with a neck 14912 configured to better retain material, such as ADM, at the base of the fang.

[0342] In some embodiments, the stapling mechanism can use an energy source to assist the fangs or staples in piercing material such as the ADM. In some embodiments, high frequency (e.g., radio frequency) current can be applied to the fangs or staples. In some embodiments, a laser can be used to puncture the material (e.g., the ADM). In some embodiments, ultrasonic energy is applied to the fangs or staples.

[0343] 149 shows a sheet 15000 of material (e.g., ADM) with a number of holes 15002. The holes 15002 can relieve the fangs or staples from having to penetrate through tough materials such as ADM. The holes 15002 allow the staple legs to easily pass through the holes.

[0344] 150A shows a bone anchor staple 15100 intended to secure soft tissue (or ADM, mesh, membrane, etc.) to bone. The bone anchor staple has a staple wire feature 15102 extending from a bone anchor feature 15104.

[0345] This device 15100 may be utilized in procedures (e.g., arthroscopic rotator cuff repair) to simplify / eliminate complex suture management. FIG. 150B shows a bone anchor feature 15104 inserted into bone 15106 with a staple wire feature 15102 protruding from the bone 15106. FIG. 150C shows material 15108 (e.g., tissue) being forced over the staple wire feature 15102. FIG. 150D shows the formed staple wire feature 15102 securing tissue 15108 to bone 15106.

[0346] 151A and 151B show diagrams of a stapler concept having a shaft 15202 that holds open a number of spring staples 15204. The shaft 15202 rotates and drives the staples 15204 through the material, such as tissue (or ADM, mesh, membrane, etc.) to be fastened together. Once the staples are off the end of the shaft, the staples 15204 contract to a smaller size, drawing, compressing and fastening together the materials 15206, 15208, as shown in FIG. 151C. The next staple is advanced to the end of the shaft, ready for deployment.

[0347] 152A-C are embodiments of a device 15300 that joins materials such as tissues (or ADM, mesh, membrane, etc.) so that staples can secure the tissue together. FIG. 152A shows textured wheels 15302, 15304 with one wheel in contact with tissue 15306 on one side of an incision 15308 (or gap). The other wheel 15304 in contact with tissue 15310 on the other side of the incision 15308 (or gap). The wheels 15302, 15304 are rotated (as indicated by the arrows) to bring the tissues together. FIG. 152B shows the textured wheels 15302, 15304 after rotation, showing that tissues 15306, 15310 from either side of the incision 15308 have been joined between the wheels. 152C shows the staples 15312 fastening together the tissue 15306, 15310. The rotating wheel may be a separate device from the stapler or may be integrated into the stapler device.

[0348] 153A shows a polymer strand 15402 with a series of openings 15404 at one end of the strand. A guide tube 15406 is used to pierce the material 15408 (e.g., tissue) to be fastened together. The tissue may be an ADM, mesh, membrane, etc. The polymer strand 15402 is advanced within the guide tube 15406 until the distal end 15410 of the polymer strand 15402 passes through the openings 15404 in the strand.

[0349] As shown in Fig. 153B, the heating element fuses the strands 15402 at the openings 15404 to create a fixed loop 15414 that compresses and secures the tissue together. A slot 15416 along the length of the inner loop of the guide tube 15406, shown in Fig. 153C, allows the guide tube to be removed leaving the stitches behind. The excess length of the polymer strands can be trimmed leaving only the fixed loop / stitches.

[0350] 154A-E show one embodiment of a device 15500 configured to join and bond tissue. As shown in FIG. 154A, the device 15500 includes a sharpened hollow or tube arm 15502 shown penetrating a material or tissue 15504. The material may be ADM, mesh, membrane, etc. FIG. 154B shows the arm 15502 being used to join the material 15504 to the material to be joined 15506. In FIG. 154C, a sharpened arm 15508 (tube arm, hollow arm) penetrates the material 15506 such that the tips of the arms 15502, 15508 mate. The tips are configured to mate with each other and may be shaped to form the arms 15502, 15508 into a loop. As shown in FIG. 154D, a material such as a heated polymeric material is injected into the lumen 15510 of the arms 15502, 15508. The material cools and hardens, forming the fasteners 15512, as shown in Figure 154E. The arms are removed leaving only the fasteners in place.

[0351] 155A-E show another embodiment of a device 15600 configured to bond and join materials. FIG. 155A shows a sharp hollow fang 15602 penetrating a first material 15604 and a second material 15606. The materials may be tissue, ADM, mesh, membrane, etc. As shown in FIG. 155B, a strand 15608 (e.g., a polymer strand) advances out the end of the fang 15602. FIG. 155C shows the fang 15602 being removed, leaving only the strand 15608 in place penetrating both materials 15604, 15606. In FIG. 155D, an anchoring tube or device 15610 is shown advanced into the repair site, past the end or edge of the strand 15608. Advancement of the device 15610 may result in bonding and compression of the materials 15604, 15606. As shown in FIG. 155E, strands 15608 are fused into loops at attachment points 15612 and device 15610 is removed.

[0352] FIG. 156 illustrates one embodiment of a device 15700 configured to grasp material such as tissue (or ADM, mesh, membrane, etc.) so that a user can pull the tissue for counter-traction during various procedures (e.g., stapling). A pincer 15702 is disposed on the end of an inner tube 15704. A pincer 15706 is disposed on the end of an outer tube 15708. The tip of the pincer 15702 on the inner tube 15704 is directed toward the tip of the pincer 15706 on the outer tube 15708. The inner tube 15704 is rotated in one direction (e.g., counterclockwise in FIG. 156) to open a gap between the outer tube pincer 15706 and the inner tube pincer 15702. The pincers 15702, 15706 are placed over the desired material or tissue and the inner tube 15704 is rotated in the opposite direction (e.g., clockwise in FIG. 156) to close the gap between the outer tube pincer 15706 and the inner tube pincer 15702, causing the pincers 15702, 15706 to grip the material. The user can pull on the tubes 15704, 15708 to lift the material or tissue as needed. A surgical device (e.g., stapler or scope) can be inserted under the lumen 15710 of the inner tube 15704 to act on the material or tissue (e.g., place staples). This tissue retraction device can be made with small (micro) pincers or larger pincers. Windows can also be drilled into the sides of the tubes to provide visibility and access to the tissue and work site. This mechanism can be separate from or integrated into the stapler (or other device).

[0353] 157A-D show a device 15800 configured to grasp material (e.g., tissue, ADM, mesh, membrane, etc.) so that a user can pull the tissue for counter traction during various procedures (e.g., stapling). The pincers 15802 are positioned within a sleeve 15804 as shown in FIG. 157A. The pincers are outwardly biased (e.g., spring loaded). The pincers 15802 are positioned over the target tissue. The sleeve 15804 is advanced, moving the pincers 15802 toward each other to grasp the material as shown in FIG. 157B. The number of pincers can vary as shown in FIG. 157C (two pincers) and 157D (six pincers). Other quantities of pincers are possible (e.g., 3, 4, 5, 6, 7, 8, or more, etc.).

[0354] In this specification, when a feature or element is referred to as being "on" another feature or element, it can be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Also, those skilled in the art will understand that a reference to a structure or feature that is located "adjacent" to another feature may have portions that overlap or underlie the adjacent feature.

[0355] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the present invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise. It will be further understood that as used herein, the terms "comprises" and / or "comprising" specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0356] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description to describe the relationship of one element or feature to another element(s) or feature(s) as shown in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, an element described as "under" or "beneath" the other element or feature would then be oriented "over" the other element or feature. Thus, the exemplary term "under" may encompass both an orientation above and below. The device may be in other orientations (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, the terms "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless otherwise indicated.

[0357] In this specification, the terms "first" and "second" may be used to describe various features / elements (including steps), but these features / elements are not intended to be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, a first feature / element described below may be referred to as a second feature / element, and similarly, a second feature / element described below may be referred to as a first feature / element without departing from the teachings of the present invention.

[0358] Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprise" and variations such as "comprises" and "comprising" mean that various components may be employed in conjunction with each other in methods and articles (e.g., devices and compositions and apparatuses that include methods). For example, the term "comprising" will be understood to mean the inclusion of any described elements or steps but not the exclusion of other elements or steps.

[0359] As used in this specification and claims, including as used in the examples, unless expressly specified otherwise, all numbers may be read as if they are preceded by the word "about" or "approximately", even if the term does not explicitly appear. The phrase "about" or "approximately" may be used when describing a size and / or location to indicate that the described value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value may have a value of ±0.1% of the stated value (or numerical range), ±1% of the stated value (or numerical range), ±2% of the stated value (or numerical range), ±5% of the stated value (or numerical range), ±10% of the stated value (or numerical range), etc. Also, any numerical value provided herein should be understood to include about that value or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical ranges mentioned herein are intended to include all subranges subsumed therein. It is also understood that where a value is disclosed, "less than or equal to that value," "greater than or equal to that value," and possible ranges between the values ​​are also disclosed, as would be understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, not only "less than or equal to X" but also "greater than or equal to X" (e.g., X is a number) are disclosed. It is also understood that throughout this application, data is provided in several different formats, and this data represents the endpoints and starting points, and ranges, of any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is also understood that greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, equal to 10 and 15, and between 10 and 15 are also disclosed. It is also understood that each unit between two particular units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0360] Although various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not in other embodiments. Thus, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0361] The examples and illustrations contained herein are illustrative and not limiting, showing specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived therefrom, allowing structural and logical substitutions and changes to be made without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention may be referred to herein, individually or collectively, under the term "invention" for convenience only, and there is no intention to spontaneously limit the scope of the present application to any single invention or inventive concept when multiple inventions are in fact disclosed. Thus, although specific embodiments have been shown and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description. [Explanation of symbols]

[0362] 100 Fixed Devices 102 needle 102 104 Shaft / Fastener Reservoir 106 Handle 108 Deployment Trigger 110 Onlay Materials 112, 220 organizations 118 Zipper 200 Fastener Implant 202 First Bar 204 Second Bar 206 Connector 210 Slotted Delivery Needle 214 Shoulder 216 needles 218 Onlay Materials 222 Deflector 300 Barb 400 blades 716 Extended Wings 800 Shaft 802 Joint End 804 Rotating end 16081 Cartridge

Claims

1. 1. A stationary device, comprising: A shaft, A handle and a needle extending from the shaft, the needle including a slot extending along at least a portion of the needle; The device is configured to receive a fastener having a first bar and a second bar connected by a bar connector, the first bar being positioned within the needle and the second bar being positioned outside the needle; and A fastening device comprising a pushing member configured to push the fastener from the needle.

2. 2. The device of claim 1, further comprising a fastener positioned such that the first bar is positioned within the needle and the second bar is positioned outside the needle.

3. 10. The device of claim 1, further comprising a fastener reservoir within the shaft.

4. The device of claim 1 or 3, wherein the second bar is positioned within the shaft.

5. 5. The device of claim 1, further comprising at least one ramp near a distal end of the device, the ramp configured to redirect the second bar while the fastener is being pushed distally.

6. 6. The device of claim 1, further comprising a shoulder located a fixed or adjustable distance proximate the distal end of the needle.

7. 7. The device of claim 1, further comprising a trigger configured to deploy a fastener by engaging the push member.

8. 8. The device of claim 1, wherein the shaft comprises one or more of an articulation end and a rotation end.

9. The device of claim 1 , wherein the shaft has a bent end.

10. 10. The device of claim 1, wherein the replaceable cartridge comprises the entire shaft.

11. The device of claim 1 , wherein the replaceable cartridge comprises a distal portion of the shaft.

12. 12. A device according to any preceding claim, wherein the needle can be retracted and / or advanced relative to the shaft.

13. 13. The device of claim 1, wherein a distal portion of the shaft can be retracted and / or advanced relative to the needle.

14. 14. The device of claim 1, wherein the needle includes one or more barbs.

15. The device of claim 14 , wherein the one or more barbs are ejectable / retractable.

16. 16. The device of claim 1 , wherein the needle comprises one or more bumps.

17. 17. A device according to any preceding claim, wherein the needle comprises one or more notches.

18. 18. The device of claim 1, wherein the needle includes an enlarged region adjacent an end of the needle.

19. 19. A device according to any preceding claim, wherein the needle comprises one or more blades.

20. The device of claim 19 , wherein the one or more blades can be actuated.

21. 21. A device according to any preceding claim, wherein the device comprises one or more auxiliary needles.

22. 22. The device of claim 21, wherein the one or more auxiliary needles include one or more auxiliary needle barbs.

23. 23. The device of claim 22, wherein the one or more auxiliary needle barbs are ejectable / retractable.

24. 24. The device of claim 1, further comprising a first ramp extending from a surface proximate to the needle, the first ramp extending away from the surface and configured to lift the bar connector and the second bar above the needle when the fastener is pushed distally.

25. 25. The device of any one of claims 1 to 24, further comprising a ramp extending from a side wall, the ramp extending away from the side wall and configured to rotate the second bar when the fastener is pushed distally, such that the second bar is caused to move toward a direction generally parallel to a material to be fastened.

26. 26. The device of claim 1 , further comprising a surface or sidewall configured to maintain the rotated position of the second bar.

27. 27. The device of any one of claims 1 to 26, wherein at least a portion of the needle slot is helical.

28. 28. The device of claim 1, further comprising a support configured to provide counter-traction to the material to be secured while the needle is withdrawn from the material.

29. 29. The device of any one of claims 1 to 28, wherein the needle is bent or curved.

30. 30. The device of any one of claims 1-29, wherein the width of the needle slot is greater than the width of the bar connector of the fastener.

31. 31. The device of any one of claims 1 to 30, wherein edges of the needle slot include rounded, broken, ground, or other non-sharp edge configurations.

32. 32. The device of any one of claims 1 to 31, wherein the size of the inner diameter of the needle and the size of the outer diameter of the needle are selected to provide a passageway large enough through the materials to be bonded such that the bar and bar connector of the fastener pass through the materials to be bonded with minimal force.

33. 33. The device of claim 32, wherein the inner and outer diameters of the needle are sized to provide a minimal insertion force in the material to be bonded.

34. 34. The device of claim 1, wherein a bevel angle of the needle tip is configured to provide minimal insertion force into the material to be bonded.

35. 35. The device of claim 34, wherein the bevel angle of the needle tip is configured to withstand repeated use.

36. 36. The device of any one of claims 1 to 35, wherein the length of the needle is selected to minimize trauma to tissue and structures surrounding the repair site.

37. 37. The device of any one of claims 1 to 36, wherein the length of the needle is selected to be suitable for placing one or more ends of the fastener within tissue.

38. 1. A tissue fastener configured for attaching tissue to another material or tissue, comprising: A first bar; A second bar; a connector coupling the first bar to the second bar, the connector configured to have sufficient strength to withstand deployment of the first bar.

39. 40. The tissue fastener of claim 38, wherein at least one of the first and second bars has one or more blunt ends.

40. 40. The tissue fastener of any one of claims 38 and 39, wherein at least one of a height, length, or width of the second bar differs from the corresponding dimension of the first bar.

41. 41. The tissue fastener of any one of claims 38-40, wherein the second bar is configured to flex.

42. 42. The tissue fastener of any one of claims 38-41, wherein at least one of the first bar and the second bar is curved.

43. 43. The tissue fastener of any one of claims 38 to 42, wherein at least one of the second bar and the first bar includes downward and / or upward projections.

44. 44. The tissue fastener of any one of claims 38-43, wherein at least one of the first bar, the second bar, and the connector bar includes one or more barbs.

45. 45. The tissue fastener of any one of claims 38-44, wherein at least one of the first bar and the second bar includes an extending wing.

46. 46. ​​The tissue fastener of any one of claims 38-45, wherein at least one of the first bar and the second bar comprises curling arms.

47. 47. The tissue fastener of any one of claims 38-46, wherein the first bar has a circular cross-section.

48. 48. The tissue fastener of any one of claims 38-47, wherein at least one of the first bar, the second bar, and the connector has a circular, oval, square, or rectangular cross-section.

49. 49. The tissue fastener of any one of claims 38 to 48, wherein the connector has a thickness or diameter that is less than a thickness or diameter of the first bar or the second bar.

50. 50. The tissue fastener according to any one of claims 38 to 49, wherein the connector material is stretched.

51. 51. The tissue fastener of any one of claims 38-50, wherein the first bar and the second bar extend in different directions.

52. 52. The tissue fastener of any one of claims 38-51, wherein at least one of the first bar and the second bar includes an end feature.

53. 53. The tissue fastener of any one of claims 38-52, wherein at least one of the first bar and the second bar comprises a bend.

54. 54. The tissue fastener of any one of claims 38 to 53, wherein the length of the connector is adjustable.

55. 55. The tissue fastener of any one of claims 38-54, wherein the connector is oriented at an angle other than perpendicular to the first bar and the second bar.

56. 56. The tissue fastener of any one of claims 38-55, wherein at least one of the first bar, the second bar, and the connector bar comprises one or more materials.

57. 57. The tissue fastener of any one of claims 38-56, wherein the connector bar is bent or curved.

58. 58. The tissue fastener of any one of claims 38 to 57, wherein the length of the tissue fastener is sized to embed one or more ends of the fastener within tissue.

59. 60. The tissue fastener of claim 58, wherein the one or more ends of the fastener that are embedded in tissue include one or more features configured to resist withdrawal from tissue.

60. 60. The tissue fastener of any one of claims 38-59, wherein one or more ends of the fastener not embedded in tissue include one or more features configured to retain an onlay material.

61. 1. A method for securing an onlay material to tissue, comprising: piercing the onlay material and tissue with a slotted needle, the needle forming part of a fixation device; advancing a fastener with a first bar disposed within the needle, the first bar being connected to the second bar by a connector.

62. 62. The method of claim 61, further comprising controlling the needle insertion depth using a stop.

63. 63. The method of any one of claims 60-62, further comprising the steps of withdrawing the needle from tissue from a first location within tissue, positioning or tensioning material on the needle, and puncturing the tissue at a second location.

64. 64. The method of any one of claims 61 to 63, further comprising the step of redirecting the second bar.

65. 62. The method of claim 61, wherein the step of advancing the fastener comprises actuating a trigger on the fixturing device.

66. 66. The method of any one of claims 61-65, further comprising the step of maintaining / stabilizing the position of the needle within the onlay material and tissue while deploying the fasteners.

67. 67. The method of any one of claims 61 to 66, wherein redirecting the second bar comprises using one or more lamps positioned near a distal end of the device.

68. 68. The method of any one of claims 61 to 67, wherein redirecting the second bar comprises moving the second bar to avoid engagement of the needle with the slot.

69. 69. The method of any one of claims 61 to 68, wherein redirecting the second bar comprises moving the second bar toward a position generally parallel to a surface of the onlay material.

70. 70. The method of any one of claims 61 to 69, wherein the step of redirecting the second bar comprises rotating the second bar such that the second bar moves in a direction that is generally parallel to a surface of the onlay material.

71. 71. The method of any one of claims 61-70, further comprising the step of deploying the first bar within the tissue.

72. 72. The method of any one of claims 61 to 71, further comprising the step of deploying a second bar to rest adjacent the onlay material.

73. 73. The method of any one of claims 61-72, further comprising the step of deploying the fasteners such that the tissue and onlay material are joined and secured by the fasteners.

74. 74. The method of any one of claims 61-73, further comprising the step of withdrawing the needle from the onlay material and tissue after the fasteners have been deployed.

75. 75. The method of any one of claims 61-74, further comprising supporting the onlay material and tissue during withdrawal of the needle.

76. 76. The method of any one of claims 61-75, further comprising the step of holding the onlay material and tissue away from underlying structures while the fasteners are deployed.

77. 1. A stationary device, comprising: two needles extending from the device, each needle having a slot extending along at least a portion of the needle; at least one fastener having a first bar and a second bar connected by a bar connector, the first bar being disposed within one needle and the second bar being disposed within the other needle; a push member configured to push the bar distally inward and outward of the needle.

78. 1. A method for securing an onlay material to tissue, comprising: piercing the onlay material and tissue with two needles, each needle having a slot, the needles forming part of a fixation device; advancing a fastener having a first bar disposed within one needle and a second bar disposed within the other needle, the first bar being connected to the second bar by a connector; and deploying the first and second bars into the tissue such that the tissue and onlay material are joined and secured by the fasteners.

79. 1. A stationary device, comprising: a needle extending from the device, the needle having a slot extending along at least a portion of the needle; at least one fastener having a first bar and a second bar connected by a bar connector, the first bar and the second bar being disposed within the needle; a push member configured to push the bar distally inward and outward of the needle.

80. 1. A method for securing an onlay material to tissue, comprising: piercing the onlay material and tissue with a slotted needle, the needle forming part of a fixation device; advancing a fastener having a first bar and a second bar disposed within the needle, the first bar being connected to the second bar by a connector; deploying the first bar in tissue at a first location; removing the needle from the onlay material and tissue at the first location; and deploying the second bar into tissue at a second location such that the tissue and onlay material are joined and secured by the fasteners.

81. a first jaw having a slotted needle; a second jaw opposing the first jaw; A fixed device comprising:

82. 82. The device of claim 81, wherein the second jaw comprises an opening configured to receive the needle when the first jaw and the second jaw are moved toward one another.

83. 1. A method for fixing tissue or material, comprising: piercing a first tissue or material with a slotted needle, the needle forming a part of a fixation device, and piercing the first tissue or material includes moving opposing jaws of the fixation device toward each other; piercing a second tissue or material with the needle, wherein joining the first and second tissues or materials and piercing the second tissue or material includes moving opposing jaws toward one another; advancing a fastener with a first bar disposed within the needle, the first bar being connected to a second bar by a connector.

84. 84. The method of claim 83, further comprising deploying the first bar through the tissue or material such that the first bar rests on a surface of one of the tissues or materials and the second bar rests on a surface of another of the other tissues or materials.

85. 85. The method of any one of claims 83 and 84, further comprising the step of deploying the first bar into tissue while the second bar rests on another surface of the other tissue or material.

86. 86. The method of any one of claims 82-85, further comprising the step of deploying the fasteners such that the tissue or material is joined and secured by the fasteners.

87. 1. A method for fixing tissue or material, comprising: piercing a first tissue or material with a first needle having a slot, said first needle forming a part of said fixation device; piercing a second tissue or material with a second needle having a slot, said second needle forming part of said fixation device; joining the first and second tissues or materials, where joining the tissues or materials includes displacing the first tissue or material with the first needle and piercing the second tissue or material with the second needle; advancing a fastener having a first bar disposed within the first needle and a second bar disposed within the second needle, the first bar being connected to the second bar by a connector; and deploying the first bar and the second bar through the tissue or material such that the tissue or material is joined and secured together by the fasteners.

88. 1. A method for securing an onlay material to tissue, comprising: placing the onlay material adjacent to the tissue; embedding a first bar of fasteners into the tissue; and positioning a second bar of the fastener adjacent to the onlay material, thereby securing the onlay material to the tissue; The method, wherein the fastener comprises a connector that joins the first bar and the second bar.

89. 1. A method for fastening a material to tissue, comprising: placing the material adjacent to the tissue; placing a first bar of a fastener adjacent to the tissue; and placing a second bar of the fastener adjacent to the material, thereby securing the material to the tissue. The fastener includes a connector that connects the first bar and the second bar. method.

90. 1. A surgical device for joining materials, comprising: a head portion, the head portion comprising: first and second fangs including a sharp tip and a hollow or partially hollow interior; a deployment member configured to expel staples from the head portion.

91. 91. The device of claim 90, wherein the first fang is configured to receive a first leg of a staple and the second fang is configured to receive a second leg of a staple.

92. a retractable backstop configured to be actuated toward the first and second fangs, the retractable backstop comprising: a first hole or partial perimeter (such as a slot) configured to receive the first fang; a second hole or partial perimeter (such as a slot) configured to receive the second fang; and a joint connecting the head portion and the retractable backstop configured to allow the retractable backstop to actuate toward the tusk; 92. The device of any one of claims 90 and 91, comprising:

93. 93. The device of any one of claims 90-92, wherein at least one of the first and second fangs includes an open side configured to allow passage of a staple leg.

94. 94. A device as claimed in any one of claims 90 to 93, wherein the open side comprises a slot.

95. 95. The device of any one of claims 90 to 94, wherein the deployment member comprises two outer dies configured to be moved downwardly towards a central die.

96. 96. The device of any one of claims 90 to 95, wherein the deployment member comprises a central die and two outer dies configured to be moved downwardly towards another central die.

97. 97. The device of any one of claims 90 to 96, wherein at least one of the first and second fangs comprises an angled or sharp tip.

98. 98. A device according to any one of claims 90 to 97, further comprising the fangs attached to a retractable shuttle.

99. 99. The device of any one of claims 90-98, further comprising a staple disposed within a retractable shuttle having a first staple leg disposed within the first fang and a second staple leg disposed within the second fang.

100. 100. A device as claimed in any one of claims 98 and 99, wherein the retractable shuttle is configured to retract the fangs.

101. 101. The device of any one of claims 90-100, wherein the head portion is configured to hold a plurality of staples.

102. 102. The device of any one of claims 90-101, wherein the head portion comprises a staple cartridge configured to hold a plurality of staples.

103. 103. A device according to any one of claims 90 to 102, wherein the head portion is at the end of a shaft.

104. 104. A device according to any one of claims 90 to 103, wherein the head portion is configured to rotate.

105. 105. A device according to any one of claims 90 to 104, wherein the head portion is configured to articulate.

106. 106. A device as claimed in any one of claims 90 to 105, wherein one or more fangs are provided with attached blades.

107. 107. A device as claimed in any one of claims 90 to 106, wherein the one or more fangs are provided with actuatable blades.

108. 108. The device of claim 107, wherein the blade tapers from the base of the fang to the end of the fang.

109. 109. A device according to any one of claims 90 to 108, wherein the one or more fangs are configured to articulate.

110. 110. The device of any one of claims 90-109, wherein the one or more fangs include internal features configured to guide the staples into a closed position.

111. 111. The device of any one of claims 90 to 110, wherein the one or more fangs are adjustable.

112. 112. The device of any one of claims 90 to 111, wherein the one or more fangs include a screw.

113. 113. A device as described in any one of claims 90 to 112, wherein the one or more fangs include at least one of a barb, a notch, or a neck.

114. 114. A device according to any one of claims 90 to 113, wherein the fangs are replaceable.

115. 115. A device as claimed in any one of claims 90 to 114, wherein the fangs are configured to evert downwardly from the head portion.

116. 116. A device as claimed in any one of claims 90 to 115, wherein the fangs are covered by an actuatable shroud.

117. 117. A device as claimed in any one of claims 90 to 116, wherein the fangs are covered by an actuatable backstop.

118. 1. A surgical device for joining materials comprising a head portion, Fangs and a deployment member configured to expel staples from the head portion.

119. The device of claim 118, wherein the fangs are configured to receive the staple legs.

120. and a retractable backstop configured to be actuated toward the tusk, the retractable backstop comprising: a hole or partial perimeter (such as a slot) configured to receive the fang; a joint connecting the head portion and the retractable backstop and configured to allow the retractable backstop to actuate toward the tusk; 120. The device of any one of claims 118 and 119, comprising:

121. 121. The device of any one of claims 118 to 120, wherein the fangs have an open side shaped to allow passage of a staple leg.

122. 122. A device according to any one of claims 118 to 121, further comprising any of the features according to claims 91 to 115.

123. 1. A method for bonding materials comprising the steps of: piercing the first material and the second material with a fang, said fang forming a part of a fixation device; and deploying a staple through the fang.

124. 124. The method of claim 123, further comprising piercing only the first material with the fang.

125. 125. The method of any one of claims 123 and 124, further comprising the step of piercing only the first material with the fang by positioning the first material between the fang and the backstop and moving the backstop towards the fang, thereby forcing the first material against the fang.

126. 126. The method of any one of claims 123 to 125, further comprising the step of moving the backstop away from the fangs to retract the backstop.

127. 127. The method of any one of claims 123 to 126, further comprising using a fang having the first material attached thereto to position the first material onto the second material.

128. 128. The method of any one of claims 123 to 127, further comprising piercing the second material with the fangs.

129. 129. The method of any one of claims 123-128, further comprising the step of retracting the first and second materials using one or more of the fangs or partially deployed staples.

130. 130. The method of any one of claims 123-129, further comprising deploying the staple to bond the first material to the second material.

131. 131. The method of any one of claims 123 to 130, further comprising the step of removing the fang from the first and second materials.

132. 132. The method of any one of claims 123-131, further comprising the step of deploying the staples by expelling the staples from the head portion.

133. 133. The method of any one of claims 123-132, further comprising the step of deploying the staples by forming the staples around a central die.

134. 134. The method of any one of claims 123-133, further comprising the step of deploying the staples by forming the staples around a central die using an outer die.

135. 135. The method of any one of claims 123 to 134, wherein the first material comprises an onlay material.

136. 136. The method of any one of claims 123 to 135, wherein the second material comprises tissue.

137. 1. A surgical device for joining materials, comprising: a head portion having a first staple exit port and a second staple exit port configured to permit passage of the first and second staple legs; a deployment member configured to expel staples from the head portion.

138. a retractable backstop configured to be actuated toward the staple legs, the retractable backstop comprising: a first hole or partial perimeter (e.g., a slot) configured to receive the first staple leg; a second hole or partial perimeter (such as a slot) configured to receive the second staple leg; 138. The device of claim 137, comprising: a joint connecting the head portion and the retractable backstop and configured to allow the retractable backstop to actuate toward the staple legs.

139. 139. The device of any one of claims 137 and 138, wherein the deployment member comprises two outer dies configured to be moved downwardly toward a single central die.

140. 140. A device as claimed in any one of claims 137 to 139, wherein the deployment member comprises a central die and two outer dies configured to be moved downwardly towards another central die.

141. 141. The device of any one of claims 137-140, wherein the first and second staple legs comprise angled or sharp tips.

142. 142. The device of any one of claims 137-141, further comprising a staple positioned within the retractable shuttle.

143. 143. The device of any one of claims 137-142, further comprising a staple disposed within a retractable shuttle having the first staple leg disposed at or within the first staple exit and the second staple leg disposed at or within the second staple exit.

144. 144. The device of any one of claims 137-143, wherein the retractable shuttle is configured to retract the staple legs.

145. 145. The device of any one of claims 137-144, wherein the head portion is configured to hold a plurality of staples.

146. 146. The device of any one of claims 137-145, wherein the head portion comprises a staple cartridge configured to hold a plurality of staples.

147. 147. A device according to any one of claims 137 to 146, wherein the head portion is at one end of a shaft.

148. 148. A device according to any one of claims 137 to 147, wherein the head portion is configured to rotate.

149. 149. The device of any one of claims 137 to 148, wherein the head portion is configured to articulate.

150. 150. A device according to any one of claims 137 to 149, wherein the head portion comprises one or more attached blades.

151. 151. A device as claimed in any one of claims 137 to 150, wherein the head portion comprises one or more actuatable blades.

152. 152. The device of any one of claims 150-151, wherein the blades taper from a base of the head portion toward the ends of the staple legs.

153. 153. The device of any one of claims 137-152, wherein the staple legs are configured to flip downwardly from the head.

154. 154. The device of any one of claims 137-153, wherein the staple legs are covered by an actuatable shroud.

155. 155. The device of any one of claims 137-154, wherein the staple legs are covered by an actuatable backstop.

156. 1. A surgical device for joining materials, comprising: a first arm, the first arm comprising: a channel configured to hold a staple; an opening in the channel to allow passage of the staple; a push member configured to advance the staple out of the channel opening; a second arm with a hole or a portion of the perimeter (such as a slot); a hinge connecting the first arm and the second arm and configured to allow the first arm and the second arm to move away from and toward each other.

157. 157. The device of claim 156, wherein the first arm comprises a stop configured to interact with a shaped feature of the staple to inhibit movement of the staple.

158. 158. A device as claimed in any one of claims 156 and 157, wherein the stop is configured to disengage.

159. 159. The device of any one of claims 156-158, wherein the first arm comprises a first forming element configured to form the staple.

160. 160. The device of any one of claims 156-159, wherein the first arm comprises a movable second forming element configured to advance and cooperate with the first forming element to form the staple.

161. 161. The device of any one of claims 156 to 160, wherein the second arm having a hole or a portion of a periphery (such as a slot) moves toward the first arm to receive the piercing end of the staple.

162. 162. The device of any one of claims 156-161, wherein the first arm comprises a push member configured to push the staple.

163. 163. The device of any one of claims 156-162, wherein the first arm comprises a push member configured to push the staple through a forming element to form the staple.

164. 164. The device of any one of claims 156-163, wherein the staple has a first preformed end configured to pierce the material to be bonded.

165. 165. The device of any one of claims 156-164, wherein the staple has a second preformed end configured to interact with the stop to retain the material to be bonded.

166. 1. A method for bonding materials comprising the steps of: moving the opposing arms or jaws toward one another to pierce one end of the staple into the material to be joined; clamping the material to be joined between the opposing arms or jaws; and c. deploying and forming the staple to secure the materials to be bonded.

167. 167. The method of claim 166, further comprising the step of advancing a first end of the staple through a channel opening of the first arm or jaw.

168. 168. The method of any one of claims 166 and 167, further comprising the step of advancing a second forming element to pierce the material to be bonded to form the first end of the staple.

169. 169. The method of any one of claims 166-168, further comprising the step of preventing movement of the staple during advancement of the second forming element using a stop that interacts with a formed feature of the staple.

170. 170. The method of any one of claims 166 to 169, further comprising the step of positioning a first of the materials between the opposing arms or jaws.

171. 171. The method of claim 170, further comprising the step of moving the opposing arms or jaws toward one another to puncture the first material on the staple.

172. 172. The method of any one of claims 166 to 171, further comprising the step of moving the opposing arms away from each other.

173. 173. The method of any one of claims 166 to 172, further comprising the step of positioning a second one of the materials between the opposing arms or jaws.

174. 174. The method of claim 173, further comprising the step of moving the opposing arms or jaws toward one another to puncture the second material on the staple.

175. 175. The method of any one of claims 166 to 174, further comprising the step of clamping the material to be joined between the opposing arms or jaws.

176. 176. The method of any one of claims 166-175, further comprising pushing the staples through one or more forming members to completely form the staples closed and secure the materials together.

177. 177. The method of any one of claims 166-176, further comprising the step of releasing the staple from the first arm or jaw to hold the materials secured together by the staple.

178. 178. The method of any one of claims 166 to 177, further comprising the step of moving the opposing arms or jaws away from each other to release the material.

179. 1. A tissue fastener or staple configured for attaching tissue to another material or tissue, comprising: A first leg; A second leg; and a span connecting said first leg and said second leg.

180. 180. The tissue fastener of claim 179, wherein the first leg and the second leg are approximately perpendicular to the span.

181. 180. The tissue fastener of claim 179, wherein the first leg and the second leg are at an acute angle to the span.

182. 180. The tissue fastener of claim 179, wherein the bend between the span and the leg comprises a bend radius of about 0.005 to 0.020 inches.

183. 180. The tissue fastener of claim 179, wherein the bend between the span and the leg comprises a bend radius of about 0.021 to 0.100 inches.

184. 184. The tissue fastener of any one of claims 179-183, wherein the ends of the closed staple legs lie relatively in the same plane above and below each other.

185. 185. The tissue fastener of any one of claims 179-184, wherein the spans are configured with bumps or humps on outer surfaces of the spans.

186. 186. The tissue fastener of any one of claims 179-185, wherein the fastener comprises a metal.

187. 187. The tissue fastener of any one of claims 179-186, wherein the fastener comprises a polymer.

188. 188. A tissue fastener according to any one of claims 179 to 187, wherein the fastener comprises an absorbent material.

189. A tissue fastener or staple configured for joining tissue and / or materials. The staple is one or more preformed bends at a first end of the staple; a sharp tip on a second end of the staple.

190. 190. The tissue fastener of claim 189, wherein the one or more preformed bends on the first end of the staple are configured to retain materials to be bonded.

191. 191. The tissue fastener of any one of claims 189 and 190, wherein a sharp tip at the second end of the staple is configured to pierce the material to be bonded.

192. 192. The tissue fastener of any one of claims 179-191, wherein the second end of the staple includes one or more preformed bends.

193. 193. The tissue fastener of any one of claims 189-192, wherein the tissue fastener comprises a metal.

194. 194. The tissue fastener of any one of claims 189-193, wherein the tissue fastener comprises a polymer.

195. 195. The tissue fastener of any one of claims 189-194, wherein the tissue fastener comprises an absorbent material.

196. 1. A tissue fastener or staple configured for joining tissue and / or materials, said staple comprising: one or more heads at a first end of the staple; a sharp tip on a second end of said staple.

197. The tissue fastener of claim 196, wherein the tissue fastener comprises a metal.

198. 198. The tissue fastener of any one of claims 196 and 197, wherein the tissue fastener comprises a polymer.

199. 200. The tissue fastener of any one of claims 196-198, wherein the tissue fastener comprises an absorbent material.

200. 1. A surgical device for joining materials, comprising: a movable housing including a track; a push member configured to be advanced along the track; a first linkage connected to the housing and a first articulation fang; a second linkage connected to the housing and a second articulation fang; A surgical device comprising:

201. 201. The device of claim 200, wherein the fangs have sharp tips configured to pierce the material to be bonded.

202. 202. A device as claimed in any one of claims 200 and 201, wherein the articulating fangs are configured to rotate the tips of the fangs towards each other.

203. 203. The device of any one of claims 200-202, wherein the fangs have internal grooves configured to guide a staple or fastener to be formed.

204. 204. The device of any one of claims 200-203, wherein the fangs have internal grooves configured to form staples.

205. 205. The device of any one of claims 200-204, wherein the fangs have internal grooves configured to shield the staples from surrounding tissue and body structures.

206. 206. The device of any one of claims 200-205, wherein the push member is configured with end features for pushing a staple or fastener to be formed.

207. 207. A device according to any one of claims 200 to 206, wherein the articular fang is disposed at an end of a shaft.

208. 1. A surgical device for joining materials, comprising: The first Joe, and a second jaw, wherein the first jaw and / or the second jaw are configured to be actuated toward each other; a hook disposed within the first jaw, an end of the hook extending toward the second jaw, the end of the hook configured to be deployed from the first jaw; one or more staples positioned within the second jaw and configured to be deployed in a direction toward the first jaw; A surgical device comprising:

209. 209. The device of claim 208, wherein the second jaw includes a window, the window having a frame at least partially surrounding the window on a side of the second jaw facing the first jaw.

210. 210. A device as claimed in any one of claims 208 and 209, wherein the hook is rigid.

211. 211. A device according to any one of claims 208 to 210, wherein the hook is flexible.

212. 1. A method for bonding materials comprising the steps of: clamping a first material between a first jaw and a second jaw of the device; deploying a hook from the first jaw to capture and stabilize the first material in the first jaw; unclamping the first jaw and the second jaw; positioning a second material adjacent to the first material and between the first jaw and the second jaw; clamping the material between the first jaw and the second jaw; deploying staples or fasteners to join the first material and the second material; The method includes:

213. 213. The method of claim 212, wherein the step of deploying staples or fasteners comprises deploying staples or fasteners from the second jaw.

214. 214. The method of any one of claims 212 and 213, wherein the step of deploying a staple or fastener comprises deploying a staple or fastener from the first jaw.

215. 215. The method of any one of claims 212-214, further comprising the step of retracting the hook from the first material.

216. 1. A device for stabilizing a material, comprising: a first jaw having one or more piercing elements; and a second jaw having one or more openings or recesses, wherein the first jaw and the second jaw are configured to be moved toward one another.

217. 217. The device of claim 216, wherein the one or more puncture elements disposed on the first jaw and extending toward the second jaw are configured to interact with the one or more openings or recesses on the second jaw when the first jaw and the second jaw are moved sufficiently toward one another.

218. A device as described in any one of claims 216 and 217, wherein the one or more puncture elements disposed on the first jaw and extending toward the second jaw are configured to enter the one or more openings or recesses on the second jaw when the first jaw and the second jaw are moved sufficiently toward one another.

219. 1. A method for stabilizing a material to be bonded, comprising the steps of: Positioning a first material between a first jaw and a second jaw of the device; moving the first jaw and the second jaw toward each other such that one or more piercing elements disposed in the first jaw pierce the first material; separating the first jaw and the second jaw; disposing a second material between the first jaw and the second jaw; moving the first jaw and the second jaw toward one another such that one or more piercing elements disposed on the first jaw pierce the second material; The method includes:

220. 220. The method of claim 219, further comprising the step of moving the first jaw and the second jaw toward each other such that the one or more piercing elements disposed on the first jaw enter the one or more openings or recesses on the second jaw to pierce material.

221. 221. The method of any one of claims 219 and 220, further comprising the step of moving or retracting the device to move or retract the first and second materials.

222. 222. The method of any one of claims 219-221, further comprising the step of joining a stapling mechanism to the stabilized material.

223. 223. The method of any one of claims 219-222, further comprising stapling the first material and the second material together.

224. 224. The method of any one of claims 219-223, further comprising the step of joining the first material and the second material using other joining means such as sutures, tacks, fasteners, adhesives, or the like.

225. 1. A device for stabilizing a material, comprising: a first jaw having a sharp tip; and a second jaw having a sharp tip, wherein the first jaw and / or the second jaw are configured to move toward each other.

226. 1. A method for stabilizing a material to be bound, comprising the steps of: positioning the first and second materials between first and second jaws of a device, the first and second jaws each having a sharp tip; moving the first jaw and the second jaw toward each other such that the sharp tip pierces the first material; The method includes:

227. 227. The method of claim 226, further comprising the steps of separating the first jaw and the second jaw while holding the first material on a sharp tip, and moving the first and second jaws toward each other so that the sharp tip pierces the second material.

228. 228. The method of any one of claims 226 and 227, further comprising the step of moving or retracting the device to increase or retract the first and second materials.

229. 229. The method of any one of claims 226-228, further comprising the step of joining a stapling mechanism to the stabilized material.

230. 230. The method of any one of claims 226-229, further comprising the step of joining the first material and the second material using other joining means, such as sutures, tacks, fasteners, adhesives, or the like.

231. 231. The method of any one of claims 226-230, further comprising the step of stapling the first material to the second material.

232. 1. A surgical device for joining materials, comprising: A long, slender shaft and a curved staple positioned at a distal end of the elongate shaft; A surgical device comprising:

233. The device of claim 232, wherein the staples are positioned in a plane perpendicular to the elongate shaft.

234. 234. The device of any one of claims 232 and 233, wherein the staples are positioned in a plane oriented at an angle other than perpendicular to the elongate shaft.

235. 235. The device of any one of claims 232-234, wherein a second arm or shaft has a slot or opening at its end configured to support the material and receive an end of the staple.

236. 236. The device of any one of claims 232-235, wherein the second arm or shaft is configured to actuate or rotate to form or close the staple.

237. 1. A method for bonding materials comprising the steps of: advancing a device comprising an elongate shaft and a curved staple positioned at a distal end of the elongate shaft, the staple being disposed in a plane perpendicular to the elongate shaft; positioning the first material over a second material; rotating the elongate shaft such that the penetrating ends of the curved staples penetrate the first material and the second material; closing the staple; The method includes:

238. 238. The method of claim 237, wherein an edge of the first material is bonded to the second material.

239. The method of any one of claims 237 and 238, further comprising positioning a second arm or shaft including a slot or opening at an end thereof to support the material and receive the piercing end of the staple.

240. 240. The method of any one of claims 237-239, further comprising the step of actuating or rotating the second arm or shaft to form or close the staple.

241. 241. The method of any one of claims 237-240, further comprising the step of releasing the staple from the device.

242. 242. The method of any one of claims 237-241, further comprising the step of actuating or rotating the elongate shaft to form or close the staple.

243. 243. The method of any one of claims 237 to 242, wherein at least one of the first and second materials comprises ADM.

244. 1. A surgical device for joining materials, comprising: a first elongate shaft configured to hold a first leg of a staple; and a second elongated shaft configured to hold a second leg of the staple, wherein the first and second elongated shafts are positioned adjacent to one another and substantially parallel, and wherein rotation of the elongated shafts causes the staple legs to move toward one another.

245. The device of claim 244, wherein the first and second staple legs are curved toward each other.

246. 1. A method for bonding materials comprising the steps of: advancing a device including a first elongate shaft holding a first leg of a staple and a second elongate shaft holding a second leg of the staple; Positioning a first material over a second material; and rotating the first and second elongate shafts relative to one another such that the first and second staple legs pierce the first and second materials to close the staple.

247. 247. The method of claim 246, further comprising the step of releasing the staple from the device.

248. 248. The method of any one of claims 246 and 247, wherein at least one of the first and second materials comprises ADM.

249. 1. A surgical device for joining materials, comprising: a first jaw configured to hold a first end of a staple, the first end of the staple including a preformed feature and a second end configured to pierce a material; A surgical device comprising a second jaw with a slot or opening, the first jaw and the second jaw configured to move toward one another.

250. 250. The device of claim 249, wherein the preformed feature on the staple comprises a loop or hook shape.

251. The device of any one of claims 249 and 250, wherein the slot or opening in the second jaw is configured to receive the second end of the staple when the first jaw and the second jaw are moved toward one another.

252. 252. The device of any one of claims 249-251, wherein the second jaw is configured to actuate or rotate to form or close the staple.

253. 253. A device according to any one of claims 249 to 252, wherein the second jaw is advanceable and retractable relative to the first jaw.

254. 254. The device of any one of claims 249-253, wherein the second jaw comprises an anvil.

255. 255. The device of claim 254, wherein the first jaw includes an actuator configured to advance the staples into the anvil on the second jaw.

256. 256. The device of any one of claims 249-255, wherein the second end of the staple comprises a bend.

257. 257. The device of any one of claims 249-256, wherein the first jaw comprises a piercing shroud or fangs configured to cover the staple.

258. 1. A method for bonding materials comprising the steps of: advancing a device with a first jaw and a second jaw, the first jaw holding a first end of a staple with a preformed feature; Positioning a first material between the first jaw and the second jaw; moving the first jaw and the second jaw toward each other such that a second end of the staple pierces the first material and enters a slot or opening in the second jaw; moving the first jaw and the second jaw away from each other; disposing a second material between the first jaw and the second jaw; moving the first and second jaws toward one another such that the second ends of the staples pierce the second material; The method includes:

259. 259. The method of claim 258, further comprising the step of transferring the first material to the preformed feature on the staple.

260. 260. The method of any one of claims 258 and 259, further comprising the step of moving or retracting the device to move or retract the first and second materials.

261. 261. The method of any one of claims 258-260, further comprising the step of actuating or rotating the second jaw to form or close the staple.

262. 262. The method of any one of claims 258-261, further comprising the step of sliding the second jaw to align the staple tip with an anvil on the second jaw prior to positioning the second material.

263. 263. The method of any one of claims 258-262, further comprising the step of moving the jaws toward each other such that the second ends of the staples pierce the second material and enter the anvil to curl, form or close the staples.

264. 264. The method of any one of claims 258-263, further comprising the step of releasing the staple from the device.

265. 1. A staple adapted for use with any of the devices or methods disclosed herein, comprising: The central part and a first leg extending from the first end of the central portion at a first bend; a second leg extending from the second end of the central portion at a second bend; The first bent portion and the second bent portion each include a hump.

266. 1. A staple adapted for use with any of the devices or methods disclosed herein, comprising: The central part and a first leg extending from a first end of the central portion at a first intersection; a second leg extending from a second end of the central portion at a second intersection; The central portion includes at least one bump adjacent the intersection.

267. 1. A device for bonding materials, comprising: a first arm having a first fang and a first hole; a second arm having a second fang and a second hole, the first arm connected to the second arm at a joint, the first arm and the second arm configured to rotate relative to one another about the joint, such that upon rotation, the first fang is configured to enter the second hole and the second fang is configured to enter the first hole.

268. 268. The device of claim 267, wherein the fangs include one or more of a notch, barb, or neck, etc., for retaining the first material on the fangs.

269. 269. A device as described in any one of claims 267 and 268, wherein the fang includes a lubricious coating to enable the opposing fang to be detached from the first material.

270. 1. A method for bonding materials comprising the steps of: advancing a device comprising a first arm including a first fang and a first hole, and a second arm including a second fang and a second hole, the first arm and the second arm being connected at a joint and configured to rotate about the joint; positioning the device over a first material, the device being in an open position; piercing the first material with the first fang and the second fang; rotating the first arm and the second arm about the junction such that the first fang enters the second hole and the second fang enters the first hole; rotating the first arm and the second arm away from each other; positioning the device and the attached first material over a second material; piercing the second material with the first and second fangs; The method includes:

271. 271. The method of claim 270, further comprising the step of deploying a staple to join the first and second materials.

272. 272. The method of any one of claims 270 and 271, further comprising the step of moving or retracting the device to move or retract the first and second materials.

273. 1. A device for bonding materials, comprising: a carrier configured to extend from a head, the head configured to deploy staples; and sharp elements configured to extend from the carrier, wherein tips of the sharp elements are configured to move towards each other to grasp the target material, and wherein the carrier is configured to retract with the sharp elements extended to join the head to the target material.

274. 274. The device of claim 273, wherein the tips of the sharp elements are configured to overlap each other to grasp and / or pierce the target material.

275. 275. A device according to any one of claims 273 and 274, wherein the sharpened element is configured to have a surface that prevents the staple ends from protruding beyond the sharpened element.

276. A prosthetic material with a plurality or array of holes.

277. 277. The device of claim 276, wherein the plurality or array of holes are configured to a size to allow staples or fasteners, or portions of staples or fasteners, to pass through the material.

278. 1. A device for bonding material to bone, comprising: A main body with a mechanism for fixing to the bone, a wire extending from the body, the wire forming an exposed end of the wire; A device with.

279. The device of claim 278, wherein the exposed end of the wire comprises a tip.

280. The device of any one of claims 278 and 279, wherein the wire is configured to bend to hold material or tissue.

281. 1. A method for bonding materials comprising the steps of: inserting into the bone one or more devices for bonding the material to the bone, the devices comprising a body with features for fastening to the bone and wires extending from the body; piercing the one or more materials that bond to bone with the wire; shaping or closing the wire to secure the one or more materials to bone; The method includes:

282. 1. A device for bonding materials, comprising: a fastener or staple in the form of a loop with at least one sharp end; and a shaft configured to expand the loops of one or more staples, the shaft being in an inner diameter of the loops of the one or more staples and rotating and pushing the ends of the one or more staples.

283. 283. The device of claim 282, wherein the staples located at the ends of the shaft are configured to pierce the materials to be bonded with their sharp ends when the staples are rotated by the shaft.

284. A device described in any one of claims 282 and 283, wherein the diameter of the staple loop returns or contracts to secure the materials to be bonded.

285. 1. A device for joining and stabilizing materials, comprising one or more rotors configured to grip a material, the rotors rotating in opposite directions to draw the material between the rotors.

286. 1. A device for joining materials, comprising:

1. A device comprising: a polymeric strand having a series of openings configured to receive ends of the polymeric strand and configured to melt and fuse joints between the openings and the strand that passes through the openings to form fixation loops.

287. Further comprising a guide tube; the guide tube having a tip configured to pierce the material to be bonded and form a loop shape; a slot running a length or a portion of the length of the tube; 287. The device of claim 286, wherein the slotted lumen of the guide tube is sized to allow a polymer strand having an opening to pass therethrough.

288. 1. A device for bonding materials, comprising: a first curved tubular lumen having a distal end; a second curved tubular lumen having a distal end; The device, wherein the first and second curved tubular lumens articulate to pierce the first and second materials to be joined and cause the opposing ends of the lumens to mate with one another.

289. The device of claim 288, wherein the mated distal ends of both tubular lumens form a continuous lumen configured to receive a material, the continuous lumen forming a loop shape.

290. The device of any one of claims 288 and 289, wherein the tubular lumen is configured to be removed leaving behind a polymer loop that joins and secures the material.

291. A device for joining materials comprising a curved cannula having a tip on one end configured to pierce the materials to be joined and form a passage through the materials so that a suture or strand can be passed through the material.

292. 300. The device of claim 291, wherein the curved cannula can be removed leaving the suture or strand in the material to be bonded.

293. 293. A device as claimed in any one of claims 291 and 292, wherein the fastening element can be attached to the material to be bonded by fastening a loop with a suture or strand.

294. 294. The device of any one of claims 291 to 293, wherein the fastening element or separate element is capable of melting the loop.

295. 295. The device of any one of claims 291 to 294, wherein excess length of the suture or strand can be removed leaving a loop that secures the material together.

296. 1. A device for stabilizing a material, comprising: an inner tube having an angled barb at one end; an outer tube having an angled barb at said same end, the angled barb on said inner tube and the angled barb on said outer tube facing each other to form a pair; and A device comprising one or more pairs of barbs that clamp or secure one or more materials to be bonded when the inner tube or outer tube is rotated in a direction that brings the tips of the one or more pairs of barbs together.

297. 300. The device of claim 296, wherein the inner tube has an internal lumen through which an instrument can be passed.

298. 298. A device as claimed in any one of claims 296 and 297, wherein the walls of the inner tube and the outer tube have windows providing visibility and access to the working area of ​​the stabilized tissue.

299. 1. A device for stabilizing a material, comprising: at least two pincers, the tips of the pincers facing each other and a portion of each pincer having an outer contour; a tube surrounding the pincers and configured to advance tips of the pincers into engagement.

300. 300. The device of claim 299, wherein the tips of the pincers are configured to grasp a material when the tips of the pincers are moved toward each other.

301. 1. A stationary device, comprising: A shaft, a needle extending from the shaft, the needle including a slot extending along at least a portion of the needle; the device is configured to receive at least one fastener having a first bar and a second bar connected by a bar connector, the first bar configured to be positioned within the needle and the second bar configured to be positioned outside the needle; a push member configured to push the fastener from the needle; and one or more control rods with connectors, the connectors configured for connection to a surgical robot.

302. The fixation device of claim 301, wherein the shaft is configured to rotate and / or articulate.

303. 303. The fixturing device of any one of claims 301 and 302, wherein at least one control rod provides motion for moving the fasteners from the transfer zone through the transition zone.

304. 304. The fixation device of any one of claims 301-303, wherein at least one control rod is configured to provide an actuation to move a fastener from a transition zone through an operating zone to deploy the fastener.

305. The fixation device of any one of claims 301-304, wherein the one or more control rod connectors are configured for connection to one or more control rods of the surgical robot.

306. The fixation device of any one of claims 301 to 305, wherein the one or more control rod connectors comprise a connection clamp or union configured to interface with a ball or end feature of the surgical robot.

307. The fixation device of claim 306, wherein the connection clamp or union includes a first location within the device for receiving a ball or end feature on the surgical robot.

308. The fixation device of any one of claims 306 and 307, wherein the connection clamp or union includes a second location within the device for fixing the control rod connection to the surgical robot.

309. The fixation device of any one of claims 301-308, wherein the connector on the fixation device includes a collar for attachment to the surgical robot.

310. The fixation device of any one of claims 301 to 310, wherein a connector of the fixation device is screwed onto the surgical robot.

311. 311. The fixation device of any one of claims 301 to 310, configured to receive a fastener cartridge comprising one or more fasteners.

312. The fixation device of claim 311, wherein the fastener cartridge is replaceable.

313. The fixation device of any one of claims 311 and 312, wherein the fastener cartridge is configured to be replaceable while the device is connected to the surgical robot.

314. 314. The fastening device of any one of claims 311 to 313, wherein the fastener cartridge includes features for fastening the cartridge to the device.

315. 315. The fastening device of any one of claims 311 to 314, wherein the fastener cartridge includes a spring-loaded feature for securing the cartridge to the device.

316. 316. The fixation device of any one of claims 311 to 315, wherein the fastener cartridge includes features that align the cartridge with a transition zone of the device.

317. 317. The fixation device of any one of claims 311 to 316, wherein the fastener cartridge includes features for aligning the cartridge with the control rod or push rod of the device.

318. The fixation device of any one of claims 311 to 317, wherein the fastener cartridge is flexible.

319. 319. The fixation device of any one of claims 301-318, wherein the needle of the device is configured to be replaceable while the device is connected to the surgical robot.

320. 1. A fixation device configured for fixation in soft tissue, comprising: A fixation device comprising one or more piercing elements having a sharp tip and a hollow or partially hollow interior in communication with an opening near or through the tip, the hollow or partially hollow interior configured to allow advancement of a fastener.

321. 321. The device of claim 320, further comprising a push member configured to advance the fastener.

322. 322. The device of any one of claims 320 and 321, further comprising a fastener configured to advance from the opening along the interior of the piercing element near or through the tip.

323. 323. The device of claim 322, wherein the length of the fastener is sized to allow one or more ends of the fastener to be embedded within tissue.

324. The device of any one of claims 322 and 323, wherein one or more ends of the fastener configured to be embedded in tissue include one or more features configured to resist withdrawal from the tissue.

325. The device of any one of claims 322-324, wherein one or more ends of the fastener that are not embedded in tissue are provided with one or more features configured to retain an onlay material.

326. 325. The device of any one of claims 320-324, wherein the length of the piercing elements is selected to minimize trauma to tissues and structures surrounding the repair site.

327. 327. The device of any one of claims 320-326, wherein the length of the piercing element is selected to be suitable for placing one or more ends of the fastener within tissue.

328. 1. A method of fixation in soft tissue comprising: piercing the material to be bonded with one or more piercing elements of the fixation device; advancing a fastener along an interior of the piercing element; pushing the fastener out of the opening near or through the distal end of the piercing element; The method includes:

329. 329. The method of claim 328, further comprising using a stop, shoulder, or the like to control the insertion depth of the puncture element(s).

330. 330. The method of any one of claims 328 and 329, further comprising placing one or more ends of the fastener within tissue.

331. 1. A method of fixation in soft tissue comprising: piercing the material to be bonded with one or more piercing elements of the fixation device; A method of fastening, wherein the piercing elements form one or more openings or passageways through the material to be bonded.

332. 332. The method of claim 331, further comprising the step of forcing a fastener through the opening(s) or passage(s) formed in the material to be bonded by the one or more piercing elements.

333. 333. The method of any one of claims 331 and 332, further comprising placing one or more ends of the fastener within tissue.

334. 1. A device for fixing a material, comprising: a piercing element configured to pierce a material to be bonded, said piercing element being sufficiently sharp to pierce said material, said piercing element comprising: a hollow interior along at least a portion of its length, the hollow interior being configured for a fastener to be advanced distally therethrough; The device further comprises an open end through which the fastener can be pushed out.

335. 335. The device of claim 334, further comprising a push member for advancing a fastener distally into and out of the piercing element.

336. A device as claimed in any one of claims 334 and 335, wherein the length of the piercing element can be selected to minimise and / or avoid trauma to surrounding structures.

337. A device according to any one of claims 334 to 336, wherein the length of the piercing element can be selected to be suitable for placing one end of the fastener within tissue.

338. The device of any one of claims 334 to 337, wherein the piercing element has a length of about 0.100 to 0.380 inches.

339. 338. The device of any one of claims 334 to 338, wherein the device is a device as described in claims 1 to 37, 77, 79, 81, 82, 90 to 122, 137 to 165, 200 to 211, 244, 245, 267 to 269, and 301 to 308.

340. 340. The device of any one of claims 334 to 339, wherein the piercing element comprises a needle or fangs.

341. 1. A method for bonding materials comprising the steps of: Inserting a piercing element of the fixation device into or through the material; advancing a fastener along an interior side of the piercing element; extruding the fastener or a portion of the fastener through the material and out the distal tip of the piercing element; The method includes:

342. 1. A method for bonding materials comprising the steps of: inserting a piercing element of the fixation device into the material to form one or more openings or passages in the material; and passing a fastener through the opening or passageway formed by the piercing element.

343. The method of any one of claims 341 and 342, wherein the material comprises a synthetic mesh, a biological mesh (e.g., ADM), and / or tissue.

344. 1. A method for bonding materials comprising the steps of: Inserting a piercing element of a fixation device into the mesh; advancing a fastener along an interior side of the piercing element; and extruding the fastener or a portion of the fastener through the material and out the distal tip of the piercing element.

345. 1. A method for bonding materials comprising the steps of: inserting a piercing element of a fixation device into or through a mesh to form one or more openings or passages through the material; and passing a fastener through the opening or passageway formed by the piercing element.

346. 346. The method of any one of claims 344 or 345, wherein the mesh comprises a synthetic mesh and / or a biological mesh.

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