Medical devices for bonding materials

Abstract

A medical device for bonding materials is provided. The device includes a piercing element configured to pierce the material to be bonded. The piercing element is sharp enough to penetrate the material to be bonded and includes a hollow interior along at least a portion of its length, the hollow interior configured to enable a fastener to be advanced distally therein; and an open tip through which the fastener can be pushed. The device can be used to fasten materials, including tissues, synthetic patches, and biological patches (e.g., ADM).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 926,273 filed on October 25, 2019 and U.S. Provisional Patent Application No. 63 / 022,286 filed on May 8, 2020.

[0003] Incorporate by Reference

[0004] 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. Technical Field

[0005] The present application relates to the field of surgical fastening devices. Background Art

[0006] Soft tissue and soft tissue are connected to materials (such as synthetic, biological or resorbable patches (mesh)) in many surgical procedures, and are usually completed using sutures, nails or tacks. However, these fixation methods have compromises. It takes a lot of time to place multiple sutures. Suturing and stapling can be relatively fast; however, if metal or rigid tip fasteners have problems (such as pain, imaging, perforation structure, retention), they may be undesirable. In addition, most existing sutures and staplers are not suitable for tougher materials, such as decellularized dermal matrix (also known as ADM, biological patch), and require time-consuming sutures.

[0007] Acellular dermal matrix (ADM) is a material made from donor skin, usually of human or porcine origin, and is processed to remove cellular content and preserve collagen and elastin fiber matrix. ADM is used to treat a series of conditions where a complete dermal scaffold is needed and sutures are used to approach tissue. Examples of surgical procedures using ADM include breast reconstruction, cosmetic breast surgery, abdominal wall repair (e.g., abdominal wall / incisional hernia repair, wall reinforcement / prevention), burns and trauma (e.g., diabetic foot ulcers), and plastic surgery (e.g., quadriceps tendon reinforcement, Achilles tendon repair, and shoulder, hip, and knee augmentation).

[0008] There are currently no staplers that can pierce ADMs, so doctors use sutures to fasten ADMs to tissues, which is a time-consuming process. In surgeries with other materials that can use staplers (e.g., using a patch), doctors use a lot of force to push the stapler into the tissue to ensure a good connection. However, this push has the risk of damaging the underlying tissue or organ because it causes the tissue to be sutured to abut the underlying tissue during the suturing process.

[0009] For example, in abdominal wall and incisional hernia repair, mesh is used to reinforce the midline closure to prevent hernia recurrence. Figure 1 In the open onlay method shown, the ADM is used, and the ADM 2 is placed on the abdominal muscle 4 and sutured in place. Multiple sutures 6 are carefully placed to secure the ADM 2 to the muscle 4 so that the ADM 2 is taut, lies flat, and has sufficient fixation points. Suturing is not only time-consuming, but also relatively difficult and technique-dependent, which may negatively affect clinical outcomes.

[0010] A quick, easy-to-use fastening device that can puncture the ADM or other patch, facilitate ADM (or other patch) positioning and tensioning, use non-metallic (polymer or resorbable) fasteners to secure the ADM (or other patch) to soft tissue, and work with inlay surgery will be a beneficial tool to reduce surgeon workload / operative time and provide a repeatable fastening structure. Summary of the invention

[0011] In a first aspect, a fastening device is provided. The device includes a shaft; a handle; a needle extending from the shaft, the needle including a slot extending along at least a portion of the needle. The device can be configured to receive a fastener, the fastener including a first rod and a second rod connected by a rod connector, the first rod being positioned within the needle, and the second rod being positioned outside the needle.

[0012] The device may also include at least one fastener including a first rod and a second rod connected by a rod connector, the first rod being positioned within the needle and the second rod being positioned outside the needle; and a pushing member configured to push the fastener out of the needle.

[0013] The device may also include a pushing member configured to push the fastener out of the needle.

[0014] In some embodiments, the device further comprises a fastener reservoir within the shaft. A second rod may be positioned within the shaft. In some embodiments, the device comprises at least one ramp located near the distal end of the device, the ramp being configured to redirect the second rod when the fastener is pushed distally. The device may comprise a shoulder positioned at a fixed or adjustable distance from the distal end of the needle. In some embodiments, the device comprises a trigger configured to deploy the fastener by engaging the pushing member. The shaft may comprise one or more of an articulated end and a rotating end. In some embodiments, the shaft comprises a curved end.

[0015] The shaft may include a replaceable cartridge. The replaceable cartridge may include the entire shaft or a distal portion of the shaft.

[0016] In some embodiments, the needle can be retracted and / or advanced relative to the shaft.The distal portion of the shaft can be retracted and / or advanced relative to the needle.

[0017] In some embodiments, the needle includes one or more barbs. The barbs may be ejectable / retractable. In some embodiments, the needle includes one or more protrusions. The needle may include one or more recesses. In some embodiments, the needle includes an area of ​​enlarged diameter near the end of the needle.

[0018] The needle may include one or more blades. The one or more blades may be retractable. The one or more blades may be actuated. In some embodiments, the device includes one or more auxiliary needles.

[0019] One or more auxiliary needles may include one or more auxiliary needle barbs. In some embodiments, one or more auxiliary needle barbs are ejectable / retractable.

[0020] 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 rod connector and the second rod above the needle when the fastener is pushed distally. In some embodiments, the device includes a ramp extending from a side wall, the ramp extending away from the side wall and configured to rotate the second rod when the fastener is pushed distally so that the second rod moves in a direction generally parallel to the material to be fastened. The device may include a surface or side wall configured to maintain the rotational position of the second rod.

[0021] In some embodiments, at least a portion of the groove of the needle is helical.The device may include a support configured to provide counter-traction to the materials being fastened as the needle is withdrawn from the materials.

[0022] The device may include a support configured to provide counter-traction to the materials being fastened as the needle is withdrawn from the materials.

[0023] In some embodiments, the needle is bent or curved.

[0024] The width of the needle slot may be greater than the width of the stem connector or fastener.In some embodiments, the edge of the needle slot includes a rounded, broken, polished or other non-sharp edge configuration.

[0025] The inner diameter size of the needle and the outer diameter size of the needle can be selected to provide a passage of sufficient size through the material to be joined so that the stem and stem connector of the fastener pass through the material to be joined with minimal force. In some embodiments, the inner diameter and outer diameter size of the needle are selected to provide minimal insertion force in the material to be joined.

[0026] The bevel of the needle tip can be configured to provide a minimum insertion force in the material to be bonded. In some embodiments, the bevel of the needle tip is configured to withstand repeated use.

[0027] The length of the needle can be selected to minimize damage to tissue and structures surrounding the repair site. In some embodiments, the length of the needle is selected to be suitable for positioning one or more ends of the fastener in the tissue.

[0028] In another aspect, a tissue fastener configured to bond tissue to another material or tissue is provided. The fastener comprises a first rod; a second rod; and a connector connecting the first rod to the second rod, wherein the connector is configured to have sufficient strength to withstand deployment of the first rod.

[0029] In some embodiments, at least one of the first rod and the second rod has one or more blunt ends. At least one of the height, length or width of the second rod may be different from the corresponding size of the first rod. In some embodiments, the second rod is configured to be flexible. At least one of the first rod and the second rod may be curved.

[0030] In some embodiments, at least one of the second rod and the first rod comprises a downwardly facing and / or upwardly facing protrusion. At least one of the first rod, the second rod, and the connector rod may comprise one or more barbs. In some embodiments, at least one of the first rod and the second rod comprises an expansion wing. At least one of the first rod and the second rod may comprise a curling arm.

[0031] In some embodiments, the first rod comprises a circular cross-section.At least one of the first rod, the second rod, and the connector may comprise a circular, oval, square, or rectangular cross-section.

[0032] In some embodiments, the thickness or diameter of the connector is less than the thickness or diameter of the first rod or the second rod.

[0033] In some embodiments, the connector material is stretched or pre-stretched. The first arm and the second arm can extend in different directions. In some embodiments, at least one of the first rod and the second rod includes an end feature. At least one of the first rod and the second rod may include a bend. In some embodiments, the length of the connector is adjustable. The connector can be positioned at an angle different from vertical relative to the first rod and the second rod. In some embodiments, at least one of the first rod, the second rod, and the connector rod includes one or more materials. The connecting rod can be curved or curvilinear.

[0034] In some embodiments, the length of the tissue fastener is sized to embed one or more ends of the fastener into tissue. One or more ends of the fastener embedded in tissue may include one or more features configured to resist pulling out of the tissue.

[0035] In some embodiments, one or more ends of the fastener that are not embedded in tissue include one or more features configured to retain inlay material.

[0036] In some embodiments, a method for fastening an inlay material to tissue is provided. The method comprises piercing the inlay material and the tissue with a needle comprising a slot, the needle forming part of a fastening device; and advancing a fastener comprising a first rod positioned within the needle, the first rod being connected to a second rod by a connector.

[0037] The method may include using a stop to control the insertion depth of the needle.

[0038] In some embodiments, the method includes withdrawing the needle from a first location in the tissue, positioning or tensioning a material on the needle, and puncturing the tissue at a second location.

[0039] In some embodiments, the method includes reorienting the second rod.

[0040] The method may include advancing the fastener, including activating a trigger on the fastening device. In some embodiments, the method includes maintaining / stabilizing the position of the needle within the inlay material and tissue while deploying the fastener.

[0041] The method may include reorienting the second rod, including using one or more bevels positioned near the distal end of the device. In some embodiments, reorienting the second rod includes moving or lifting the second rod to avoid engaging the slot of the needle. Reorienting the second rod may include moving the second rod to a position parallel to the surface of the inlay material. In some embodiments, reorienting the second rod includes rotating the second rod so that the second rod moves toward a surface parallel to the inlay material.

[0042] In some embodiments, the method includes deploying the first rod within the tissue. The method may include deploying the second rod so that it is placed adjacent to the inlay material. In some embodiments, the method includes deploying a fastener so that the tissue and the inlay material are approximated and fixed together by the fastener. The method may include withdrawing the needle from the inlay material and tissue after the fastener is deployed. In some embodiments, the method includes supporting the inlay material and tissue while withdrawing the needle. The method may include keeping the inlay material and tissue away from the underlying structure while the fastener is deployed.

[0043] In another aspect, a fastening device is provided. The device includes two needles extending from the device, each needle including a slot extending along at least a portion of the needle; at least one fastener including a first rod and a second rod connected by a rod connector; a first rod positioned in one needle and a second rod positioned in the other needle; and a pushing member configured to push the rod distally into and out of the needle.

[0044] In yet another aspect, a method for fastening an inlay material to tissue is provided. The method comprises puncturing the inlay material and tissue with two needles, each needle comprising a slot, the needles forming part of a fastening device; advancing a fastener comprising a first rod positioned within one needle, a second rod positioned within the other needle, the first rod being connected to the second rod by a connector; and deploying the first rod and the second rod in the tissue such that the tissue and the inlay material are approximated and secured together by the fastener.

[0045] In another aspect, a fastening device is provided. The device includes a needle extending from the device, the needle including a slot extending along at least a portion of the needle; at least one fastener, the at least one fastener including a first rod and a second rod connected by a rod connector, the first rod and the second rod being positioned within the needle; and a pushing member configured to push the rod distally into and out of the needle.

[0046] In another aspect, a method for fastening an inlay material to tissue is provided. The method comprises puncturing an inlay material and tissue with a needle comprising a slot, the needle forming part of a fastening device; advancing a fastener comprising a first rod and a second rod positioned within the needle, the first rod being connected to the second rod by a connector; deploying the first rod in tissue at a first position; removing the needle from the inlay material and tissue at the first position; and deploying the second rod in tissue at a second position such that the tissue and inlay material are approximated and secured together by the fastener.

[0047] In another aspect, a fastening device is provided. The device includes a first jaw including a needle including a slot; and a second jaw opposite the first jaw.

[0048] The device may include an opening configured to receive the needle when the first jaw and the second jaw are moved toward each other.

[0049] In another aspect, a method for fastening tissue or material is provided. The method comprises piercing a first tissue or material with a needle comprising a slot, the needle forming part of a fastening device, wherein piercing the first tissue or material comprises moving opposing jaws of the fastening device toward each other; piercing a second tissue or material with the needle and bringing the first tissue or material and the second tissue or material into proximity, wherein piercing the second tissue or material comprises moving the opposing jaws toward each other; and advancing a fastener comprising a first rod positioned within the needle, the first rod being connected to a second rod by a connector.

[0050] In some embodiments, the method includes deploying a first rod through the tissue or material so that the first rod rests on a surface of one of the tissues or materials and the second rod rests on a surface of another of the other tissues or materials. The method may include deploying a fastener so that the tissues or materials are approximated and secured together by the fastener.

[0051] In another aspect, a method for fastening tissue or material is provided. The method comprises puncturing a first tissue or material with a first needle including a slot, the first needle forming part of the fastening device; puncturing a second tissue or material with a second needle including a slot, the second needle forming part of the fastening device; approximating the first tissue or material and the second tissue or material, wherein approximating the tissues or materials comprises moving the first tissue or material with the first needle and puncturing the second tissue or material with the second needle; advancing the fastener, the fastener comprising a first rod positioned within the first needle, a second rod positioned within the second needle, the first rod connected to the second rod by a connector; and deploying the first rod and the second rod through the tissue or material so that the tissues or materials are approximated and fixed together by the fastener.

[0052] In yet another aspect, a method for fastening an inlay material to tissue is provided. The method includes placing an inlay material adjacent to the tissue; embedding a first shaft of a fastener into the tissue; and positioning a second shaft of the fastener adjacent to the inlay material, thereby fastening the inlay material to the tissue, wherein the fastener includes a connector coupling the first shaft to the second shaft.

[0053] In another aspect, a method for fastening a material to tissue is provided. The method includes placing a material adjacent to the tissue, placing a first rod of a fastener adjacent to the tissue, and placing a second rod of the fastener adjacent to the material, thereby fastening the material to the tissue, wherein the fastener includes a connector coupling the first rod to the second rod.

[0054] In a first aspect, a surgical device for bonding materials is provided. The device includes a head portion having a first cusp and a second cusp with a sharp end and a hollow or partially hollow interior, and a deployment member configured to push a staple out of the head portion.

[0055] The first cusp may be configured to receive a first leg of a staple; and a second arm, the second arm configured to receive a second leg of a staple. The device may also include a retractable stop configured to be actuated toward the first cusp and the second cusp, the stop including a first hole or a portion of the periphery configured to receive the first cusp; and a second hole or a portion of the periphery configured to receive the second cusp; and a joint connecting the head portion and the retractable stop and configured to enable the retractable stop to be actuated toward the head portion.

[0056] In some embodiments, at least one of the first cusp and the second cusp includes an open side shaped to allow the nail leg to pass through. The open side may include a slot. The deployment member may include two outer molds configured to move downward toward the center mold. In some embodiments, the deployment member includes a center mold and two outer molds configured to move downward toward the center mold. At least one of the first cusp and the second cusp may include an angled or sharp tip.

[0057] In some embodiments, the cusps may be attached to a retractable shuttle. The device may include a nail positioned in the retractable shuttle, the retractable shuttle having a first nail leg positioned in the first cusps and a second nail leg positioned in the second cusps. In some embodiments, the retractable shuttle is configured to retract the cusps.

[0058] In some embodiments, the device includes a nail positioned in a retractable head having a first leg positioned within a first cusp and a second leg positioned within a second cusp. The retractable head can be configured to retract while the head portion maintains its position. The head portion can be configured to hold a plurality of nails. In some embodiments, the head portion includes a nail magazine configured to hold a plurality of nails.

[0059] In some embodiments, the head portion is located on one end of the shaft. The head portion may be configured to be rotatable or articulated.

[0060] One or more fangs may include an attached blade. In some embodiments, one or more fangs include an actuable blade. The blade may taper from the base of the fang to the end of the fang. In some embodiments, one or more fangs are configured to be hinged. One or more fangs may include an internal feature shaped to guide the nail to a closed position. In some embodiments, the one or more fangs are adjustable. One or more fangs may include threads. In some embodiments, one or more fangs include at least one of a barb, a recess, or a neck. The fangs may be replaceable. In some embodiments, the fangs are covered by an actuable shield or stop.

[0061] In another aspect, a surgical device for bonding materials is provided. The device includes a head portion including fangs and a deployment member configured to push the staples out of the head portion.

[0062] The tines may be configured to receive the legs of the staples.

[0063] The device may include a retractable stop configured to be actuated toward the canine. The retractable stop includes a first hole or a portion of the periphery configured to receive the canine and a joint connecting the head portion and the retractable stop and configured to actuate the retractable stop toward the canine.

[0064] In some embodiments, the head portion is configured to be able to rotate at least 180°.In some embodiments, the fangs include open sides shaped to allow the nail legs to pass through.

[0065] The head portion may be configured to be articulated. In some embodiments, the first fang includes a blade attached thereto. The blade may taper from the base of the fang toward the end of the fang. In some embodiments, the fang is configured to be articulated. The fang may include an internal feature shaped to guide the nail to a closed position. In some embodiments, the 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 recess, and a neck. The fang may be replaceable. In some embodiments, the fang is configured to be flipped down from the head portion.

[0066] In yet another aspect, a method for joining materials is provided. The method includes piercing a first material and a second material with a fang, the fang forming part of a fastening device; and deploying a staple through the fang.

[0067] The method may include first piercing the first material with the fangs. The method may include first piercing only the first material with the fangs by positioning the first material between the fangs and a stopper, moving the stopper toward the fangs, and thereby pushing the first material onto the fangs. In some embodiments, the method includes moving the stopper away from the fangs and retracting the stopper. The method may include positioning the first material to the second material using the fangs with the first material attached. The method may include piercing the second material with the fangs. In some embodiments, the method includes retracting the first material and the second material using one or more fangs or partially deployed pins. The method may include deploying pins to bond the first material to the second material. In some embodiments, the method includes removing the fangs from the first material and the second material. The method may include deploying the pins by pushing the pins out of the head portion. In some embodiments, the method includes deploying the pins by forming the pins around a central mold. The method may include deploying the pins using an outer mold to form the pins around the central mold. The first material may include an inlay material. The second material may include tissue.

[0068] In another aspect, a surgical device for bonding materials is provided, the device comprising a head portion, the head portion comprising a first staple outlet configured to allow passage of a first staple leg, a second staple outlet configured to allow passage of a second staple leg, and a deployment member configured to push a staple out of the head portion.

[0069] The device may also include a retractable stop configured to be actuated toward the nail leg, the retractable stop including a first hole or partial periphery configured to receive the first nail leg; and a second hole or partial periphery, the second hole or partial periphery being configured to receive the second nail leg; and a joint connecting the head portion and the retractable stop and being configured to enable the retractable stop to be actuated toward the nail leg.

[0070] In some embodiments, the deployment member includes a center mold and two outer molds configured to move downwardly toward the center mold.

[0071] In some embodiments, the first and second staple legs comprise angled or sharpened tips.

[0072] The device may include a nail positionable in a retractable shuttle. In some embodiments, the device includes a nail positioned in a retractable shuttle, wherein a first nail leg is positioned at or within a first nail exit, and a second nail leg is positioned at or within a second nail exit. The retractable shuttle may be configured to retract the nail legs.

[0073] The head portion may include a staple cartridge configured to hold a plurality of staples. The head portion may include a staple cartridge configured to hold a plurality of staples. The head portion may be located on one end of the 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 taper from the base of the head portion toward the ends of the staple legs. The staple legs may be configured to flip downward from the head. The staple legs may be covered by an actuatable shield or stop.

[0074] In another aspect, a surgical device for bonding materials is provided. The device includes a first arm, the first arm including a channel configured to hold a staple; an opening in the channel, the opening allowing the staple to pass through during deployment of the staple; and a pushing member configured to push the staple out of the first hole. The device also includes a second arm, the second arm including a second hole or a portion of the periphery; and 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 each other and toward each other.

[0075] The first arm may include a stopper configured to interact with the forming feature of the nail to prevent the movement of the nail. The stopper may be configured to be disengaged.

[0076] In some embodiments, the first arm includes a first forming member configured to form a nail. In some embodiments, the first arm includes a movable second forming element, which is configured to be able to advance and work with the first forming element to form a nail. In some embodiments, the second arm including a portion of a hole or a periphery (e.g., a narrow groove) moves toward the first arm to receive the piercing end of the nail. In some embodiments, the first arm includes a pushing member configured to push the nail. The first arm may include a pushing member, which is configured to push the nail through the forming element to form the nail. In some embodiments, the nail has a first preformed end configured to pierce the material to be bonded. The nail may have a second preformed end, which is configured to interact with a stopper and hold the material to be bonded.

[0077] In another aspect, a method of bonding materials is provided. The method includes moving opposing arms or jaws toward each other to pierce the materials to be bonded with the ends of a staple; securing the materials to be bonded between the opposing arms or jaws; and deploying and forming the staples to secure the materials to be bonded.

[0078] The method may include pushing the first end of the staple out of the passage opening in the first arm or jaw. In some embodiments, the method includes advancing a second forming element to form the first end of the staple for piercing the material to be bonded. The method may include using a stopper to interact with the forming feature of the staple to prevent movement of the staple during advancement of the second forming feature.

[0079] In some embodiments, the method includes positioning a first material in the material between opposing arms or jaws. The method may include moving the opposing arms or jaws toward each other to puncture the first material on the nail. The method may include moving the opposing arms away from each other. The method may also include positioning a second material in the material between opposing arms or jaws. The method may include moving the opposing arms or jaws toward each other to puncture the second material on the nail. The method may include fastening the materials to be combined between the opposing arms or jaws. In some embodiments, the method includes pushing the nail through one or more forming members to fully form and close the nail, fixing the materials together. The method may include releasing the nail from the first arm or jaw, leaving the material fixed together by the nail. The method may include moving the opposing arms or jaws away from each other to release the material.

[0080] On the other hand, a tissue fastener or staple is provided that is configured to bond tissue to another material or tissue. The fastener or staple includes a first leg; a second leg; and a cross portion connecting the first leg and the second leg. The first leg and the second leg may be approximately perpendicular to the cross portion. In some embodiments, the first leg and the second leg are at an acute angle to the cross portion. In some embodiments, the bend between the cross portion and the legs includes a bend radius of approximately 0.005-0.020". In some embodiments, the bend between the cross portion and the legs includes a bend radius of approximately 0.021-0.100". In some embodiments, the ends of the closed staple legs are relatively located in the same plane above and below each other. In some embodiments, the cross portion is configured to have multiple ridges or bumps on the lateral aspects of the cross portion. The fastener may include metal, polymers and / or resorbable materials.

[0081] On the other hand, a tissue fastener or staple is provided that is configured to bond tissue and / or material. The staple includes one or more preformed bends on a first end of the staple; and a sharp tip on 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 bonded. In some embodiments, the sharp tip on the second end of the staple is configured to pierce the material to be bonded. In some embodiments, the second end of the staple includes one or more preformed bends. The fastener may include metal, polymer, and / or resorbable material.

[0082] In another aspect, a tissue fastener or staple is configured to bind tissue and / or material. The fastener includes one or more heads located on a first end of the staple; and a sharp tip located on a second end of the staple. The fastener may include metal, polymer, and / or resorbable material.

[0083] In another aspect, a surgical device for bonding materials is provided. The device includes a movable housing including a track, a push member configured to be able to be advanced along the track, a first link and a first articulated arm connected to the housing, and a second link and a second articulated arm connected to the housing.

[0084] In some embodiments, the fangs have sharp tips configured to pierce the material to be joined. The articulated fangs can be configured to rotate the fang tips toward each other. The fangs can have internal grooves that are configured to guide the nails or fasteners to be formed. The fangs can have internal grooves that are configured to form nails. In some embodiments, the fangs have internal grooves that are configured to shield the nails from surrounding tissues and body structures. The pushing member can be configured to have an end feature for pushing the nails or fasteners to be formed. In some embodiments, the articulated fangs are located at the ends of the shaft.

[0085] In another aspect, a surgical device for bonding materials is provided. The device includes a first jaw; a second jaw, wherein the first jaw and / or the second jaw are configured to be actuated toward each other; a hook positioned within the first jaw, one end of the hook extending upward toward the second jaw, the one end of the hook being configured to be deployed from the first jaw; and one or more staples positioned within the second jaw and configured to be deployed in a direction toward the first jaw.

[0086] In some embodiments, the second jaw comprises a window, wherein the frame at least partially surrounds the window on a side of the second jaw facing the first jaw.The hook may be rigid or flexible.

[0087] In another aspect, a method of connecting materials is provided. The method 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; loosening 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.

[0088] In some embodiments, deploying the nail or fastener includes deploying the nail or fastener from the second jaw. In some embodiments, deploying the nail or fastener includes deploying the nail or fastener from the first jaw. The method may include retracting the hook from the first material.

[0089] In another aspect, a device for stabilizing a material is provided. The device includes a first jaw, the first jaw including one or more piercing elements; a second jaw, the second jaw including one or more openings or recesses, wherein the first jaw and the second jaw are configured to be movable toward each other

[0090] In some embodiments, one or more puncture elements positioned on the first jaw and extending toward the second jaw are configured to interact with one or more openings or recesses on the second jaw when the first jaw and the second jaw are fully moved toward each other. In some embodiments, one or more puncture elements positioned on the first jaw and extending toward the second jaw are configured to enter one or more openings or recesses on the second jaw when the first jaw and the second jaw are fully moved toward each other.

[0091] In another aspect, a method for stabilizing materials to be bonded is provided. The method includes positioning a first material between a first jaw and a second jaw of a device; moving the first jaw and the second jaw toward each other so that one or more piercing elements located 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 each other so that one or more piercing elements located on the first jaw pierce the second material.

[0092] In some embodiments, the method includes moving the first jaw and the second jaw toward each other such that one or more piercing elements positioned on the first jaw pierce material by entering one or more openings or recesses on the second jaw.

[0093] The method may include moving or retracting the device to move or retract the first material and the second material. The method may include bringing the suturing mechanism into proximity with the stabilized material. The method may include suturing the first material and the second material. The method may include joining the first material and the second material using other connecting means, such as sutures, tacks, fasteners, glue, etc.

[0094] In another aspect, a device for stabilizing materials to be surgically stapled is provided, the device comprising a first jaw including a sharp tip and a second jaw including a sharp tip, wherein the first jaw and / or the second jaw are configured to be movable toward the other jaw.

[0095] In another aspect, a method for stabilizing materials to be bonded is provided, the method comprising positioning a first material between a first jaw and a second jaw of a device, the first jaw and the second jaw each comprising a sharp tip, and moving the first jaw and the second jaw toward each other so that the sharp tip pierces the first material.

[0096] The method may include separating the first jaw and the second jaw while holding the first material on the sharp tip, moving the first jaw and the second jaw toward each other so that the sharp tip pierces the second material. The method may include moving or retracting the device to move or retract the first material and the second material. The method may include bringing the suturing mechanism close to the stabilized material. The method may include using other bonding means such as sutures, tacks, fasteners, glue, etc. to bond the first material and the second material. In some embodiments, the method includes suturing the first material to the second material.

[0097] In another aspect, a surgical device for bonding materials is provided. The device includes an elongated shaft; and a curved spike at a distal end of the elongated shaft.

[0098] The nail can be positioned in a plane perpendicular to the elongated axis. In some embodiments, the nail is positioned in a plane oriented at an angle different from that perpendicular to the elongated axis. The second arm or shaft can include a slot or opening at its end that is configured to support material and receive the end of the nail. The second arm or shaft can be configured to be actuated or rotated to form or close the nail.

[0099] In another aspect, a method for joining materials is provided. The method includes advancing a device including an elongated shaft and a curved spike positioned at a distal end of the elongated shaft to a surgical site, the spike being positioned in a plane perpendicular to the elongated shaft; positioning a first material on a second material; rotating the elongated shaft so that the piercing end of the curved spike pierces the first material and the second material; and closing the spike.

[0100] 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 the nail. The method may include actuating or rotating the second arm or shaft to form or close the nail. The method may include releasing the nail from the device. The method may include actuating or rotating the elongated shaft to form or close the nail. At least one of the first material and the second material may include an ADM.

[0101] In another aspect, a device for bonding materials is provided, the device comprising a first elongated shaft configured to hold a first leg of a staple, and a second elongated shaft configured to hold a second leg of a staple, the first elongated shaft and the second elongated shaft being positioned adjacent to each other and substantially parallel, wherein rotation of the elongated shafts causes the staple legs to move toward each other.

[0102] In some embodiments, the first staple leg and the second staple leg are bent toward each other.

[0103] In another aspect, a method of surgically suturing material is provided. The method includes advancing a device to the surgical site, the device including a first elongated shaft and a second elongated shaft, the first elongated shaft including a first leg of a staple, the second elongated shaft including a second leg of a staple; positioning a first material on a second material; and rotating the first elongated shaft and the second elongated shaft relative to each other so that the first leg and the second leg penetrate the first material and the second material and close the staple.

[0104] In some embodiments, the method includes releasing the staple from the device. In some embodiments, at least one of the first material and the second material includes an ADM.

[0105] In another aspect, a surgical device for bonding materials is provided. The device includes a first jaw configured to hold a first end of a staple, the first end of the staple including a preformed feature, and the second end configured to pierce a material; and a second jaw including a slot or opening, the first jaw and the second jaw configured to move toward each other.

[0106] 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 nail when the first jaw and the second jaw move toward each other. In some embodiments, the second jaw is configured to actuate or rotate to form or close the nail. In some embodiments, the second jaw can be advanced and retracted relative to the first jaw. The second jaw may include an anvil. The first jaw may include an actuator that is configured to advance the nail into the anvil on the second jaw. The second end of the nail may include a bend. The first jaw may include a piercing shield or fangs that are configured to cover the tip of the nail.

[0107] In another aspect, a method for bonding materials is provided. The method includes advancing a device including 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 each other so that the 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; positioning a second material between the first jaw and the second jaw; and moving the first jaw and the second jaw toward each other so that the second end of the staple pierces the second material.

[0108] The method may include moving the first material into a preformed feature on the staple.The method may include moving or retracting a device to move or retract the first material and the second material.

[0109] The method may include actuating or rotating the second jaw to close the nail. In some embodiments, the method includes sliding the second jaw to align the nail tip with an anvil on the second jaw before positioning the second material. The method may include moving the jaws toward each other so that the second end of the nail pierces the second material, enters the anvil and curls, forms or closes the nail. The method may include releasing the nail from the device.

[0110] In another aspect, a nail configured for use with any of the devices or methods disclosed herein is provided. The nail comprises 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, wherein the first bend and the second bend each comprise a ridge.

[0111] In yet another aspect, a nail configured for use with any of the devices or methods disclosed herein is provided. The nail includes 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, wherein the central portion includes at least one ridge proximate the intersection.

[0112] In another aspect, a device for joining materials is provided. The device includes a first arm, the first arm including a first cusp and a first hole; a second arm including a second cusp and a second hole, wherein the first arm is connected to the second arm at a joint, and wherein the first arm and the second arm are configured to be able to rotate toward each other about the joint, and wherein when rotated, the first cusp is configured to be able to enter the second hole, and the second cusp is configured to be able to enter the first hole. The cusps may include one or more of a recess, a barb, a neck, etc. to retain the first material on the cusps. The cusps may include a lubricious coating so that the opposing flanges can be removed from the first material.

[0113] In another aspect, a method for joining materials is provided. The method includes advancing a device including a first arm and a second arm, the first arm including a first cusp and a first hole; the second arm including a second cusp 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 cusp and the second cusp; rotating the first arm and the second arm about the joint so that the first cusp enters the second hole and the second cusp 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 cusp and the second cusp.

[0114] The method may include deploying a staple to join the first material and the second material. The method may include moving or retracting a device to move or retract the first material and the second material.

[0115] In another aspect, a device for bonding materials is provided. The device includes a bracket configured to extend from a head, the head configured to deploy a staple, and a sharp element configured to extend from the bracket, wherein the tips of the sharp elements are configured to move toward each other to grasp a target material, the bracket configured to retract while the sharp element remains extended to bring the head into proximity with the target material.

[0116] The tips of the sharp elements may be configured to overlap each other to grasp and / or pierce the target material. The sharp elements may be configured to have a surface that prevents the nail ends from protruding beyond the sharp elements.

[0117] In another aspect, a prosthetic material is provided that includes a plurality of holes or an array of holes. The plurality of holes or the array of holes may be configured to a size that allows a nail or fastener or a portion of a nail or fastener to pass through the material.

[0118] In another aspect, a device for bonding materials is provided. The device includes a body including features for anchoring in bone, and a filament extending from the body, forming an exposed end of the filament.

[0119] The exposed end of the wire may include a pointed tip.

[0120] The wires may be configured to bend in order to hold material or tissue.

[0121] In another aspect, a method for bonding materials is provided. The method includes inserting one or more devices for bonding materials to bone into the bone, wherein the device includes a body and a wire extending from the body, the body including a feature for anchoring in the bone; using the wire to pierce one or more materials to be bonded to the bone; and forming or closing the wire to fasten the one or more materials to the bone.

[0122] In another aspect, a device for bonding materials is provided. The device includes a ring-shaped fastener or staple, the ring including at least one pointed end, and a shaft configured to expand the one or more staple rings, wherein the shaft is located within the inner diameter of the one or more staple rings and rotates and pushes the ends of the one or more staples.

[0123] The nail may be located at the end of the shaft, which is configured to penetrate the material to be bonded through the sharp end when the nail is rotated by the shaft. In some embodiments, the diameter of the nail ring is restored or contracted to fix the material to be bonded.

[0124] In another aspect, a device for joining materials is provided. The device includes a polymer strand including a series of openings, wherein the openings are configured to receive and terminate the polymer strand and are configured to melt and fuse the openings and the joint between the strand passing through the openings, thereby creating a fixed loop.

[0125] The device may include a guide tube comprising a pointed tip configured to pierce the material to be bonded and form a loop, and a slot along the length of the tube or a portion of the length of the tube, wherein the slotted lumen of the guide tube is sized to allow passage of the polymer strand having an opening.

[0126] In another aspect, a device for bonding materials is provided, the device comprising a first curved tubular lumen having a sharp tip; and a second curved tubular lumen having a sharp tip, wherein the first curved tubular lumen and the second curved tubular lumen are articulated to pierce the first material and the second material to be bonded, and the opposing tips of the two tubular lumens cooperate with each other.

[0127] In some embodiments, the mating tips of the two tubular lumens form a continuous lumen configured to receive the material, the continuous lumen forming a ring. The tubular lumens can be configured to be removed, leaving behind a polymer ring that approximates and secures the materials together.

[0128] In yet another aspect, a device for bonding materials is provided. The device includes a curved sleeve having a pointed tip on one end that is configured to pierce the material to be bonded and create a passage through the material so that a suture or strand can pass through the material. In some embodiments, the curved sleeve can be removed, leaving the suture or strand in the material to be bonded. In some embodiments, a tightening element can tighten a loop with the suture or strand to approach the material to be bonded. In some embodiments, a tightening element or a separating element can fuse the loop. In some embodiments, excess length of the suture or strand can be removed, leaving a loop that secures the materials together.

[0129] In another aspect, a device for stabilizing materials is provided. The device includes an inner tube including a plurality of angled barbs on one end; and an outer tube including angled barbs on the same end, wherein the angled barbs on the inner tube and the angled barbs on the outer tube point toward each other to form a pair; and one or more pairs of barbs that clamp or secure one or more materials to be joined when the inner tube or the outer tube is rotated in a direction that brings the ends of the one or more pairs of barbs together.

[0130] The inner tube may have a lumen through which a device may pass. In some embodiments, the walls of the inner and outer tubes include windows to provide visibility and access to the working area for stabilizing tissue.

[0131] In another aspect, a device for stabilizing a material is provided. The device includes at least two jaws, wherein the tips of the jaws point toward each other and a portion of each jaw has an outward profile, a tube surrounds the jaws and is configured to be able to push and bring the tips of the jaws together. In some embodiments, the tips of the jaws are configured to be able to grasp the material when the tips of the jaws move toward each other.

[0132] In another aspect, a fastening device is provided. The device includes 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, the fastener including a first rod and a second rod connected by a rod connector, the first rod being configured to be positioned within the needle and the second rod being configured to be positioned outside the needle; a push member configured to push the fastener out of the needle; and one or more control rods including a connector, the connector being configured to be connected to a surgical robot.

[0133] In some embodiments, the shaft is configured to be able to rotate and / or articulate. In some embodiments, at least one control rod provides a motion for moving the fastener from the delivery region through the transition region. In some embodiments, at least one control rod is configured to provide a motion for moving the fastener from the transition region through the manipulation region and deploying the fastener. One or more control rod connectors can be configured to be connected 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 joint configured to interact with a ball or end feature on the surgical robot. In some embodiments, the connection clamp or joint includes a first position in the device to receive a ball or end feature on the surgical robot. In some embodiments, the connection clamp or joint includes a second position in the device to fasten the control rod connection to the surgical robot. In some embodiments, the connector on the fastening device includes a collar attached to the surgical robot. In some embodiments, the connector on the fastening device is threadedly connected to the surgical robot. In some embodiments, the device is configured to receive a fastener bin including one or more fasteners. The fastener bin can be replaceable. The fastener bin can be configured to be replaced while the device remains connected to the surgical robot. In some embodiments, the fastener bin includes a feature that fixes the bin to the device. The fastener bin may include a spring loaded feature to secure the bin to the device. In some embodiments, the fastener bin includes a feature to align the bin to a transition zone of the device. In some embodiments, the fastener bin includes a feature to align the bin to a lever or push rod of the device. The fastener bin may be flexible. In some embodiments, the needle of the device is configured to be replaceable while the device remains connected to the surgical robot.

[0134] In another aspect, a fastening device configured for fixation in soft tissue is provided. The device includes one or more piercing elements including a sharp tip and a hollow or partially hollow interior communicating with an opening near or through the tip, wherein the hollow or partially hollow interior is configured to allow advancement of a fastener.

[0135] The device may include a pushing member configured to advance a fastener. In some embodiments, the device includes a fastener configured to advance along the interior of the puncture element and leave the opening near or through the tip. The length dimension of the fastener may be set to allow one or more ends of the fastener to be embedded in the tissue. In some embodiments, one or more ends of the fastener configured to be embedded in the tissue include one or more features configured to prevent pulling out from the tissue. One or more ends of the fastener not embedded in the tissue may include one or more features configured to maintain an inlay material. In some embodiments, the length of the puncture element is selected to minimize damage to tissue and structure around the repair site. In some embodiments, the length of the puncture element is selected to be suitable for arranging one or more ends of the fastener in the tissue.

[0136] In another aspect, a method for fastening in soft tissue is provided. The method comprises piercing a material to be bonded using one or more piercing elements of a fastening device; advancing a fastener along the interior of the piercing element; and pushing the fastener out of an opening near or through the tip of the piercing element.

[0137] The method may include using stops, shoulders, etc. to control the insertion depth of the piercing element. The method may include positioning one or more ends of the fastener in the tissue.

[0138] In another aspect, a method for fastening in soft tissue is provided. The method includes piercing a material to be joined using one or more piercing elements of a fastening device, wherein the piercing elements create one or more openings or channels through the material to be joined.

[0139] The method may include pushing the fastener through an opening or passageway formed by one or more piercing elements in the material to be bonded. The method may include positioning one or more ends of the fastener in the tissue.

[0140] In another aspect, a device for fastening materials is provided. The device includes a piercing element configured to pierce materials to be joined, wherein the piercing element is sharp enough to pierce these materials, wherein the piercing element includes a hollow interior along at least a portion of its length, the hollow interior configured to enable a fastener to be advanced distally therethrough; and an open tip through which the fastener can be pushed.

[0141] The device may include a push element to push the fastener distally into and away from the puncture element. In some embodiments, the length of the puncture element may be selected to minimize and / or avoid damage to surrounding structures. In some embodiments, the length of the puncture element may be selected to be suitable for arranging one end of the fastener in the tissue. In some embodiments, the length of the puncture element is approximately 0.100 inches to 0.380 inches. The puncture element may include a needle or a rod.

[0142] In another aspect, a method for bonding materials is provided, the method comprising inserting a piercing element of a fastening device into or through a material, advancing a fastener along an interior of the piercing element, and pushing the fastener or a portion of the fastener through the material and out of a distal end of the piercing element.

[0143] In another aspect, a method for bonding materials is provided, the method comprising inserting a piercing element of a fastening device into the material, thereby creating one or more openings or channels through the material; and passing a fastener through the openings or channels formed by the piercing element.

[0144] Materials may include synthetic patches, biological patches (eg, ADM), and / or tissue.

[0145] In another aspect, a method for bonding materials is provided, the method comprising inserting a piercing element of a fastening device into a patch, advancing a fastener along the interior of the piercing element, and pushing the fastener or a portion of the fastener through the material and out of the distal end of the piercing element.

[0146] In another aspect, a method for bonding materials is provided, the method comprising inserting a piercing element of a fastening device into or through a patch to create one or more openings or channels through the material; and passing a fastener through the openings or channels formed by the piercing element.

[0147] Patches may include synthetic patches and / or biological patches. BRIEF DESCRIPTION OF THE DRAWINGS

[0148] The novel features of the present invention are particularly set forth in the appended claims. The features and advantages of the present invention will be better understood by reference to the following detailed description and accompanying drawings which set forth exemplary embodiments in which the principles of the present invention are utilized, wherein:

[0149] Figure 1 is a schematic diagram of the inlay process.

[0150] Figure 2 An embodiment of a fastening device is shown.

[0151] Figure 4-9Shown in the inlay process Figure 2 Embodiments of the method of the apparatus.

[0152] Fig.10 An embodiment of a fastener is shown.

[0153] Fig.11 An embodiment of a fastener positioned within a needle of a fastening device is shown.

[0154] Figure 12-15 Shown for use in the inlay process Fig.11 An embodiment of a method of fastening a device includes an embodiment of a deflector interacting with a filament of a fastener.

[0155] Figure 16-19 Shown is the use of a process using only transparent materials Fig.11 Embodiments of a method of fastening a device to allow visualization.

[0156] Fig. 20 An embodiment of a fastener including a blunt tip is shown.

[0157] Fig.21 An embodiment of a fastener is shown in which the second stem has a shorter length L and a different height H than the first stem.

[0158] Fig. 22 An embodiment of a fastening device comprising a needle at the distal end of the shaft is shown.

[0159] Figure 23-26 Embodiments of fastening devices are shown that include features that can help retain inlay material on the needles of the fastening device and reduce / eliminate the amount of stabilizing force required during fastener deployment.

[0160] Figure 27A-31 Additional embodiments of fastening devices are shown that include features that can reduce / eliminate the amount of stabilizing force required during fastener deployment.

[0161] Figure 32-35 An example of improper placement of a deployed fastener and a second rod is shown.

[0162] Figure 36-37 An embodiment of a fastener having a flexible second rod deployed from a fastening device is shown.

[0163] Figure 38-39 An embodiment of a deflector that interacts with a second stem of a fastener is shown.

[0164] Figure 40-42OAnother embodiment of a fastener deflector is shown that is configured to interact with a filament and a second rod of a fastener to redirect the second rod.

[0165] Figures 43A-43D An embodiment of a needle comprising a helical slot is shown.

[0166] Figure 44-45 The retraction force occurring on the needle is shown.

[0167] Figures 46-48 An embodiment of a support for a fastening device is shown.

[0168] Figures 49A-51C Embodiments of needles comprising one or more blades are shown.

[0169] Fig.52 An embodiment of a fastener having one or more curved rods is shown.

[0170] Fig.53 An embodiment of a fastener having one or more protrusions is shown.

[0171] Fig.54 An embodiment of a fastener including barbs is shown.

[0172] Figure 55-56B An embodiment of a fastener including expansion wings is shown.

[0173] Fig.57 An embodiment of a fastener including crimp arms is shown.

[0174] Figures 58A-59C Different views of two embodiments of fasteners including different cross-sectional geometries are shown.

[0175] Fig.60 An embodiment of a first rod of a fastener positioned within a needle is shown.

[0176] Fig.61A and 61B An embodiment of a fastener is shown that is manufactured in multiple steps.

[0177] Fig.62A -C shows an embodiment of a fastener having stems extending in different directions.

[0178] Fig.63 An embodiment of a fastener having a stem including an end feature is shown.

[0179] Fig.64 An embodiment of a fastener having a stem including a bend is shown.

[0180] Fig.65Embodiments of fasteners including adjustable connectors or filaments are shown.

[0181] Figures 66-70 Embodiments of fasteners are shown that include a connector or filament positioned at an oblique angle relative to the stem of the fastener.

[0182] Fig.71 Embodiments of fasteners comprising more than one material are shown.

[0183] Fig.72A -C shows an embodiment of a shaft with articulated and / or pivoted ends.

[0184] Fig.73 An embodiment of a shaft having a bend at its distal end is shown.

[0185] Fig.74A and 74B An embodiment of a fastening device having a replaceable cartridge is shown.

[0186] Fig.75A and 75B An embodiment is shown having a shaft with a needle that can be retracted and / or advanced relative to the shaft.

[0187] Fig.76A and 76B An embodiment of a shaft having a sheath that can be retracted and / or advanced relative to the needle / shaft is shown.

[0188] Figures 77-79 An embodiment of a fastening device is shown.

[0189] Figures 80-83 Another embodiment of a fastening device is shown.

[0190] Figures 84-89 An embodiment of a fastening device comprising opposing jaws is shown.

[0191] Figure 90-94B Another embodiment of a fastening device is shown.

[0192] Figures 95A-96F An embodiment of a fastener is shown.

[0193] Figures 97A-97C Embodiments of fasteners including bent filaments or connectors are shown.

[0194] Fig.98A -B shows an embodiment of a slotted needle.

[0195] Fig.99A -B shows an embodiment of a curved, slotted needle.

[0196] Fig.100A-B shows an embodiment of a slotted needle.

[0197] Figures 101A-101G An embodiment of a device configured to grasp and sew material is shown.

[0198] Figures 102A-102F An embodiment of a device configured to grasp and sew material is shown.

[0199] Figures 103A-103H An embodiment of a device configured to clamp and staple material is shown.

[0200] Fig.104 An embodiment of an upper jaw of a device configured to clamp material is shown.

[0201] Figures 105A-105G An embodiment of the lower jaw comprising a hook is shown.

[0202] Figures 106A-106B An embodiment of a device for grasping and positioning material to be sutured is shown.

[0203] Figures 107A-107H Shows the use of Figures 106A-106B Embodiments of the method of the apparatus.

[0204] Figure 8 A-8D illustrate embodiments of devices for grasping and positioning material to be sutured.

[0205] Figures 109A-109B An embodiment of a suturing device is shown.

[0206] Figures 110A-110L Shows the use of Fig. 9 An embodiment of the device of A-9B.

[0207] Figures 111A-111D An embodiment of a suturing device is shown.

[0208] Figures 112A-112B An embodiment of a staple closure mechanism is shown.

[0209] Figures 113A-113J An embodiment of a stapling device using staples having pre-formed features is shown.

[0210] Figures 114A-114C Another embodiment of a stapling device using staples having pre-formed features is shown.

[0211] Fig.115A -F shows the use Figures 114A-114C Embodiment of the device.

[0212] Figures 116A-116B An alternative embodiment for closing the staples is shown.

[0213] Fig.117 An embodiment of a nail having a pre-formed feature and a pre-bent tip is shown.

[0214] Figures 118A-118C An embodiment of a nail having a pre-formed feature and a pre-bent tip is shown.

[0215] Figures 119A-119C An embodiment of a nail comprising a plurality of pre-curved portions is shown.

[0216] Fig.120 An embodiment is shown that includes a jaw that is configured to cover a shroud that can cover a staple.

[0217] Figures 121A-121C An embodiment of a suturing device is shown.

[0218] Figures 122A-122M Shows the use of Figures 121A-121C Embodiment of the device.

[0219] Figures 123A-123B An embodiment of a suturing device is shown.

[0220] Figures 124A-124K Shows the use of Fig.123A and 123B Embodiment of the device.

[0221] Fig.125 An embodiment of a staple reservoir is shown.

[0222] Fig.126 Including similar to Fig.125 An embodiment of the device 12700 having a stapler head 12702 of the illustrated structure.

[0223] Fig.127A and 127B Show includes similar to Fig.123A and 123B An embodiment of a device of a stapler head of the structure shown.

[0224] Figures 128A-128C An embodiment of a suturing device having an articulating head is shown.

[0225] Figures 129A-129B An embodiment of a tine and a pin for drawing a hole in a target material is shown.

[0226] Figures 130A-130C An embodiment of a device having retractable cusps is shown.

[0227] Figures 131A-131C An embodiment of a fang comprising a blade is shown.

[0228] Fig.132 An embodiment of an articulated canine is shown.

[0229] Figures 133A-133B An embodiment is shown that includes tines configured to close an internal feature of a staple.

[0230] Figures 134A-134C An embodiment with adjustable position cusps is shown.

[0231] Fig.135 An embodiment of a cusp comprising external threads is shown.

[0232] Figures 136A-136C Various embodiments of canines are shown.

[0233] Fig.137 An embodiment of a canine configured to be flipped downward is shown.

[0234] Fig.138 An embodiment of a fang covered by a shield is shown.

[0235] Fig.139 An embodiment of the fangs hidden in holes in the stop is shown.

[0236] Fig.140A and 140B Embodiments with nails of different shapes are shown.

[0237] Fig.141A and 141B An embodiment of a closed staple shape is shown.

[0238] Figures 142A-142D An embodiment in which the nail pops open is shown.

[0239] Figures 143A-143C An embodiment of a staple is shown that includes legs configured to be retained in a closed position.

[0240] Fig.144 An embodiment of a staple is shown that includes legs configured to be retained in a closed position.

[0241] Figures 145A-145D A single user embodiment of using a suturing device as disclosed herein is shown.

[0242] Figures 146A-146D An embodiment of a method of forming staple legs using a stapler at different times is shown.

[0243] Figures 147A-147E An embodiment of a suturing mechanism is shown.

[0244] Figures 148A-148D An embodiment of a fang is shown.

[0245] Fig.149An embodiment of a material including a plurality of fabricated holes is shown.

[0246] Figures 150A-150D An embodiment of a bone anchoring nail is shown.

[0247] Figures 151A-151C An embodiment of a suturing device is shown.

[0248] Figures 152A-152C An embodiment of a device configured to access a material is shown.

[0249] Figures 153A-153C An embodiment using polymer strand bonding materials is shown.

[0250] Figures 154A-154E An embodiment of a device configured to bond materials is shown.

[0251] Figures 155A-155E An embodiment of a device configured to bond materials is shown.

[0252] Fig.156 An embodiment of a device configured to clamp a material is shown.

[0253] Figures 157A-157D An embodiment of a device configured to clamp a material is shown.

[0254] Fig.158 An embodiment of a surgical robotic manipulator end comprising a fastening device as described herein is shown.

[0255] Fig.159 A comparison of embodiments of a robotic end effector fastening device and a fastening device with a handle is shown.

[0256] Figures 160-162 An embodiment of a connection between a fastening device and a surgical robot is shown.

[0257] Figures 163-165 Detailed view showing an embodiment of a connection between a fastening device and a surgical robot.

[0258] Figures 166-168 An embodiment of a delivery cartridge inserted into a fastening device is shown. DETAILED DESCRIPTION

[0259] Embodiments of fastener devices that can puncture ADM or other materials (e.g., synthetic patches, resorbable patches, tissues), facilitate positioning and tensioning of ADM (or other materials), secure ADM (or other materials) to soft tissue using (polymer, resorbable or metal) fasteners, and work with inlay procedures are disclosed herein. The tool can also be used for any other process of joining soft tissues together or joining soft tissues to materials. The device may include a stapler. If any pushing forces are applied to the tissue during deployment, the device may require very little pushing forces and is compatible for use in a variety of surgeries. This device is a unique tool that will reduce the surgeon's workload and surgical time and prevent damage to underlying tissues and organs.

[0260] The device disclosed herein can advantageously provide the ability to access restricted locations. Embodiments of the device can also hide sharp features during device insertion and removal. The device can penetrate the toughness of the material (e.g., ADM). The device can be used to aim / control the position of the material to be sutured (e.g., ADM). The device can be configured to be used in an inlay process. The device can be configured to grasp the desired tissue or material (e.g., ADM) and retract it to avoid the structure below. Some devices can be configured to shield / protect the structure below. Embodiments of the device can also be configured to be used to supplement tissue and close nails. The concepts described herein can be applied to many surgeries (e.g., pelvic slings, dura mater closures) that can benefit from the advantages listed above. It should be understood that the device disclosed herein can be used to manipulate materials, such as ADM, but can also be used to manipulate other materials, such as other patches, membranes, etc.

[0261] Some examples of surgeries utilizing patches (e.g., ADM) in which the devices disclosed herein may be used include breast reconstruction, abdominal wall surgery, treatment of diabetic foot ulcers, and plastic surgery (e.g., augmentation of quadriceps tendon repair, augmentation of Achilles tendon repair, and augmentation of rotator cuff repair). Breast reconstruction after mastectomy traditionally occurs in two stages, a tissue expansion stage and an implant stage. The introduction of ADM provides the option of converting a two-stage process to a single stage (also known as direct implant reconstruction). Two techniques used in direct implant reconstruction are described below. In the subpleural technique, the pectoralis muscle is released from the chest wall at the inframammary fold. The ADM is sutured to the chest wall at the inframammary fold. The implant is inserted into a subpleural pouch. The ADM is attached to the pectoralis muscle to close the implant pouch. In the prepectoral technique, the implant is wrapped with the ADM. The implant / ADM is placed in a mastectomy bag on top of the pectoralis muscle. The ADM is secured to the chest wall.

[0262] In abdominal wall surgery, ADMs are used to repair ventral / incisional hernias and to prophylactically reinforce the abdominal wall to prevent incisional hernias. ADMs can be placed in a variety of locations to repair the abdominal wall, and the devices disclosed herein can facilitate ADM onlay procedures.

[0263] When treating a diabetic foot ulcer, after the wound is cleaned, the ADM is secured in place over the wound so dermal integration and healing can occur. To enhance a quadriceps tendon repair, the ADM is placed over the repair site and secured in place. To enhance an Achilles tendon repair, the ADM is wrapped around the repaired tendon and held high in place. As noted in the preceding examples, there are many procedures in which devices and methods for puncturing, manipulating, and bonding materials (including ADMs) would be very useful.

[0264] Throughout the disclosure, the term "target material" is used to refer to a material that can be combined or otherwise manipulated by a device and using the methods described herein. The target material can include a patch (e.g., ADM, synthetic patch) tissue, membrane, etc. In some embodiments, the first target material includes an ADM to be combined to a second target material including tissue. In some embodiments, the first target material includes tissue to be combined to a second target material including tissue. Other combinations are also possible.

[0265] Throughout this disclosure, the terms "fang" and "needle" may be used to refer to a sharp element that may or may not have a hollow region along at least a portion of its interior.

[0266] Embodiments of fastening devices (e.g., sutures, etc.) capable of fastening materials and tissues (e.g., tissue to tissue, material to tissue) are described herein, including synthetic patches and tough biological patches, such as acellular dermal matrix (ADM). As described herein, tough materials (e.g., ADM) typically require time-consuming suturing because they are not suitable for conventional fastening devices.

[0267] The fastening device described herein utilizes one or more sharp puncture elements (e.g., needles or fangs) to penetrate the material, and then deploys a fastener (e.g., nail) therethrough. The puncture element is sharp enough to penetrate the material (e.g., a synthetic patch, ADM). The puncture element includes a hollow interior along at least a portion of its length. The fastener or a portion of the fastener can be advanced distally within the hollow portion. The puncture element includes an open tip through which the fastener or a portion of the fastener can be pushed through the material to be bonded. A pushing member can be used to advance the fastener distally into the puncture element and away from the puncture element.

[0268] In some embodiments, the length of the puncture element can be selected to minimize / avoid damage to surrounding structures. For example, during an inlay procedure, the length of the puncture element can be selected to minimize or avoid contact with tissue and structures below the repair site. The length of the puncture element can also be selected to be suitable for placing one end of the fastener at a certain depth in the tissue.

[0269] For example, the piercing element may have a length of about 0.240 inches (or about 0.100 inches to 0.380 inches, or about 0.140 inches to 0.340 inches, or about 0.190 inches to 0.290 inches, or about 0.220 inches to 0.260 inches, or about 0.230 inches to 0.250 inches, or about 0.235 inches to 0.245 inches, etc.).

[0270] Known devices deliver fasteners through hollow needles. An example of such a device is taught in U.S. Pat. No. 4,006,747. However, such devices are taught to have long needles for passing through the tissue to be joined, so that the needles leave the tissue on the opposite side of the wound to be closed. These needles are not suitable for preventing damage to the underlying structure (e.g., in inlay surgery). In addition, such devices are generally configured to be able to be used with more than one operator. The fastening devices described herein can be used by a single person to perform a repair.

[0271] The fastening means may include designs including but not limited to Figure 2-9 , those shown in any one or combination of 11-19, 22-51C, 72A-84B, 98A-101G, 103A-107H, 121A-148D.

[0272] The method of using such a fastening device includes inserting or passing one or more puncture elements of the fastening device through a material (e.g., a synthetic patch, ADM, or tissue). The method also includes advancing a fastener (e.g., a stapler, other fastener, etc.) along the interior of the puncture element. The method includes pushing the fastener or a portion of the fastener through the material and away from the distal tip of the puncture element.

[0273] The method may include forming one or more openings or passages through the material by inserting a piercing element into or through the material. The method may include passing a fastener or a portion of a fastener through an opening or passage formed by the piercing element.

[0274] As described above, the devices disclosed herein are particularly advantageous in onlay surgeries such as abdominal wall repair. The devices and methods disclosed herein provide many advantages over currently available ones. Currently, other options for highly onlay patches in open abdominal wall repairs include sutures, metal staples or tacks, and fibrin glue. If the surgeon uses an ADM, they may have to use sutures (with needles) to penetrate the toughness of the ADM. However, suturing greatly increases the operating time and is relatively difficult and technique-dependent, which may affect clinical outcomes. Suturing and stapling are not suitable for penetrating the toughness of the ADM, and fibrin glue is expensive. The devices disclosed herein can advantageously penetrate the toughness of the ADM or other patch-like objects, and can quickly deploy repeatable fasteners, thereby providing solutions to these problems.

[0275] In an intraperitoneal onlay patch repair (IPOM repair), a device including barbed nails and spiral metal tacks can be used. In this repair, a patch is usually introduced into the abdominal cavity and covers the hernia defect on the ventral side of the peritoneum. The tacks are deployed outward and embedded in the abdominal muscles, which usually causes pain to the patient. When resorbable tacks are used, the pain is considered to subside because the tacks are reabsorbed. When metal tacks are used, the patient may have to return for a second operation to remove the tacks to relieve the pain. The device disclosed herein can advantageously be highly bonded to a material (e.g., a patch) by anchoring one end of the fastener to the fascia. This will eliminate the need to embed a portion of the fastener into the muscle, increasing the comfort of the patient.

[0276] Figure 2 An embodiment of a fastening device 100 is shown, which includes a needle 102, a shaft / fastener reservoir 104, a handle 106, a deployment trigger 108, and a fastener 118 ( Figure 8 ). Needle 102 may be sharp enough to penetrate tough materials such as ADM and may be configured to allow a fastener to pass therethrough.

[0277] Figure 3 An inlay material (eg, ADM) 110 and tissue 112 to be bonded are shown. Figure 4-9 The basic process of using the fastening device 100 to secure a material 110 (e.g., ADM) to a tissue 112 is shown. Figure 4 In the embodiment of the present invention, the user applies a distal force through the handle to pierce material 110 and tissue 112 with needle 102.

[0278] exist Figure 5-7 In the embodiment of the present invention, the user may choose to move the needle from the first position 114 ( Figure 5 ) Extract tissue, position or tension material (e.g. ADM) as needed ( Figure 6 ), then at the second position 116 ( Figure 7 )Puncture tissue.

[0279] Because there is friction / compression between the material (e.g., ADM) and the needle, material may remain on the needle when the user withdraws the needle from the tissue. Figure 23-26 ) Several features that aid in relocalization.

[0280] exist Figure 8 In the embodiment of the present invention, the user applies a steady force to the material (e.g., ADM) and tissue and simultaneously actuates the deployment trigger 108. This deploys the fastener 118 and secures the material 110 to the tissue 112. Figure 23-31 ) Various ways to reduce / eliminate the required stabilizing force.

[0281] exist Fig. 9 In the present invention, the user applies a proximal force through the handle to withdraw the needle from the material (e.g., ADM) and tissue. Figure 44-5 1) A number of features that facilitate needle extraction are described in more detail.

[0282] Fig.10 An embodiment of a fastener implant 200 made of a polymer or resorbable material or metal is shown. For example, the implant may include nylon, polyethylene, polypropylene, various resorbable polymers, or nitinol. The fastener has a first rod 202 and a second rod 204 at either end of a connector 206 (e.g., a filament). Fig.11 In the embodiment, the first rod is located in the lumen 208 of the slotted delivery needle 210. The fastener may include a rectangular cross-section, such as Fig.10 As shown. The rectangular cross-section of the first rod includes flat surfaces to improve the resistance of the fastener to being pulled out of the tissue. Other shapes of cross-sections are also 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 sizes. The filament 206 of the fastener exits the delivery needle slot 212 and the second rod 204 is located outside the needle. The filament length is sized to approximate and / or compress the tissue and patch to be joined. For example, in an open onlay repair, the filament length can be selected so that the rod is embedded in the muscle. Reference Figures 95A-96C Examples of appropriate sizes are described. In a laparoscopic IPOM repair, the filament length can be selected so that the rod is deployed on the opposite side of the peritoneum / fascia and is not embedded in the muscle to avoid pain for the patient.

[0283] Fig.12A shoulder 214 is shown to control and limit the insertion depth of the needle. The shoulder may be a fixed or adjustable distance from the needle tip 216. The shoulder may control the deployment depth of the first rod of the fastener and control the amount of approximation and / or compression between the inlay material and the tissue. In embodiments including a fixed distance shoulder, the distance may be about 0.235" (or about 0.17-0.30" or about 0.185-0.285" or about 0.20-0.27", etc.).

[0284] exist Fig.13 In the embodiment, needle 216 penetrates inlay material 218 (e.g., ADM or other patch) and tissue 220 until shoulder 214 contacts material 218 (e.g., ADM). The user may choose to advantageously withdraw needle 216 from tissue 220 before deploying fasteners (material remaining on needle) to position or tension inlay material 218 as desired.

[0285] exist Fig.14 In the embodiment of the present invention, when a push rod (not shown, within the needle lumen) pushes the first rod down the needle lumen, the deflector 222 acts on the filaments of the fastener. This action redirects the second rod 204 and prepares it to be placed on the surface of the inlay material (e.g., ADM). Figure 32-43D ) Various other embodiments are described to optimize placement of the second rod 204 and approximation and / or compression of the inlay material / tissue.

[0286] exist Fig.15 In the embodiment of the present invention, the first rod and filament are delivered through the inlay material 218 (e.g., ADM) and embedded in the tissue 220 by passing through the hole in the material 218 (forming a slotted needle). At the same time, the second rod 204 is located on the surface of the inlay material 218 (e.g., ADM). During this step, the user applies a steady force to the inlay material 218 and tissue 220 to ensure that the material is not pushed out of the needle.

[0287] exist Fig.16 and 17 , push rod 224 deploys first rod 202 into tissue 220 (shown for clarity to allow visualization).

[0288] exist Fig.18 and 19 In the process, the push rod is retracted and the needle is withdrawn from the tissue 220 and the inlay material 218 (eg, ADM), leaving the inlay material and tissue approximated and / or compressed and secured together by the fastener.

[0289] In some embodiments, Fig. 20As shown, the shaft of the fastener includes a blunt end 226. The blunt end can advantageously prevent the shaft from inadvertently penetrating any fascia that may be located beneath the target muscle tissue. Because the needle is manipulated to pierce the inlay material (e.g., ADM), the fastener does not have to include a sharp end. The blunt end may include, for example, Fig. 20 The square or rectangular end shown. In some embodiments, the blunt end can be rounded.

[0290] Fig.21 An embodiment of a fastener is shown in which the second rod has a different (in this example, shorter) length L and a different (in this example, taller) height H than the first rod. The shorter length allows the fastener to be positioned close to the edge of the inlay material (e.g., ADM) without the end of the rod protruding significantly beyond the edge of the material. The taller height increases the stiffness and strength of the rod. In another embodiment, the shorter height reduces the profile of the rod on the inlay material (e.g., ADM), which can be beneficial for repair. In some embodiments, the larger width of the second rod can be used to increase the contact surface area of ​​the rod.

[0291] Fig. 22 An embodiment of a needle 228 is shown on the end of a shaft 230. The dimensions of the shaft (eg, diameter and length) can be accessed for open or laparoscopic surgery.

[0292] Embodiments of Features to Facilitate Repositioning

[0293] Fig.23 An embodiment of a needle is shown that includes one or more barbs 300 that help retain an inlay material 302 (e.g., an ADM) on the needle to (re)position and / or tension the material 302. The needle pierces the inlay material 302, and the barbs 300 retain the inlay material 302 on the needle. The user pulls the needle out of the tissue from a first position, but the barbs retain the inlay material on the needle. The user repositions the needle to (re)position or tension the inlay material, and then inserts the needle into the tissue at a second position. To enable the needle to be withdrawn from the ADM, a support member (e.g., Figures 46-48 ) to withdraw the barbed needle from the ADM. Alternatively, the barbs can be retracted to facilitate needle withdrawal.

[0294] Fig.24 An embodiment is shown that includes one or more raised bumps 304 that help retain the inlay material (eg, ADM) on the needle in order to (re)position and / or tension the inlay material.

[0295] Fig.25 An embodiment is shown that includes one or more notches 306 that help retain the inlay material (eg, ADM) on the needle to facilitate (re)positioning and / or tensioning the inlay material.

[0296] Fig.26 An embodiment is shown that includes an enlarged portion 308 on the needle. The enlargement increases the compressive force 310 of the inlay material (e.g., ADM) on the needle. The increased compressive force helps to hold the inlay material on the needle, to (re)position and / or tension the inlay material.

[0297] Embodiments of features that reduce or eliminate the amount of stabilizing force required during fastener deployment

[0298] When the first rod and filament pass through the hole in the inlay material (e.g., ADM) formed by the needle, the amount of interference that the first rod and filament encounter with the inlay material depends on the size of the channel through the inlay material formed by the needle. The amount of interference affects the force required to push the first rod and filament through the needle channel in the inlay material. The force applied by the first rod and filament to the inlay material must have an offsetting "stabilizing" force on the inlay material so that the first rod and filament can pass through the channel without pushing the inlay material away from the needle. One way to keep the inlay material on the needle is to allow the user to apply a distal force to the device / needle during fastener deployment. Current design features balance the competing demands of 1) reducing the amount of force required for the needle to penetrate the ADM and 2) reducing the required stabilizing force. In order to reduce the required stabilizing force, the inner and outer diameters of the needle are sized to form a channel of sufficient size in the ADM so that the first rod and (folded) filament of the fastener can pass through the ADM with minimal force. By minimizing the force to pass the fastener through the ADM, the stabilizing force required by the user is also reduced. Using a larger sized needle will create a larger channel in the ADM, which will further reduce the force required to pass the fastener through the ADM (and further reduce the stabilizing force required by the user). However, a larger sized needle will also increase the amount of force required for the needle to puncture the ADM. Therefore, the design of the needle achieves a balance between two competing demands by using a three-bevel tip design with a main bevel that minimizes the amount of force required for the needle to puncture the ADM. The three-bevel tip design also maintains the durability of the needle tip for repeated use. Examples of the first bevel include 20-24 degrees and 14-30 degrees. The following concepts describe embodiments of feature portions that help further minimize the amount of stabilizing force required by the user during fastener deployment.

[0299] Figure 23-26 The features shown in the drawings can also be used to help hold the inlay material (e.g., ADM) on the needle during fastener deployment. This assistance can reduce or eliminate the amount of stabilizing force that the user needs to apply during fastener deployment. To enable needle withdrawal, a support member (e.g., Figures 46-48 ) to remove the needle from the inlay material. Alternatively, refer to Fig.23 , the barbs can be retracted to facilitate needle retraction.

[0300] Fig.27AAn embodiment is shown that includes one or more blades 400 located on the needle. The blades cut a slit 402 through an inlay material (e.g., ADM) 404 so that when the inlay material flaps 406 in the needle lumen fold over as the first rod and filaments pass through the inlay material, the taller flaps create more space through the inlay material. As a result, the first rod and filaments can pass through the inlay material with less force, so that the user can also apply less force on the inlay material during fastener deployment. Fig.27B A comparison with a smaller fin size (without the slits) is shown.

[0301] like Fig.28 , after the fastener delivery needle 408 pierces the inlay material 410 (e.g., ADM) and enters the tissue 412, one or more barbs 414 can be deployed from the fastener delivery needle into the tissue. The user can then lift / hold the inlay material and tissue away from any underlying structure and deploy the fastener without inadvertently fastening the underlying structure. Inadvertently fastening the underlying structure can sometimes be caused by having to push into the inlay material / tissue during deployment.

[0302] like Figure 29-31 In the embodiment shown in FIG. 1 , a fastener delivery needle 416 pierces an inlay material 410 (eg, ADM) and enters tissue 412 ( Fig.29 ) thereafter, one or more barbed deployment needles 418 pierce the inlay material and enter the tissue ( Fig.30 ). The barbs 420 are then deployed from the barbed deployment needle into the tissue. The user can then lift / hold the inlay material and tissue away from any underlying structure and deploy the fastener without inadvertently fastening the underlying structure. Inadvertently fastening the underlying structure can sometimes be caused by having to push into the inlay material / tissue during deployment.

[0303] Embodiments of features for optimizing the placement of the second rod

[0304] In the absence of one or more deflectors (e.g. Fig.14 In the absence of a deflector 222 ), deployment of the second rod may be prevented, resulting in less than optimal proximity and / or compression between the inlay material (e.g., ADM) and the tissue. Fig.32 A second rod 506 is shown outside of the needle slot 504 as the needle slot 504 moves toward the inlay material. Fig.33 and 34 As shown, the distal end of rod 500 itself rests on the inlay material, and the proximal end of rod 502 can enter needle slot 504. This configuration prevents the second rod 506 from resting on the inlay material during deployment. Fig.35As shown, the gap 508 created between the second rod 506 and the inlay material prevents the second rod 506 from approximating and / or compressing the inlay material onto the tissue. The deflector 222 solves this problem by deflecting the filaments of the fastener to redirect the second rod 506 so that the second rod 506 is positioned over the inlay material to approximate and / or compress the inlay material onto the tissue. The following concepts describe alternative ways to optimize the placement of the second rod and the inlay material / tissue approximation and / or compression.

[0305] Fig.36 An embodiment of a fastener having a second rod of shorter height is shown. The shorter height makes the second rod more flexible so that when the second rod encounters Fig.34 In the configuration shown, the rod is bent. The bent second rod 510 allows the joint 512 between the filament and the second rod to be advanced into the inlay material. By allowing the joint between the filament and the second rod to be advanced into the inlay material, the gap between the second rod and the inlay material is eliminated, and the fastener can approximate and / or compress the inlay material to the tissue, such as Fig.37 shown.

[0306] Fig.38 and 39 An embodiment of a deflector 514 is shown that interacts directly with a second rod 516 of a fastener. The deflector flexes in one or more directions, such as a first direction 518 (e.g., upward, such as Fig.38 ) and a second direction 520 (eg, inward, as shown in the side view of Fig.39 The two curvatures or directions work together to deflect the second rod. The deflector 514 redirects the second rod 516 to sit on the inlay material (e.g., ADM).

[0307] Figure 40-42O Another embodiment of a fastener deflector is shown that is configured to interact with a filament and a second stem of a fastener to redirect the second stem to rest on an inlay material (eg, ADM). Fig.40 and 41 A side view and a top view, respectively, of the distal end of the fastening device 4100 are shown. Fig.40 and 41 A slotted needle 4102 is shown extending from the distal end of the shaft 4104. Moving distally along the shaft 4104, a first or bottom bevel 4106 extends upward or away from the bottom side 4108 of the shaft. Disposed away from the origin of the first bevel 4106 is a second or side bevel 4110 that protrudes from the side wall 4112.

[0308] Fig.42A -O shows the Fig.40 and 41 An embodiment of a fastener 4200 deployed by a fastening device 4100 is shown. Fig.42A -C show a top view, a side view, and a front view, respectively, of a fastener filament 4202 extending from a slotted needle 4102.

[0309] Fig.42D -F respectively illustrate a top view, a side view, and a front view of the fastener 4200 , which is pushed distally along the slotted needle 4102 , causing the bottom bevel 4106 to lift the fastener filament 4202 , lifting the fastener's second rod 4204 above the needle 4102 .

[0310] Figure 42G -I respectively show the top view, side view and front view of the fastener 4200 that continues to be pushed distally along the needle 4102, so that the bottom slope 4106 continues to lift the filament 4202 and the second rod 4204, and the side slope 4110 rotates the second rod 4204 so that the end 4206 of the second rod rotates toward the needle 4102.

[0311] Fig.42J -L respectively illustrate the top, side, and front views of the fastener 4200 as it continues to be pushed distally along the needle 4102, such that the bottom bevel 4106 continues to lift the second rod 4204, and the side bevel 4110 continues to rotate the second rod 4204 over the needle 4102. As shown in this set of figures, the second rod 4204 is now generally parallel to the surface of the inlay material.

[0312] Figure 42M -O respectively show the top view, side view and front view of the side wall 4208, Figure 42N Maintaining the position of the second rod 4204 during fastener deployment is clearly shown.

[0313] Figures 43A-43D An embodiment of a needle is shown that includes a helical slot 530 in the needle. When the fastener is deployed from the needle, the helical slot redirects the second rod 532 to sit on the inlay material (e.g., ADM). When the end 534 of the second rod 532 contacts the inlay material (e.g., ADM), the rotational movement of the fastener 536 causes the second rod 532 to pivot about the end 534 so that it sits on the inlay material.

[0314] As described above, reorienting the second rod to move toward a position parallel to the surface of the inlay material provides the advantage of improved approximation and / or compression of the inlay material and tissue. It also provides the advantage of allowing the surgeon to hold the fastening device at an angle other than perpendicular relative to the inlay material and tissue. The surgeon can approach the treatment site from any angle while still ensuring reliable and consistent positioning of the fastener.

[0315] Embodiments of Features to Facilitate Needle Removal

[0316] After the needle 600 pierces the inlay material 602 (e.g., ADM), a compressive force 604 exists between the inlay material and the needle, which serves to hold the inlay material on the needle. Thus, a "withdrawal" force 606 is required to pull the needle out of the inlay material ( Fig.44 ). The withdrawal force also causes the inlay material 602 to exert a "pull-out" force 608 that serves to pull the fastener 610 out of the tissue 612 and / or compromise the fastener's retention in the tissue ( Fig.45 The following concepts describe ways to assist with needle withdrawal to keep the fastener in the tissue. When used with any features that help to maintain (re)position of the inlay material on the needle and / or tension the inlay material, the following concepts will also assist with needle withdrawal (e.g., similar to the description of the invention). Figure 23-26 those described).

[0317] Fig.46 An embodiment of a support 614 is shown that actuates and contacts a fastener 616 to provide reverse traction when a needle 618 is withdrawn from an inlay material 620 (e.g., ADM). The support may include one or more elongated features or shafts that extend through the needle and that may provide a force on the inlay material as the needle is withdrawn. Fig.47 An alternative embodiment of a support 622 that contacts the inlay material to provide reverse traction is shown. The support 622 has a distal feature that extends radially outward so that the support 622 does not contact the fastener 616, but only contacts the inlay material surrounding the fastener. Fig.48 Another embodiment of a support 624 is shown that contacts the fastener and inlay material to provide reverse traction. Figures 46-48 In some embodiments, the shoulder 214 (above) can also be used as a support. Alternatively, the support can be a separate element. In some embodiments, the support is dual purpose and also serves as a needle protector / cover.

[0318] Fig.49A A front view of an embodiment of a needle 626 passing through an inlay material 628 (eg, ADM) is shown. Fig.49B A bottom view of the inlay material hole showing the outer diameter (OD) of the compressed needle is shown. One or more blades 630 are positioned around the periphery of the needle 626. Fig.50A Front view and Fig.50B In the bottom view of the embodiment, the blade 630 is actuated (e.g., advanced distally) to cut a slit through the periphery of the hole, thereby releasing the compression of the inlay material on the OD of the needle. By releasing the compression, the needle can be easily withdrawn from the inlay material.

[0319] Figures 51A-51CAn alternative embodiment is shown in which one or more blades 630 are secured around the perimeter of the needle 626. As the needle pierces the inlay material 628 (e.g., ADM), the blades simultaneously cut slits through the perimeter of the hole, thereby relieving compression of the inlay material on the OD of the needle. By relieving compression, the needle can be easily withdrawn from the inlay material.

[0320] Other Fastener Embodiments

[0321] Fig.52 An embodiment of a fastener is shown having a curved first rod 700 to improve retention of the fastener in tissue, and a curved second rod 702 to improve retention of the fastener in an inlay material (e.g., ADM). The curved rod also helps approximate and / or compress the inlay material onto the tissue. The curved second rod 702 can also prevent the end of the rod from pointing upward (e.g., away from the inlay material, like a "V") and moving (e.g., rotating) on ​​the inlay material.

[0322] Fig.53 An embodiment of a fastener is shown having one or more downwardly directed protrusions 704 on a second shaft 706 (eg, toward the first shaft) that prevent movement (eg, rotation) of the second shaft on the inlay material (eg, ADM).

[0323] Fig.54 An embodiment of a fastener is shown having a plurality of barbs 708 on the fastener filament 710 and / or the fastener first shaft 712. The barbs are oriented to allow the filament and first shaft to be easily deployed through an inlay material (e.g., ADM) and into tissue, but to make it difficult to pull the fastener out of the tissue and inlay material.

[0324] Fig.55 An embodiment of a fastener having a first shaft 714 is shown with one or more extended wings 716. The wings are oriented to allow the first shaft to be easily deployed into tissue, but make it difficult to pull the fastener out of tissue. The wings are oriented in the same plane as the fastener.

[0325] Fig.56A and 56B An embodiment of a fastener having a first shaft 718 with one or more expansion wings 720 is shown. The wings are oriented to allow the first shaft to be easily deployed into tissue, but make it difficult to pull the fastener out of the tissue. Fig.56B As shown, the wings are also oriented to deploy out of the plane of the fastener so that if the first rod 718 is deployed in the same direction as the muscle fibers 722, the wings are deployed across the muscle fibers to improve the retention strength of the fastener in the tissue.

[0326] Fig.57An embodiment of a fastener having a first stem 724 with arms 726 that curl when deployed from a needle is shown. The arms curl from the plane of the fastener across the muscle fibers 728 so that if the first stem is deployed in the same direction as the muscle fibers, the curled arms improve the retention strength of the fastener in the tissue.

[0327] Fig.58A -C and 59A-C show the front view, side view and enlarged side view of the two fasteners, respectively. Fig.58A -C shows a fastener 730 having a first rod 732 with a circular cross section. The diameter 734 of the circular cross section is smaller than the diameter 736 of the circumscribed circle of the first rod 738 surrounding the fastener 740, as shown in FIG. Fig.59A -C, fastener 740 has a rectangular / square cross-section of similar stiffness / strength. The smaller diameter 734 allows the first shaft 732 to fit within a needle with a smaller inner diameter (ID). In other words, a fastener with a rectangular / square cross-section requires a larger diameter slotted needle than a fastener with a circular cross-section of comparable stiffness / strength. Potential benefits of a needle with a correspondingly smaller outer diameter (OD) include requiring less force to puncture an inlay material (e.g., ADM) with the needle and requiring less force to extract the needle from the inlay material. Another potential benefit of the smaller diameter 734 of the first shaft 732 is the additional space in the needle, which is sized for the rectangular / square cross-section. This additional space can reduce the amount of stabilizing force required by the user during deployment of the fastener (e.g., as described above with respect to Figure 23-31 described above).

[0328] like Fig.58A As shown in FIG. 7-C, in some embodiments, the fastener 730 may also have a connector or filament 742, whose height 744 is less than the diameter 734 of the first rod 732. Fig.60 As shown, this allows the needle slot 746 to prevent the first shaft 732 from inadvertently exiting the needle lumen 748. The second shaft 750 can have a different or the same diameter as the first shaft 732.

[0329] like Fig.61A As shown in FIG. 1 and B, in some embodiments, the fastener 752 may be manufactured in multiple steps, wherein an initial step produces a preliminary shorter filament length 754 ( Fig.61A In subsequent manufacturing steps, the filaments may be stretched to longer lengths 756 ( Fig.61B). Stretching can be used for a variety of purposes. First, for polymers that tend to stretch under certain loads, the stretching manufacturing process can reduce / eliminate stretching that may occur after implantation. As a result, the proximity and / or compression between the inlay material (e.g., ADM) and the tissue achieved at the time of implantation can be better maintained over time to benefit healing. Second, stretching will reduce the cross-sectional geometry of the filament. This can create more room in the lumen of the needle for the first rod 758 and filament 756 to pass through the inlay material. This additional space can reduce the amount of stabilizing force required by the user during fastener deployment (e.g., as described above with respect to Figure 23-31 The smaller cross-sectional geometry of the filament will also allow for a smaller needle slot width, which can prevent the first rod from inadvertently exiting the lumen of the needle (e.g. Fig.60 Third, stretching will make the filaments more flexible. The additional filament flexibility can facilitate reorientation of the second rod 760 to optimize placement of the second rod and approximation and / or compression of the inlay material / tissue (e.g., as described above with respect to Figure 32-43D described above).

[0330] Alternatively, stretching to a variable or predetermined length may also be performed within the device during deployment.

[0331] Fig.62A -C shows an embodiment of a fastener having a first shaft 762 and a second shaft 764 extending in different directions. The directions may be different than those shown in FIG. 62. Extending the second shaft in a different direction than the first shaft may optimize placement of the second shaft and inlay material (e.g., ADM) / tissue approximation and / or compression (e.g., as described with respect to FIG. Figure 32-43D The fasteners may be delivered to the shaft / fastener reservoir 104 and deployed in an unstressed configuration as shown in FIG. 62. Alternatively, the ... Fig.10 62 ) and then returned to an unstressed (out-of-plane) configuration (e.g., as shown in FIG. 62 ) for deployment.

[0332] Fig.63 An embodiment of a fastener having a second shaft 766 having an end feature 768 (e.g., a chamfer) is shown. When the end feature contacts the inlay material (e.g., ADM) during deployment, the end feature causes the proximal end 770 of the second shaft to be tilted and away from the needle slot. This can optimize placement of the second shaft and inlay material (e.g., ADM) / tissue approximation and / or compression (e.g., as described above with respect to Figure 32-43D described above).

[0333] Fig.64An embodiment of a fastener having a second shaft 772 is shown, the second shaft 772 having a bend 774. The bend causes the second shaft to sweep over the needle and avoid the needle slot as the curved end travels toward the needle slot during deployment. This can optimize placement of the second shaft and inlay material (e.g., ADM) / tissue approximation and / or compression (e.g., as described above with respect to Figure 32-43D described above).

[0334] To provide additional control over inlay material (e.g., ADM) / tissue approximation and / or compression, the fastener may include filaments of adjustable length. One such embodiment is Fig.65 , with an adjustable length filament 776. After the filament is adjusted to the appropriate length (before or after implantation), the excess filament 778 can be trimmed if necessary.

[0335] Fig.66 and 67 An embodiment of a fastener is shown having a filament 780 that is angled relative to a first stem 782 and a second stem 784 of the fastener to facilitate a smaller cross profile 786 of the shaft / fastener reservoir 104 . Fig.67 A larger cross profile 788 is shown with the shaft / fastener reservoir containing the fasteners ( Fig.68 ) compared to a smaller cross profile 786, the fastener having filaments ( Fig.69 ).

[0336] Fasteners can be Fig.66 and 67 The stress-free configuration shown is delivered and deployed along the shaft / fastener reservoir 104. Alternatively (eg Fig.70 As shown), the fasteners can be Fig.69 The structure shown is deformed / stressed to Fig.66 The fasteners may return to their unstressed configuration (e.g., Fig.69 as shown) to deploy.

[0337] Fig.71 Embodiments of fasteners are shown that may include or be made of more than one material that will 1) have more favorable strain-related properties in the filament direction 790, which may promote elastic benefits in retaining / approximating and / or compressing an inlay material (e.g., ADM) / tissue, and / or 2) have different properties on both / either the first shaft 792 and / or the second shaft 794 to prevent mobility.

[0338] Figures 95A-95C 9500 of an embodiment of a fastener having a single thickness. The thickness 9520 of the fastener ( Fig.95C) may be about 0.03 inches (or about 0.01 inches to 0.05 inches, about 0.02 inches to 0.04 inches, about 0.025 inches to 0.035 inches, etc.). In some embodiments, the dimensions of the first and second rods are selected so that the first rod has flexibility or rigidity to curl (or disengage from the needle) when deployed from the fastening device, and the filament or connector connecting the first and second rods is strong enough to withstand the forces applied thereto when the first rod is deployed from the needle. In some embodiments, the length 9508 of the first rod is about 0.33 inches (or about 0.23 inches to 0.43 inches, or about 0.325 inches to 0.335 inches, etc.). In some embodiments, the height 9510 of the first rod is about 0.03 inches (or about 0.01 inches to 0.05 inches, about 0.02 inches to 0.04 inches, about 0.025 inches to 0.035 inches, etc.). In some embodiments, the width 9512 of the filament or connector is about 0.02 inches (or about 0.01 inches to 0.03 inches or about 0.015 inches to 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 inches to 0.24 inches, 0.15 inches to 0.19 inches, 0.16 inches to 0.18 inches, 0.165 inches to 0.175 inches, etc.). In some embodiments, the length 9516 of the second rod is about 0.23 inches (or about 0.13 inches to 0.33 inches or about 0.225 inches to 0.235 inches, etc.). In some embodiments, the height 9518 of the second rod is about 0.04 inches (or about 0.01 inches to 0.07 inches, 0.02 inches to 0.06 inches, 0.03 inches to 0.05 inches, 0.035 inches to 0.045 inches, etc.).

[0339] Fig.96A-C shows another embodiment of a fastener 9600 of unique dimensions including a first rod 9602, a second rod 9604, and a filament 9606. For example, the first rod 9602 and the second rod 9604 have a circular cross-section. As described above, the dimensions of the first rod and the second rod are selected so that the first rod has the flexibility or rigidity to curl (or disengage from the needle) when deployed from the fastening device, and the filament or connector connecting the first rod and the second rod is strong enough to withstand the forces applied thereto when the first rod is deployed from the needle. In some embodiments, the diameter 9608 of the first rod 9602 is about 0.035 inches (or about 0.02 inches-0.05 inches, 0.025 inches-0.045 inches, or about 0.03 inches-0.04 inches, etc.). In some embodiments, the diameter 9610 of the second rod 9604 is about 0.04 inches (or about 0.01 inches to 0.07 inches, 0.02 inches to 0.06 inches, 0.03 inches to 0.05 inches, 0.035 inches to 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 inches to 0.036 inches or about 0.021 inches to 0.031 inches, etc.). In some embodiments, the length 9614 of the first rod 9602 is about 0.33 inches (or about 0.23 inches to 0.43 inches, or about 0.325 inches to 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 inches to 0.24 inches, 0.15 inches to 0.19 inches, 0.16 inches to 0.18 inches, 0.165 inches to 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 inches to 0.03 inches or about 0.015 inches to 0.025 inches, etc.). In some embodiments, the length 9620 of the second rod 9604 is about 0.23 inches (or about 0.13 inches to 0.33 inches or about 0.225 inches to 0.235 inches, etc.).

[0340] Fig.96D -F shows another embodiment of a fastener 9630 having unique dimensions including a first rod 9632, a second rod 9634, and a filament 9636. For example, the first rod 9632, the second rod 9634, and the filament 9636 have a rectangular cross-section. As described above, the dimensions of the first rod and the second rod are selected so that the first rod has the flexibility or rigidity to curl (or detach from the needle) when deployed from the fastening device, and the filament or connector connecting the first rod and the second rod is strong enough to withstand the forces exerted on it when the first rod is deployed from the needle. In some embodiments, the first rod ( Fig.96F) may have a thickness 9638 of about 0.039 inches (or about 0.019 inches to 0.059 inches, about 0.029 inches to 0.049 inches, about 0.034 inches to 0.044 inches, etc.), the first rod ( Fig.96E ) may have a height 9640 of about 0.033 inches (or about 0.013 inches to 0.053 inches, about 0.023 inches to 0.043 inches, about 0.028 inches to 0.038 inches, etc.), and the first rod ( Fig.96E ) can be about 0.33 inches (or about 0.23 inches to 0.43 inches, or about 0.325 inches to 0.335 inches, etc.). In some embodiments, the thickness 9644 ( Fig.96F ) 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 946 of the filament or connector 9636 ( Fig.96E ) 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 of the filament or connector 9636 ( Fig.96E ) 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 second rod ( Fig.96F ) may have a thickness 9650 of about 0.039 inches (or about 0.019 inches to 0.059 inches, about 0.029 inches to 0.049 inches, about 0.034 inches to 0.044 inches, etc.), and the second rod ( Fig.96E ) may have a height 9652 of about 0.026 inches (or about 0.016 inches to 0.036 inches, about 0.021 inches to 0.031 inches), and the second rod ( Fig.96E )'s length 9654 may be approximately 0.23 inches (or approximately 0.13 inches-0.33 inches or approximately 0.225 inches-0.235 inches, etc.).

[0341] Fig.97A -D shows another embodiment of a fastener 9700 having a curved filament or connector 9702. The curved filament or connector may facilitate a smaller cross profile 9704 of the shaft / fastener reservoir 104. Fig.97C A larger cross profile 9706 ( Fig.97D) compared to the smaller cross profile 9704. The curved filaments can also be used to optimize the placement of the second rod 9710 and the inlay material (e.g., ADM) / tissue approximation and / or compression (e.g., as described above with respect to Figure 32-43D described).

[0342] Other Delivery Device Embodiments

[0343] like Fig.72A -C, in some embodiments, the shaft 800 may have a hinged end 802 ( Fig.72A and B) and / or rotating end 804 ( Fig.72C ) to facilitate access during open and / or laparoscopic surgery.

[0344] like Fig.73 As shown, the shaft may have a fixed bend 806 at the distal end to facilitate access during the opening procedure.

[0345] like Fig.74A and 74B As shown, in some embodiments, the delivery device may have a replaceable cartridge (e.g., when the fasteners are exhausted). The replaceable cartridge may include the entire shaft 808 ( Fig.74A ) or only the distal end portion 810 of the shaft ( Fig.74B ). If the needle is part of a replaceable cartridge, the user will also benefit from a new needle on the cartridge.

[0346] like Fig.75A and 75B As shown, in some embodiments, needle 812 can be advanced away from shaft 814 ( Fig.75B ) and retract into the shaft ( Fig.75A ). With the needle in the retracted position, when the user inserts the device into the repair site (e.g., via laparoscopy or an open approach), the sharp needle tip is protected and prevents non-traumatic injury. Once the device is at the repair site, the user pushes the needle out of the shaft.

[0347] like Fig.76A and 76B As shown, in some embodiments, the sheath 816 can be advanced over the needle 818 ( Fig.76A ) and retract to expose the needle ( Fig.76B ). With the sheath in the advanced position, when the user inserts the device into the repair site (e.g., via laparoscopy or open surgery), the sharp needle tip is protected and prevents non-traumatic injury. Once the device is at the repair site, the user retracts the sheath to expose the needle. After the fastener is deployed, the sheath can be advanced to also apply countertraction to the inlay material (e.g., ADM) as the user withdraws the needle from the inlay material (e.g., similar to reference Figure 44-51 described embodiments that facilitate needle extraction).

[0348] Fig.98A -B shows another embodiment of a slotted needle 9800, which includes a unique outer diameter (OD) 9802, inner diameter (ID) 9804, and slot width 9806. As described above, the ID size is selected so that the stem of the fastener can reside in the ID, and the slot width size is selected so that the stem connector (aka filament) can travel along the length of the slot (with an interference fit or clearance fit with the slot). In some embodiments, OD 9802 is about 0.078 inches (or about 0.018 inches-0.148 inches, 0.048 inches-0.108 inches, 0.068 inches-0.088 inches, etc.). In some embodiments, ID 7804 is about 0.063 inches (or about 0.010 inches-0.140 inches, 0.040 inches-0.100 inches, 0.060 inches-0.080 inches, etc.). In some embodiments, the slot width 9806 is approximately 0.035 inches (or approximately 0.020 inches-0.050 inches, 0.025 inches-0.045 inches, 0.030 inches-0.040 inches, etc.), such that the slot width is larger than the filament to minimize or eliminate deformation and / or indentation on the fastener filament during deployment, and smaller than the fastener rod to prevent the rod from inadvertently exiting the needle lumen.

[0349] Fig.99A Another embodiment of a curved (not straight) slotted needle 9900 is shown, where the needle tip 9902 is on the outside of the curvature and the slot 9904 is on the inside of the curvature. Fig.99B Another embodiment of a slotted needle 9906 is shown that is curved with the needle tip 9908 on the inside of the curvature and the slot 9910 on the outside of the curvature.

[0350] Fig.100A -B shows a slotted needle 10000 ( Fig.100A ) embodiment, the slotted needle 10000 includes a non-sharp edge 10002 ( Fig.100B ), these non-sharp edges, such as broken edges, rounded edges, polished edges, etc., are used for a narrow slot of a certain length, so that these non-sharp narrow slot edges will not break, cut or damage the filaments of the fastener during deployment.

[0351] Additional Embodiments of Apparatus and Methods for Fastening Inlay Materials

[0352] Fig.77 An embodiment of a device 900 comprising two deployment needles 902 is shown. The two needles penetrate an inlay material 904 (e.g., ADM) and tissue 906. Fig.78As shown, each needle deploys a rod 908 of the fastener in the tissue. The filaments 910 hold and approximate and / or compress the inlay material to the tissue, such as Fig.79 shown.

[0353] Fig.80 An embodiment of a device 912 including a deployment needle 914 is shown. Fig.81 In the embodiment, the needle pierces the inlay material 904 (e.g., ADM) and the tissue 906 at a first location 916, and deploys a first rod 918 in the tissue. Fig.82 In the embodiment, the needle is retracted from the first position 916, pierces the inlay material and tissue at the second position 920, and deploys the second rod 922 in the tissue. The filament 924 holds and approximates and / or compresses the inlay material to the tissue, such as Fig.83 shown.

[0354] Embodiments of devices and methods allowing interrupted suturing

[0355] The following concepts illustrate how fasteners may be used in other device platforms to deliver rapid, interrupted suturing to join two or more tissues.

[0356] Fig.84 An embodiment of a device 1000 having opposing jaws is shown. A first jaw 1002 has a slotted needle 1004 (to deploy the fastener), and a second jaw 1006 has an opening or slot 1008 at the end of the jaw.

[0357] exist Fig.85 In the embodiment, the user aims the needle tip at a fixed location on a first tissue 1010 (or other material), and then closes the opposing jaws 1002, 1006 so that the needle pierces the first tissue at the target fixed location and moves through the opening 1008 at the end of the second jaw 1006.

[0358] exist Fig.86 In the embodiment of the present invention, the user opens the opposing jaws 1002, 1006 and holds the first tissue 1010 on the needle.

[0359] exist Fig.87 In the embodiment, when the first tissue 1010 is located on the needle, the user can move the device to bring the first tissue 1010 close to the second tissue 1012 (or other materials). The user uses the needle tip to aim at a fixed position on the second tissue, and then closes the relative jaws 1002, 1006, so that the needle pierces the second tissue at the target fixed position and moves through the opening 1008 at the end of the second jaw 1006.

[0360] exist Fig.88 and 89, a user deploys a first rod 1014 and a filament 1016 of a fastener through two tissues such that the first rod 1014 and the second rod 1018 hold / secure / approximate together the second tissue 1012 and the first tissue 1010, respectively.

[0361] exist Fig.89 In the process, the user opens the opposing jaws to remove the needle and device from the fixation site, leaving the tissues approximated and fixed together by the fasteners. The user repeats the process for the next fixation site.

[0362] The benefit of this platform over existing methods is that the user can quickly access tissue and / or materials and secure them together with intermittent fixation using only one hand or without an assistant.

[0363] The opposing jaws may be joined by a single hinge (e.g., closed like scissors / hemostats). The opposing jaws may also be joined by multiple hinges (e.g., closed like parallel jaw clamps).

[0364] In some embodiments, Figures 84-89 The device shown in includes features described with respect to other embodiments of the fastening device described herein. For example, in some embodiments, the device includes one or more inclined surfaces (e.g., as described with respect to Figure 38-4 20), the bevel is configured to redirect a portion of the fastener (e.g., the second rod) as it is deployed. Examples also include features (such as a guide) that can help retain tissue on the needle and / or allow the user to lift tissue from underlying structures and deploy the fastener without inadvertently fastening the underlying structure. Figure 23-26 and Figure 28-31 ).

[0365] Fig.90 An embodiment of a device 1020 including two deployment needles 1022 is shown. Fig.91 As shown, one of the deployed needles punctures the first tissue 1024. Fig.92 and 93 In the embodiment, the device is moved to bring the first tissue 1024 into proximity with the second tissue 1026 by puncturing the second tissue with another deployment needle. Fig.94A In each needle, a rod 1028 of a fastener is deployed through tissue / in tissue. Fig.94B In the embodiment of the present invention, the filaments 1030 hold and approximate and / or compress the tissue together. The device may also incorporate any of the embodiments described in this document to facilitate the procedure. Examples include features (such as a needle) that help hold the tissue on the needle and / or allow the user to lift the tissue away from the underlying structure and deploy the fastener without inadvertently fastening the underlying structure. Figure 23-26 and Figure 28-31For another example, in some embodiments, the device includes one or more inclined surfaces (e.g., as described with respect to Figure 38-4 20), these slopes are configured to redirect a portion of the fastener (e.g., the second rod) when it is deployed.

[0366] The benefit of this platform over existing methods is that the user can quickly access tissue and / or materials and secure them together with intermittent fixation using only one hand or without an assistant.

[0367] Embodiments of Features Allowing Robotic Control

[0368] In some embodiments, the fastening devices and mechanisms described herein may be configured to function under robotic control.It should be appreciated that any embodiment or combination of the embodiments and features described herein may be used in robotic applications.

[0369] In the operational embodiments of the fastening device described above, the manipulation and deployment of the fastener occurs within the distal end of the device. The proximal handle provides the required interface / motion for delivering the fastener within the shaft and translating the fastener to the distal end where it is manipulated into the needle or tines for deployment.

[0370] For surgical robotic applications, instead of the robot holding the fastening device by the handle and squeezing the trigger as the surgeon does, the distal end of the device is converted into an end effector (which may include a transition element) and the mechanical action of the handle is replaced by the basic function of the surgical robotic arm.

[0371] Fig.158 An end effector 15810 is shown attached to a surgical robot 15812. Using a combination of rotation 15816 and joint 15818, the surgical robot can position the end effector and, in combination with other robotic tools (e.g., forceps) as needed, position and puncture a patch on tissue prior to deploying a fastener (or vice versa).

[0372] Fig.159 Embodiments of the paths that a fastener takes as it moves from transport to deployment in a handled and robotic end effector form of a fastening device are compared. In some embodiments, the function of the end effector is to transfer and manipulate the fastener from transport to prepare it for deployment. As previously described, transport can include a variety of configurations and hold as few as one fastener and as many fasteners as desired.

[0373] A unique aspect of the robotic interface may be to replicate the cyclic action of the handle mechanism to deliver and transfer the fastener from the delivery reservoir to the end effector, preparing the fastener for another element of the deployment fastener. In some embodiments, the delivery pusher 15814 advances in length increments that are approximately the same as the length of the fastener. These increments may be long enough to transition the fastener from the delivery reservoir to a position in front of the deployment element 15813. The delivery pusher 15814 is held in place to prevent other fasteners in the queue from advancing prematurely and blocking the mechanism before the deployment element 15813 is activated. Once activated, the deployment element 15813 pushes the fastener through the end effector, manipulating the configuration of the fastener before the motion fastener passes through the needle / cusp, the inlay material (e.g., the patch) into the tissue and is released from the needle / cusp. The deployment element 15813 may start and stop during the deployment process, but must be fully deployed before retracting to ensure that the fastener is fully deployed, and the transition area is transparent and ready to repeat the cycle.

[0374] Fig.160 Shown is 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 end effector position (e.g., move in, move out, rotate, and articulate) and internal push / pull control rods to replicate the fastener handle motion to deploy the fastener.

[0375] The proximal end of the fastening device has the necessary features to quickly connect the fastening device to the surgical robot. The internal push / pull rod in the fastening device 16021 is oriented and advanced to capture the mating features on the push / pull rod 16023 in the surgical robot 16020. The fastening device is then rigidly secured to the robot by advancing the clamping collar 16025 on the device end 16024 and screwing onto the robot 16020 ( Fig.162 ). Additional interface / indexing features (e.g., pins / holes and / or slots / keys) can be used to improve control / rigidity. In some embodiments, hollow features are utilized to pass other mechanical / electrical / fluid interfaces or supply lines (e.g., additional fasteners).

[0376] Removing the fastener for quick change requires the robot to position the lever 16023 to release ("home"), unscrew the threaded collar 16025, and pull the fastener off the end.

[0377] Figures 163-165 A more detailed view of an embodiment of the interface between the robotic device and the push / pull rod 16021 of the fastening device is shown. The push / pull rod on the fastening device is oriented and brought close to the robot, moving the ball portion of the connecting rod 16023 and deploying the connecting clip 16052 ( Fig.163As the fastening device is advanced toward the robot, the connecting rod advances into the connecting clamp pivot within the tube in the fastening device 16024, thereby capturing the connecting rod 16023 ( Fig.164 ). When attached to the robot, the pushrod / gripper assembly is pushed further into the fastener, establishing a lever connection that the robot can use to replicate the mechanical motion of the handle to advance and deploy the fastener.

[0378] In some embodiments, the robotic delivery portion (which stores a plurality of fasteners) includes a quick change interface, allowing the surgeon to replace an empty fastener cartridge with a new, full cartridge.

[0379] In some embodiments, the fastener bin can be replaced with or without removing the fastening device from the robot. The delivery section of the device holds the fasteners, where the fasteners are moved and deployed along the transition region. In some embodiments, the delivery section (e.g., box) is removable. When the fastener supply is exhausted, the delivery bin can be removed and replaced without having to remove / replace the fastening device from the robot. Fig.166 As shown, the delivery cartridge 16081 is filled with fasteners. The cartridge may have features that lock the cartridge within the device housing 16080.

[0380] Reference Fig.167 , cartridge 16081 is inserted into the device housing. The guide ensures that the cartridge is aligned with the features in the transition area of ​​the fastener. Fig.168 , the cartridge interface can be spring loaded to lock the cartridge 16081 in place and ensure that the deployment and delivery push rods (from the proximal end of the fastener) are aligned to move the fastener into the transition zone and deploy the fastener.

[0381] In some embodiments, the delivery reservoir, delivery pusher, and deployment element are flexible. The delivery cartridge may be made of flexible plastic, such as high and low density polyethylene, allowing it to bend within the fastener head and have a transition zone and deployment zone when the head is articulated.

[0382] Additional embodiments of the fastening device

[0383] In some embodiments disclosed herein, a target material to be bonded to another material (e.g., ADM) is held against a stop or other portion of an assembly while a fang or staple is inserted into the target material. Stabilizing the target material in this manner allows the staple to be inserted into a tough material such as an ADM. Currently, only sutures are used in tough materials such as an ADM. Devices and mechanisms such as those described herein allow the use of a suturing device to bond an ADM during a surgical procedure.

[0384] Figure 101A-1G shows an embodiment of a device configured to grasp and bind materials such as tissue or ADM. Fig.101A As shown, the device 10100 includes a housing 10102 , a push rod 10104 , and a connecting rod 10106 . Fig.101B The clamps 10108 are shown, each of which is connected to the connecting rod 10106 by a hinge. When the housing 10102 is pushed in, as shown in FIG. Fig.101C As shown, the clamp 10108 is closed and grasps the first target material (e.g., ADM). The device 10100 can be used to position the material as needed. The clamp 10108 can be opened, placed on the second target tissue or material and driven to pierce the two target materials. After the clamp 10108 has pierced the two materials, the entire device 10100 can be manipulated to retract the material so as to avoid the underlying structure during nail deployment.

[0385] Then push the push rod 10104, as Fig.101D and 101E As shown, the nail legs move along the clamp groove 10110, causing the nail 10112 ( Fig.101F ) are closed to each other and fix the target material. The clamp 10108 can also be used as a guard to prevent the nail legs from grabbing unintended materials during nail formation. If necessary, additional clamp actuation can be applied to close the nail more tightly, thereby increasing the compression on the bonding material.

[0386] Fig.101G Another embodiment of the device 10100 is shown in which the tips of the jaws 10108 meet after actuation. This capability can improve the grip of the jaws on the material (e.g., when pulling tissue or ADM away from underlying structures).

[0387] In some embodiments, the mechanism shown in device 10100 is located at the end of the shaft to facilitate access to restricted areas.

[0388] Fig.102A 10200 and 10204 show a device 10200 including a head 10202 at the end of a shaft 10201. A bracket 10204 extends from the head 10202 (e.g., when actuated). Fig.102C As shown, the pliers 10206 can be actuated and deployed from the bracket 10204 to grasp the target material so that the user can position the material when needed. Once the material is positioned, the pliers 10206 can be retracted, the bracket 10204 is placed against the material, and the pliers 10206 are actuated to pierce the material, such as Fig.102D As shown. Fig.102E As shown, while the forceps 10206 hold the pierced material, the bracket 10204 is retracted to position the material against the head 10202. The device 10200 can be manipulated to retract the material to avoid underlying structures during the nail deployment process. Fig.102FAs shown, the nail 10208 is deployed to fasten the materials to each other. The pliers 10206 also serve as a guard to prevent the nail legs from grabbing unexpected materials during the nail forming process.

[0389] Fig.103A -H shows an embodiment of using a device 10300 with clamping jaws, configured to be capable of deploying a hook 10304 (e.g., a flexible hook, a nitinol hook) from a lower jaw 10308 and a staple 10306 deployed from an upper jaw 10310. Fig.103A As shown, the hook 10304 is positioned in the lower jaw 10308 when the device is inserted into the surgical site. Fig.103B The upper jaw 10310 is shown clamped onto a target material 10312 (eg, ADM or tissue). Fig.103C The hook 10304 is shown actuated, with the target material secured to the device. Fig.103D The upper jaw 10310 is shown opened to allow the target material to be positioned to the second target material 10314 (to be joined). Fig.103E In the present invention, two materials are positioned together (eg, ADM is positioned on tissue). Fig.103F Shown is the upper jaw 10310 for clamping two materials. Figure 103G As shown, the nail 10306 is deployed to fasten the material together. The lower jaw 10308 also serves as a guard to prevent the nail legs from grabbing unexpected materials during the nail forming process. Fig.103H The hook 10304 is shown retracted, allowing movement or removal of the device 10300.

[0390] Fig.104 An embodiment of an upper jaw 10400 is shown that includes a window 10402. A frame 10404 around the window 10402 is used to clamp the material to be joined (e.g., ADM and tissue) between the upper and lower jaws. A staple 10406 ​​is shown in the upper jaw 10400 near the window 10402. The clamping holds the material taut, allowing the hook to pierce the material and the window.

[0391] Fig.105A -G shows an alternative embodiment of the device 10500 having clamping jaws, a rigid hook 10504 (instead of a flexible (e.g., Nitinol) hook) connected to the lower jaw 10502 by a hinge 10506, and a staple 10508 deployed from the upper jaw 10510. Fig.105B The upper jaw 10510 is shown clamped onto a target material 10512 (eg, ADM or tissue). Fig.105C The actuated rigid hook 10504 is shown, with the target material secured to the device. Fig.105DThe upper jaw 10510 is shown opened to allow the target material to be positioned to the second target material 10514 (to be joined). Fig.105E In the present invention, two materials are positioned together (eg, ADM is positioned on tissue). Fig.105F Shown is an upper jaw 10510 for clamping two materials and a staple 10508 for securing the materials together. The lower jaw 10502 also serves as a guard to prevent the staple legs from grabbing unexpected materials during the staple forming process. Figure 105G The rigid hook 10504 is shown retracted, allowing the device 10500 to be moved or removed.

[0392] Figures 106A-108B An embodiment of a device that can be used to secure and stabilize a first material and a second material to be joined is shown. Such a device is particularly useful for positioning and stabilizing tough materials (such as ADM) to be pierced by a nail. Stitching can be performed using an integrated or separate (e.g., currently available) stapler or suturing mechanism to secure the materials together.

[0393] Fig.106A and 106B A view of a device 10600 is shown including a needle 10602 (or other piercing member) attached to a first jaw 10604. A second jaw 10606 includes an opening 10608. Fig.106B As shown, the position and configuration of needle 10602 and hole 10608 allow needle 10602 to enter hole 10608 when jaws 10604, 10606 are closed.

[0394] Fig.107A -H shows the usage Fig.106A -B is an embodiment of a method of fastening a first material 10702 (e.g., ADM) to a second material 10704 (e.g., tissue). Fig.107A A needle tip 10706 is shown for targeting a fixed location on the first material 10702. Fig.107B As shown, jaws 10604, 10606 are closed, causing needle 10602 to pierce the first material through a hole in the second jaw (not shown). Fig.107C In the embodiment, the jaws 10604 and 10606 are opened. Fig.107D As shown, the first material 10702 is positioned at a desired fixed position on the second material 10704 using the needle 10602, and the fixed position on the second material 10704 is targeted using the needle tip 10706. Fig.107E In the embodiment, the jaws 10604, 10606 are closed and the second material 10704 is compressed onto the needle tip 10706 by inserting the needle 10602 into the hole of the second jaw. The entire device 10600 can be manipulated to retract the material to avoid underlying structures during the nail deployment process. Fig.107FA suturing mechanism 10708 is shown that can be extended to a fixation site and deploy staples 10710 to fix the target materials to each other. Figure 107G As shown, the suturing mechanism 10708 is retracted. The jaws 10604, 10606 are opened and the device 10600 is removed, as shown. Fig.107H In some embodiments, the device 10600 is modified so that the needle has a channel for the nail leg to easily pass through the first material (eg, tough ADM) and the second material.

[0395] Fig.108A and 108B Another jaw embodiment is shown having two opposing sharp tips 10802. Tips 10802 can be used to position a first target material 10806 to a second target material 10808, and can then be used to pierce the first material and secure the second material, such as Fig.108C and 108D As shown. The entire device 10800 can be manipulated to retract the target material (e.g., ADM and tissue) to avoid underlying structures during the nail deployment process. The suturing mechanism telescopes to a fixed position and deploys the nail to the material. The device can be modified so that each sharp tip has a channel for the corresponding nail leg to travel and easily pass through the first material (e.g., tough ADM) and the second material. The tip can also be modified to act as a guard to prevent the nail leg from grabbing undesirable materials during nail formation.

[0396] Fig.109A and 109B An embodiment is shown in which the nail 10902 is mounted on the end of the shaft 10904. The nail 10902 can be curved, with one end mounted to the end of the shaft 10904 and its sharp end separated from the shaft. The nail can be bent in a plane perpendicular to (or at a certain angle to) the shaft 10904. This positioning can allow the shaft to be rotated to drive the nail through adjacent materials.

[0397] Exemplary applications of such devices are Fig.110A As shown, the nail and shaft are inserted into the incision 11008. Fig.110B In the process, the pin and shaft are inserted into position to attach the ADM to the tissue. Fig.110C In the process, the shaft drives the staple through the ADM and tissue. Before closing the staple, the entire device can be manipulated to lift the tissue / ADM and check for inadvertent capture of underlying structures. Fig.110D In the embodiment of the present invention, the fork 11008 is advanced around the tip of the nail. Fig.110E In the , the shaft and fork actuate to bend and close the nail. Fig.110F During surgery, the device is removed and the closed staples secure the ADM to the tissue.

[0398] A device having this configuration can also be used to place the nail away from the edge of the target material (e.g., ADM). Figure 110G In the embodiment, the staples 10902 penetrate the ADM 11002 and the tissue 11004. The forks 11008 act as a stop for the top of the ADM to apply reverse traction so the staple tip can back up and penetrate the ADM 11002. Before closing the staples, the entire device can be manipulated to lift the tissue / ADM and check for accidental capture of underlying structures. Figure 110H In the embodiment, the shaft and fork are driven to bend and close the staples 10902, securing the ADM 11002 to the tissue 11004, as shown in FIG. Fig.110I shown.

[0399] Alternatively, the staples 10902 may pierce the ADM 11002 and the tissue 11004 without penetrating the ADM 11002, such as Fig.110J Before closing the staples, the entire device can be manipulated to lift the tissue / ADM and check for accidental grabbing of underlying structures. The staples 10902 legs above the ADM 11002 can then be bent to secure the ADM 11002 to the tissue 11004, as shown. Figure 110K and 110L shown.

[0400] Fig.111A and 111B Another embodiment is shown in which a nail 11102 is mounted on the end of a shaft 11104. The shaft 11104 may include two rods 11106, each connected to one side of the nail. This structure can be used to place the nail on or away from the edge of the target material (e.g., ADM).

[0401] The nail tip is placed on the ADM / tissue 11108, as Fig.111C The rod 11106 of the shaft 11104 rotates to close the nail 11102, as shown. Fig.111D As shown. The nail can then be released from the rod. This can be performed using a variety of methods (e.g., a push rod that pushes the nail off the shaft, a spring that pushes the nail off the shaft, etc.).

[0402] 112 shows another mechanism for closing staples 11202. The staple cross-section is located on a die 11204. Die 11206 is actuated toward die 11204, causing staples 11202 to close.

[0403] Fig.113A An embodiment of a staple 11302 having a pointed end 11304 and a pre-formed feature 11306 is shown. Fig.113B A staple 11302 is shown being grasped by a first jaw 11308 . Fig.113BAlso shown is a slot 11310 in the second jaw 11312 such that the nail tip 11304 enters the slot 11310 when the jaws 11308 , 11312 are closed.

[0404] The nail tip 11304 is used to target a fixed position on the target material 11314 (e.g., ADM). The jaws 11308, 11312 are closed, causing the nail tip 11304 to pierce the ADM 11314 by entering the narrow slot 11310 of the second jaw 11312, such as Fig.113C By sliding the nail, the ADM 11314 moves within the preformed nail feature 11306 until the ADM is positioned within the preformed nail feature, as shown. Fig.113D The jaws 11308 and 11312 are opened, the ADM 11314 is moved into position, and the nail tip 11304 is used to aim at a fixed position on the tissue, such as Fig.113D As shown. Fig.113E In the embodiment, the jaws 11308, 11312 are closed, causing the nail tip 11304 to pierce the tissue. When the nail tip 11304 enters the narrow slot 11310 of the second jaw 11312, the tissue 11316 is compressed onto the nail 11302. The entire device can be manipulated to lift the tissue / ADM and check whether the underlying structure is accidentally captured.

[0405] With the staple legs positioned in the slots of the second jaw 11312, the second jaw 11312 is rotated to close the staples ( Fig.113F ) and secure the ADM to the tissue. Figure 113G and 113H As shown, the preformed nail features and closed nail legs secure the ADM to the tissue. In some embodiments, the preformed nail features can be combined with Fig.113A -H, as long as the preformed features are used to prevent the target material (e.g., ADM) from separating from the nail. Examples may include one or more barbs ( Fig.113I ) or stop feature ( Fig.113J ).

[0406] Fig.114A Another embodiment of a staple 11402 having a staple tip 11404 and a preformed feature 11406 is shown. The staple 11402 is gripped by a first jaw 11408, such as Fig.114A The second jaw 11410 includes a hole 11412 and an anvil 11414, as shown. Fig.114B and 114C As shown. Fig.114B As shown, in some embodiments, hole 11412 can be positioned distal to anvil 11414. Alternatively, anvil 11414 can be positioned distal to hole 11412, such as Fig.114C shown.

[0407] Fig.115A -G shows the use of reference Fig.114A -C is an embodiment of the method of nail 11402 and jaws 11410, 11408. The nail tip 11404 is used to target a fixed location on the target material 11502 (e.g., ADM). Fig.115A As shown, the jaws 11408, 11410 are closed, causing the nail tip 11404 to pierce the ADM 11502 by entering the hole 11412 of the second jaw 11410. Fig.115B , the jaws 11408, 11410 are opened and the second jaw 11410 is actuated to align the anvil 11414 with the nail tip 11404. The ADM 11502 is positioned to target a fixed location on a second target material 11504 (eg, tissue) using the nail tip 11404.

[0408] exist Fig.115C and Fig.115D In the embodiment, the jaws 11408, 11410 are closed, the tissue 11504 is compressed against the nail tip 11404, and the nail tip 11404 is fed into the nail anvil 11414 in the second jaw 11410. The entire device can be manipulated to lift the tissue / ADM and check for inadvertent grasping of underlying structures. Fig.115E , the jaws 11408, 11410 continue to close, causing the anvil 11414 to curl / close the staple legs 11506 and secure the ADM 11502 to the tissue 11504. The anvil 11414 also serves as a guard to prevent the staple legs from grabbing unexpected materials during the staple forming process. Fig.115F The staples 11402 are shown in position when the jaws are retracted.

[0409] Fig.116A and 116B An alternative embodiment for closing the staples is shown. In the first jaw 11602, an element 11604 (e.g., a wedge or other mechanism) is actuated. This causes the staples to advance within the first jaw toward the anvil (where the anvil is within the second jaw), causing 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 conjunction with the closing jaws, as shown in FIG. 115 .

[0410] Fig.117 An alternative embodiment of a staple 11802 is depicted having a pre-formed feature 11806 and a pre-bent tip 11804 which enables the staple legs to bend in the proper direction in the anvil (rather than becoming stuck or bent in the anvil).

[0411] Fig.118A-C shows an alternative embodiment of a nail 11902 having a pre-formed feature 11904 and a pre-bent tip 11906 that enables the nail leg 11908 to be bent in the proper direction in the anvil (not shown). The pre-bent tip 11906 helps prevent the nail anvil from getting stuck or bent. Fig.118B As shown, by bending the distal end or leg 11908 in the anvil, and as Fig.118C As shown, the proximal end or leg 11910 is bent using a plunger or other mechanism to achieve staple closure.

[0412] Fig.119A -C shows an alternative embodiment of a staple 12002 that includes a plurality of pre-bends 12004 on a distal leg 12006 and a plurality of pre-bends 12008 on a proximal leg 12010. Staple closure is accomplished by bending the distal end or leg in the staple anvil and bending the proximal end or leg with a plunger or other mechanism. Fig.119C Staple 12002 is shown in a closed configuration.

[0413] Fig.120 A shield 12102 is shown having a sharp tip 12104 attached to a jaw 12106. A nail 12108 is located in a lumen 12110 of the shield. The sharp shield tip facilitates penetration of the target material (e.g., ADM). The shield 12102 provides rigidity to the nail 12108. This design mitigates unwanted bending or deformation of the nail legs caused by user-applied forces (e.g., which may cause the nail legs to miss the nail forming features on the second jaw, or may cause the nail to be improperly closed). The shield slot 12112 allows the nail to be closed. The nail may or may not have a sharp tip. The rigid shield may also allow for smaller nails because the shield takes the force applied by the user instead of the nail.

[0414] Fig.121A -C shows various views of an embodiment of the device 12200 having a staple 12202 with the staple barbs 12204 positioned in the first jaw 12206. Fig.121A As shown, the first end of the nail is bent at an angle so that it extends toward the outlet 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 stopper 12214, a cover (transparent to be able to see the internal features) and a second jaw 12216. Fig.121C The hole 12218 in the second jaw 12216 is shown.

[0415] Fig.122A -M shows the use Fig.121A -C. The device 12200 is inserted into the surgical site with the nail tip remaining in the lower jaw 12206. Fig.122AAs shown, the push rod 12212 is advanced until the nail barb 12204 contacts the stopper 12214 , causing the nail tip 12220 to extend out of the first jaw 12206 .

[0416] Fig.122B and 122C An advancing sliding forming member 12210 is shown bending the nail tips by pressing the nails 12202 against the forming features 12208. Fig.122B A schematic diagram of device 12200 is shown so that the internal components are visible, and Fig.122C The device used in surgery is shown so that the internal components are not visible. Alternatively, the above-mentioned nail tip bending can be performed before insertion into the surgical site, and when the device is inserted into the surgical site, the second jaw can be closed to hide the nail tip.

[0417] Fig.122D 12 and E show the nail tip 12220 being used to aim at a fixed position on the target material 12304 (in this case, the ADM). The jaws 12206, 12216 are then closed so that the nail tip 12220 pierces the ADM 12304 by entering the hole 12218 in the second jaw 12216.

[0418] like Fig.122F As shown in FIG. 1 and G, the stopper 12214 (contact nail barb) is disengaged. The jaws 12206, 12216 are then opened. In this case, the target material ADM is positioned to the second target material 12306 (e.g., tissue). The nail tip 12220 is used to aim at a fixed position of the second target material 12306. Fig.122F A schematic diagram of the device 12200 is shown, and Figure 122G Device 12200 is shown while performing a suturing procedure.

[0419] exist Figure 122H and 122I , the jaws 12206, 12216 are closed, compressing the tissue 12306 onto the staple tip 12220. The entire device can be manipulated to retract the tissue / ADM to avoid underlying structures during staple deployment. Fig.122H A schematic diagram of apparatus 12200 is shown, and Fig.122I Device 12200 is shown while performing a suturing procedure.

[0420] exist Fig.122J and 122K12206, the push rod 12212 is advanced. When the slide forming member 12210 is in its forward position, it bends the nail by pressing the nail against the forming feature 12208 in the first jaw 12206. As the push rod 12212 advances the nail, the compression area (created by the forming feature 12208 and the slide forming member 12210) continuously deforms the nail as the nail advances through the compression area, causing the nail to curl. The curled nail secures the ADM 12304 to the tissue 12306. The second jaw 12216 also serves as a guard to prevent the nail legs from grabbing unintended material during the nail forming process. Fig.122J A schematic diagram of apparatus 12200 is shown, and Figure 122K Device 12200 is shown performing a suturing procedure.

[0421] Figure 122L and 122M The staples 12202 are shown after being released from the device 12200. Figure 122L A schematic diagram of a closed staple 12202 is shown, and Figure 122M The closed staples 12202 are shown after a suturing procedure has been performed.

[0422] Fig.123A and 123B A portion of a device 12400 is shown with a pin 12402 positioned in a canine 12404. The canine 12404 is part of a head 12410 of the device. The device 12400 also includes a retractable stop 12406. The stop 12406 has a hole 12408 shaped to receive the canine 12404. The stop 12406 is retracted relative to the canine 12404 of the device. When retracted, the stop 12406 moves proximally relative to the canine 12404 (in a Fig.124E ). Using a stopper having a hole shaped to receive a puncture element (e.g., a fang) allows the device to puncture tough materials such as ADM without having to apply high force or pressure to the tissue. In some embodiments, the nail itself can be used as a puncture element.

[0423] Fig.124A -L shows the use Fig.123A and 123B An embodiment of a method of apparatus 12400 is shown in FIG. Fig.124A and Fig.124B The operation of the device 12400 is shown such that the target material 12502 (e.g., ADM) to be bonded is positioned between the fangs 12404 and their associated stop holes 12408. The fangs 12404 are used to target a fixed position on the ADM 12502. The stop 12406 is then actuated to push the ADM 12502 onto the fangs 12404. Fig.122A -L is similar, Fig.124AA schematic diagram of the device 12400 is shown, and Fig.124B The device is shown while performing a suturing procedure.

[0424] Fig.124C and 124D The stop 12406 is shown opened to disengage from the canine 12404, causing the hole 12408 to exit from the canine 12404. Fig.124C A schematic diagram of the device 12400 is shown, and Fig.124D The device is shown performing an anastomosis procedure.

[0425] Fig.124E and 124F The stop 12406 is shown retracted so that it moves proximally relative to the canine 12404, thereby exposing the canine 12404. Fig.124E A schematic diagram of the device 12400 is shown, and Fig.124F The device is shown performing an anastomosis procedure.

[0426] exist Figure 124G and 124H In the embodiment of the present invention, the fangs 12404 are used to target a fixed location on the second target material, in this case tissue 12504, and position the ADM 12502. 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 nail 12402 from grabbing / damaging the underlying structure.

[0427] Fig.124I and 124J The nail 12402 is shown being formed. The cross section of the nail 12402 is located on the central mold 12510. The outer mold 12508 is activated to bend the nail on the central mold 12510. Actuating the outer mold 12508 includes Fig.124I and 124J The staple legs 12506 bend inwardly, gathering, compressing and securing the ADM to the tissue.

[0428] The nails can also be deployed in stages. In the first stage, Fig.124I As shown, staples 12402 grasp ADM 12502 and tissue 12504. Before fully closing the staples, the device can be manipulated to retract the tissue / ADM to avoid underlying structures before fully closing the staples. While keeping the tissue / ADM away from underlying structures, the staples can be fully closed, such as Fig.124J shown.

[0429] exist Figure 124K During stapler operation, the staples are separated from the center mold and separated from the stapler. The ejector can help push the staples away from the center mold.

[0430] use Figures 123A-124K Another approach to the device described in is to not use a stopper, but to directly penetrate the inlay material and the underlying tissue with the canine, so that the canine penetrates the inlay material and enters the underlying tissue. Figures 124I-124J The nail can also be deployed in stages. In the first stage, as Fig.124I As shown, staples 12402 grasp ADM 12502 and tissue 12504. Before fully closing the staples, the device can be manipulated to retract the tissue / ADM to avoid underlying structures before fully closing the staples. While keeping the tissue / ADM away from underlying structures, the staples can be fully closed, such as Fig.124J shown.

[0431] In some embodiments, the device 12400 includes a staple storage device 12600 that is shaped and configured to accommodate a plurality of staples, such as Fig.125 Staple storage device 12600 may be fixed to stapling device 12400 or may be a replaceable cartridge.

[0432] Fig.126 Including similar to Fig.125 An embodiment of a device 12700 having a stapler head 12702 of the structure shown. The stapler head 12702 is located at the distal end of the shaft 12704 and is capable of placing staples in a restricted area. The device 12700 includes a handle 12706 and an actuator 12708, which can be used to control the function of the stapling mechanism.

[0433] Fig.127A and 127B An embodiment of a device 12800 is shown having teeth 12802 on a rotating head 12804 to enable placement of staples on both sides and / or in restricted locations of, for example, a breast implant. Fig.127A Device 12800 is shown with the rotating head positioned so that the fangs 12802 are located on a first side of the device 12806. Fig.127B The device 12800 is shown with the head rotated approximately 180° so that the fangs 12802 are located on a second side of the device 12806. The head may also be rotated through a range of angles.

[0434] Fig.128A -C shows an embodiment of a device 12900 with an articulated head 12902. The articulated head 12902 can place the nail in a restricted area. In some embodiments, the head 12902 can be articulated by rotating around a hinge point 12904. Fig.128A -C shows the head 12902 articulated in a first position, a second position, and a third position, respectively.

[0435] In the embodiments of the staple formation described herein, as Fig.129Aand 129B As more clearly shown in FIG. 1 , when the staple 13002 is formed, the fangs 13004 and the staple 13002 stretch the hole 13006 in the target material 13008 (e.g., ADM). The stretched hole 13006 prevents the staple from closing. In some embodiments, the device or mechanism also includes a feature that enhances or improves staple formation.

[0436] Fig.130A -C shows a device 13100 with retractable fangs 13102. When the nail 13104 begins to clamp (the nail closing mold is not shown), the fangs 13102 are retracted, such as Fig.130C As the tines are retracted, the ADM can more easily conform to the formed nail legs.

[0437] Fig.131A -B shows an embodiment of an optional feature that may be present on a cusp or device portion. In some embodiments, the cusp 13202 includes a blade 13204 that creates a slit 13208 in the cusp hole 13206 (the hole created by the cusp in the target material). As shown, the blade can extend along the length of the cusp (e.g., on its shorter side) and can include a tapered shape. When the nail is formed, the nail leg 13210 can enter the slit so that the leg can be completely closed. Fig.131C Shown by Fig.131A and 131B Top view of exemplary fang holes 13206 and slits 13208 formed by the combination of fangs 13202 and blades 13204.

[0438] Fig.132 An embodiment of an articulated fang 13302 is shown. Fangs 13302 can be used to bend the nail tip 13304 inwardly and assist in nail closure. The articulated fangs can also grasp the two target materials to be joined. The entire device can be manipulated to retract the material to avoid the underlying structure during the deployment of the suture nail. Fangs 13302 can also be used as a guard to prevent the nail legs from grabbing unexpected materials during nail formation.

[0439] Fig.133A and 133B An embodiment of a fang 13402 is shown that includes internal features configured to close the staple. These features also serve as guards to prevent the staple legs from grabbing unwanted material during staple formation. Fig.133A and 133BAs shown, the feature can include an angled edge or surface 13404 configured to push the staple legs 13406 inwardly when the staple legs 13406 are moved toward the edge or surface 13404. The feature can also include another edge or surface 13408 about which the staple legs 13406 bend when pushed in that direction and proximate to the angled edge or surface 13404.

[0440] Fig.134A -C shows a canine 13502 with adjustable positions. In a first position, as Fig.134A As shown, during the insertion and removal of the device, the fangs 13502 are hidden to prevent damage to surrounding structures. Fig.134B In the second position shown, the tines 13502 are slightly exposed and configured to penetrate tissue at a shallow depth. Fig.134C In the third position shown, the canine 13502 is further exposed and configured to penetrate tissue at a deeper depth. The staples can be configured to not extend beyond the tip of the canine, thereby protecting the underlying structures. Optional depth markings 13504 on the canine can help the user set the canine to the proper length.

[0441] Fig.135 An embodiment of a fang 13602 having external threads 13604 is shown. When the fang is placed on top of a first target material 13606, such as an ADM, and a second target material 13608, such as tissue, the fang 13602 is rotated to penetrate the material. The fang 13602 can be rotated until a desired depth into the material is reached, thereby avoiding underlying structures. When the threads are engaged in the ADM and tissue, during nail deployment, the fang can be used to pull the ADM and tissue apart to protect the underlying structures.

[0442] Fig.136A -C shows various embodiments of fang 13702. Fig.136A A canine 13702 is shown having barbs 13704 positioned along the length of the canine 13702. Fig.136B A canine 13702 is shown having a plurality of notches 13706 positioned along the length of the canine 13702 . Fig.136C A cuspid 13702 is shown having a plurality of necks 13708 positioned along the length of the cuspid 13702. When the cuspid is inserted into the target material to a desired depth, the barbs, notches, and / or necks grip the target material. During nail deployment, the cuspid can be used to pull the material apart to protect the underlying structure.

[0443] In some embodiments, the fang tip has various sharp tip designs, such as a lancet tip, a vet (reverse grind) tip, a trocar tip, etc. These various tip designs can facilitate easy insertion through tough materials, such as ADM.

[0444] In some embodiments, the fangs can be replaceable. For example, the fangs can be part of a replaceable nail cartridge, as described herein. In other embodiments, no matter how the cartridge is used, the fangs themselves are replaceable.

[0445] Fig.137 An embodiment of a canine 13802 configured to flip downward (or rotate, or snap, or hinge, etc.) is shown. The canine can be configured to be hidden within the head 13804 of the device to protect surrounding structures. Then, when needed, the canine 13802 can be configured to flip downward, such as Fig.137 shown.

[0446] In some embodiments, the fangs 13902 are covered by a shield 13904 to protect surrounding structures, such as Fig.138 As shown. The shield 13904 is configured to be retracted when the canines are needed.

[0447] In some embodiments, the fangs 14002 may be hidden in the stop holes 14004, such as Fig.139 As shown. The stopper 14006 can be configured to be actuated and retracted when the canine 14002 is needed.

[0448] The embodiments described herein (wherein the fangs are used to penetrate the target material) can be adapted to allow the nail legs to perform the function of the fangs. In other words, the nail legs can be configured to penetrate the target material instead of the fangs, thereby eliminating the fangs.

[0449] Fig.140A and 140B Embodiments with nails of different shapes are shown. Fig.140A The nail 14102 has a more square shape, while Fig.140B The nail 14102 has a more rounded shape. Fig.140B The radius on the nail 14102 can enable the target material to slide more easily along the nail leg during nail formation (e.g., to prevent snagging).

[0450] In some embodiments, the stapler or stapler is configured so that the staple formation results in one staple leg being positioned above the other, such as Fig.141A As shown in the front view. Fig.141B As shown in the top view of the figure, this configuration can help prevent the nail legs from spreading out of the plane.

[0451] like Fig.142A-D, after the nail is formed and the forming die is retracted, the nail legs can spring apart slightly. Fig.143A -C shows the nail forming. Fig.142A In the embodiment, the forming mechanism 14302 is located above the pin 14304 and the center mold 14306. Fig.142B In the process, the forming mechanism descends onto the nail and bends the nail legs 14308 around the center mold 14306. Fig.142C , the forming mechanism 14302 is lifted from the staples 14304. Removing the compressive force of the forming mechanism 14302 causes the staple legs 14308 to spring apart slightly. Fig.142D Another embodiment of a staple 14310 is shown in which the legs 14312 are slightly sprung apart.

[0452] Fig.143A An embodiment of a staple 14402 is shown having features that hold the staple legs 14404 closed after the forming die is retracted. Fig.143A As shown, staples 14402 include protuberances 14406 whose geometry, size, and position can be varied to adjust the position of the closed staple legs. Fig.143B The staples 14402 are shown compressed into a closed position by the mold 14408. Fig.143C The nail 14402 is shown with the mold removed and the legs 14404 remaining closed.

[0453] Fig.144 Another embodiment of a staple 14502 is shown in which the staple legs remain closed after the forming die is retracted. The staple 14502 includes a protuberance 14504. The geometry, size, and position of the protuberance can be varied to adjust the position of the closed legs 14506.

[0454] In some embodiments, the staples are made of a resorbable material.

[0455] Figures 123A-144 The illustrated embodiment may allow a single user to access the incision and place staples. Currently, two people may be required to sew an incision: two hands to grasp and close the tissue on both sides of the incision, and another hand to deploy the staples (three hands in total). The user can operate the Figures 123A-124K The device described is to secure tissue on side 1 of the incision in one canine, approximate tissue on side 2 of the incision, secure tissue on side 2 of the incision in the other canine, and then deploy the staples.

[0456] Fig.145A -D shows an example of a single user using this device. Fig.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 the tip 14606. Fig.145BThe materials are shown when the device is used to approach the materials. The first material 14602 and the second material 14604 are brought closer together. Fig.145C The materials are shown adjacent to each other. A second cusp (not shown) holds the second material 14604 at the tip 14608. Fig.145D Materials 14602 , 14604 are shown after pins 14610 have been deployed to join materials 14602 , 14604 .

[0457] Fig.146A -D illustrates a method of using a stapler (not shown) that forms the staple legs 14702, 14704 at different times. Fig.146A Two materials 14706, 14708 to be bonded are shown. Fig.146B As shown, the surgeon can activate the stapler to close one leg 14702 of the staple in the tissue 14706 (or material). Fig.146C As shown, the surgeon can then move the stapler to approximate the tissue (or material). Fig.146D The material 14706, 14708 is shown after the stapler is actuated a second time to close the other leg 14704 of the staple in the second tissue 14708 (or material). The method can be applied to staplers with cusps, or to staplers that use staple legs to perform the cusp function without cusps.

[0458] Fig.147A -D shows something like Figures 101A-101G Another embodiment of the suturing mechanism 14800 described. Fig.147A A first arm 14802 is shown having a first cusp or clamp 14804 and a first stop hole 14806. The suturing mechanism 14800 also includes a second arm 14808 having a second cusp or clamp 14810 and a second stop hole 14812.

[0459] Fig.147B The fangs 14804, 14810 are shown placed on a first target material 14814 (e.g., ADM) and used to target a fixed position on the ADM. The arms 14802, 14808 are actuated, folding the ADM. This causes the fangs 14804 to pierce the folded ADM 14814 and enter the stop hole 14812, and the fangs 14810 to pierce the folded ADM and enter the stop hole 14806.

[0460] exist Fig.147C , arms 14802, 14808 are opened so that canine 14804 is pulled out of stop hole 14812 and the corresponding position of the ADM, and canine 14810 is pulled out of stop hole 14806 and the corresponding position of the ADM. The ADM adjacent to the base of the canine remains attached to canine 14804 and canine 14810. Fig.147DIn the embodiment of the present invention, the ADM 14814 is positioned, the tines 14804, 14810 are used to target a fixed location on a second target material 14816 (e.g., tissue), and the tines 14804, 14810 are inserted into the tissue. If the device has a staple forming mold (e.g., as described with respect to FIGS. 112 and 124I-J), the staples can be deployed to collect, compress, and secure the ADM to the tissue. The staples can also be deployed in stages (e.g., Fig.124I -J) to pull the tissue / ADM apart and protect the underlying structures prior to closing the staples.

[0461] If the device uses a cusp-shaped nail (e.g., as described in Figures 101A-101G As described), arms 14802, 14808 are partially actuated, such as Fig.147E As shown. The device can be manipulated to retract tissue 14816 and ADM 14814 to avoid underlying structures during nail deployment. In some embodiments, to close the nail, the push rod is advanced to deploy the nail; the nail legs are advanced and travel along the cusp grooves, and the nail is closed to collect, compress and fix the ADM to the tissue. The cusps also serve as guards to prevent the nail legs from grabbing undesirable materials during nail formation.

[0462] Fig.148A -D shows an embodiment of a fang including features configured to enhance the performance of the device in Figure 147. For example, Fig.148A An embodiment of a canine 14902 is shown that includes a notch 14904 to better retain material (e.g., ADM) at the base of the canine. The canine 14902 also includes a tapered portion 14906 to enable the distal end of the canine 14902 to be easily pulled out of a material such as ADM. Fig.148B An embodiment of a fang 14902 is shown that includes a lubricious coating 14908 that is configured to allow the distal end of the fang 14902 to be easily pulled out of a material such as ADM. Fig.148B The fang 14902 also includes a notch 14904. Fig.148C An embodiment of a canine 14902 is shown that includes a barb 14910 that is configured to better retain a material, such as ADM, at the base of the canine. Fig.148D An embodiment of a canine 14902 is shown that includes a neck 14912 that is configured to better retain a material, such as an ADM, at the base of the canine.

[0463] In some embodiments, the suturing mechanism can use an energy source to assist the fangs or nails in piercing the material, such as ADM. In some embodiments, a high frequency (e.g., radio frequency) current can be applied to the fangs or nails. In some embodiments, a laser can be used to cut a hole in the material (e.g., ADM). In some embodiments, ultrasonic energy is applied to the fangs or nails.

[0464] Fig.149 A sheet 15000 of a material (e.g., ADM) is shown that has been prepared with a plurality of holes 15002. The prepared holes 15002 eliminate the burden on the fangs or nails due to having to pierce the toughness of materials like ADM. With the prepared holes 15002, the nail legs can easily pass through the holes.

[0465] Figure 150A A bone anchor 15100 for securing soft tissue (or ADM, patch, membrane, etc.) to bone is shown. The bone anchor has a nail wire feature 15102 extending from the bone anchor 15104.

[0466] The device 15100 may be used to simplify / eliminate procedures involving complex suture management (eg, arthroscopic rotator cuff repair). Fig.150B The bone anchoring feature 15104 inserted into the bone 15106 and the nail wire feature 15102 protruding from the bone 15106 are shown. Fig.150C Material 15108 (eg, tissue) is shown pushed onto the nail wire feature 15102 . Fig.150D A formed staple feature 15102 is shown securing tissue 15108 to bone 15106 .

[0467] Fig.151A and 151B A view of a stapler concept is shown with a shaft 15202 holding a plurality of spring staples 15204 open. The shaft 15202 rotates and drives the staples 15204 through the material to be secured together, such as tissue (or ADM, patch, membrane, etc.). Fig.151C As shown, as the nail falls off the end of the shaft, the nail 15204 shrinks to a smaller size to gather, compress and secure together the materials 15206, 15208. The next nail is advanced to the end of the shaft and is ready for deployment.

[0468] Fig.152A -C shows an embodiment of a device 15300 that is in proximity to a material such as tissue (or ADM, patch, membrane, etc.) so that the staples can secure the tissue together. Fig.152ATextured wheels 15302, 15304 are shown with one wheel contacting tissue 15306 on one side of an incision 15308 (or gap). The other wheel 15304 is contacting tissue 15310 on the other side of the incision 15308 (or gap). The wheels 15302, 15304 are rotated (as indicated by the arrows) to collect tissue. Fig.152B The textured wheels 15302, 15304 are shown after rotation, wherein tissue 15306, 15310 from either side of the incision 15308 has been approximated between the wheels. Fig.152C Staples 15312 are shown securing tissues 15306, 15310 together. The rotating wheel can be a separate device from the stapler or integrated into the stapler device.

[0469] Fig.153A A polymer strand 15402 is shown having a series of openings 15404 at one end of the strand. A guide tube 15406 is used to penetrate a material 15408 (e.g., tissue) to be secured together. The tissue may also be an ADM, a patch, a membrane, etc. The polymer strand 15402 is advanced in the guide tube 15406 until the distal end 15410 of the polymer strand 15402 passes through the openings 15404 in the strand.

[0470] like Fig.153B As shown, the heating element fuses the strands 15402 at the openings 15404 to create a fixation ring 15414 that compresses and secures the tissue together. Fig.153C As shown, slots 15416 along the length of the inner ring of the guide tube 15406 allow the guide tube to be removed, leaving behind the suture. The excess length of the polymer strands can be trimmed, leaving only the fixed ring / suture.

[0471] Fig.154A -E shows an embodiment of a device 15500 configured to approximate and engage tissue. Fig.154A As shown, device 15500 includes a sharp hollow or tubular arm 15502, which is shown penetrating a material or tissue 15504. The material can be an ADM, a patch, a membrane, or the like. Fig.154B An arm 15502 is shown for bringing material 15504 into proximity with material 15506 to be joined. Fig.154C In the embodiment, the sharp arms 15508 (tube arms, hollow arms) have penetrated the material 15506 so that the tips of the arms 15502, 15508 fit together. The tips can be shaped so that they are configured to fit together, thereby forming the arms 15502, 15508 into a loop. Fig.154D As shown, a material, such as a heated polymeric material, is injected into the lumen 15510 of the arms 15502, 15508. Fig.154EAs shown, the material cools and hardens to form fastener 15512. The arm is removed, leaving only the fastener in place.

[0472] Fig.155A -E shows another embodiment of a device 15600 configured to access and bond a material. Fig.155A Sharp hollow fangs 15602 are shown penetrating a first material 15604 and a second material 15606. The materials may be tissue, ADM, patch, membrane, etc. Fig.155B As shown, a strand 15608 (e.g., a polymer strand) extends from the end of the fang 15602. Fig.155C The fangs 15602 are shown removed, leaving only the strands 15608 in place passing through the two materials 15604, 15606. Fig.155D , a fusion tube or device 15610 is shown being advanced over the end or branch of strand 15608 and reaching the repair location. The advancement of device 15610 may result in the approximation and compression of materials 15604, 15606. Fig.155E As shown, the strands 15608 are fused into a loop at the connection point 15612 and the device 15610 is removed.

[0473] Fig.156 An embodiment of a device 15700 is shown that is configured to clamp a material such as tissue (or ADM, patch, membrane, etc.) so that a user can pull the tissue for reverse traction when performing various procedures (e.g., suturing). Clamp 15702 is located at the end of inner tube 15704. Clamp 15706 is located at the end of outer tube 15708. The tip of clamp 15702 on inner tube 15704 points to the tip of clamp 15706 on outer tube 15708. Inner tube 15704 is directed in one direction (e.g., Fig.156 The outer tube clamp 15706 and the inner tube clamp 15702 are rotated in a counterclockwise direction to open the gap between the outer tube clamp 15706 and the inner tube clamp 15702. The clamps 15702, 15706 are placed on the material or tissue of interest, and the inner tube 15704 is rotated in the opposite direction (e.g., Fig.156 The outer tube clamp 15706 and the inner tube clamp 15702 are rotated clockwise (in the clockwise direction) to close the gap between the outer tube clamp 15706 and the inner tube clamp 15702, so that the clamps 15702 and 15706 clamp the material. The user can pull the tubes 15704 and 15708 to lift the material or tissue as needed. A surgical device (e.g., a stapler or an endoscope) can be inserted along the lumen 15710 of the inner tube 15704 to process the material or tissue (e.g., place a staple). The tissue retractor can be made with a small (micro) clamp or a larger clamp. A window can also be cut on the side of the tube to provide visibility and access to the tissue and the working site. The mechanism can be separated from the stapler (or other device) or integrated into the stapler (or other device).

[0474] Fig.157A -D shows a device 15800 that is configured to clamp a material (e.g., tissue, ADM, patch, membrane, etc.) so that a user can pull the tissue for reverse traction when performing various procedures (e.g., suturing). The clamp 15802 is located within the sleeve 15804, as shown in FIG. Fig.157A As shown. The clamps are biased outward (e.g., spring loaded). The clamps 15802 are placed on the tissue of interest. The cannula 15804 is advanced, causing the clamps 15802 to move toward each other and clamp the material, such as Fig.157B The number of clamps can vary, such as Fig.157C (2 clamps) and 157D (6 clamps). Other numbers of clamps are also possible (e.g., 3, 4, 5, 6, 7, 8, more, etc.).

[0475] When a feature or element is referred to as "on another feature or element" in this article, it may be directly on another feature or element, or there may also be intermediate features and / or elements. On the contrary, when a feature or element is referred to as "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it may be directly connected, attached or coupled to another feature or element, or there may be intermediate features or elements. On the contrary, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there is no intervening feature or element. Although described or shown relative to an embodiment, the features and elements described or shown in this way can be applied to other embodiments. Those skilled in the art will also understand that the reference to the structure or feature set of "adjacent" another feature may have an overlapping or part located under the adjacent feature.

[0476] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "one", "an" and "the" are also intended to include plural forms, unless the context clearly indicates otherwise. It will also be understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of the features, steps, operations, elements and / or components, but do not exclude 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 associated listed items and can be abbreviated as " / ".

[0477] Spatially relative terms such as "below", "under", "below", "lifetime", "above", etc. may be used herein to facilitate description of the relationship of one element or feature to another element or feature as shown in the figure. It should be understood that, in addition to the orientation shown in the figure, the spatially relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the figure is inverted, the elements described as "below" or "below" other elements or features will be oriented as "above" other elements or features. Therefore, the exemplary term "below" can include both above and below orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptors used herein are interpreted accordingly. Similarly, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein for the purpose of explanation unless otherwise specifically noted.

[0478] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below can be referred to as the second feature / element, and similarly, the second feature / element discussed below can be referred to as the first feature / element without departing from the teachings of the present invention.

[0479] In this specification and the appended claims, unless the context requires otherwise, the word "comprise" and variations such as "include" and "comprising" mean that various components can be used together in methods and articles (e.g., compositions and devices including devices and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0480] As used herein in the specification and claims, including as used in the examples, and unless otherwise expressly provided, all numbers may be interpreted as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. When describing a value and / or position, the phrase "about" or "approximately" may be used to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, a numerical value may have a value of + / -0.1% of the value (or range of values), a value of + / -1% of the value (or range of values), a value of + / -2% of the value (or range of values), a value of + / -5% of the value (or range of values), a value of + / -10% of the value (or range of values), etc. Unless the context indicates otherwise, any numerical value given herein is also understood to include approximately or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range listed herein is intended to include all subranges contained therein. It should also be understood that when a numerical value is disclosed, "less than or equal to" the numerical value, "greater than or equal to the numerical value," and possible ranges between the numerical values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15 are considered disclosed. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0481] Although various exemplary embodiments are described above, any of a number of changes may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, 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. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention, which is set forth in the claims.

[0482] The examples and descriptions included herein show specific embodiments in which the present invention can be practiced in an illustrative and non-limiting manner. As described above, other embodiments can be utilized and derived therefrom so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. If more than one invention or inventive concept is actually disclosed, these embodiments of the subject matter of the present invention can be referred to individually or collectively by the term "invention" herein, which is only for convenience and is not intended to voluntarily limit the scope of the present application to any single invention or inventive concept. Therefore, although specific embodiments are shown and described herein, any arrangement calculated to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or changes of various embodiments. After reading the above description, the combination of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A fastening device, comprising: axis; handle; a needle extending from the shaft, the needle including a slot extending along at least a portion of the needle, wherein the device is configured to receive a fastener comprising a first rod and a second rod connected by a rod connector, the first rod being configured to be positioned within the needle and the second rod being configured to be positioned outside the needle; a pushing member configured to push the fastener out of the needle; as well as At least one ramp or deflector is positioned adjacent to the slot, wherein the at least one ramp or deflector is configured relative to the slot so that when the fastener is pushed distally by the pushing member, the second rod is redirected relative to the first rod by the at least one ramp or deflector.

2. The device according to claim 1, wherein: The device also includes a fastener positioned such that the first rod is positioned within the needle and the second rod is positioned outside the needle.

3. The device according to claim 1, wherein: The device also includes a fastener reservoir located within the shaft.

4. The device according to any one of claims 1 and 3, wherein: The second rod is positioned within the shaft.

5. The device according to claim 1, wherein: The at least one ramp or deflector is configured to lift the stem connector to redirect the second stem when the fastener is pushed distally.

6. The device according to claim 1, wherein: The device also includes a shoulder positioned at a fixed or adjustable distance proximal to the distal end of the needle.

7. The device according to claim 1, wherein: The device also includes a trigger configured to deploy the fastener by engaging the pushing member.

8. The device of claim 1, the shaft comprising one or more of an articulated end and a pivoting end.

9. The device of claim 1, wherein the shaft comprises a curved end.

10. The device according to claim 1, wherein: The replaceable cartridge includes the entire shaft.

11. The device according to claim 1, wherein: The replaceable cartridge includes a distal portion of the shaft.

12. The device according to claim 1, wherein: The needle may be retractable and / or advanceable relative to the shaft.

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

14. The device according to claim 1, wherein: The needle includes one or more barbs.

15. The device according to claim 14, wherein: The one or more barbs are pop-out / retractable.

16. The device according to claim 1, wherein The needle includes one or more protrusions.

17. The device according to claim 1, wherein: The needle includes one or more recesses.

18. The device according to claim 1, wherein: The needle includes a region of enlarged diameter proximate an end of the needle.

19. The device according to claim 1, wherein: The needle includes one or more blades.

20. The device according to claim 19, wherein The one or more blades are actuatable.

21. The device according to claim 1, wherein The device comprises one or more auxiliary needles.

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

23. The device according to claim 22, wherein: The one or more auxiliary needle barbs are ejectable / retractable.

24. The device according to claim 1, wherein: The at least one ramp or deflector extends from a surface adjacent the needle, the at least one ramp or deflector extending away from the surface and configured to lift the stem connector and second stem away from the needle when the fastener is pushed distally.

25. The device according to claim 1, wherein The device also includes a side ramp or deflector extending from the side wall, and wherein the side ramp or deflector is configured to rotate the second rod when the fastener is pushed distally so that the second rod moves in a direction generally parallel to the material to be fastened.

26. The device according to claim 1, wherein The device also includes a surface or side wall configured to maintain the rotational position of the second rod.

27. The device according to claim 1, wherein At least a portion of the needle's slot is helical.

28. The device according to claim 1, wherein The device also includes a support configured to provide reverse traction to the material being fastened as the needle is withdrawn from the material.

29. The device according to claim 1, wherein The needle is bent or curved.

30. The device according to claim 1, wherein The width of the needle slot is greater than the width of the stem connector of the fastener.

31. The device according to claim 1, wherein The edges of the needle slot may include rounded, fractured, polished or other non-sharp edge structures.

32. The device according to claim 1, 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 passage of sufficient size through the material to be joined so that the stem and stem connector of the fastener pass through the material to be joined with minimal force.

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

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

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

36. The device according to claim 1, wherein The length of the needle is sized to minimize or avoid contact with tissue underlying the repair site.

37. The device according to claim 1, wherein: The length of the needle is sized to accommodate placement of one or more ends of the fastener in tissue.

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