STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0001] None.

RELATED APPLICATION DATA

[0002] The present application claims benefit of co-pending U.S. provisional application Serial No. 63/346,897, filed May 29, 2022, the entire disclosure of which is expressly incorporated by reference herein.

TECHNICAL FIELD

[0003] The present application relates to medical devices and, more particularly, to eyelets or grommets for reinforcing tissue and/or sutures, and to devices and methods for delivering such eyelets or grommets.

BACKGROUND

[0004] Partial or complete detachment of ligaments, tendons and/or other soft tissues from their associated bones within the body are commonplace injuries. Such injuries generally result from excessive stresses being placed on these tissues, e.g., resulting from a fall, over-exertion, or during an athletic event. For partial detachments, the injuries may heal themselves; however, for cases of complete detachment, surgery is often needed to reattach the soft tissue to its associated bone.

[0005] Various devices are availabl e to reattach soft tissue to bone, such as screws, staples, suture anchors, and the like. For example, in soft tissue reattachment procedures, a suture anchor or other fastener may be screwed or otherwise secured into a target bone and a suture may be used to secure the desired soft tissue to the bone. For example, once a suture anchor is screwed or otherwise inserted into the bone, free ends of the suture may extend out of the bone, which may be extended through or around the soft tissue being secured, and tensioned, e.g., by pulling the suture to secure the soft tissue to the bone. However, pulling the suture can cause damage to the tissue, e.g., during the procedure, or later during the subject’s recovery, e.g., if tension is applied to the tissue during subsequent activity. Such damage may disrupt healing or even require further surgical intervention, e.g., to reattach the tissue to the bone.

[0006] Therefore, there is a need for improved methods and devices for securing sutures to tissue and/or preventing tearing or other damage to secured tissue.

SUMMARY

[0007] The present application is directed to medical devices and, more particularly, to eyelets or grommets for reinforcing tissue and/or sutures, and to devices and methods for delivering such eyelets or grommets,

[0008] For example, one or more soft eyelets, e.g., formed from suture material or other flexible filament, may be introduced around a repair suture, e.g., extending from a suture anchor secured in bone, to improve load sharing and/or otherwise reinforce the repair suture, e.g., to prevent recurrent tears or other subsequent damage to the soft tissue secured to the repair suture.

[0009] Alternatively, a grommet or other tubular reinforcement structure may be introduced over a repair suture and secured to surrounding tissue to reinforce a repair suture. Optionally, the grommet may include two components, e.g., mating halves, that may be used sandwich the tissue around the repair suture. Alternatively, the grommet may include an enclosed loop of material that may be stitched into the soft tissue, e.g., similar to an eyelet in clothing or fabric.

[00010] The eyelets or grommets may be fastened to the tissue in a variety of manners, e.g., stitched, clamped, sewn, passed, and/or may be fixed with a knot or in a knotless fashion. For example, a knot may be advanced over material of the eyelet and tied or, alternatively, a knotless zip tie, noose, or finger trap technology may be used to secure the eyelet. The eyelets may be implanted in a variety of shapes and/or patterns, e.g., in a substantially circular arrangement, a figure eight arrangement, a box shape, and the like. The eyelets may remain indefinitely within the subject’s body or, alternatively, the eyelet material may be bioabsorbable such that the material dissolves, e.g., after sufficient time for the repaired tissue to heal.

[00011] In addition, a tool or other delivery device may be provided for passing or otherwise implanting one or more eyelets into target tissue. In one example, the delivery device may be a separate instrument than the instrument(s) used to introduce and/or implant the repair suture and/or suture anchor. Alternatively, the components of the delivery device may be incorporated into a suture passer or other instalment used to introduce and/or manipulate a repair suture. The delivery device may include one or more flexible needles, sutures, or wires, e.g., necessary' to penetrate the tissue and/or manipulate the material of the eyelet during introduction and/or implantation.

[00012] For example, the delivery device may include one or more jaws that may be positioned adjacent the soft tissue, e.g., opposing jaws that may positioned on either side of the tissue, such that the eyelet material may be directed through the tissue around the repair suture. For example, the delivery' device may direct the eyelet material, e.g., one or more lengths of suture material, through the tissue from top to bottom, bottom to top, or any combination, e.g., if the material is directed through the tissue multiple times around the repair suture. The delivery' device may be a single use/disposable device or at least a portion of the delivery device, e.g., a handle and shaft portion, may be reusable. Optionally, the devices may include cartridges, e.g., a single-use cartridge that mav be loaded into a reusable jaw ⁷ or other structure of the device, to load one or more eyelets into the device for use during a procedure. Such cartridges may be loaded into the top or bottom of the device or in between.

[00013] The delivery devices and eyelets described herein may be used anywhere sutures are used to repair soft tissue. For example, they may be used to secure patches or any soft tissue reinforcement products to tissue, e.g., as an alternative to staples typically used to attach patches to soft tissue. In one example, the eyelets and delivery devices may be used to secure a patch and/or tissue to a native tendon for reinforcement. During delivery, the eyelets may pass through arid compress and/or fixate both the native tissue and the patch material,

[00014] In accordance with one example, a method is provided for reinforcing a repair suture securing soft tissue within a subject’s body, comprising implanting an eyelet into the soft tissue that at least partially surrounds the repair suture.

[00015] In accordance with another example, a method is provided for reinforcing a repair suture securing soft tissue within a. subject’s body, comprising implanting a grommet into the soft tissue that at least partially surrounds the repair suture.

[00016] In accordance with still another example, a device is provided for reinforcing a repair suture securing soft tissue within a subject’s body that includes an elongate shaft comprising a proximal end and a distal end sized for introduction into a subject’s body; a first jaw on the distal end carrying eyelet material; and a second jaw on the distal end such that tissue may be positioned between the jaw ⁷ s, at least one of the first and jaws being movable to pass the eyelet material through the tissue.

[00017] In accordance with yet another example, a device is provided for reinforcing a repair suture securing soft tissue within a subject’s body that includes an elongate shaft comprising a proximal end, a distal end sized for introduction into a subject’s body, and one or more lumens extending between the proximal and distal ends; a handle on the proximal end comprising a port communicating with the one or more lumens, an end effector on the distal end comprising a first jaw, a pair of receivers spaced apart from one another on the first jaw and carrying eyelet material such that an intermediate portion of the eyelet material extends between the receivers, a second jaw, and a pair of needles on the second jaw generally opposite the receivers; and an actuator on the handle configured to move one or both jaws from an open position in which the needles are spaced apart from the receivers and a closed position in which the needles are located adjacent the receivers to engage the eyelet material on either side of the intermediate region, and to move one or both jaw back from the closed position to the open position to pass the eyelet material through the tissue. [00018] In accordance with still another example, a device is provided for reinforcing a repair suture securing soft tissue within a subject’s body that includes an elongate shaft comprising a proximal end, a distal end sized for introduction into a subject’s body, and one or more lumens extending between the proximal and distal ends; a handle on the proximal end comprising a port communicating with the one or more lumens; an end effector on the distal end comprising first and second jaws and a first grommet member carried by the first jaw, and an actuator on the handle configured to direct one or both jaws from an open position in which the first grommet member is spaced apart from the second jaw to a closed position in which the first grommet member is directed towards the second jaw to direct the first grommet member into tissue between the jaws around a repair suture extending from the tissue. Optionally, the first grommet member may include one or more features for securing the first grommet member to the tissue around the repair suture. In addition or alternatively, a second grommet may be carried by the second jaw such that, when the one or both jaws are directed to the closed position, the tissue is engaged between the first and second grommet members such that the grommet members surround the repair suture.

[00019] Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[00020] It is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [00021] FIG. 1 show's examples of eyelets formed from sutures implanted around respective repair sutures.

[00022] FIGS. 2A-2C are partial cross-sectional views showing eyelets implanted in soft tissue around repair sutures extending from suture anchors secured into bone underlying the soft tissue.

[00023] FIGS. 3 A and 3B show examples of grommets implanted in soft tissue around a repair suture.

[00024] FIG. 4 shows an example of eyelets being delivered through native tissue and overlying patch material to secure the patch/tissue to a native tendon for reinforcement.

[00025] FIGS. 5A and 5B show an example of a delivery device for delivering an eyelet into soft tissue including an end effector with a pair of jaws in open and closed positions, respectively, and a pair of needles for passing suture material through tissue to create a reinforcing eyelet.

[00026] FIG. 5C is a detail of an exemplary head that may be provided on a needle of the device of FIGS. 5 A and 5B.

[00027] FIG. 6A and 6B are details of the end effector of the device of FIGS, 5 A and 5B.

[00028] FIG. 6C shows an alternative example of an end effector including a suture passer in addition to needles for creating a reinforcing eyelet.

[00029] FIGS. 7A-7C are cross-sectional view's of an anchor and repair suture implanted into a patient’s bone and overlying tissue, showing a method for passing eyelet material through the tissue.

[00030] FIGS. 8A-8C show additional examples of distal portions of delivery' devices for delivering eyelets.

[00031] The drawings are not intended to be limiting in any way, and it is contemplated that various examples of the invention may be carried out in a variety’ of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

[00032] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. [00033] Before the examples are described, it is to be understood that the invention is not limited to particular examples described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

[00034] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[00035] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

[00036] It must be noted that as used herein and in the appended claims, the singular forms “a,” ‘"an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

[00037] Certain ranges are presented herein with numerical values being preceded by the term “about ” The term “about” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number.

[00038] Turning to the drawings, FIG. 1 shows an example of eyelets 80 formed from suture material or other flexible filaments implanted around respective repair sutures. F or example, as shown, each eyelet 80 may include a length of suture that has been passed through tissue 90 multiple times around a repair suture 92 (or underlying anchor, not shown) placed through the tissue 90, e.g., using conventional methods. The eyelet 80 may include one or more knots 84 formed with the suture material, e.g., to secure ends 86 of the suture 82 relative to the tissue 90 and repair suture 92

[00039] The eyelets 80 may be made from a variety of biocompatible materials, e.g., synthetic suture materials, such as nylon, PTFE, and the like, or natural materials, such as collagen, silk, and the like, which may be delivered independently or in conjunction with a repair suture into soft tissue. The eyelet material may be substantially inelastic along its length or may be formed to include elasticity, e.g., while maintaining flexibility of the material. The eyelets 80 may remain indefinitely within the subject’s body or, alternatively, the eyelet material may be bioabsorbable such that the material dissolves, e.g., after sufficient time for the repaired tissue to heal.

[00040] FIGS. 2A-2C show further examples of eyelets 80 directed into and through soft tissue 90 around repair sutures 92 extending from suture anchors 94 secured into bone 96 underlying the tissue. For example, a suture anchor 94 including one or more repair sutures 92 may be screwed or otherwise secured into the bone 96 and the repair suture(s) 92 passed through or otherwise secured to the soft tissue 90 and tightened to secure the tissue 90 to the bone 96.

[00041] Simultaneously or subsequent to delivering the repair suture(s) 92, one or more eyelets 80 may be passed through the tissue 90 around each repair suture 92. The eyelets 80 may be fastened to the tissue 90 in a variety of manners, e.g., stitched, clamped, sewn, passed, and/or may be fixed with a knot or in a knotless fashion. For example, as shown in FIG. 1, a knot 84 may be advanced over material of the eyelet 80, e.g., from one or both ends of the eyelet material, and tied against the tissue 90. Alternatively, a knotless zip tie, noose, or finger trap device (not shown) may be used to secure the eyelet 80. Once secured, excess material may be cut or otherwise removed, leaving the eyelet 80 in place to support the repair suture 92 and tissue 90.

[00042] Alternatively, as shown in FIGS. 3A and 3B, one or more grommets or tubular reinforcing structures 180, 180’ may be implanted in tissue 90 surrounding a repair suture 92. In one example, e.g., as shown in FIG. 3 A, the grommet 180 may include an enclosed loop of material or a tubular structure 182 including a portion 184 that is inserted into the soft tissue 90 around the repair suture 92, e.g., similar to an eyelet in clothing or fabric. For example, the inserted portion 182 may include a plurality of teeth, serrations, sharpened edges, and/or other features (not shown) that may be embedded in, grab, and/or otherwise secure the grommet 180 against the tissue 90 around the repair suture 92. Alternatively, as shown in FIG. 3B, the grommet 180’ may include two components, e.g., mating halves 182’, that may be positioned on opposite sides of the soft tissue 90 around the repair suture 92, and coupled together to sandwich the tissue between the components. For example, each half 182’ may include a connecting portion 184’ that includes one or more detents, snaps, grooves, or other connectors (not shown) that interlock to secure the halves 182’ together. In addition or alternatively, the grommet 180, 180’ may be deformed to secure the grommet in place, and/or one or more stitches or other fasteners (not shown) may be used to secure the grommet 180, 180’ to the tissue 90 around the repair suture 92.

[00043] Turning to FIG. 4, in another example, one or more eyelets 80 and/or grommets (not shown) may be used to secure a patch, sheet, or other reinforcement material 88 to tissue 90, e.g., to a native tendon for reinforcement. During delivery , the eyelets 80 may pass through and compress and/or fixate both the native tissue 90 and the patch material 88.

[00044] The eyelets and/or grommets may be delivered independently of the repair sutures, e.g., using a separate tool or delivery device than the tool or instrument used to deliver the repair suture and/or anchor. Alternatively, the components to deliver the eyelets and/or grommets may be included in a tool also used to deliver and/or manipulate the repair sutures, as described further elsewhere herein. [00045] For example, turning to FIGS. 5A-6B, an exemplary device 10 is shown for delivering an eyelet, e.g., to reinforce a repair suture securing soft tissue within a subject’s body. Optionally, as shown in FIG. 6C, the device 10’ may also include a suture passer for delivering a repair suture, e.g., such that a repair suture may be delivered and then reinforced using a single device, as described further elsewhere herein.

[00046] Generally, as best seen in FIGS. 5 A and 5B, the device 10 includes an elongate shaft 12 including a proximal end 14 and a distal end 16 sized for introduction into a subject’s body, thereby defining a longitudinal axis 18 of the device 10 therebetween. The distal end 16 includes an end effector 20 for delivering one or more eyelets (or alternatively grommets, as described elsewhere herein), and the proximal end 14 includes a handle 50, e.g., shaped to facilitate manipulation of the device 10 and including one or more actuators, e.g., trigger 52. The shaft 12 may be substantially rigid between the proximal and distal ends 12, 14, e.g., formed from metal, plastic, and/or composite materials. Alternatively, the shaft 12 may be malleable and/or may be semi-rigid or flexible along one or more regions between the proximal and distal ends 12, 14, if desired.

[00047] The shaft 12 may include one or more lumens 13 extending between the proximal and distal ends 12, 14, e.g., individual tubular bodies carried within a housing of the shaft 12 and/or lumens integrally formed within a wall of the shaft 12 itself. For example, a pair of needle lumens 13a may extend axially through the shaft 12 communicating between one or more ports 54a on the handle 50 and the end effector 20, e.g., for slidably receiving respective needles 40. In addition, the shaft 12 may include one or more filament lumens 13b for receiving lengths of suture or other filament 82 that, may be used to create an eyelet, as described further elsewhere herein.

[00048] For example, as best seen in FIGS. 6A and 6B, the end effector 20 includes a pair of jaws 22, 32 that may be actuated to pass eyelet material through tissue positioned between the jaws 22, 32 using needles 40, e.g., to form or deliver an eyelet (or grommet) around a repair suture (not shown). The end effector 20 may be permanently attached to the distal end 16 of the shaft 12. Alternatively, the end effector 20 may be removably coupled to the distal end 16 of the shaft 12, e.g., using one or more cooperating connectors (not shown). For example, the handle 50 and shaft 12 of the device 10 may be reusable, while the end effector 20 and needles 40 may be single-use components atached to and/or inserted into the shaft 12 before a procedure and discarded after being used on an individual patient. [00049] Alternatively, a cartridge (not shown) may be provided that may be received in one or both jaws 22, 32 to deliver an eyelet. For example, the jaws 22, 32 may be permanently attached to the shaft 12, e.g., such that the device may be cleaned and sterilized for reuse, and a cartridge may be loaded into the device immediately before an individual procedure to provide a desired arrangement of needles and/or eyelet material. In a further alternative, the end effector 20 and/or needles 40 may be permanently integrated into the device 10 and the entire device 10 may be single-use or may be cleaned and sterilized for reuse, if desired.

[00050] In the example shown, the first jaw 22 on the end effector 20 is fixed and/or substantially stationary relative to the shaft 12, while the second jaw 32 is movable, e.g., connected by a hinge to the first jaw 22 and/or distal end 16, such that the second jaw 32 is movable between an open position where the jaws 22, 32 are spaced apart from one another, e.g., as shown in FIGS. 5 A and 6A, and a closed position in which the second jaw 32 is immediately adjacent the first jaw 22, e.g., as shown in FIGS. 5B and 6B.

[00051] The trigger 52 on the handle 50 may be coupled to the second jaw 32, e.g., such that pulling or otherwise activating the trigger 52 may cause the second jaw 32 to move to the closed position. In one example, activation of the trigger 52 may cause the second jaw 32 to close and then automatically release and move back to the open position. In another example, as long as the trigger 52 is pulled and held, the second jaw- 32 may remain closed until the trigger 52 is released, whereupon the second jaw 32 may open again. [00052] The end effector 20 and shaft 12 may be sized to be received through a trocar, port, or other access device (not shown) used during a laparoscopic or other minimally invasive procedure. For example, the device 10 may include a lock (not shown) that may secure the second jaw 32 in the closed position, e.g., to facilitate introducing the end effector 20 into a surgical site, whereupon the lock may be released to open the second jaw 32 before creating an eyelet.

[00053] The first jaw 22 may carry eyelet material 82, e.g., within a pair of receivers 24, that may be manipulated using the needles 40 to create an eyelet. For example, a length of suture or other filament 82 may extend through the shaft 12 from the handle 50 through a lumen 13b into the first receiver 24 across to the second receiver 24 and back to the handle 50, e.g., through the same or a separate lumen 13b. The free ends 82a of the eyelet material 82 may extend from port 54b on the handle 50 or may be positioned within the shaft 12, e.g., adjacent the handle 50, and an intermediate portion 82b of the eyelet material 82 may extend between the receivers 24. Alternatively, the eyelet material may be carried entirely within the end effector, e.g., spooled or otherwise arranged within a chamber on the first jaw and/or within a cartridge received in the first jaw (now shown), such that the eyelet material may unspool or otherwise be released when the eyelet is being created, as described further elsewhere herein. For example, two ends of suture material may be carried within the receivers and/or other chamber of the first jaw having sufficient length to extend through the shaft of the device when an eyelet is being created.

[00054] The second jaw 32 includes one or more elements, e.g., needles 40, configured to penetrate the tissue and pass the eyelet material 82 through the tissue. For example, as shown in FIG. 5B, the second jaw 32 may include a pair of outlets 34 communicating with the respective lumens 13a in the shaft 12 through passages 35 in the second jaw 32, e.g., such that the needles 40 may be slidably inserted into respective lumens 13a and passages 35 until heads 42 of the needles 40 extend from the outlets 34.

Optionally, the needles 40 and/or handle 50 may include one or more locks or other features that secure the needles 40 within the device 10, e.g., to secure the heads 42 in position beyond the outlets 34 until the feature(s) are released.

[00055] The passages 35 may be enclosed tubular structures extending along the second jaw 32, which may be substantially rigid and/or flexible. For example, a flexible portion of the passages 35 may extend from the second jaw 32 to the shaft 12 that accommodates movement of the second jaw 32 between the open and closed positions, while providing a continuous passage for the needles 40 from the lumens 13 to the outlets 34. Alternatively, the passages 35 may have a non-enclosed cross-section (not shown), e.g., defining tracks to guide the needles 40 to the outlets 34 while providing an open slot along the length of the passages 35, e.g., to accommodate manipulation of the eyelet material, if desired. In this alternative, the needles 40 may be introduced into a single lumen in the shaft 12 and the tracks may direct the needles 40 to the respective outlets 34, i.e., to position the heads 42 opposite the receivers 24 in the first jaw 22.

[00056] As best seen in FIG. 5A, each needle 40 may include an elongate wire or shaft 44 including proximal and distal ends 46, 48 sized to be slidably received in one of the lumens 13 in the main shaft 12, and having sufficient length such that, when the distal end 46 is inserted into the lumen 13, a head 42 extends from the outlet 34 when the proximal end 46 is positioned outside or adjacent the handle 50, e.g., extending from port 54. Optionally, the proximal end 46 may include a hub, handle, or other feature 47, e.g., to facilitate manipulation of the needle 40 and/or provide a stop to limit insertion of the needle 40, e.g., when the hub 47 contacts the port 54b. The needle wares 44 may have sufficient column strength to allow the distal ends 47 of the needles 40 to be inserted by pushing their proximal ends 46 into the lumens 13, but may be sufficiently flexible to extend through the passages 35, e.g., such that the needles flex or bend as needed when the second jaw ⁷ 32 moves.

[00057] As shown in FIG. 5C, the head 42 of each needle 40 may terminate in a pointed, beveled, or otherwise sharpened tip 42a to facilitate advancing the tip 42 through tissue, and may include a slot, pocket, or other feature 42b adjacent the tip to capture the eyelet material within the corresponding receiver 24. In addition or alternatively, the head 42 may include a blunt edge or rim 42c spaced proximally from the tip 42a, which may be sized to receive a loop or other feature (not shown) of the eyelet material 82 located within the receiver 24 to capture the eyelet material 82.

[00058] Although the device 10 shown includes the receivers 24 on the first, stationary jaw 22 and the needles 40 on the second, movable jaw 32, it will be appreciated that the arrangement of the components on the jaws 22, 32 may be reversed, if desired, e.g., such that the needles 40 are on the lower jaw and the receivers are on the upper jaw. Alternatively, the jaws may be configured such that both jaws move when the end effector is directed between the open and closed positions.

[00059] As shown in FIGS. 7A-7C, during use, the end effector 20 may be introduced into a surgical space, e.g., where a repair suture 92 and/or tissue anchor 94 have already been delivered to support soft tissue 90 relative to bone 96. In one approach, the jaws 22, 32 may be in the closed position when the end effector 20 is introduced into the surgical space (not shown), e.g., to minimize the profile of the end effector 20 during introduction, and then the second jaw 32 (or both jaws) may be opened or otherwise released. With the second jaw 32 in the open position, the jaws 22, 32 may be positioned on opposite sides of the tissue 90, e.g., with the repair suture 92 positioned between the receivers 24, e.g., as shown in FIG. 7A. The trigger 52 on the handle (not shown) may be actuated to close the second jaw 32, thereby directing the heads 42 of the needles 40 through the tissue 90 into the receivers 24 to capture the eyelet material 82, e.g., in the features in the heads 42, as shown in FIG. 7B, The second jaw 32 may then be opened again (automatically or by releasing the trigger 52) to withdraw the heads 42 back through the tissue 90, thereby passing the eyelet material 82 through the tissue 90. For example, each needle 40 may pull a section of the eyelet material through the tissue 90 on either side of the repair suture 92.

[00060] The portions of the eyelet material 82 on the anterior side of the tissue 90 (opposite the bone) may then be secured adjacent the repair suture 92 to create a reinforcing eyelet. In one exemplary' method, one or more knots (or other fasteners) may then be delivered to the tissue 90 to create an eyelet 80 around the repair suture 92, e.g., as shown in FIG. 1. In addition or alternatively, other fasteners may be used to secure the ends of the eyelet material, e.g., one or more clips, knotless zip ties, nooses, or finger trap devices (not shown), and/or the eyelet material may be further manipulated to create the desired shape of the final eyelet.

[00061] For example, with additional reference to FIGS. 5 A and 5B, when the tissue 90 is positioned between the jaws 22, 32, the heads 42 of the needles 40 may be positioned adjacent the tissue 90 opposite the eyelet material 82 carried by the receivers 24, e.g., with the repair suture 92 centered between the needles 40, e.g., as shown in FIG. 7A. When the second jaw 32 is actuated, e.g., by pulling the trigger 52, the second jaw 32 may close towards the first jaw 22, thereby causing the needles 40 to penetrate through the tissue 90 and engage the eyelet material 82 carried by the receivers 24, as shown in FIG. 7B. When the second jaw 32 is then further actuated to open (or released and automatically opening), the heads 42 of the needles pass the eyelet material 82 through the tissue 90, as shown in FIG. 7C. As a result, the eyelet material 82 may form at least a portion of a loop surrounding the repair suture. Alternatively, if the needles are provided on the lower jaw, the intermediate portion of the eyelet material may be on the upper side of the tissue and the needles may pass the eyelet material through to the lower side of the tissue (not shown).

[00062] Once the eyelet material 82 is captured by the heads 42, the needles 40 may be retracted proximally from the end effector 20, e.g., by pulling the proximal ends 46 of the needles 40 to withdraw the needles 40 through the lumens 13 to draw the eyelet material 82 to the proximal end 14 of the shaft 12, e.g., out ports 54b. The needles 40 may be retracted individually or simultaneously. Optionally, the needles 40 may be coupled together at their proximal ends 46, e.g., connected to a hub, ring, or other feature (not shown) adjacent the port 54b on the handle 50 such that the feature may be pulled to simultaneously withdraw the needles through the lumens 13 from the shaft 12.

[00063] Thus, when the needles 40 engage the eyelet material, i.e., at the two spaced apart locations on either side of the intermediate region 82b of the eyelet material 82, and are then retracted, the needles 40 may pass the eyelet material 82 through the tissue at two locations on either side of the repair suture 92 such that the intermediate region 82b is located behind or within the tissue 90. As the needles 40 are retracted, the ends 82a of the eyelet material 82 may be directed distally through the lumen(s) 13b, e.g., to direct the two ends 82a of the eyelet material 82 through the tissue 90 and back to the proximal end 14 of the shaft 12 through the needle lumens 13a, e.g., out ports 54b. Alternatively, if the eyelet material is spooled or otherwise contained entirely in the end effector, withdrawal of the needles 40 may cause the eyelet material to unspool and follow' the heads 42 through the lumens 13b until ends 82a are exposed from the ports 54b.

[00064] The ends 82a of the eyelet material 82 may then be secured to close or otherwise secure the eyelet around the repair suture 92. For example, one or more knots (not shown) may be advanced over the ends 82a of the eyelet material 82 through the lumens 13a until they contact the tissue 92. For example, a knot pusher (not shown) may be provided that is sized to be advanced into a lumen 13 a of the shaft 12 over the eyelet material 82, thereby advancing a knot (also not shown) formed on the eyelet material 82 through the lumen 13a and passage 35 out the outlet 34 to position the knot against the anterior side of the tissue 90 adjacent the repair suture 92. Alternatively, if the ends 82a of the eyelet material 82 pass through the same lumen 13a from the tissue 90, a knot may be formed with both ends, and a knot pusher used to advance the knot through the lumen 13a to the tissue 90. This process may be repeated as many times as desired, and then excess material may be cut or otherwise removed to provide a knotted loop, e.g., similar to the eyelets 80 shown in FIG. 1 .

[00065] Alternatively, the needles 40 may be permanently integrated or attached to the end effector 20, e.g., such that the heads 42 are fixed to the second jaw 32 and may be directed through the tissue into the receivers 24 to capture the eyelet material 82 when the second jaw 32 is closed. In this alternative, after the second jaw 32 is opened to pass the eyelet material 82 through the tissue 90, the end effector 20, e.g., the entire device 10, may be withdrawn from the surgical site to pull the eyelet material 82 until the ends 82a pass through the tissue 90 and extend from the patient’s body. One or more knots may then be advanced over the exposed ends 82a, e.g., using a knot pusher or other device (not shown), to create the eyelet.

[00066] Optionally, as shown in FIG. 6C, a device 10’ may be provided that includes a receptacle and/or other features for receiving and/or delivering a repair suture and/or tissue anchor (not shown), e.g., such that a repair suture and/or tissue anchor may be delivered using the device 10,’ e.g., allowing an eyelet to be formed around the repair suture using the same device. For example, as shown, the end effector 20’ may include a suture passer 60,’ e.g., carried on the first jaw 22,’ and the device 10’ may also include a second trigger (not shown) on the handle for manipulating the repair suture, e.g., including a needle or other device 62’ for passing a repair suture through tissue, similar to conventional suture passers. The suture passer 60’ may include a needle 62’ that may be deployed once the jaws 22’, 32’ are positioned on opposite sides of a target tissue structure, to pass a repair suture through the tissue. The device 10’ may then be manipulated to secure the repair suture similar to conventional suture passers, and then any excess suture material may be removed. The device 10’ may simultaneously or sequentially pass the needles 40’ through the tissue to engage the eyelet material carried by the receivers 24’, and then manipulated to create an eyelet around the repair suture, as described elsewhere herein.

[00067] Although a pair of needles 40 and corresponding receivers 24 are shown in FIGS. 5A-6B, alternatively, the device may include one or more additional needles and/or receivers, e.g., arranged on the jaws to facilitate creating an eyelet surrounding a repair suture. For example, two pairs of needles and receivers (not shown) may be provided on the end effector that are spaced circumferentially around a central region, e.g., such that the jaws may be positioned on opposite sides of tissue with a repair suture located in the central region. When the jaws are closed and reopened, each pair of needles may pass separate filaments of eyelet material through the tissue. Each pair of needles may then be withdrawn to pull the ends of the respective eyelet material through the device to allow knots and/or other fasteners to be used to secure the eyelet material to the tissue, e.g., thereby using multiple lengths of eyelet material to create an eyelet around a repair suture.

[00068] Alternatively, the devices herein may be used to deliver a grommet or other tubular structure through the soft tissue around a repair suture. In this alternative, the device may be used to advance the grommet over the repair suture, e.g., after passing the repair suture through the tissue between the jaws. For example, similar to the device 10 shown in FIGS. 5A and 5B, a device may be provided that includes an elongate shaft including a proximal end, a distal end sized for introduction into a subject’s body, and one or more lumens extending between the proximal and distal ends. A handle may be provided on the proximal end, and an end effector may be provided on the distal end including first and second jaws, which may be directed between open and closed positions. Unlike the device 10, a first grommet member is carried by one of the jaws, e.g., the second, movable jaw, e.g., positioned in a receptacle on the second jaw (not shown) such that actuation of the jaws may direct the grommet through tissue positioned between the jaws, e.g., around a repair suture. The grommet member may be provided in either jaw, e.g., anterior or posterior to the tissue, such that the grommet member may be secured into the tissue from above or below. The grommet member may include one or more features, e.g., teeth and the like, for engaging tissue, e.g., similar to the grommet 180 shown in FIG. 3 A. Optionally, the grommet may be deformed to secure it. within the tissue and/or one or more stitches and/or other fasteners may be used to secure the grommet.

[00069] In another example, a grommet member may be carried by both jaws, e.g., a first grommet, member on the movable jaw and a second grommet member on the stationary jaw such that, when the jaws are directed to the closed position, the tissue is engaged between the first, and second grommet members with the grommet members surround the repair suture, e.g., similar to the grommet 180’ shown in FIG. 3B. Optionally, the first and second grommet members may include features that interlock to secure the grommet members together and/or features that engage the tissue. Thus, the resulting grommet may include a pair of annular rings that contact opposing surfaces of the tissue to reinforce the tissue and/or repair suture.

[00070] Optionally, the device may include a suture passer on the end effector for delivering a repair suture through tissue positioned between the jaws. For example, the suture passer may include a needle carried by one of the first and second jaws coupled to the repair suture, and the device may include a second actuator configured to advance the needle through the tissue between the jaws to pass the repair suture through the tissue. The needle and/or other suture passer features may be positioned on the jaws such that the repair suture is aligned with a central region of the grommet, member(s) such that the repair suture passes through the central region when the grommet member(s) are directed into the tissue. [00071] While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.