Knotless anchor temporary suture capture

Abstract

A variety of exemplary devices, systems, and methods are provided for temporary suture capture of a knotless anchor. Generally, an inserter tool is configured for knotless anchor insertion in a soft tissue repair surgical procedure. The inserter tool is configured to insert the anchor into a patient's bone to secure the soft tissue relative to the bone. Sutures coupled to the soft tissue are secured to the bone by being captured between an outer surface of the anchor and a bone surface defining a hole in the bone in which the anchor is positioned. The inserter tool and anchor are configured to cooperate with one another to temporarily capture and lock the sutures relative to the anchor and inserter tool before the anchor is secured within the bone hole.

Description

[Technical field]

[0001] The present disclosure relates generally to temporary suture capture in a knotless anchor. [Background technology]

[0002] A variety of injuries and conditions require repair of soft tissue damage or reattachment of soft tissue to bone and / or surrounding tissue. For example, when otherwise healthy tissue has been detached from the bone, such as when the labrum has detached from the glenoid cavity (shoulder instability), surgery is often required to reattach the tissue to the bone to allow healing to occur in the proper position. Numerous devices and methods have been developed to perform these surgical repairs. Some of the methods that provide better results include the use of suture fixation members, such as suture anchors, which typically have an anchor body with a suture attachment mechanism and a tissue or bone engaging mechanism for holding the suture anchor in or adjacent to the tissue or bone. Depending on the particular injury, one or more suture anchors connected to one or more segments of suture or interconnected with one or more segments of suture may be used to perform the repair.

[0003] Surgery may also be required when tears occur in large areas of a single type of tissue. Sutures may also be used with one or more suture anchors to repair such tissue tears. The sutures may be fastened to the suture anchors and tissue with a knot tied by the surgeon during the repair procedure, or with a "knotless" device and method in which one or more anchors and one or more sutures may be connected and tensioned without the surgeon having to tie a knot during surgery. Knotless fastening is particularly useful in minimally invasive surgical procedures, such as endoscopic or arthroscopic repair. In minimally invasive surgical procedures, the surgeon remotely manipulates the sutures at the surgical site using instruments inserted percutaneously through small diameter cannulas, endoscopic tubes, or otherwise, making the tying process difficult and time-consuming. Furthermore, the knots themselves may irritate the surrounding tissue. However, while knotless anchors can be very effective at reattaching soft tissue to bone, the small size of the anchor and the patient's anatomy can make it difficult to locate and insert the anchor into the bone hole. Additionally, visualization of the hole can be difficult due to the challenging angles and the tight nature of the joint space. Summary of the Invention [Problem to be solved by the invention]

[0004] Thus, there remains a need for improved devices, systems, and methods for knotless anchors. [Means for solving the problem]

[0005] Generally, devices, systems, and methods are provided for temporary suture capture in a knotless anchor.

[0006] In one aspect, a surgical system is provided, and in one embodiment, the surgical system includes an anchor and an inserter tool. The anchor is configured to be embedded in a bone hole, the anchor having a pair of slots formed therein. The inserter tool includes an outer shaft and an inner shaft. The anchor is configured to be releasably coupled to the inserter tool. With the anchor releasably coupled to the inserter tool, the inner shaft is configured to selectively be in one of a first position in which the inner shaft occludes the pair of slots and a second position in which the inner shaft does not occlude the pair of slots. The inner shaft in the second position is configured to extend distally beyond the anchor and the outer shaft, whereafter the outer shaft is configured to translate axially distally relative to the inner shaft, thereby axially translating the anchor distally into the bone hole.

[0007] The surgical system may differ in any number of respects. For example, the anchor may be configured to be releasably coupled to a suture with the suture extending through a slot in the anchor and seated within a suture retaining channel in the inner shaft, the suture may be in a locked position relative to the anchor with the inner shaft in a first position, and the inner shaft changing from the first position to a second position may be configured to move the suture from a locked position to an unlocked position relative to the anchor. Axial translation of the inner shaft in the second position in the distal direction may be configured to push the suture out of the slot. The surgical system may also include a suture.

[0008] In yet another example, each of the slots can have an open distal end and a closed proximal end. Changing of the inner shaft from the second position to the first position can be configured to urge a suture extending through the slot to move proximally within the slot, and axial translation of the inner shaft in the distal direction can be configured to move the suture distally within the slot and out the open distal end of the slot. Each of the slots can have an L-shape, or each of the slots can have a helical shape.

[0009] In yet another example, the inner shaft can have a pair of distal arms and the anchor can have a pair of distal arms, and when the inner shaft is in a first position, the distal arms of the inner shaft can be out of alignment with the distal arms of the anchor, and when the inner shaft is in a second position, the distal arms of the inner shaft can be aligned with the distal arms of the anchor.

[0010] In yet another example, the inner shaft can have a pair of distal arms, and when the inner shaft is in a first position, the distal arms of the inner shaft can be aligned with the slot of the anchor, and when the inner shaft is in a second position, the distal arms of the inner shaft are out of alignment with the slot of the anchor.

[0011] In another example, in the first position, the inner shaft cannot extend distally beyond the anchor.

[0012] In yet another example, after translation of the outer shaft, the outer shaft and the inner shaft can be configured to simultaneously translate axially in the proximal direction relative to the anchor in the bone hole.

[0013] In another example, prior to distal translation of the outer shaft, the distal end of the outer shaft can abut the proximal end of an anchor having an inner shaft positioned within the inner lumen of the anchor.

[0014] In another embodiment, a surgical system includes an anchor, an inner shaft, and an outer shaft. The anchor is configured to be implanted into a bone hole, and the anchor has a pair of distal arms defining a pair of slots therebetween. The inner shaft is configured to be placed within an inner lumen of the anchor, the inner shaft has a pair of distal arms, and the anchor is configured to rotate relative to the inner shaft while the inner shaft is within the inner lumen of the anchor, such that the distal arms of the inner shaft change from being aligned with the distal arms of the anchor and out of alignment with the slots of the anchor to being out of alignment with the distal arms of the anchor and in alignment with the slots of the anchor. The outer shaft is configured to translate longitudinally distally relative to the inner shaft and the anchor, thereby moving the anchor distally into the bone hole.

[0015] The surgical system can have any number of variations. For example, the inner shaft can be configured to move longitudinally into the bone hole before the outer shaft is longitudinally translated distally relative to the inner shaft and the anchor. The longitudinal movement of the inner shaft can be configured to push a suture placed in a slot of the anchor out of the slot and into the bone hole.

[0016] In another example, the anchor can be configured to be releasably coupled to a suture with the suture extending through a slot in the anchor and seated within a suture retaining channel in the inner shaft, the suture can be in a locked position relative to the anchor with a distal arm of the inner shaft out of alignment with the distal arm of the anchor and in alignment with the slot in the anchor, and the suture can be in an unlocked position relative to the anchor with the distal arm of the inner shaft aligned with the distal arm of the anchor and out of alignment with the slot in the anchor. The surgical system can also include a suture.

[0017] In yet another example, prior to translation of the outer shaft, the distal end of the outer shaft can abut the proximal end of an anchor having an inner shaft positioned within the inner lumen of the anchor.

[0018] In yet another example, each of the slots can have an L-shape, or each of the slots can have a spiral shape.

[0019] In another aspect, a surgical method is provided, and in one embodiment, the method includes rotating an outer shaft of an inserter tool and an anchor releasably coupled to the inserter tool relative to an inner shaft of the inserter tool. Rotation of the outer shaft and anchor moves a suture extending through a slot in the anchor from a locked position to an unlocked position. Rotation of the outer shaft and anchor pushes the suture out of the slot and into the bone hole. The surgical method also includes, after rotation of the outer shaft and anchor, longitudinally translating the outer shaft distally relative to the inner shaft, thereby pushing the anchor into the bone hole to secure the anchor within the bone hole.

[0020] The surgical method may differ in any number of ways. For example, the rotation of the outer shaft and anchor may be in a first direction, the surgical method may also include rotating the outer shaft and anchor in a second direction opposite the first direction prior to the rotation of the outer shaft and anchor in the first direction, the rotation of the outer shaft and anchor in the second direction may be relative to the inner shaft, and the rotation of the outer shaft and anchor in the second direction may move a suture extending through a slot in the anchor from an unlocked position to a locked position. The rotation of the outer shaft and anchor in the first direction may change a distal arm of the inner shaft from being aligned with the slot in the anchor to being out of alignment with the slot in the anchor, and the rotation of the outer shaft and anchor in the second direction may change a distal arm of the inner shaft from being out of alignment with the slot in the anchor to being aligned with the slot in the anchor. Rotation of the outer shaft and anchor in a first direction can change the distal arm of the inner shaft from being out of alignment with the distal arm of the anchor to being aligned with the distal arm of the anchor, and rotation of the outer shaft and anchor in a second direction can change the distal arm of the inner shaft from being aligned with the distal arm of the anchor to being out of alignment with the distal arm of the anchor.

[0021] In another example, rotation of the outer shaft and anchor in a first direction can change the distal arm of the inner shaft from being aligned with the slot of the anchor to being out of alignment with the slot of the anchor, rotation of the outer shaft and anchor in a first direction can change the distal arm of the inner shaft from being out of alignment with the distal arm of the anchor to being aligned with the distal arm of the anchor, and rotation of the outer shaft and anchor in a second direction can change the distal arm of the inner shaft from being aligned with the distal arm of the anchor to being out of alignment with the distal arm of the anchor.

[0022] In yet another example, the inner shaft can be positioned within the inner lumen of the anchor during rotation of the outer shaft and anchor and longitudinal translation of the outer shaft.

[0023] In yet another example, the surgical method may also include longitudinally translating the outer shaft and the inner shaft proximally relative to the anchor such that after axial translation of the outer shaft, the inner shaft is removed from the bone hole and the anchor and suture remain in the bone hole.

[0024] In yet another example, each of the slots can have an L-shape, or each of the slots can have a spiral shape. [Brief description of the drawings]

[0025] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 13 is a side view of one embodiment of an inserter tool having a suture anchor releasably coupled thereto. [Diagram 2] 2 is another side view of the inserter tool and anchor of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of the inserter tool and anchor of FIG. 1. [Figure 4]2 is a perspective view of the anchor and distal portion of FIG. 1 inserter tool. [Diagram 5] 2 is a perspective view of a portion of the inserter tool of FIG. 1 with the locking feature of the inserter tool in a locked position. [Figure 6] 6 is a perspective view of a portion of the inserter tool of FIG. 5 with the locking mechanism in an unlocked position. [Figure 7] 7 is a perspective view of a portion of the inserter tool of FIG. 6 after striking the strike cap of the inserter tool. [Figure 8] 2 is a side view of the anchor and distal portion of the inserter tool of FIG. 1 with a suture releasably coupled thereto and an inner shaft of the inserter tool in a first position. [Figure 9] 9 is a side view of the anchor, suture, and distal portion of the inserter tool of FIG. 8 with the inner shaft of the inserter tool in a second position. [Figure 10] FIG. 2 is a side view of a proximal portion of the inserter tool of FIG. 1. [Figure 11] FIG. 1 is a side schematic view of a bone having a hole formed therein. [Figure 12] 12 is a side view of the inserter tool and anchor of FIG. 1 positioned adjacent the outside of the bone hole of FIG. 11. [Figure 13] 13 is a side view of the inserter tool and anchor of FIG. 12 with the inner shaft of the inserter tool and the suture advanced into the bone hole. [Figure 14] 14 is a side view of the anchor and suture of FIG. 13 secured within a bone hole. [Figure 15] 11 is a perspective view of a distal portion of the inserter tool of FIG. 1 and another embodiment of a suture anchor releasably coupled to the inserter tool. [Figure 16] 13 is a perspective view of yet another embodiment of a suture anchor. FIG. [Figure 17] 17 is a side view of the anchor of FIG. 16 and the suture of FIG. 8 releasably coupled to the inserter tool of FIG. 1. [Figure 18] 18 is a side view of the anchor and suture of FIG. 17 with the suture and the inner shaft of the inserter tool advanced distally relative to the anchor. [Figure 19] 1. FIG. 4 is a perspective view of a distal portion of the inserter tool of FIG. 1 and yet another embodiment of a suture anchor releasably coupled to the inserter tool. [Figure 20] 20 is a side view of the anchor and distal portion of the inserter tool of FIG. 19 with the suture of FIG. 8 releasably coupled thereto and with the inner shaft of the inserter tool in a first position. [Figure 21] 21 is a side view of the inserter tool, suture, and anchor of FIG. 20 positioned adjacent the outside of the bone hole of FIG. 11 . [Figure 22] 22 is a side view of the anchor and suture of FIG. 21 with the suture and the inner shaft of the inserter tool advanced into a bone hole. [Figure 23] 23 is a side view of the anchor and suture of FIG. 22 secured within a bone hole. [Figure 24] 13 is a partially see-through side view of another embodiment of an inner shaft of an inserter tool and another embodiment of a suture anchor releasably coupled to the inserter tool. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Certain exemplary embodiments will now be described to provide a general understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will appreciate that the devices, systems, and methods detailed herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the invention.

[0027] Furthermore, in this disclosure, like-named components of the embodiments generally have similar characteristics, and therefore, in a particular embodiment, each feature of each like-named component is not necessarily described in full detail. Additionally, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that the equivalent of such linear and circular dimensions can be easily determined for any geometric shape. The size and shape of the systems and devices and their components may depend, at least, on the subject's anatomical structure within which the systems and devices are used, the size and shape of the components with which the systems and devices are used, and the methods and procedures with which the systems and devices are used.

[0028] A variety of exemplary devices, systems, and methods are provided for temporary suture capture of a knotless anchor. Generally, an inserter tool is configured for knotless anchor insertion in a soft tissue repair surgical procedure. The inserter tool is configured to insert an anchor into a patient's bone to secure the soft tissue relative to the bone. Sutures coupled to the soft tissue are secured to the bone by being captured between an outer surface of the anchor and a bone surface defining a hole in the bone in which the anchor is positioned. Thus, the anchor allows for the sutures to be secured in place without the need for knots, which may be time consuming and / or difficult to perform during surgery due to small suture diameters, limited working area in the joint space, wet surgical environment, and / or limited visualization at the surgical site due to the challenging angles and tight nature of the joint space.

[0029] The inserter tool is configured to releasably couple each of the suture and anchor, and the suture and anchor are releasably coupled to insert the suture and anchor into the bone hole. The inserter tool is configured to position the suture within the bone hole before the anchor is secured to the bone hole. In an exemplary embodiment, the inserter tool includes a suture retaining channel configured to releasably hold the suture, and the anchor includes a pair of slots configured to releasably seat the suture. The suture retaining channel and the pair of slots are configured to cooperate with one another to temporarily capture and lock the suture relative to the anchor and the inserter tool before the anchor is secured within the bone hole. Thus, the anchor and suture can be advanced together into position relative to the bone to which the anchor is secured without the suture becoming dislodged from the anchor or the inserter tool. The inserter tool is configured to move relative to the anchor to unlock the suture relative to the anchor and the inserter tool after the anchor and suture are in position relative to the bone before the anchor is secured within the bone hole. With the suture unlocked, the inserter tool can be used to push the suture into the bone hole and then the anchor can be advanced into the bone hole. Thus, the suture can be tensioned and positioned within the bone hole before the anchor secures the suture therein. Additionally, the inclusion of a pair of slots in the anchor for releasably seating the suture helps to reduce anchor material, which can limit anchor strain, bone weakening, and disruption of bone anatomy, especially in areas where the bone is restricted.

[0030] In an exemplary embodiment, the suture has a U-shape before and after the anchor is advanced into and secured to the bone hole. In the U-shape, each of the legs of the suture extends longitudinally along opposing sides of the anchor, and an intermediate portion of the suture connecting the legs extends along the distal end of the anchor so as to loop around the distal end of the anchor. The U-shaped configuration of the suture relative to the anchor may maximize the length of the suture that the anchor presses against the bone to secure the suture in place, which may help ensure that the soft tissue coupled to the suture remains in place relative to the bone to facilitate healing.

[0031] The inserter tool is configured to advance the anchor into the bone hole by longitudinally translating the anchor distally into the bone hole, for example, by striking the inserter tool with a mallet, hammer, or other tool, thereby capturing the suture between an outer surface of the anchor and a bone surface defining the bone hole. After the anchor is inserted into the bone, the inserter tool is configured to be longitudinally translated proximally so as to be removed from the patient's body with the suture remaining within the anchor and bone. By longitudinally translating the inserter tool along its longitudinal axis, separating the inserter tool from the suture and anchor may take less time and / or require the user to apply less force than other methods of separating the tool from the implanted anchor, including rotating the tool about its longitudinal axis. Unlike longitudinal translation of the inserter tool for removal, rotation of the tool for removal can cause the anchor to rotate and / or result in unintended off-axis loading, which can prevent the anchor from being securely positioned in the bone and / or can cause damage to the sutures and / or anchor.

[0032] The systems, devices, and methods described herein are applicable in a variety of surgical procedures for soft tissue repair, for example, in tissue repair surgical procedures in joints such as the shoulder, knee, or hip.

[0033] 1-3 illustrate one embodiment of an inserter tool 100 (also referred to herein as an "inserter"). The inserter tool 100 is configured for use in inserting a knotless anchor in a soft tissue repair surgical procedure. In general, the inserter tool 100 is configured to insert the anchor 102 into a patient's bone to secure soft tissue relative to the bone. As shown in FIG. 4, an inner lumen 102i extends through the anchor 102 such that the anchor 102 is cannulated. A plurality of bone-engaging surface features 102f are formed on an outer surface of the anchor 102. The bone-engaging surface features 102f are configured to engage bone to retain the anchor 102 within the bone, e.g., to engage a surface of the bone that defines a hole in the bone in which the anchor 102 is positioned. The bone-engaging surface features 102f include a plurality of ribs that each extend circumferentially around the anchor 102 at different axial positions along the longitudinal length of the anchor. However, the bone engaging surface feature 102f may have another configuration, such as a plurality of barbs or other forms of protrusions formed on the outer surface of the anchor. The bone engaging surface feature 102f is also configured to engage the suture to the bone to aid in securing the suture to the bone.

[0034] 4, the anchor 102 includes a pair of opposing slots 104 formed therein. As will be described further below, the slots 104 are configured to releasably seat the suture therein. Also, as will be described further below, the anchor 102 and the inner shaft 110 are configured to cooperate with one another to form a temporary enclosure with the suture placed and captured within the slots 104.

[0035] The slots 104 are independent of each other and do not intersect with each other. Each slot 104 extends proximally from the distal end of the anchor 102 and communicates with the inner lumen 102i of the anchor 102 and with the distal opening of the inner lumen 102i at the distal end of the anchor 102. Each slot 104 extends transversely to the longitudinal axis 102a of the anchor 102. When the anchor 102 is releasably coupled to the inserter tool 100, the longitudinal axis 102a of the anchor 102 is coaxial with the longitudinal axis 100a of the inserter tool 100, which is also the longitudinal axis of each of the outer shaft 108 and the inner shaft 110 of the inserter tool 100. Thus, the slots 104 extend transversely to the longitudinal axes 100a of the inserter tool 100, the outer shaft 108, and the inner shaft 110.

[0036] Each slot 104 in the illustrated embodiment has a helical shape, such that the slots 104 extend partially helically around the anchor 102. The slots 104 spiral in the same direction. In the illustrated embodiment, the slots 104 spiral counterclockwise in the distal to proximal direction, but may alternatively spiral clockwise in the distal to proximal direction.

[0037] Each slot 104 in the anchor 102 is located completely distal to the bone-engaging feature 102f of the anchor. Thus, the slot 104 does not interfere with the engagement of the bone-engaging feature 102f with the bone. Thus, the anchor 102 has a proximal portion that includes the bone-engaging feature 102f but not the slot 104, and a distal portion that includes the slot 104 but not the bone-engaging feature 102f.

[0038] The anchor 102 includes a pair of opposing distal arms 102m located between the slots 104. The distal arms 102m of the anchor are thus located in a distal portion of the anchor 102 that includes the slots 104 but not the bone engaging features 102f.

[0039] The anchor 102 can be absorbable or non-absorbable. The anchor 102 can be made from any of a variety of materials, such as, for example, Polyether ether ketone (PEEK), Polylactic acid or polylactide (PLA), BIOCRYL®, BIOCRYL®, RAPIDE®, titanium, ceramic, carbon fiber, stainless steel, etc. The anchor 102 can be formed by a variety of techniques, such as, for example, machining, molding, metal injection molding, overmolding, or post-molding processes such as post-molding machining.

[0040] The inserter 100 includes a handle 106. The handle 106 is configured to be held by hand during use of the inserter 100. In a robotic surgical implementation, the handle 106 may be held by a mechanical member of a robotic surgical system. The handle 106 has a generally cylindrical, distally tapered shape in this illustrated embodiment, but may have any of a variety of shapes.

[0041] An outer shaft 108 of the inserter 100 extends distally from the handle 106, and an inner shaft 110 of the inserter 100 (also referred to herein as the “inserter shaft”) also extends distally from the handle 106. The handle 106 has an inner lumen extending therethrough. The outer shaft 108 and the inner shaft 110 are positioned within the inner lumen of the handle 106 and extend distally out of the inner lumen of the handle 106. The proximal ends of one or both of the outer shaft 108 and the inner shaft 110 may be located within the inner lumen of the handle 106, or one or both of the outer shaft 108 and the inner shaft 110 may extend proximally beyond the handle 106, such that the proximal ends of the outer shaft 108 and the inner shaft 110 are located proximal to the handle 106. For example, as in this illustrated embodiment, the proximal end of the inner shaft 110 can be attached to the handle 106 and the proximal end of the outer shaft 108, also referred to herein as the "push tube," can be located within the inner lumen of the handle 106. In another example, the proximal end of the inner shaft 110 can be attached to the handle 106 and the proximal end of the outer shaft 108 can be located proximal to the handle 106.

[0042] The handle 106 in this illustrated embodiment includes facets 106f on opposing sides, e.g., its left and right sides, that are configured to aid in a user's grip and fine motor movements.

[0043] The handle 106 in this illustrated embodiment includes a suture retaining member configured to releasably hold the suture to keep the suture in a desired position at a desired tension. The suture is traditionally held using a hemostat. The inserter tool 100, including a suture retaining member, can eliminate the need to use a hemostat for the suture. The suture retaining member is located at the distal end of the handle 106, but may be located elsewhere, as described above.

[0044] Various embodiments of the suture retaining member are further described, for example, in U.S. Patent Publication No. 2021 / 0338223, entitled "Knotless Anchor Insertion," issued Nov. 4, 2021, which is incorporated herein by reference in its entirety. The suture retaining member in this illustrated embodiment includes a pair of grooves 107a, 107b on opposing sides (e.g., left and right sides) of the handle 106. Providing suture retaining members on opposing sides of the handle 106 may help accommodate use of the inserter tool 100 by left-handed and right-handed users and / or may facilitate engagement of a suture with one of the suture retaining members regardless of the orientation in which the inserter tool 100 is held and the angle of the suture's approach into the handle 106. However, the inserter tool 100 may include only one suture retaining member, for example, on either the left or right side of the handle.

[0045] A first one of the suture retaining grooves 107a is defined between the handle 106 and a first elastomeric cleat 109a fixedly attached to the handle 106. A second one of the suture retaining grooves 107b is defined between the handle 106 and a second elastomeric cleat 109b fixedly attached to the handle 106. The first elastomeric cleat 109a and the second elastomeric cleat 109b are each made from an elastomeric material such as rubber or other polymers. The handle 106 is made from a rigid, non-elastomeric material such as a plastic such as polycarbonate or other plastics, metals (e.g., stainless steel, titanium, etc.), polytetrafluoroethylene (PTFE), or other biocompatible materials. Thus, each of the grooves 107a, 107b is located at the junction between the elastomeric material and the rigid material. The elastomeric material of the first elastomeric crete 109a and the second elastomeric crete 109b dynamically increases the width of the associated groove 107a, 107b to adjust to the size and shape of the suture placed therein, allowing the suture to be securely held in the groove 107a, 107b and gripped between the elastomeric material and the rigid material. Thus, the suture retaining member is self-adjusting. Different sutures have different sizes and shapes, and the first elastomeric crete 109a and the second elastomeric crete 109b are each configured to dynamically adapt to the particular size and shape of the suture placed therein. The suture being securely held in the groove 107a, 107b may help ensure that tension in the suture is maintained, for example, without reduction, while the suture is held by the suture retaining member. Once the suture is released from the grooves 107a, 107b, the elastomeric cleat 109a, 109b no longer grips the suture and is thus permitted to return to its original smaller width as the elastomeric material elastically returns to its original configuration.

[0046] The suture retaining member is located in a hammerhead-shaped portion of the inserter tool 100 defined by the handle 106 and the elastomeric creases 109a, 109b. A proximal surface of the hammerhead-shaped portion defined by the proximal surface of the handle 106 and the proximal of each of the elastomeric creases 109a, 109b extends radially outward and tapers distally. This taper is configured to urge the suture along the proximal surface of the handle 106 toward one of the elastomeric creases 109a, 109b to accommodate the associated groove 107a, 107b. Each of the elastomeric creases 109a, 109b has a beveled edge facing the associated groove 107a, 107b, which may also help urge the suture into the groove 107a, 107b.

[0047] The body 100 also includes a striking cap 112 extending proximally from the handle 106. The distal end of the striking cap 112 abuts the proximal end of the push tube 108 in the initial insertion configuration, which can help maximize the transfer of distal force applied to the striking cap 112 to the push tube 108, thereby efficiently advancing the push tube 108 distally to advance the anchor 102 distally into the bone hole. However, the distal end of the striking cap may be spaced a distance proximal to the proximal end of the push tube, or the striking cap 112 may be integrally formed with the push tube 108. The striking cap 112 is configured to have its proximal surface 112s struck with a mallet, hammer, or other tool. The proximal surface 112s in this illustrated embodiment is convexly curved, which can provide more feedback (compared to a flat surface) to a user striking the striking cap 112. The strike cap 112 , however, may have a flat surface, which may facilitate a uniform strike of the strike cap 112 and thus a uniform transmission of distal force from the strike cap 112 to the push tube 108 .

[0048] The striking cap 112 has a hexa-lobe shape in this illustrated embodiment, but may have other shapes such as circular, oval, trilobe, tetralobe, pentalobe, square, rectangular, etc.

[0049] The proximal surface 112s of the striking cap 112 is exposed for striking with a mallet, hammer, or other tool. In other embodiments, the inserter tool may include a striking cap and a protective member configured to cover or conceal at least the striking surface of the striking cap. The protective member may help prevent premature striking of the striking cap and / or unintended distal movement of the striking cap and thus unintended distal advancement of an anchor coupled to the inserter tool. In some embodiments, the protective member may completely cover or conceal the striking cap. Various embodiments of the protective member are further described, for example, in the aforementioned U.S. Patent Publication No. 2021 / 0338223, issued Nov. 4, 2021, entitled "Knotless Anchor Insertion."

[0050] As will be described further below, the striking cap 112 is configured as a knob that is configured to be rotated to move the outer shaft 108 and anchor 102 relative to the inner shaft 110 .

[0051] In other embodiments, instead of a rotatable knob configured to move the outer shaft 108 and anchor 102, another mechanism can be used, such as a depressible button on the handle 106 configured to be depressed to cause movement of the outer shaft 108 and anchor 102. In another example, a lever on the handle 106 can be configured to be moved to cause movement of the outer shaft 108 and anchor 102.

[0052] The inner lumen extends through the outer shaft 108 such that the outer shaft 108 is cannulated. In the initial configuration of the inserter 100 shown in Figures 1-4, the inner shaft 110 is disposed within the inner lumen 102i of the anchor 102 and within the inner lumen of the outer shaft 108. As described further below, the inner shaft 110 is configured to extend distally beyond the outer shaft 108 and anchor 102 to facilitate manipulation of the suture, and the anchor 102 and outer shaft 108 are each configured to be movable relative to the inner shaft 110 to facilitate delivery of the anchor 102 into the bone hole.

[0053] The distal end 108d of the outer shaft 108 is located proximal to the proximal end 102p of the anchor 102. In an exemplary embodiment, as shown in FIG. 4, the distal end 108d of the outer shaft abuts the proximal end 102p of the anchor in the initial configuration of the inserter, which can facilitate extending the inner shaft 110 distally beyond the outer shaft 108 and the anchor 102, and can also help maximize the transfer of distal forces applied to the push tube 108 to the anchor 102, thereby efficiently advancing the anchor 102 distally into the bone hole. The proximal end 102p of the anchor 102 includes a mating element (obscure in FIG. 4) configured to releasably mate with a mating feature (obscure in FIG. 4) at the distal end 108d of the outer shaft 108. The mating element and the mating feature are configured to releasably hold the anchor 102 and the outer shaft 108 together until after the anchor 102 is implanted in the bone, which facilitates the inner shaft extending distally beyond the outer shaft 108 and the anchor 102, as described further below. The mating element and the mating feature can have a variety of configurations. For example, one of the mating element and the mating feature can include one or more recesses, and the other of the mating element and the mating feature can include one or more protrusions, each configured to releasably seat in one of the one or more recesses. The shape and size of each of the protrusions corresponds to the shape and size of the recess in which it is releasably seated, for example, the protrusions and recesses each have a hemispherical shape such that the protrusions are releasably snapped into the recesses.

[0054] The outer shaft 108 includes a distal knob 108k that tapers distally and defines a distal end 108d of the outer shaft 108. The distal taper of the knob 108k allows a distal portion of the outer shaft 108 to have a larger diameter than the distal end 108d of the outer shaft 108 such that the smaller diameter at the distal end 108d of the outer shaft 108 corresponds to the diameter of the anchor 102 at its proximal end 102p, which may help the outer shaft 108 releasably mate with the anchor 102 and efficiently apply a distal force to the anchor 102.

[0055] The inserter tool 100 includes a locking mechanism 118 configured to lock the outer shaft 108 such that the outer shaft 108 cannot move distally relative to the inner shaft 110 when the locking mechanism 118 is in a locked position. FIGS. 1-3 and 5 show the locking mechanism 118 in a locked position. FIGS. 6 and 7 show the locking mechanism 118 in an unlocked position in which the outer shaft 108 is configured to move distally relative to the inner shaft 110. The locking mechanism 118 is configured to move from the locked position to the unlocked position by sliding relative to the outer shaft 108, the inner shaft 110, the striking cap 112, and the handle 106. The sliding movement of the locking mechanism 118 is a lateral movement substantially perpendicular to the longitudinal axes of the outer shaft 108 and the inner shaft 110. The initial position of the locking mechanism 118 is a locked position to help prevent premature distal translation of the outer shaft 108 relative to the inner shaft 110, and therefore helps to prevent premature distal advancement of the anchor 102 relative to the inner shaft 110.

[0056] The locking mechanism 118 includes a recess 118d on its side. The recess 118d is configured to communicate where to place a finger on the locking mechanism 118. The recess surface is configured as a push surface on which a finger can be placed to push the locking mechanism 118 from the locked position to the unlocked position. The curvature of the recess 118d matches the curvature of the handle 106 adjacent the locking mechanism 118 in the unlocked position. The matching curvature of the recess 118d and the handle 106 is configured to indicate to a user that the locking mechanism 118 has been fully moved to the unlocked position.

[0057] The locking mechanism 118 includes a keyway 120 formed therein, within which the outer shaft 108 and the strike cap 112 are configured to move, respectively. The keyway 120 includes a reduced diameter portion 120a and an enlarged diameter portion 120b. With the locking mechanism 118 in the locked position, the outer shaft 108 extends through the reduced diameter portion 120a and the strike cap 112 is located proximal to the keyway 120. The diameter of the reduced diameter portion 120a is smaller than the diameter of the strike cap 112 at least at the distal end of the end cap 112. Thus, the strike cap 112 cannot move distally into the keyway 120, thereby preventing the outer shaft 108 from moving distally by striking the proximal surface 112s of the strike cap 112. With the locking mechanism 118 in the unlocked position, the outer shaft 108 extends through the enlarged diameter portion 120b and the striking cap 112 is proximal to the keyway 120. The diameter of the enlarged diameter portion 120b is greater than the diameter of the striking cap 112 at least at the distal end of the striking cap 112. Thus, the striking cap 112 can move distally into the keyway 120, thereby allowing the outer shaft 108 to move distally by striking the proximal surface 112s of the striking cap 112. Because the diameter of the enlarged diameter portion 120b is less than the diameter of the head of the striking cap 112, including the proximal surface 112s, it prevents the striking cap 112 from passing completely through the keyway 120, as the distal surface of the striking cap 112 abuts the locking mechanism 118 around the keyway 120. FIG. 7 shows the locking mechanism 118 in an unlocked position, with the distal surface of the striking cap 112 abutting the locking mechanism 118 about the keyway 120 after the striking cap 112 has been struck.

[0058] The locking mechanism 118 in the illustrated embodiment is not releasable from the inserter tool 100. In other embodiments, the locking mechanism is releasable from the inserter tool 100. Various embodiments of locking mechanisms are further described, for example, in the aforementioned U.S. Patent Publication No. 2021 / 0338223, published November 4, 2021, and entitled "Knotless Anchor Insertion."

[0059] As shown in FIG. 4, the distal end of the inner shaft defines a fork. The inner shaft 110 includes a pair of opposing distal arms 122 that define a suture retaining channel 124 therebetween. The suture retaining channel 124 has an open distal end and a closed proximal end. The suture retaining channel 124 is configured to releasably retain a suture therein, with the suture extending through the slot 104 of the anchor 102, as will be further described below. As also shown in FIG. 4, with the anchor 102 coupled to the inserter 100 and the inserter 100 in an initial configuration, the suture retaining channel 124 is located within the anchor 102, e.g., within the inner lumen 102i of the anchor 102, and is located distal to the outer shaft 108 but not distal to the anchor 102.

[0060] Because the suture(s) do not have to be folded for insertion into an opening, eyelet, or other opening that is coupled to the inserter tool or anchor, the suture retaining channel 124 may allow more sutures and / or larger diameter suture(s) to be coupled to the inserter 100 than with other types of inserter tools.

[0061] Although the suture-retaining channel 124 has a substantially constant diameter in this illustrated embodiment, different portions may have different diameters, such as, for example, a proximal portion of the suture-retaining channel 124 having a larger diameter than a distal portion of the suture-retaining channel, a distal portion of the suture-retaining channel 124 having a larger diameter than a proximal portion of the suture-retaining channel, or other different diameters. One of ordinary skill in the art will understand that values ​​such as diameter values ​​may not be exactly the same but would nevertheless be considered substantially the same for any of one or more reasons, such as manufacturing tolerances and sensitivities of measuring equipment.

[0062] 8 and 9 show one embodiment in which the suture 126 is coupled to the inserter tool 100 and anchor 102 by placing the suture 126 in the suture retaining channel 124 of the inner shaft and the slot 104 of the anchor. In an exemplary embodiment, the suture 126 is coupled to the inserter tool 100 and anchor 102 by a user, which allows the user to select the particular size and type of suture appropriate for the surgical procedure being performed and whether to use one or more sutures. Figures 8 and 9 show coupling a single suture 126 to the inserter tool 100 and anchor 102.

[0063] 4 and 8, with the inserter 100 in the initial configuration, each of the distal arms 122 of the inner shaft 110 is aligned with one of the distal arms 102m of the anchor 102, and the distal arms 122 of the inner shaft are not aligned with the slots 104 of the anchor. With the inner shaft 110 and the anchor 102 in this relative position with respect to one another, the distal end of each of the slots 104 is open and unobstructed. Thus, the suture 126 can be slid or otherwise moved into the slot 104 and positioned within the suture retaining channel 124, as shown in FIG. 8. The legs 126g of the suture 126 extend outside the anchor 102 and the outer shaft 108, and an intermediate portion of the suture 126 between the legs 126g is in the distal portion of the slot 104 and the distal portion of the suture retaining channel 124. The suture 126 extends along the distal end of the anchor so as to loop around the distal end of the anchor. The suture 126 may be slid directly into the slot 104, or the suture 126 may be first placed in the suture retaining channel 124 with the inner shaft 110 extending distally beyond the anchor 102, and then the outer shaft 108 and anchor 102 are moved distally relative to the inner shaft 110 to move the suture 126 into the slot 104.

[0064] With an intermediate portion of the suture 126 within the slot 104 and the suture retaining channel 124, the outer shaft 108 and anchor 102 are rotated about the longitudinal axis 100a relative to the inner shaft 110. The knob 112 is configured to be rotated in a first direction, as shown by the arrow 128 in FIG. 10, to rotate the outer shaft 108 and anchor 102 relative to the inner shaft 110. The anchor 102 is releasably mated to the outer shaft 108, allowing the anchor 102 to rotate as a unit with the outer shaft 108. The knob 112, outer shaft 108, and anchor 102 are rotated counterclockwise in this illustrated embodiment, but may alternatively be rotated clockwise. The outer shaft 108 and anchor 102 are rotated approximately 90°, for example, by rotating the knob 112 approximately 90°, whereby the arms 122 of the inner shaft are placed in a maximum obstruction position relative to the slots 104 of the anchor. One of ordinary skill in the art will appreciate that the values ​​may not be exactly equal, but are nevertheless considered to be approximately equal for any one or more reasons, such as manufacturing tolerances or sensitivity of the measurement equipment.

[0065] The inserter tool 100 may include an indicator configured to indicate the rotational position of the knob 112, and thus the rotational position of the anchor 102 and the outer shaft 108 relative to the inner shaft 110. The indicator is configured to be located outside the patient's body when the anchor 102 is located within the patient's body, thereby allowing a user to easily determine the rotational position of the anchor 102 and the outer shaft 108 even if the anchor 102 and / or the outer shaft 108 are not currently visible within the patient's body. The indicator may have a variety of configurations. For example, the indicator may include a first marking on the knob 112 and a second marking on the handle 106 and / or the locking mechanism 118. The first and second markings may have any of a variety of configurations, such as dots, lines, numbers, letters, arrows, or other marks. The first and second markings are not aligned with the inserter tool 100 in an initial configuration. As the knob 112 rotates, the first and second markings move toward alignment. Alignment of the first and second markings indicates that the knob 112, and thus the anchor 102 and outer shaft 108, have been rotated 90°. In another example, the indicator may include a stop surface on the knob 112 configured to abut a corresponding stop surface on the handle 106 and / or locking mechanism 118. When the stop surfaces abut one another, the knob 112 is prevented from further rotation in the first direction, thereby indicating that the inner shaft 110 is in the proper rotational position relative to the anchor 102 and the suture 126 is locked in place.

[0066] Rotation of the anchor 102 relative to the inner shaft 110 disaligns the inner shaft's distal arm 122 from the anchor's distal arm 102m and aligns it with the anchor's slot 104, as shown in FIG. 9. Rotation of the anchor 102 causes the inner shaft's distal arm 122 to push the suture 126 proximally within the slot 104 and suture-retaining channel 124, so that the middle portion of the suture 126 is located more proximally than it was before rotation of the anchor, as shown in FIG. 8 (before rotation) and FIG. 9 (after rotation). The inner shaft 110's distal arm 122 locks the suture 126 within the slot 104 by effectively closing off the slot 104. The inner shaft 110 and anchor 102 can then form a temporary enclosure for the suture that is seated within the suture-retaining channel 124 and extends through the slot 104. The locked suture 126 is in a fixed position relative to the anchor 102 , the inner shaft 110 , and the outer shaft 108 .

[0067] Alternatively, instead of rotating the anchor 102 and outer shaft 108 relative to the inner shaft 110 , the inner shaft 110 can be rotated relative to the anchor 102 and outer shaft 108 .

[0068] 11-14 illustrate one embodiment of a method for inserting a suture anchor into bone using an inserter tool. The method is described with respect to inserter tool 100 and anchor 102 of FIGS. 1-10, but may be similarly performed with other inserter tools and anchors.

[0069] With the suture 126 coupled to the inserter 100 and anchor 102, the inserter 100 is used to insert the suture 126 and anchor 102 into a hole 130 in a bone 132. In an exemplary embodiment in which the inserter 100 is used to insert the suture 126 and anchor 102 into a bone hole 130, as will be understood by one of ordinary skill in the art, a drill or other bone removal tool is inserted into the patient's body to form a bone hole 130 in the bone 132 as shown in FIG. 11 . As will be further understood by one of ordinary skill in the art, the drill or other bone removal tool may be advanced into the patient's body through an opening, e.g., a cannula positioned in an incision, formed in the patient's skin, and then removed from the patient's body. The cannula may then act as a guide for distal advancement of the inserter toward the bone hole 130.

[0070] Before or after the bone hole 130 is formed, the suture 126 is coupled and locked to the anchor 102 as discussed above and shown in FIG. 9. With the suture 126 coupled and locked to the anchor 102 so as to be fixed in place relative to the anchor 102, the inner shaft 110, and the outer shaft 108, the inserter 100 is advanced distally into the patient's body and positioned relative to the bone hole 130. Thus, the suture 126 and the anchor 102 can be ziplined into place relative to the bone hole 130 from outside the body while in a predictable, fixed position relative to one another without risk of the suture 126 falling out of the anchor 102. Thus, the suture 126 does not need to be reloaded during surgery or outside the patient's body, and the inserter 100 is first removed from the patient's body to allow for reloading of the suture.

[0071] With the anchor 102 and inserter 100 positioned relative to the bone hole 130, the suture 126 is unlocked by rotating the anchor 102 and outer shaft 108 relative to the inner shaft 110 in a direction opposite to that described above to lock the suture 126 in place. Thus, the inner shaft 110 is changed from the position of FIG. 9 to the position of FIG. 8 by rotating the knob 112 in a second, opposite direction, e.g., clockwise, to rotate the anchor 102 and outer shaft 108 relative to the inner shaft 110. Rotating the anchor 102 in the second direction relative to the inner shaft 110 causes the distal arm 122 of the inner shaft to be realigned with the distal arm 102m of the anchor and to be realigned out of alignment with the slot 104 of the anchor. FIG. 12 shows the inserter 100 and anchor 102 positioned relative to the bone hole 130 and the suture 126 in the unlocked position after rotating the inner shaft 110 in the second direction. Continued rotation of the knob 112 moves the outer shaft 108 and anchor 102 proximally relative to the inner shaft 110 such that the inner shaft 110 extends distally beyond the anchor 102 and outer shaft 108. The anchor 102 is releasably mated to the outer shaft 108, allowing the anchor 102 to move as a unit with the outer shaft 108. As shown in FIG. 13, as the knob 112 is rotated, downward (distal) axial pressure is applied to the anchor 108 against the mouth of the bone hole 130, which will allow the inner shaft 110 to extend into the bone hole 130. (The inner shaft 110 is shown in longitudinal cross section in FIG. 13 to better illustrate the position of the suture relative to the inner shaft 110 and bone 132.)

[0072] Distal extension of the inner shaft 110 beyond the anchor 102 correspondingly pushes the suture 126 distally out of the slot 104 and into the bone hole 130. As the inner shaft 110 moves into the bone hole 130, the suture 126 abuts the proximal end of the fork defined by the distal arm 122 of the inner shaft such that continued distal advancement of the inner shaft 110 also moves the suture 126 distally and into the bone hole 130. Thus, the suture 126 is positioned within the bone hole 130 before the anchor 102 is secured thereto. In other words, the suture 126, placed in the suture retaining channel 124 of the inner shaft and the slot 104 of the anchor, can be positioned in the bone hole 130 distal to the anchor 102, thereby allowing the anchor 102 to be advanced distally into the bone hole 130 with the suture 126 already positioned in the bone hole 130. The bottom surface of the bone hole 130 can act as a stop surface to stop the inner shaft 110 against the bone 132. The interior of the bone hole 130 cannot be visualized with the inserter 100 positioned in the bone hole 130, and therefore the bottom surface of the bone hole 130 acting as a stop can help ensure that the inserter 100 is advanced as distally as possible within the bone hole 130, and can help ensure that the anchor 102 is secured in the bone hole 130 with the proximal end of the anchor flush or nearly flush with the proximal end of the bone hole 130.

[0073] With the suture 126 positioned within the bone hole 130 and the distal portion of the inner shaft 110 positioned within the bone hole 130, the suture 126 can be tensioned as desired prior to distally advancing the anchor 102 relative to the inner shaft 110. The suture 126 can be slid relative to the anchor 102 (and relative to the inner shaft 110 and outer shaft 108), for example, by pulling on the legs 126g of the suture 126, thereby desirably tensioning the suture 126 and thus desirably positioning soft tissue tied or otherwise attached to the suture 126 relative to the bone 132 to which the anchor 102 is to be secured. As shown in FIG. 13, the suture 126 positioned within the bone hole 130 has a U-shape. The U-shape of the suture 126 before the anchor 102 is inserted into the bone hole 130 enables the suture 126 to have two legs 126g each extending longitudinally along opposite sides of the anchor 102 after the anchor 102 is inserted into the bone hole 130, and an intermediate portion of the suture 126 connecting the legs 126 that extends along the distal end of the anchor so as to loop around the distal tip of the anchor.

[0074] With the suture 126 positioned within the bone hole 130, the distal portion of the inner shaft 110 positioned within the bone hole 130, and the suture 126 at a desired tension, the locking mechanism 118 is moved from the locked position to the unlocked position. The outer shaft 108 is now free to move distally relative to the inner shaft 110 in response to a strike against the strike cap 112.

[0075] With the suture 126 positioned within the bone hole 130, the distal portion of the inner shaft 110 positioned within the bone hole 130, the suture 126 at a desired tension, and the locking mechanism 118 in an unlocked position, the anchor 102 is advanced distally into the bone hole 130 by longitudinally translating the anchor 102 distally relative to the inner shaft 110. In other words, the anchor 102 is pushed axially along the longitudinal axis 100a of the inserter 100. The striking cap 112 is struck with a mallet, hammer, or other tool to move the outer tube 108 distally relative to the inner shaft 110, and to move the anchor 102 distally relative to the inner shaft 110 and advance it distally into the bone hole 130. The striking cap 112 may be struck one or more times to fully advance the anchor 102 into the bone hole 130. The anchor 102 in the bone hole 130 captures the suture 126 , for example, its leg 126 g , between an outer surface of the anchor 102 and the interior bone surface that defines the bone hole 130 .

[0076] After the anchor 102 is inserted into the bone hole 130, the inserter 100, including the outer shaft 108 and the inner shaft 110, is translated longitudinally in a proximal direction and, for example, pulled axially along the longitudinal axis 100a of the inserter 100 to remove it from the patient's body with the anchor 102 and the suture 126 remaining in the bone 132. The proximal movement of the outer shaft 108 releases the mating elements of the anchor 102 and the mating features of the outer shaft 108, since the anchor 102 is secured in the bone 132 and thus can remain in the bone hole 130 as the outer shaft 108 is moved proximally. FIG. 14 shows the anchor 102 advanced distally and positioned in the bone hole 130 after removal of the inserter 100. The suture 126 automatically exits the suture retaining channel 124 of the inner shaft in response to pulling the inner shaft 110 proximally out of the bone hole 130. The tails of the suture 126 can be trimmed if necessary.

[0077] FIG. 15 illustrates another embodiment of an anchor 202. Although the anchor 202 is shown in FIG. 15 coupled to an inserter tool 100, the anchor 202 can be used with other inserter tools as well. The inserter tool 100 is shown in an initial configuration in FIG. 15, similar to the position of the inserter tool in FIG. 4. The anchor 202 is configured and used similarly to the anchor 102 of FIGS. 1-4, 8, 9, and 12-14, except that the pair of opposing slots 204 of the anchor 202 has a different configuration than the pair of opposing slots 104 of the anchor 102. In this illustrated embodiment, each slot 204 has an L-shape. Each slot 204 has a vertical arm with an open distal end extending proximally from the open distal end of the anchor 202, and a horizontal arm extending laterally from the proximal end of the vertical arm. The vertical arm is substantially parallel to the longitudinal axis 100a of the inserter and therefore to the longitudinal axis of the coaxial anchor, and the horizontal arm is transverse to (and in this illustrated embodiment substantially perpendicular to) the longitudinal axis 100a of the inserter and to the longitudinal axis of the anchor. Those skilled in the art will appreciate that the axes may not be exactly parallel or may not be exactly perpendicular, but are nevertheless considered to be substantially parallel or substantially perpendicular for any of one or more reasons, such as manufacturing tolerances and sensitivities of the measurement equipment. The horizontal arm is wider than the vertical arm, which may help lock the suture in the slot 204, e.g., in the horizontal arm, by providing sufficient space for the suture to be seated and captured.

[0078] FIGURE 16 illustrates another embodiment of an anchor 302. The anchor 302 is constructed and used similarly to the anchor 102 of FIGURES 1-4, 8, 9, and 12-14, including for use with the inserter tool 100 or other inserter tools, except that the pair of opposing slots 304 of the anchor 302 has a different configuration than the pair of opposing slots 104 of the anchor 102. In this illustrated embodiment, each slot 304 has an L-shape similar to the slot 204 of FIGURE 15. However, in this illustrated embodiment, the vertical and horizontal arms of each slot have the same width.

[0079] FIG. 17 shows the anchor 302 and inner shaft 110 with the suture 126 secured thereto. The suture 126 is placed in the suture retaining channel 124 and extends through the slot 304, with the suture 126 positioned in the horizontal arm of the slot 304. The arm 122 of the inner shaft 110 occludes the slot 304. FIG. 18 shows the anchor 302, inner shaft 110, and suture 126 of FIG. 17 after the anchor 302 has been rotated to unlock the suture 126 and moved proximally relative to the anchor 302 with the outer shaft 108 to push the suture 126 out of the slot 304. The anchor 302 is shown in FIGS. 17 and 18 with the inserter tool 100 of FIGS. 1-3, but may be used with other inserter tools as well. Also, although anchor 302 is shown in Figures 17 and 18 with suture 126 of Figures 12-14, it can be used with other sutures as well.

[0080] FIG. 19 illustrates another embodiment of an anchor 402. Although the anchor 402 is shown in FIG. 19 coupled to an inserter tool 100, the anchor 402 can be used similarly to other inserter tools. The inserter tool 100 is shown in an initial configuration in FIG. 19, similar to the position of the inserter tool in FIG. 4. The anchor 402 is configured and used similarly to the anchor 102 of FIGS. 1-4, 8, 9, and 12-14, except that the pair of opposing slots 404 of the anchor 402 has a different configuration than the pair of opposing slots 104 of the anchor 102. In this illustrated embodiment, each slot 404 includes a notch. The notch is formed in a distal portion of the anchor 402 that does not include the bone engaging feature 402f and is defined by opposing distal arms 402m of the anchor 402.

[0081] Each slot 404 includes a distal suture guide groove 404g, a proximal cutout 404c, and a channel 404h connecting the distal suture guide groove 404g and the proximal cutout 404c. Each distal suture guide groove 404g is defined by opposing wings at the distal end of the anchor's distal arm 402m. The wings each extend radially outward to define a V-shape. Thus, each suture guide groove 404g is V-shaped with the tip of the "V" facing proximally. Each cutout 404c is located distal to its corresponding suture guide groove 404g. Although the cutouts 404c in this illustrated embodiment each have a pentagonal shape defined by a square and a triangle, with the triangle distal to and facing distally relative to the square, the cutouts 404c can have other shapes, e.g., teardrop shaped, diamond shaped, etc.

[0082] Generally, slot 404 is configured to receive a suture therein. The suture can travel distally through suture guide groove 404g into channel 404h and then into cutout 404c. Suture guide groove 404g and cutout 404c each have a width greater than the width of channel 404h, which can help retain the suture within cutout 404c by impeding, if not preventing, the suture from traveling distally out of cutout 404c prior to the desired time of separation of the suture from anchor 402, for example, by pushing the suture distally with the inner shaft of an inserter tool.

[0083] The suture guide grooves 404g are configured to receive therein a suture that engages the inner surface of the arm's wing. The suture can then be slid proximally along the inner surface of the wing to guide the suture to the apex of each suture guide groove 404g, for example, to the V-shaped point of the groove. The suture can be slid along any of the inner surfaces of the wings. The suture continues to be slid proximally to enter the longitudinal channel 404h. Thus, the movement of the suture proximally in the suture guide grooves 404g causes the suture to enter the channel 404h. Continuing to move the suture proximally in the channel 404h causes the suture to enter the cutout 404c. The closed proximal end of cutout 404c acts as a stop surface for the suture within cutout 404c, although in some embodiments, the suture may be positioned within cutout 404c but may not abut one or both stop surfaces. As described further below, a suture received within and extending through cutout 404c may be pushed distally out of cutout 404c, then pushed distally through channel 404h, and then pushed distally out of suture guide groove 404g. As described below, distal arm 402m of anchor 402 may be configured to spread radially outward as the suture enters and passes through channel 404h, and may be configured to spread radially inward after the suture exits channel 404h and enters cutout 404c or suture guide groove 404g.

[0084] The distal arms 402m of the anchor 402 are configured to bounce back and forth relative to one another, similar to tweezers arms. The movement of the distal arms 402m relative to one another is configured to change the width of the channel 404h to facilitate placement of the suture in and removal of the suture from the cutout 404c. FIG. 19 shows the arms 402m in a rest configuration in which the width of the channel 404h is at a minimum. The distal arms 402m are configured to move from the rest configuration to an expanded configuration in which the arms 402m are moved radially outward such that the width of the channel 404h increases. The expanded width of the channel 404h provides more space for the suture to enter and exit the cutout 404c. The arm 402m is biased to a static configuration such that the arm 402m is configured to dynamically move from the static configuration to the extended configuration in response to the suture advancing proximally into the cutout 404c or distally out of the cutout 404c such that the arm 402m is configured to dynamically move from the extended configuration to the static configuration in response to the suture advancing proximally out of the suture guide groove 404g and into the cutout 404c such that the arm 402m is configured to dynamically move from the static configuration to the extended configuration in response to the suture advancing distally out of the cutout 404c and into the suture guide groove 404g.

[0085] Alternatively, the distal arms 402m of the anchor 402 may not be configured to bounce back and forth relative to one another. In such embodiments, the compressibility of the suture may be sufficient to allow the suture to move through the channel 404h.

[0086] Figure 20 shows the suture 126 placed within the slot 404. Although the anchor 402 is shown in Figure 20 coupled to the inserter tool 100 and the suture 126, the anchor 402 can be used with other inserter tools and sutures as well. The inserter tool 100 in Figure 20 is in an initial configuration, with each of the distal arms 122 of the inner shaft 110 aligned with one of the distal arms 402m of the anchors 402, and the distal arms 122 of the inner shaft misaligned from the slots 404 of the anchors.

[0087] Figures 21-23 show one embodiment of a method for inserting a suture anchor 402 into bone 132 using the inserter tool 100. The method is described with respect to the inserter tool 100 of Figures 1-10, the bone 132 and bone hole 130 of Figures 11-14, the suture 126 of Figures 12-14, and the anchor 402 of Figure 18, but may be similarly performed with other inserter tools, bones, bone holes, sutures, and anchors.

[0088] With the suture 126 coupled to the inserter 100 and anchor 402, the inserter 100 is used to insert the suture 126 and anchor 402 into the bone hole 130, which may be formed as described above. Either before or after the bone hole 130 is formed, the suture 126 is coupled to the anchor 402 as shown in FIG. 20. The suture 126 is then locked to the anchor 402 in a manner similar to that described above with respect to the anchor 102 and suture 126, and the outer shaft 108 and anchor 402 are rotated to align the arms 122 of the inner shaft with the slots 404 of the anchor 402.

[0089] With the suture 126 coupled and locked to the anchor 402 so as to be fixed in position relative to the anchor 402, the inner shaft 110, and the outer shaft 108, the inserter 100 is advanced distally into the patient's body and positioned relative to the bone hole 130. Thus, the suture 126 and anchor 402 can be ziplined into position relative to the bone hole 130 from outside the patient's body while in a predictable, fixed position relative to one another, without risk of the suture 126 falling off the anchor 402.

[0090] With the anchor 402 and inserter 100 positioned relative to the bone hole 130, the suture 126 is unlocked by rotating the anchor 402 relative to the inner shaft 110 in the opposite direction as described above to lock the suture 126 in place, for example by rotating the knob 112 of the inserter 100 to rotate the anchor 402 and the outer shaft 108. Rotating the anchor 402 in a second direction relative to the inner shaft 110 realigns the distal arm 122 of the inner shaft with the distal arm 402m of the anchor and out of alignment with the slot 404 of the anchor. FIG. 21 shows the inserter 100 and anchor 402 positioned relative to the bone hole 130 and the suture 126 in an unlocked position after rotating the anchor 402 in the second direction. The inner shaft 110 is then positioned within the bone hole 130 as shown in FIG. 22, in a manner similar to that described above with respect to the anchor 102.

[0091] Movement of the inner shaft 110 into the bone hole 130 correspondingly forces the suture 126 distally out of the slot 404 and into the bone hole 130. As the inner shaft 110 advances into the bone hole 130, the suture 126 abuts the proximal end of the fork defined by the distal arm 122 of the inner shaft such that continued distal advancement of the inner shaft 110 also moves the suture 126 distally and into the bone hole 130. Thus, the suture 126 is positioned within the bone hole 130 before the anchor 402 is secured to the bone hole 130. In other words, the suture 126, placed within the inner shaft's suture retaining channel 124 and the anchor's slot 404, can be positioned within the bone hole 130 distal to the anchor 402, such that the anchor 402 can be advanced distally into the bone hole 130 with the suture 126 already positioned within the bone hole 130. The bottom surface of the bone hole 130 can act as a stop surface for the inner shaft 110 to stop, as described above.

[0092] With the suture 126 positioned within the bone hole 130 and the distal portion of the inner shaft 110 positioned within the bone hole 130, the suture 126 can be tensioned as described above prior to distally advancing the anchor 402 relative to the inner shaft 110. The suture 126 positioned within the bone hole 130 in FIG. 22 has a U-shape as described above.

[0093] With the suture 126 positioned within the bone hole 130, the distal portion of the inner shaft 110 positioned within the bone hole 130, and the suture 126 at a desired tension, the locking mechanism 118 is moved from the locked position to the unlocked position. The outer shaft 108 is now free to move relative to the inner shaft 110 in response to a strike against the strike cap 112.

[0094] With the suture 126 positioned within the bone hole 130, the distal portion of the inner shaft 110 positioned within the bone hole 130, the suture 126 at a desired tension, and the locking mechanism 118 in an unlocked position, the anchor 402 is advanced distally into the bone hole 130 by longitudinally translating the anchor 402 distally relative to the inner shaft 110. In other words, the anchor 402 is pushed axially along the longitudinal axis 100a of the inserter 100. The striking cap 112 is struck with a mallet, hammer, or other tool to move the outer tube 108 distally relative to the inner shaft 110 and to move the anchor 402 distally relative to the inner shaft 110 and advance it distally into the bone hole 130. The striking cap 112 may be struck one or more times to fully advance the anchor 402 into the bone hole 130. The anchor 402 in the bone hole 130 captures the suture 126 , for example, its leg 126 g , between an outer surface of the anchor 402 and the interior bone surface that defines the bone hole 130 .

[0095] After the anchor 402 is inserted into the bone hole 130, the inserter 100, including the outer shaft 108 and the inner shaft 110, is longitudinally translated proximally and, for example, pulled axially along the longitudinal axis 100a of the inserter 100 to remove it from the patient's body with the anchor 402 and the suture 126 remaining in the bone 132. FIG. 23 shows the anchor 402 advanced distally and positioned within the bone hole 130 after removal of the inserter 100. The suture 126 automatically exits the inner shaft suture retaining channel 124 in response to pulling the inner shaft 110 proximally out of the bone hole 130. The tails of the suture 126 can be trimmed if necessary.

[0096] In some embodiments, the outer shaft of the inserter tool and the anchor are not rotated to cooperate with the anchor releasably coupled to the inserter tool to form a temporary enclosure for the suture. In such embodiments, the inner shaft of the inserter tool is configured to move axially along the coaxial longitudinal axis of the inserter tool and the anchor releasably coupled to the inserter tool to facilitate suture capture prior to securing the suture in the bone with the anchor. In such embodiments, the striking cap of the inserter tool need not be configured to rotate. Various embodiments of a non-rotating striking cap are described in the aforementioned U.S. Patent Publication No. 2021 / 0338223, published November 4, 2021, entitled "Knotless Anchor Insertion."

[0097] FIG. 24 illustrates another embodiment of an inserter tool and another embodiment of an anchor 502. The inserter tool of FIG. 24 is constructed and used similarly to the inserter tool 100 of FIGS. 1-3, except that the inner shaft 510 of the inserter tool is configured to move axially along the coaxial longitudinal axes 500a, 502a of the inserter tool, and the anchor 502 is releasably coupled to the inserter tool to facilitate capture of the suture 126 prior to securing the suture 126 to the bone with the anchor 502. Although the suture 126 of FIGS. 8 and 9 is shown in FIG. 24, another suture may be used. The inner shaft 510 also does not need to be advanced distally to push the suture 126 out of the slot 504 of the anchor. Additionally, the inner shaft 510 in this illustrated embodiment includes only a single distal arm 522. The single distal arm 522 can effectively capture the suture 126 within the slot 504 of the anchor such that two distal arms are not required.

[0098] Anchor 502 is constructed and used similarly to anchor 102 of Figures 1-4, 8, 9, and 12-14, except that anchor 502 includes a single slot 504. Although not shown in Figure 24, anchor 502 includes a bone-engaging feature. In the illustrated embodiment, slot 504 is formed as a proximally angled notch formed in anchor 502.

[0099] The inserter tool and anchor 502 are generally used similarly to the inserter tool and anchor described above. The suture 126 is configured to be placed in the slot 504 of the anchor 502 before the anchor 502 is advanced into the patient, similar to the embodiment described above. However, in this illustrated embodiment, with the suture 126 placed in the slot 504, the inner shaft 510 is configured to move axially in a distal direction to capture and lock the suture 126 in the slot 504 with the distal arm 522 of the inner shaft 510 aligned with the slot 504. The inner shaft 510 in a distal position prevents the slot 504 from capturing and locking the suture 126 therein, similar to that described above. The inner shaft 510 is not positioned distally beyond the anchor 502 before the anchor 502 is advanced distally into the bone hole. Alternatively, after the anchor 502 has been advanced distally into the bone hole, the inner shaft 510 is moved axially in a proximal direction, e.g., with the remainder of the inserter tool, to remove the inner shaft 510 from within the anchor 502 while the anchor 502 and suture 126 remain secured within the bone hole. The inner shaft 510 can be moved proximally after the anchor 502 has been advanced into the patient and before the anchor 502 is secured within the bone hole to allow the suture 126 to be tensioned.

[0100] Those skilled in the art will appreciate additional features and advantages of the devices, systems, and methods based on the above-described embodiments. Accordingly, the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety for all purposes.

[0101] The present disclosure has been described above for purposes of example only, within the context of the overall disclosure provided herein. It will be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the disclosure.

[0102] [Embodiment] (1) A surgical system, comprising: an anchor configured to be implanted within a bone hole, the anchor having a pair of slots formed therein; an inserter tool including an outer shaft and an inner shaft, the anchor configured to be releasably coupled to the inserter tool; with the anchor releasably coupled to the inserter tool, the inner shaft is configured to selectively be in one of a first position in which the inner shaft occludes the pair of slots and a second position in which the inner shaft does not occlude the pair of slots; A surgical system, wherein the inner shaft in the second position is configured to extend distally beyond the anchor and the outer shaft, and then the outer shaft is configured to translate axially in a distal direction relative to the inner shaft, thereby axially translating the anchor in the distal direction into the bone hole. (2) the anchor is configured to be releasably coupled to a suture with the suture extending through the slot of the anchor and seated within a suture-retaining channel of the inner shaft; the suture is in a locked position relative to the anchor with the inner shaft in the first position; 2. The system of embodiment 1, wherein the change of the inner shaft from the first position to the second position is configured to move the suture from the locked position to an unlocked position relative to the anchor. (3) The system of embodiment 2, wherein axial translation of the inner shaft in the distal direction in the second position is configured to push the suture out of the slot. (4) The system of claim 2, further comprising a suture. (5) The system of embodiment 1, wherein each of the slots has an open distal end and a closed proximal end.

[0103] (6) a change in the inner shaft from the second position to the first position is configured to bias a suture extending through the slot to move proximally within the slot; The system of embodiment 5, wherein axial translation of the inner shaft in a distal direction is configured to move the suture distally within the slot and out the open distal end of the slot. (7) The system of embodiment 5, wherein each of the slots has an L-shape or each of the slots has a spiral shape. (8) the inner shaft having a pair of distal arms; the anchor having a pair of distal arms; with the inner shaft in the first position, the distal arm of the inner shaft is misaligned from the distal arm of the anchor; 2. The system of claim 1, wherein when the inner shaft is in the second position, the distal arm of the inner shaft is aligned with the distal arm of the anchor. (9) the inner shaft having a pair of distal arms; with the inner shaft in the first position, the distal arm of the inner shaft is aligned with the slot of the anchor; 2. The system of claim 1, wherein when the inner shaft is in the second position, the distal arm of the inner shaft is out of alignment with the slot of the anchor. (10) The system of embodiment 1, wherein in the first position, the inner shaft does not extend distally beyond the anchor.

[0104] (11) The system of embodiment 1, wherein after translation of the outer shaft, the outer shaft and the inner shaft are configured to simultaneously translate axially in a proximal direction relative to the anchor in the bone hole. (12) A surgical system comprising: an anchor configured to be implanted in a bone hole, the anchor having a pair of distal arms defining a pair of slots therebetween; an inner shaft configured to be placed within an inner lumen of the anchor, the inner shaft having a pair of distal arms, the anchor configured to rotate relative to the inner shaft while the inner shaft is within the inner lumen of the anchor such that the distal arms of the inner shaft change from being aligned with the distal arms of the anchor and out of alignment with the slot of the anchor to being out of alignment with the distal arms of the anchor and in alignment with the slot of the anchor; an outer shaft configured to translate distally longitudinally relative to the inner shaft and the anchor, thereby moving the anchor distally into the bone hole. (13) The system of embodiment 12, wherein the inner shaft is configured to move longitudinally into the bone hole before the outer shaft is longitudinally translated distally relative to the inner shaft and the anchor. (14) The system of embodiment 13, wherein the longitudinal movement of the inner shaft is configured to push a suture placed in the slot of the anchor out of the slot and into the bone hole. (15) The anchor is configured to be releasably coupled to a suture with the suture extending through the slot of the anchor and seated within a suture retaining channel of the inner shaft; the suture is in a locked position relative to the anchor with the distal arm of the inner shaft out of alignment with the distal arm of the anchor and in alignment with the slot of the anchor; 13. The system of claim 12, wherein the suture is in an unlocked position relative to the anchor with the distal arm of the inner shaft aligned with the distal arm of the anchor and out of alignment with the slot of the anchor.

[0105] (16) The system of claim 15, further comprising a suture. (17) The system of embodiment 12, wherein prior to distal translation of the outer shaft, a distal end of the outer shaft abuts a proximal end of the anchor having the inner shaft positioned within the inner lumen of the anchor. (18) A surgical method comprising: rotating an outer shaft of an inserter tool and an anchor releasably coupled to the inserter tool relative to an inner shaft of the inserter tool, the rotation of the outer shaft and the anchor moving a suture extending through a slot in the anchor from a locked position to an unlocked position, the rotation of the outer shaft and the anchor pushing the suture out of the slot and into a bone hole; and after said rotation of the outer shaft and the anchor, longitudinally translating the outer shaft distally relative to the inner shaft, thereby impacting the anchor into the bone hole to secure the anchor therein. (19) The rotation of the outer shaft and the anchor is in a first direction; 19. The method of embodiment 18, wherein the method further comprises rotating the outer shaft and the anchor in a second direction opposite to the first direction prior to the rotation of the outer shaft and the anchor in the first direction, the rotation of the outer shaft and the anchor in the second direction being relative to the inner shaft, and the rotation of the outer shaft and the anchor in the second direction moving the suture extending through a slot of the anchor from the unlocked position to the locked position. (20) The method of embodiment 18, wherein the rotation of the outer shaft and the anchor in the first direction changes the distal arm of the inner shaft from being aligned with the slot of the anchor to being out of alignment with the slot of the anchor.

Claims

1. 1. A surgical system comprising: an anchor configured to be implanted within a bone hole, the anchor having a pair of slots formed therein; an inserter tool including an outer shaft and an inner shaft, the anchor configured to be releasably coupled to the inserter tool; with the anchor releasably coupled to the inserter tool, the inner shaft is configured to selectively be in one of a first position in which the inner shaft occludes the pair of slots and a second position in which the inner shaft does not occlude the pair of slots; A surgical system, wherein the inner shaft in the second position is configured to extend distally beyond the anchor and the outer shaft, and thereafter the outer shaft is configured to translate axially in a distal direction relative to the inner shaft, thereby axially translating the anchor in the distal direction into the bone hole.

2. the anchor is configured to be releasably coupled to a suture with the suture extending through the slot of the anchor and seated within a suture retaining channel of the inner shaft; the suture is in a locked position relative to the anchor with the inner shaft in the first position; The system of claim 1 , wherein changing of the inner shaft from the first position to the second position is configured to move the suture from the locked position to an unlocked position relative to the anchor.

3. The system of claim 2 , wherein axial translation of the inner shaft in the distal direction in the second position is configured to push the suture out of the slot.

4. The system of claim 2 further comprising the suture.

5. The system of claim 1 , wherein each of the slots has an open distal end and a closed proximal end.

6. a change in the inner shaft from the second position to the first position is configured to urge a suture extending through the slot to move proximally within the slot; The system of claim 5 , wherein distal axial translation of the inner shaft is configured to move the suture distally within the slot and out the open distal end of the slot.

7. The system of claim 5 , wherein each of the slots has an L-shape or each of the slots has a spiral shape.

8. the inner shaft having a pair of distal arms; the anchor having a pair of distal arms; with the inner shaft in the first position, the distal arm of the inner shaft is misaligned from the distal arm of the anchor; The system of claim 1 , wherein with the inner shaft in the second position, the distal arm of the inner shaft is aligned with the distal arm of the anchor.

9. the inner shaft having a pair of distal arms; with the inner shaft in the first position, the distal arm of the inner shaft is aligned with the slot of the anchor; The system of claim 1 , wherein with the inner shaft in the second position, the distal arm of the inner shaft is misaligned from the slot of the anchor.

10. The system of claim 1 , wherein in the first position, the inner shaft does not extend distally beyond the anchor.

11. The system of claim 1 , wherein the outer shaft and the inner shaft are configured to simultaneously translate axially proximally relative to the anchor in the bone hole following translation of the outer shaft.

12. 1. A surgical system comprising: an anchor configured to be implanted in a bone hole, the anchor having a pair of distal arms defining a pair of slots therebetween; an inner shaft configured to be placed within an inner lumen of the anchor, the inner shaft having a pair of distal arms, the anchor configured to rotate relative to the inner shaft while the inner shaft is within the inner lumen of the anchor such that the distal arms of the inner shaft change from being aligned with the distal arms of the anchor and out of alignment with the slot of the anchor to being out of alignment with the distal arms of the anchor and in alignment with the slot of the anchor; an outer shaft configured to translate distally longitudinally relative to the inner shaft and the anchor, thereby moving the anchor distally into the bone hole.

13. The system of claim 12 , wherein the inner shaft is configured to move longitudinally into the bone hole before the outer shaft is longitudinally translated distally relative to the inner shaft and the anchor.

14. The system of claim 13 , wherein the longitudinal movement of the inner shaft is configured to push a suture placed in the slot of the anchor out of the slot and into the bone hole.

15. the anchor is configured to be releasably coupled to a suture with the suture extending through the slot of the anchor and seated within a suture retaining channel of the inner shaft; the suture is in a locked position relative to the anchor with the distal arm of the inner shaft out of alignment with the distal arm of the anchor and in alignment with the slot of the anchor; The system of claim 12 , wherein the suture is in an unlocked position relative to the anchor with the distal arm of the inner shaft aligned with the distal arm of the anchor and out of alignment with the slot of the anchor.

16. The system of claim 15 further comprising the suture.

17. The system of claim 12 , wherein prior to distal translation of the outer shaft, a distal end of the outer shaft abuts a proximal end of the anchor having the inner shaft positioned within the inner lumen of the anchor.

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