Removal of the Knotless Anchor Inserter Tool

Abstract

Various exemplary devices, systems, and methods are provided for removing a knotless anchor inserter tool. Generally, the 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 soft tissue to the bone. The inserter tool includes a retraction mechanism configured to cause the inserter tool to be removed from within the anchor.

Description

[Technical field]

[0001] The present disclosure relates generally to removal of a knotless anchor inserter tool. [Background technology]

[0002] A variety of disorders and conditions require the repair of soft tissue damage or reattachment of soft tissue to bone and / or surrounding tissue. For example, when previously 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 and natural reattachment to occur. 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 connected to one another 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 tying process can be difficult and time-consuming, as the surgeon remotely manipulates the sutures at the surgical site using tools inserted percutaneously through small diameter cannulas, endoscopic tubes, or otherwise. 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 and anchor can be difficult due to the difficult 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 anchor insertion. [Means for solving the problem]

[0005] Generally, devices, systems and methods are provided for removal of a knotless anchor inserter tool.

[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 implanted into bone. The inserter tool includes an outer shaft, an inner shaft, and a retraction mechanism. The outer shaft is configured to push the anchor distally along a longitudinal axis of the inserter tool. The inner shaft is positioned within the outer shaft and within the anchor, and a distal end of the inner shaft is positioned distal to the outer shaft and the anchor. The distal end of the inner shaft is configured to releasably couple to a suture. The retraction mechanism is configured to be actuated to move the inner shaft proximally relative to the outer shaft and the anchor along the longitudinal axis of the inserter tool.

[0007] The surgical system can be modified in any number of ways. For example, the retraction mechanism can be configured as a lever. The retraction mechanism can include a lever handle operably coupled to the inner shaft and configured to be moved relative to the outer shaft and anchor, thereby moving the inner shaft proximally relative to the outer shaft and anchor. The retraction mechanism can further include a lock configured to prevent the lever handle from moving relative to the outer shaft and anchor before the outer shaft pushes the anchor distally. The outer shaft pushing the anchor distally is configured to move the lock from a locked position where the lock prevents the lever handle from moving relative to the outer shaft and anchor, to an unlocked position where the lock allows the lever handle to move relative to the outer shaft and anchor. The retraction mechanism can also include a yoke fixedly attached to the inner shaft, where the lever handle being moved relative to the outer shaft and anchor can also move the yoke proximally relative to the outer shaft and anchor.

[0008] As another example, the reversing mechanism may be configured as a rack and pinion mechanism.

[0009] In yet another example, the retraction mechanism may be configured as a lead screw mechanism.

[0010] In yet another example, the retraction mechanism can include a locking portion configured to prevent the retraction mechanism from being actuated before the outer shaft has pushed the anchor distally. The inserter tool can further include a locking mechanism configured to move from a locked position, where the locking mechanism prevents the outer shaft from pushing the anchor distally, to an unlocked position, where the locking mechanism allows the outer shaft to push the anchor distally.

[0011] In yet another example, the inserter tool can also include a handle including a retention mechanism configured to hold the outer shaft in a fixed position relative to the handle during actuation of the retraction mechanism, and the inner shaft can also be moved proximally relative to the handle by actuation of the retraction mechanism. The outer shaft can be configured to move distally relative to the handle to push the anchor distally along the longitudinal axis of the inserter tool.

[0012] In another example, the inserter tool can further include a handle configured to be positioned outside of the patient's body with the distal end of the inner shaft positioned within the bone hole, the outer shaft can extend distally from the handle, the inner shaft can extend distally from the handle, and the retraction mechanism can be configured to be positioned outside of the patient's body with the distal end of the inner shaft positioned within the bone hole.

[0013] In yet another example, the inserter tool may have a sealed passage configured to seat a suture therethrough and to releasably couple the inner shaft to the suture. Activation of the retraction mechanism may be configured to automatically spread a flexible member of the inserter tool in response to the inner shaft moving proximally relative to the outer shaft and the anchor, thereby opening the sealed passage. The surgical system may further include a suture seated through the sealed passage. The suture may be seated through the sealed passage prior to activation of the retraction mechanism and prior to the distal end of the inner shaft being positioned within the hole in the bone, and may be seated through the sealed passage after the outer shaft pushes the anchor distally such that the anchor captures the suture between an outer surface of the anchor and a wall of the hole in the bone. The flexible member may be integral with the inner shaft, or the flexible member may be a separate element attached to the inner shaft.

[0014] In yet another example, the distal end of the inner shaft can include a suture retaining channel configured to seat a suture therethrough to releasably couple the inner shaft to the suture, and the suture retaining channel can be configured to be positioned within a hole in the bone before the outer shaft drives the anchor distally into the bone.

[0015] In another aspect, a surgical method is provided that, in one embodiment, includes positioning a distal end of an inner shaft of an inserter tool within a bone hole. The distal end of the inner shaft is releasably coupled to a suture such that the suture is also positioned within the bone hole. The surgical method also includes moving an outer shaft of the inserter tool axially and distally relative to the inner shaft, thereby sliding the anchor along the inner shaft and positioning the anchor within the bone hole such that the anchor captures the suture between an outer surface of the anchor and a wall of the bone hole. The surgical method also includes, after moving the outer shaft axially and distally, actuating a retraction mechanism of the inserter tool, thereby moving the inner shaft axially and proximally relative to the outer shaft and the anchor such that the inner shaft is removed from the bone hole and the anchor and suture remain within the bone hole.

[0016] The surgical method can have any number of variations. For example, the retraction mechanism can be configured as a lever. The retraction mechanism can include a lever handle, which can include a yoke fixedly attached to the inner shaft, and actuating the retraction mechanism can include moving the lever handle relative to the outer shaft and anchor, thereby moving the yoke and inner shaft proximally relative to the outer shaft and anchor. The retraction mechanism can further include a lock that prevents the lever handle from moving relative to the outer shaft and anchor before the outer shaft pushes the anchor distally. The outer shaft pushing the anchor distally can move the lock from a locked position where the lock prevents the lever handle from moving relative to the outer shaft and anchor, to an unlocked position where the lock allows the lever handle to move relative to the outer shaft and anchor.

[0017] As another example, the reversing mechanism may be configured as a rack and pinion mechanism.

[0018] In yet another example, the retraction mechanism may be configured as a lead screw mechanism.

[0019] In yet another example, prior to axially and distally moving the outer shaft, the inserter tool can have a sealed passage in which the suture is installed, and actuation of the retraction mechanism can also move a flexible member of the inserter tool relative to the outer shaft and anchor, bending the sealed passage open. The flexible member can be integral with the inner shaft or the flexible member can be a separate element attached to the inner shaft.

[0020] In another example, striking a strike cap on the inserter tool can move the outer shaft axially and distally, and striking the strike cap can move a lock on the retraction mechanism from a locked position where the lock prevents actuation of the retraction mechanism to an unlocked position where the lock allows actuation of the retraction mechanism. A retention feature on the handle of the inserter tool can hold the outer shaft in a fixed position relative to the handle during actuation of the retraction mechanism. The surgical method can also include moving the locking mechanism from a locked position where the locking mechanism prevents the outer shaft from moving axially and distally relative to the inner shaft to an unlocked position where the locking mechanism allows the outer shaft to move axially and distally relative to the inner shaft.

[0021] In yet another example, the inserter tool can include a handle positioned outside the patient's body with a distal end of the inner shaft positioned within the bone hole, the outer shaft can extend distally from the handle, the inner shaft can extend distally from the handle, and the retraction mechanism can be positioned outside the patient's body with the distal end of the inner shaft positioned within the bone hole.

[0022] In another embodiment, the surgical method includes positioning a distal end of an inner shaft of an inserter tool and positioning a flexible member of the inserter tool within the bone hole. The surgical method also includes moving an outer shaft of the inserter tool axially and distally relative to the inner shaft, thereby moving the anchor axially and distally so that the anchor is positioned within the bone hole such that it captures the suture between an outer surface of the anchor and a wall of the bone hole. The surgical method also includes activating a retraction mechanism of the inserter tool after moving the outer shaft axially and distally, thereby moving the inner shaft and flexible member axially and proximally relative to the outer shaft and anchor such that the inner shaft and flexible member are removed from the bone hole and the anchor and suture remain within the bone hole. The flexible member expands during the axial and proximal movement of the flexible member.

[0023] The surgical method can be modified in any number of ways. For example, the retraction mechanism can be configured as a lever. The retraction mechanism can include a lever handle, which can include a yoke fixedly attached to the inner shaft, and actuating the retraction mechanism can include moving the lever handle relative to the outer shaft and anchor, thereby moving the yoke and inner shaft proximally relative to the outer shaft and anchor. The retraction mechanism can further include a lock that prevents the lever handle from moving relative to the outer shaft and anchor before the outer shaft moves axially and distally relative to the inner shaft. Axial and distal movement of the outer shaft relative to the inner shaft can move the lock from a locked position where the lock prevents the lever handle from moving relative to the outer shaft and anchor, to an unlocked position where the lock allows the lever handle to move relative to the outer shaft and anchor.

[0024] As another example, the reversing mechanism may be configured as a rack and pinion mechanism.

[0025] In yet another example, the retraction mechanism may be configured as a lead screw mechanism.

[0026] In yet another example, striking a strike cap on the inserter tool can move the outer shaft axially and distally, and striking the strike cap can move a lock on the retraction mechanism from a locked position where the lock prevents actuation of the retraction mechanism to an unlocked position where the lock allows actuation of the retraction mechanism. A retention feature on the handle of the inserter tool can hold the outer shaft in a fixed position relative to the handle during actuation of the retraction mechanism. The surgical method can also include moving the locking mechanism from a locked position where the locking mechanism prevents the outer shaft from moving axially and distally relative to the inner shaft to an unlocked position where the locking mechanism allows the outer shaft to move axially and distally relative to the inner shaft.

[0027] In yet another example, the inserter tool can include a handle positioned outside the patient's body with a distal end of the inner shaft positioned within the bone hole, the outer shaft can extend distally from the handle, the inner shaft can extend distally from the handle, and the retraction mechanism can be positioned outside the patient's body with the distal end of the inner shaft positioned within the bone hole.

[0028] In yet another example, the flexible member may be integral with the inner shaft, or the flexible member may be a separate element attached to the inner shaft. [Brief description of the drawings]

[0029] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: [Figure 1] 1A is a perspective view of an embodiment of an inserter tool and an embodiment of an anchor releasably coupled to the inserter tool. [Diagram 2] FIG. 2 is a side view of the inserter tool and anchor of FIG. 1. [Diagram 3] 2 is another perspective view of an embodiment of the inserter tool and anchor of FIG. 1 and a loading aid coupled to the inserter tool. [Figure 4] FIG. 4 is a top view of the inserter tool, anchor, and loading aid of FIG. [Diagram 5] FIG. 4 is a side view of the inserter tool, anchor, and loading aid of FIG. [Figure 6] 2 is a side view of the inserter tool and a distal portion of the anchor of FIG. 1. [Figure 7] FIG. 2 is a perspective view of the anchor of FIG. 1. [Figure 8] 2 is a cross-sectional view of a proximal portion of the inserter tool of FIG. 1. [Figure 9] FIG. 4 is a proximal end view of the inserter tool and loading aid of FIG. 3. [Figure 10] 2 is a perspective view of a proximal portion of the inserter tool of FIG. 1 with the locking mechanism of the inserter tool in an unlocked position prior to striking the striking cap of the inserter tool. [Figure 11] 2 is a perspective view of a proximal portion of the inserter tool of FIG. 1 with the locking feature of the inserter tool in a locked position. [Figure 12] 11 is a perspective view of a proximal portion of the inserter tool of FIG. 10 after striking the striking cap. [Figure 13] 2 is a perspective view of a proximal portion of the inserter tool of FIG. 1 with the handle of the inserter tool partially removed. [Figure 14] FIG. 2 is a perspective cross-sectional view of a portion of the inserter tool of FIG. 1. [Figure 15] 2 is another perspective cross-sectional view of a portion of the inserter tool of FIG. 1. [Figure 16] 2 is another perspective cross-sectional view of the proximal portion of the inserter tool of FIG. 1. [Figure 17] 4 is a perspective view of the loading aid and a distal portion of the inserter tool of FIG. 3 with one embodiment of a suture extending through the loops of the loading aid. [Figure 18] FIG. 18 is a perspective view of a proximal portion of the inserter tool of FIG. 17. [Figure 19] 18 is another perspective view of the proximal portion of the inserter tool of FIG. 17. [Figure 20] 18 is another perspective view of the portion of the inserter tool of FIG. 17 with the handle of the inserter tool partially omitted. [Figure 21] 18 is a side partial cross-sectional view of the distal portion of the inserter tool of FIG. 17 with the sutures tied and the distal portion of the inner shaft of the inserter tool positioned within one embodiment of a bone hole. [Figure 22] FIG. 22 is a perspective view of a proximal portion of the inserter tool of FIG. 21. [Figure 23] 23 is a perspective view of a proximal portion of the inserter tool of FIG. 22 with a suture held by a suture retaining member of the inserter tool. [Figure 24] 24 is a perspective view of a proximal portion of the inserter tool of FIG. 23 with the locking mechanism of the inserter tool in an unlocked position. [Diagram 25] 25 is a side partial cross-sectional view of a distal portion of the inserter tool of FIG. 24 with an anchor positioned within a bone hole. [Figure 26]FIG. 26 is a perspective view of a portion of the inserter tool of FIG. 25 with the handle of the inserter tool partially omitted. [Figure 27] FIG. 27 is another perspective view of the portion of the inserter tool of FIG. 26 with the handle of the inserter tool partially omitted. [Figure 28] FIG. 28 is a perspective view of the proximal portion of the inserter tool of FIG. 27 after striking the striking cap. [Figure 29] 29 is a perspective view of a proximal portion of the inserter tool of FIG. 28, with the suture not being held by the suture retaining member of the inserter tool. [Diagram 30] 30 is a perspective view of the proximal and distal portions of the inserter tool of FIG. 29 with the bone omitted and the retraction mechanism of the inserter tool in an inactivated position. [Diagram 31] 31 is a perspective view of the proximal and distal portions of the inserter tool of FIG. 30 with the bone omitted and the retraction mechanism of the inserter tool in an activated position. [Diagram 32] 32 is a perspective view of the proximal and distal portions of the inserter tool of FIG. 31 with the bone omitted and the inner shaft of the inserter tool retracted relative to the anchor. [Diagram 33] FIG. 33 is a perspective view of a proximal portion of the inserter tool of FIG. 32 showing the direction of removal of the inserter tool. [Diagram 34] 33 is a top view of the bone hole, anchor, and suture of FIG. 32 after removal of the inserter tool. [Diagram 35] FIG. 35 is a side cross-sectional view of the bone hole, anchor, and suture of FIG. 34. [Diagram 36] 11 is a perspective view of another embodiment of an inserter tool coupled to the anchor of FIG. 1 and the loading aid of FIG. 3. [Figure 37] FIG. 37 is a top view of the inserter tool, anchor, and loading aid of FIG. 36. [Figure 38] FIG. 38 is a top view of the inserter tool and anchor of FIG. 37. [Figure 39] FIG. 38 is a side view of the inserter tool and anchor of FIG. 37. [Diagram 40] FIG. 39 is a perspective view of a distal portion of the inserter tool and anchor of FIG. 38. [Diagram 41]FIG. 37 is a perspective view of the outer shaft of the inserter tool of FIG. 36. [Diagram 42] 13 is a perspective view of a proximal portion of another embodiment of an inserter tool. FIG. [Diagram 43] FIG. 43 is a perspective view of a proximal portion of the inserter tool of FIG. 42 with the handle of the inserter tool partially omitted. [Diagram 44] 13 is a perspective view of a portion of another embodiment of an inserter tool with the handle of the inserter tool partially omitted. FIG. [Diagram 45] FIG. 45 is a perspective view of a portion of the inserter tool of FIG. 44 without the handle. [Diagram 46] FIG. 45 is a perspective view of the ring actuator and lead screw of the inserter tool of FIG. 44. [Figure 47] FIG. 47 is another perspective view of the ring actuator and lead screw of FIG. 46. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] 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 present invention.

[0031] 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.

[0032] Various exemplary devices, systems, and methods are provided for removing a knotless anchor inserter tool. Generally, the 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 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.

[0033] The inserter tool is configured to releasably couple each of the suture and anchor to insert each of 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. Thus, the inserter tool is configured to allow the suture to be under tension relative to the bone and anchor after the suture is positioned within the bone hole and before the anchor is secured to the bone hole to attach the suture in position relative to the bone, thereby allowing the soft tissue to be desirably positioned relative to the bone before being secured in position for healing. 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 anchors are inserted into the bone, the inserter tool is configured to be removed from the patient's body, leaving the anchors and sutures remaining in the bone.

[0034] With the anchor embedded in the bone and the suture fixed relative to the bone, a portion of the inserter tool is positioned within the inner lumen of the anchor. The anchor in the bone can exert a force on the portion of the inserter tool positioned within the inner lumen of the anchor. Thus, the anchor can act as a vice that tends to hold the inserter tool within the inner lumen of the anchor. In addition, the denser the bone in which the anchor is embedded, the greater the force that can be applied to the inserter tool. The force applied by the anchor to the inserter tool needs to be overcome to remove the inserter tool from within the anchor before the inserter tool can be removed from the patient's body. The inserter tool includes a retraction mechanism configured to cause the inserter tool to be removed from within the anchor. The retraction mechanism is configured to cause the portion of the inserter tool positioned within the anchor to translate longitudinally relative to the anchor along a longitudinal axis of the inserter tool that is coaxial with the longitudinal axis of the anchor. The longitudinal translation of the inserter tool is in a proximal direction as opposed to a distal direction in which the inserter tool was advanced into the patient to the bone and the anchor was driven into the bone so that the inserter tool is retracted. Thus, the retraction mechanism provides a mechanical mechanism for removing the inserter tool from within the implanted anchor, thereby relieving the user from having to manually apply longitudinal force to the inserter tool for removal from within the anchor and corresponding user concerns that excessive longitudinal force is being applied such that the anchor and / or suture may become loose or be removed from the bone. Removing the inserter tool from within the anchor by longitudinally translating the inserter tool along the longitudinal axis of the inserter tool and the longitudinal axis of the anchor may take less time and / or require less user applied 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, rotating the tool for removal can cause the anchor to rotate and / or experience unintended off-axis loads, which can result in the anchor not being firmly seated in the bone and / or can cause damage to the suture and / or anchor.

[0035] The retraction mechanism is located on a proximal portion of the inserter tool, which is typically located completely outside of the patient's body during use of the inserter tool in a surgical procedure. Conversely, the portion of the inserter tool that is positioned within the anchor after the anchor is inserted into the bone is located on a distal portion of the inserter tool that is located completely within the patient's body during the surgical procedure. A retraction mechanism located in the proximal portion of the inserter tool may provide a mechanical advantage by allowing the removal force applied by the retraction mechanism to the portion of the inserter tool positioned within the anchor to be applied a distance away from the portion of the inserter tool positioned within the anchor.

[0036] It may be difficult to visualize an anchor embedded in a bone because the anchor is positioned quasi-flush with respect to the bone, difficult angles, and / or tight joint spaces. Even if the embedded anchor can be visualized, it may not be possible to visualize the portion of the inserter tool positioned within the anchor due to obstructions from the bone, the anchor, portions of the inserter tool located outside the anchor and outside the bone, and / or other material located outside the anchor and outside the bone. Thus, it may not be possible for the user to visually confirm that the inserter tool has been removed from within the anchor because the anchor, the inserter tool, or both the anchor and the inserter tool may not be fully or even partially visualized within the patient's body. A retraction mechanism located within a proximal portion of the inserter tool is visible by the user because the retraction mechanism is located outside the patient's body, and thus may allow the user to visually confirm that the inserter tool has been removed from within the anchor even if the user is unable to visualize the anchor and / or the inserter tool within the patient's body. As described further below, the retraction mechanism is configured to move from an initial, unactuated position to an actuated position to remove the inserter tool from within the anchor. The retraction mechanism in the actuated position provides a visual indication to the user that the inserter tool has been removed from within the anchor.

[0037] The suture is releasably coupled to the inserter tool prior to advancement of the inserter tool into the patient's body. The inserter tool includes a suture retaining channel configured to mount the suture therein. The suture retaining channel is located distal to the anchor releasably coupled to the inserter tool. Thus, the suture mounted in the suture retaining channel may be positioned in a bone hole distal to the anchor, thereby allowing the anchor to be advanced distally into the bone hole with the suture already positioned in the bone hole. In an exemplary embodiment, the suture has a U-shape before and after the anchor is secured to the bone hole. In the U-shape, each of the legs of the suture extend longitudinally along opposing sides of the anchor, and an intermediate portion of the suture connecting the legs extends along the distal tip of the anchor to loop around the distal tip of the anchor. The U-shaped configuration of the suture relative to the anchor can maximize the length of the suture that the anchor presses against to secure the suture in place relative to the bone, which can help ensure that the soft tissue attached to the suture remains in place relative to the bone to facilitate healing.

[0038] Retracting the inserter tool from within the anchor using the retraction mechanism does not interfere with the suture after the anchor and suture are secured within the bone hole. With the anchor and suture secured within the bone hole, each of the suture legs extends longitudinally along opposite sides of the anchor and proximally from the bone hole, and the inserter tool extends longitudinally from the anchor between the suture legs. Thus, longitudinal proximal movement of the portion of the inserter tool within the anchor that is removed from within the anchor does not interfere with the sutures positioned on either side of the inserter tool, which can remain fixed relative to the anchor and bone as desired before, during, and after retraction of the inserter tool.

[0039] 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.

[0040] 1-5 illustrate one embodiment of an inserter tool 100, also referred to herein as an "inserter," for knotless anchor insertion in soft tissue repair surgical procedures. Generally, the inserter tool 100 is configured to insert an anchor 102 into a patient's bone to secure soft tissue to the bone. As shown in FIGS. 6 and 7, an inner lumen 102i extends through the anchor 102 such that the anchor 102 is cannulated. FIGS. 1-6 illustrate the anchor 102 releasably coupled to the inserter tool 100. FIG. 7 illustrates the anchor 102 as a stand-alone element. 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, for example, to engage a surface of the bone defining a bone hole within which the anchor 102 is positioned. The bone engaging surface feature 102f includes a plurality of ribs each extending circumferentially around the anchor 102 at a different axial position 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 anchoring the suture to the bone.

[0041] The anchor 102 in this illustrated embodiment includes a plurality of gussets 102g configured to reinforce the anchor 102. Each of the gussets 102g extends longitudinally along the anchor 102. As shown in FIG. 7, a first set of gussets 102g1 are aligned with one another along the length of the anchor, a second set of gussets 102g2 are aligned with one another along the length of the anchor, a third set of gussets 102g3 are aligned with one another along the length of the anchor, and a fourth set of gussets 102g are aligned with one another along the length of the anchor. The fourth set of gussets 102g is hidden in FIG. 7. The first, second, third, and fourth sets of gussets 102g are arranged equidistantly around the circumference of the anchor 102, which may serve to reinforce the anchor 102 around its entire circumference. In other embodiments, the anchor can include a different number of gusset sets and / or the gusset sets can be arranged non-equidistantly around the circumference of the anchor.

[0042] 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. Exemplary embodiments of anchors include Healix Advance™ anchors and Gryphon® anchors (available from DePuy Mitek, Inc., Raynham, MA), and various exemplary embodiments of anchors and their features are further described in U.S. Patent Application Publication No. 2012 / 0338223, entitled "Knotless Anchor Insertion," published on November 4, 2021, U.S. Patent No. 8,114,128, entitled "Cannulated Suture Anchor," published on February 14, 2012, U.S. Patent No. 8,882,801, entitled "Dual Thread Cannulated Suture Anchor," published on November 11, 2014, and U.S. Patent No. 8,133,257, entitled "Bioabsorbable Suture Anchor System For Use In Small Joints," published on March 13, 2012, which are incorporated by reference in their entireties herein.

[0043] The inserter tool 100 includes a handle 106, an outer shaft 108 (also referred to herein as a "push tube") extending distally from the handle 106, an inner shaft 110 extending distally from the handle 106, and a strike cap 112 extending proximally from the 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.

[0044] 1 and 8, the handle 106 has an inner lumen 106i extending therethrough. The outer and inner shafts 108, 110 are positioned within and extend distally from the handle inner lumen 106i. The proximal ends of one or both of the outer and inner shafts 108, 110 can be located within the handle inner lumen 106i, or one or both of the outer and inner shafts 108, 110 can extend proximally beyond the handle 106 such that the respective proximal ends of the outer and inner shafts 108, 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 located within the handle inner lumen 106i and the proximal end of the outer shaft 108 can extend proximally beyond the handle 106 and be located within the striking cap 112. In another example, the proximal end of the inner shaft 110 and the proximal end of the outer shaft 108 can be located within the inner lumen 106 i of the handle 106 .

[0045] 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.

[0046] 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 the 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 discussed above. Various embodiments of suture retaining mechanisms are further described, for example, in the aforementioned U.S. Patent Publication No. 2021 / 0338223, published November 4, 2021, entitled "Knotless Anchor Insertion."

[0047] The suture retaining member in this illustrated embodiment includes a groove 107 on the side of the handle 106. Although the inserter 100 includes a single suture retaining member in this illustrated embodiment, it may include multiple suture retaining mechanisms, such as first and second suture retaining members on either side of the handle 106. The groove 107 is defined between the handle 106 and an elastomeric cleat 109 fixedly attached to the handle 106. The elastomeric cleat 109 is made from an elastomeric material, such as rubber or other polymer. The handle 106 is made from a rigid, non-elastomeric material, such as a plastic, such as polycarbonate, or other plastic. The handle 106 is made from a rigid, non-elastomeric material, such as a metal (e.g., stainless steel, titanium, etc.), polytetrafluoroethylene (PTFE), or other biocompatible material. Thus, the groove 107 is located at the junction between the elastomeric material and the rigid material. The elastomeric material of the elastomeric cleat 109 dynamically increases the width of the groove 107 to adjust to the size and shape of the suture mounted therein, firmly holding the suture within the groove 107 and allowing it to be 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 elastomeric cleat 109 is configured to dynamically adjust to the particular size and shape of the suture mounted therein. The firm retention of the suture within the groove 107 may help ensure that tension in the suture is maintained, e.g., not weakened, while the suture is retained by the suture retaining member. Once the suture is released from the groove 107, the elastomeric cleat 109 is no longer gripping the suture and can return to its original smaller width as the elastomeric material elastically returns to its original configuration.

[0048] The proximal surface of the handle 106 and the proximal surface of the elastomeric cleat 109 extend radially outward and taper distally. The taper is configured to urge the suture along the proximal surface of the handle 106 and toward the elastomeric cleat 109 to seat the groove 107. The elastomeric cleat 109 has a beveled edge facing the groove 107, which may also help urge the suture into the groove 107.

[0049] As shown in FIG. 8, the inner lumen 108i extends through the outer shaft 108 such that the outer shaft 108 is cannulated. In the initial configuration of the inserter 100 shown in FIGS. 1-6 and 8, the inner shaft 110 is mounted within the inner lumen 102i of the anchor 102 and within the inner lumen 108i of the outer shaft 108. As described further below, the inner shaft 110 is configured to be movable relative to the anchor 102 and the outer shaft 108 to facilitate retraction of the inner shaft 102, and the anchor 102 and the outer shaft 108 are each configured to be movable relative to the inner shaft 110 to facilitate delivery of the anchor 110 into the bone hole. In other embodiments, the outer shaft 108 is not cannulated, but instead has an inner bore having an open distal end and a closed proximal end, within which the inner shaft 110 is movably mounted.

[0050] 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. 6, the distal end 108d of the outer shaft abuts the proximal end 102p of the anchor in the initial configuration of the inserter, which may help maximize the transfer of distal forces applied to the outer shaft 108 to the anchor 102, thereby efficiently advancing the anchor 102 distally into the bone hole. However, the distal end 108d of the outer shaft may be spaced a distance proximal to the proximal end 102p of the anchor in the initial configuration of the inserter. The outer shaft 108 is distally tapered and includes a distal knob 108k (also referred to herein as a "bushing") that defines the distal end 108d of the outer shaft 108. The distal taper of the bushing 108k allows the proximal 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 to efficiently apply a distally directed force to the anchor 102.

[0051] 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 may provide more feedback to a user striking the striking cap 112 (compared to a flat surface). The striking cap 112, however, may have a flat surface, which may facilitate a uniform strike of the striking cap 112, and thus a uniform transfer of distal force from the striking cap 112 to the push tube 108. However, the proximal surface 112s may have another shape, such as a convex shape, textured with ribs, raised dome protrusions, or the like.

[0052] 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, published November 4, 2021, entitled "Knotless Anchor Insertion."

[0053] The inserter tool 100 includes a locking mechanism 118 configured to lock the outer shaft 108 in place relative to the inner shaft 110 when the locking mechanism 118 is in a locked position. Figures 3, 8, 9, and 11 show the locking mechanism 118 in a locked position. Figures 1, 2, 4, 5, 10, and 12 show the locking mechanism 118 in an unlocked position where the outer shaft 108 is not locked in place 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 motion of the locking mechanism 118 is a lateral motion substantially perpendicular to the coaxial longitudinal axes of the outer shaft 108 and the inner shaft 110. Those skilled in the art will appreciate that the axes or other features may not be exactly perpendicular, but are nevertheless considered to be substantially perpendicular, either for one or more reasons, such as manufacturing tolerances or sensitivity of the measuring equipment. 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 thus helps prevent premature distal advancement of the anchor 102 relative to the inner shaft 110.

[0054] 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.

[0055] As shown in FIGS. 9-12, the locking mechanism 118 includes a keyway 120 formed therein, within which the striking cap 112 is configured to move. In embodiments in which the outer shaft 108 extends proximally from the handle 106 into the striking cap 112, such as in this illustrated embodiment as shown in FIG. 9, the outer shaft 108 is also configured to move within the keyway 120. 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 striking cap 112 is located proximal to the keyway 120. The diameter of the reduced diameter portion 120a is smaller than the diameter of the striking cap 112, at least at the distal end of the striking cap 112. Thus, the striking 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 striking cap 112. With the locking mechanism 118 in the unlocked position, the striking cap 112 is also located 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. 12 shows the locking mechanism 118 in an unlocked position after the striking cap 112 has been struck with the distal surface of the striking cap 112 abutting the locking mechanism 118 around the keyway 120 .

[0056] The locking mechanism 118 in this 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, entitled "Knotless Anchor Insertion."

[0057] As shown in FIG. 6, the inner shaft 110 includes a notch formed therein that defines a suture retaining channel 116. The notch is formed in a distal end of the inner shaft 110 and is defined by a distal arm 110a of the inner shaft 110. The suture retaining channel 116 is configured to mount a suture therein. The suture retaining channel 116 is configured to receive a suture therein through an open distal end of the suture retaining channel 116. The suture retaining channel 116 has a substantially constant diameter in this illustrated embodiment, but can have different diameters in different portions, for example, a proximal portion of the suture retaining channel 116 has a larger diameter than a distal portion of the suture retaining channel 116, a distal portion of the suture retaining channel 116 has a larger diameter than a proximal portion of the suture retaining channel 116, or other different diameters. Those skilled in the art will appreciate that values ​​such as diameter values ​​may not be exactly the same, but are nevertheless considered to be substantially the same, for any one or more reasons, such as manufacturing tolerances and sensitivity of the measurement equipment.

[0058] Because the suture(s) do not need 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 116 can allow more sutures and / or larger diameter suture(s) to be coupled to the inserter 100 than with other types of inserter tools.

[0059] 6, the suture retaining channel 116 is located distal to the anchor 102 releasably coupled to the inserter tool 100. A suture mounted within the suture retaining channel 116 can thus be positioned within the bone hole distal to the anchor 102, thereby allowing the anchor 102 to be advanced distally into the bone hole with the suture already positioned within the bone hole.

[0060] In this illustrated embodiment, as shown in FIG. 6, the inserter tool 100 includes a flexible member 130 (also referred to herein as a "flexible member"). The flexible member 130 is located distal to the anchor 102 having an inner shaft 110 positioned within its inner lumen. The flexible member 130 is configured to fold or bend without breaking, cracking, or otherwise losing structural integrity. The flexible member 130 has a free end configured to move relative to the inner shaft 110 such that the flexible member 130 may fold or bend relative to the inner shaft 110 to facilitate release of the suture from within the suture retaining channel 116, as described further below. The flexible member 130 in this illustrated embodiment is a metal extension finger fixedly attached to the inner shaft 110, but may have other configurations, such as a metal monofilament wire, a metal multifilament wire, a braided fabric, a woven strand, a monofilament fiber, etc. Various embodiments of the flexible member are further described, for example, in the aforementioned U.S. Patent Publication No. 2021 / 0338223, published on November 4, 2021, entitled "Knotless Anchor Insertion."

[0061] The flexible member 130 cooperates with the distal end of the inner shaft 110, which includes the suture retaining channel 116, to define a sealed passage 134. Thus, the distal arm 110a of the inner shaft 110 defines a portion of the sealed passage 134. The flexible member 130 defines a distal end of the sealed passage 134. The suture is configured to extend through the suture retaining channel 116 and the sealed passage 134 during use of the inserter tool 100, as described further below. The flexible member 130 is configured to move to open the sealed passage 134, thereby allowing release of the suture from the suture retaining channel 116, as described further below. Generally, the flexible member 130 is configured to bend to open the sealed passage 134 by no longer providing a distal end of the sealed passage 134.

[0062] In an exemplary embodiment, the flexible member 130 is made from a shape memory or superelastic material, such as Nitinol or other material that may facilitate movement of the flexible member 134 between the rest configuration shown in FIG. 6 and the bent configuration. The default configuration of the flexible member 130 is the rest configuration in which the sealed passage 134 is present. The sealed passage 134 is not present in the flexible member 130 in the bent configuration. The flexible member 130 defaulting to the rest configuration may help ensure that the suture remains seated within the suture retaining channel 116 until desired.

[0063] The suture is positioned within the suture retaining channel 116, and therefore within the sealed passage 134, by a user of the inserter tool 100, which may provide the user of the inserter 100 with flexibility in determining the size and type of suture to use that is appropriate for a particular patient and a particular surgical procedure. The suture may be manually positioned within the suture retaining channel 116 and sealed passage 134 by the user, similar to threading a needle. Alternatively to manual positioning, the suture may be positioned within the suture retaining channel 116 and sealed passage 134 with a tool such as a pusher tube or loading aid. One embodiment of the loading aid 122 is shown in Figures 3-5 and 9 (the loading aid 122 is only partially shown in Figure 5).

[0064] The loading aid 122 is shown releasably attached to the inserter tool 100 in Figures 3-5 and 9 before the suture is positioned within the suture retaining channel 116 and the sealed passage 134. In an exemplary embodiment, the loading aid 122 is preloaded onto the inserter tool 100 during manufacture, which may help ensure that the loading aid 122 is correctly positioned on the inserter 100 and / or may provide a reminder to a user of the inserter 100 that a suture should be coupled to the inserter 100 before the inserter 100 is advanced into a patient's body. Alternatively, the loading aid 122 may be loaded onto the inserter tool 100 by a user, which may allow the inserter 100 to be sold without the loading aid 122 and therefore at a lower cost than an inserter 100 sold with the loading aid 122.

[0065] The loading aid 122 in this illustrated embodiment includes a suture threader. The suture threader can have a variety of configurations, as will be appreciated by those skilled in the art. In this illustrated embodiment, the loading aid 122 includes a base 124 and a wire loop 126 attached to the base 124 and defining a sealed passage 128. The base 124 of the loading aid 122 includes a plurality of clips 122c configured to releasably clip onto the outer shaft 108 to releasably attach the loading aid 122 to the inserter tool 100. The suture is configured to be mounted within the passage 128 defined by the loop 126. With the suture extending through the loop 126 of the loading aid 122, the loading aid 122 can be pulled by the base 124 in the direction of the arrow 124a on the base 124, e.g., printed thereon, etched therein, adhered thereto as a sticker, etc., to release the clip 122c from the outer shaft 108 and pull the suture through the sealed passage 134 defined by the inner shaft 110 and the suture retainer 132, threading the suture through the sealed passage 134 and the suture retaining channel 116. Thus, the suture extending through the sealed passage 134 and the suture retaining channel 116 can be releasably coupled to the inserter tool 100 and have a U-shape with the inserter tool 100 in its initial configuration.

[0066] The inserter tool 100 includes a retraction mechanism 136 configured to cause the inserter tool 100 to be removed from within the anchor 102. The retraction mechanism 136 is configured to be actuated to translate the portion of the inserter tool 100 positioned within the anchor 102 longitudinally and proximally relative to the anchor 102, and thus out of the anchor 102 through the open proximal end of the anchor. As described further below, a distal portion of the inner shaft 110 of the inserter tool 100 is positioned within the anchor 102, e.g., within its inner lumen 102i, after the anchor 102 is advanced into the bone hole. Thus, the retraction mechanism 136 is configured to cause the inner shaft 110 to be withdrawn from within the anchor 102 by moving the inner shaft 110 proximally relative to the anchor 102. As described above, the suture retainer 132 is fixedly attached to the inner shaft 110 at a distal portion of the inner shaft 110. Thus, the retraction mechanism 136 is also configured to retract the suture holder 132 proximally with the inner shaft 110. The suture mounted within the sealed passage 134 defined by the inner shaft 110 and the suture holder 132 does not retract with the inner shaft 110 and the suture holder 132, as described further below. The anchor 102 and the suture coupled thereto may therefore remain secured to the bone during and after actuation of the retraction mechanism 136.

[0067] As shown in FIGS. 1-4, the retraction mechanism 136 is located at a proximal portion of the inserter tool 100, including the handle 106. The retraction mechanism 136 is coupled to and partially contained within the handle 106. The proximal portion of the inserter tool 100, including the handle 106 and the retraction mechanism 136, is typically located completely outside the patient's body during use of the inserter tool 100. Thus, the retraction mechanism 136 is easily accessible and visible to a user during use of the inserter tool 100. Conversely, the portion of the inserter tool 100 that is positioned within the anchor 102 after the anchor 102 is inserted into the bone is located at a distal portion of the inserter tool 100 and is located completely within the patient's body during use of the inserter tool 100. As will be further described below, the retraction mechanism 136 is configured to move from an initial, non-actuated position to an actuated position to remove the inserter tool 100 from within the anchor 102. FIGS. 1-4, 8, and 13-16 show the retraction mechanism 136 in an initial position. 31-33, described further below, show the retraction mechanism 136 in an activated position. Thus, the retraction mechanism 136 in an activated position and visible to the user provides a visual indication to the user that the inserter tool 100 has been removed from within the anchor 102, even if the inserter tool 100 and / or anchor 102 cannot be fully or partially visualized within the patient's body.

[0068] The retraction mechanism 136 can have a variety of configurations. In the illustrated embodiment, the retraction mechanism 136 includes a lever. As shown in Figures 8 and 13-16, the retraction mechanism 136 includes a lever handle 138, a yoke 140, and a lever lock 142. The lever handle 138 is configured to be moved by a user to actuate the retraction mechanism 136. The lever handle 138 is partially disposed outside the handle 106 and partially disposed inside the handle 106. Thus, the lever handle 138 is accessible to and visible by the user from outside the handle 106 to facilitate actuation and visualization of the retraction mechanism 136. The yoke 140 and the lever lock 142 are disposed inside the handle 106.

[0069] As shown in Figure 13, the lever handle 138 includes a pair of opposing pins 138p (one of the pins 138p is hidden in Figure 13) configured to mount in opposing holes defined by the handle 106. Because of the perspective view of Figure 13, and because the handle 106 is only partially shown in Figure 13, only a half 106h of one of the holes is shown in Figure 13. The pins 138p are configured to rotate within their respective holes in response to actuation of the retraction mechanism 136.

[0070] The lever handle 138 also includes a pair of opposing openings 138g (see FIGS. 13 and 15) formed in opposing arms 138m (see FIGS. 14 and 15) of the lever handle 138. Each of the openings 138g in the lever handle is configured to seat one of a pair of opposing pins 140p of the yoke 140 therein (see FIGS. 14-16).

[0071] The lever handle 138 also includes a pair of mating features (hidden in FIG. 13) on its inner surface configured to releasably mate with a pair of mating elements 106e of the handle 106 (see FIGS. 31 and 32, which show the mating elements 106e within cavities 106v formed in the handle 106). The mating of the mating features and the mating elements 106e is configured to help hold the lever handle 138 in a fixed position relative to the handle 106 prior to actuation of the retraction mechanism 136. In this illustrated embodiment, the mating features are male members and the mating elements 106e are female members configured to releasably mount the male members therein, although the lever handle 138 could alternatively include female mating elements and the handle 106 could include male mating features.

[0072] As shown in FIGS. 14-16, the yoke 140 includes a pair of opposing rails 140r configured to be mounted within opposing longitudinal channels 108c formed in the outer shaft 108. As shown in FIGS. 15 and 16, the inner shaft 110 includes a pair of opposing grooves 110g formed therein. Each of the rails 140r of the yoke is configured to be mounted within one of the grooves 110g of the inner shaft. The inner shaft 110 is disposed within the inner lumen 108i of the outer shaft, while the rails 140r of the yoke 140 extend through the longitudinal channels 108c of the outer shaft and are configured to be mounted within the grooves 110g of the inner shaft. The rails 140r of the yoke 140 are configured to slide proximally within the respective longitudinal channels 108c of the outer shaft 108 in response to actuation of the retraction mechanism 136. The rails 140r of the yoke 140 are configured to seat within the grooves 110g of the inner shaft 110 such that proximal movement of the yoke 140 causes corresponding longitudinal movement of the inner shaft 110 (and the suture holder 132 fixedly attached thereto) in a proximal direction relative to the outer shaft 108, handle 106, and anchor 102. Thus, the inner shaft 110 (and the suture holder 132 fixedly attached thereto) may be removed from within the anchor 102 by moving proximally from the anchor 102 in response to actuation of the retraction mechanism 136. The outer shaft 108 is configured as a stop that stops proximal movement of the yoke 140 when the yoke 140 (e.g., its rails 140r) abuts the proximal end of the outer shaft's longitudinal channel 108c.

[0073] As described above, the retraction mechanism 136 is configured to move between an initial unactuated position and an actuated position. In the unactuated position, the lever lock 142 is in a locked position in which the lever lock 142 is configured to lock the lever handle 138 and the yoke 140 such that the lever handle 138 cannot be moved by a user to retract the inner shaft 110 (and the suture holder 132 fixedly attached thereto). Advancement of the anchor 102 into the bone, for example by striking the striking cap 112 to push the push tube 108 distally, is configured to move the lever lock 142 from the locked position to an unlocked position in which the lever lock 142 does not lock the lever handle 138 and the yoke 140 such that the lever handle 138 can be moved by a user to retract the inner shaft 110 (and the suture holder 132 fixedly attached thereto). 13-16 show the lever lock 142 in a locked position. FIG. 26, described further below, shows the lever lock 142 in an unlocked position. Thus, the retraction mechanism 136 is not prematurely activated before the anchor 102 has been advanced into the bone. As described further below, the lever lock 142 is fixedly attached to the push tube 108 such that distal movement of the push tube 108 is configured to cause corresponding longitudinal movement of the lever lock 142 in a distal direction to move the lever lock 142 from the locked position to the unlocked position. Thus, the locking mechanism 118, configured to lock the push tube 108 as described herein, is also configured to lock the lever lock 142, thereby further preventing premature activation of the retraction mechanism 136 before the anchor 102 has been advanced into the bone.

[0074] The lever lock 142 is configured to prevent the lever handle 138 from moving relative to the handle 106, and thus the yoke 140 and inner shaft 110 (and the suture holder 132 fixedly attached thereto) from moving relative to the handle 106. A pair of opposing arms 142m of the lever lock 142 are positioned distal to the arm 138m of the lever handle 138. The lever lock 142 is thus configured to prevent the lever handle 138 from moving relative to the handle 106 with the retraction mechanism 136 in the initial, unactuated position because the lever lock 142, e.g., the lever lock arm 142m, prevents the lever handle 138 from moving relative to the handle 106, e.g., the lever handle arm 138m is prevented from moving by the lever lock 142, thereby preventing the lever handle pin 138p from rotating within the handle bore.

[0075] As shown in FIGS. 15 and 16 , the outer shaft 108 includes a pair of opposing grooves 108g formed therein. Each of the arms 142m of the lever lock is configured to seat in one of the grooves 108g of the outer shaft. The arms 142m of the lever lock 142 are configured to seat in the grooves 108g of the outer shaft 108 such that distal movement of the outer shaft 108, for example, by striking the strike cap 112, causes corresponding longitudinal movement of the lever lock 142 in a distal direction relative to the inner shaft 108, the lever handle 138, the yoke 140, and the handle 106. Thus, the lever lock 142 is configured to move distally relative to the lever handle 138 such that the arm 138m of the lever handle 138 is no longer constrained by the lever lock 142, thereby allowing movement of the lever handle 138 relative to the handle 106 to actuate the retraction mechanism 136.

[0076] 13, the outer shaft 108 also includes a pair of opposing locking slots 108s formed therein and a pair of opposing locking grooves 108r formed therein, the pair of opposing locking grooves 108r being proximal to the outer shaft's pair of opposing slots 108s and distal to the outer shaft's pair of opposing grooves 108g. The handle 106 includes a retention mechanism configured to help retain the outer shaft 108 in its distal position after striking the striking cap 112. In this illustrated embodiment, the retention mechanism includes a pair of opposing fingers 106n internal to the handle 106, each finger configured to be releasably seated in one of the outer shaft's slots 108s with the inserter tool 100 in an initial configuration, as shown in FIG. The fingers 106n seated within the locking slots 108s are configured to help hold the outer shaft 108 in its proximal position prior to striking the strike cap 112 to advance the outer shaft 108 distally, such that the anchor 102 is not prematurely advanced distally by distal movement of the outer shaft 108 relative to the handle 106. The fingers 106n are each configured to be releasably seated within one of the locking grooves 108r of the outer shaft after the outer shaft 108 has been advanced distally, e.g., in response to a strike of the strike cap 112, to advance the anchor 102 distally. The fingers 106n seated in the locking grooves 108r are configured to help hold the outer shaft 108 in its distal position after striking the striking cap 112, so that when the retraction mechanism 136 is subsequently actuated to retract the inner shaft 110 (and suture retainer 132), the outer shaft 108 remains in a fixed position relative to the handle 106, anchor 102, and inner shaft 110. As the outer shaft 108 moves distally from its position where the fingers 106n of the handle are seated in the locking slots 108s of the outer shaft, the fingers 106n are configured to automatically change from being seated in the locking slots 108s to being seated in the locking grooves 106r.Each of the fingers 106n has a free end that allows the fingers 106n to flex as needed as the outer shaft 108 moves distally relative to the handle 106 to move the fingers 106n from the locking slots 108s into the locking grooves 108g. The fingers 106n slide proximally along the outer shaft 108 until they are seated in the locking grooves 106g.

[0077] Figures 19-35 illustrate one embodiment of a method of using an inserter tool. The method is described with respect to the inserter tool 100, anchor 102, and loading aid 122 of Figures 1-5, however, other inserter tools, anchors, and loading aids may be used as well. Also, as noted above, it is not necessary to use a loading aid at all.

[0078] 17-20 simultaneously show various portions of the inserter tool 100 in a manner in which a suture 144 is loaded onto the inserter tool 100 using the loading aid 122. The inserter tool 100 is in an initial configuration (see FIGS. 17-20), the loading aid 122 is coupled to the inserter tool 100 (see FIG. 17), the locking mechanism 118 is in its locked position (see FIGS. 18 and 19), the retraction mechanism 136 is in its inactivated position (see FIGS. 18 and 19), the lever lock 142 is in its locked position, and the handle fingers 106n are seated within the locking slots 108s of the outer shaft (see FIG. 20).

[0079] The suture 144 includes a single strand in this illustrated embodiment, but may include multiple strands. The suture 144 is coupled (e.g., tied, threaded, etc.) to tissue 146 which is positioned against the bone. The tissue 146 may be any of a variety of tissues, natural or artificial, as appropriate for the particular surgical procedure being performed, such as the labrum for a rotator cuff repair procedure.

[0080] As shown in Fig. 17, the loading aid 122 is releasably coupled to the inserter tool 100, with the suture 144 extending through the loop 126 of the loading aid 122. With the suture 144 extending through the loop 126 of the loading aid 122, the loading aid 122 is pulled by the base 124, pulling the suture 144 through the sealed passage 134 of the inserter tool such that the suture 144 extends through the sealed passage 134. The loading aid 122 is pulled in the direction indicated by arrow 148 in Fig. 17, which corresponds to the direction of the arrow 124a on the base 124, pulling the suture 144 through the sealed passage 134.

[0081] With the suture 144 coupled to the inserter tool 100 by being seated within the sealed passage 134, and therefore also seated within the suture retaining channel 116, and with the loading aid 122 removed from the inserter tool 100 (if the loading aid 122 was used to facilitate the suture coupling to the inserter tool 100), the inserter tool 100 is used to insert the suture 144 and anchor 102 into a bone hole 150 formed in a bone 152 (see FIG. 21 ). In an exemplary embodiment in which the inserter 100 is used to insert the suture 144 and anchor 102 into the bone hole 150, 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 the bone hole 150. 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 within an incision, formed in the patient's skin, and then removed from the patient's body. The cannula can then act as a guide for distal advancement of the inserter towards the bone hole 150 .

[0082] The inserter 100 is advanced distally into the patient's body as shown in FIG. 21 until the distal end of the inner shaft 110 is positioned within the bone hole 150. FIGS. 21 and 22 simultaneously show the distal and proximal portions, respectively, of the inserter tool 100 in this method. Thus, the suture 144 extending through the sealed passage 134 and the suture retaining channel 116 is positioned within the bone hole 150 before the anchor 102 is secured within the bone hole 150. The bottom surface of the bone hole 150 can function as a stop surface to stop distal movement of the inserter 100 relative to the bone 152, for example, by abutting the inner shaft 110 and / or the suture retainer 132, and / or the outer surface 152e of the bone 152 can function as a stop surface to stop distal movement of the inserter 100 relative to the bone 152, for example, by abutting the anchor 102 or the bushing 108k. The interior of the bone hole 150 cannot be visualized with the inserter 100 positioned therein, and therefore the stop can help ensure that the inserter 100 has advanced as far distally as possible into the bone hole 150, which can help ensure that the anchor 102 is secured within the bone hole 150 with the proximal end of the anchor flush or near flush with the proximal end of the bone hole 150. Alternatively, the inserter 100 can be inserted into the bone hole 150 a specified distance before the distal end of the anchor 102 engages the open proximal end of the bone hole 150. Because the anchor 102 does not easily advance into the bone hole 150 without hitting the striking cap 112, the distance the inserter 100 protrudes from the anchor 102 controls the distance the inserter 100 advances into the bone hole 150.

[0083] With the distal end of the inner shaft 110 positioned within the bone hole 150, the suture 144 can be tensioned as desired prior to advancing the anchor 102 distally relative to the inner shaft 110. Alternatively, the tension in the suture 144 can be approximated prior to placement of the inserter 100 within the bone hole 150, with advancement of the inserter 100 into the bone hole 150 applying a tension approximately equal to the length of the distance the inserter protrudes from the distal end of the anchor 102. 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 of one or more reasons, such as manufacturing tolerances and sensitivity of the measuring device. With the suture 144 desirably tensioned, the suture 144 is seated within the groove 107 as shown in FIG. 23 such that the suture tension is maintained and held by the suture retaining member.

[0084] With the suture 144 and the distal end of the inner shaft 110 positioned within the bone hole 150, the locking mechanism 118 is moved from the locked position to the unlocked position. FIG. 24 shows the locking mechanism 118 in the unlocked position having been moved from the locked position of FIGS. 18, 19, 22, and 23 by being pushed as indicated by arrow 154 to move relative to the handle 106, outer shaft 108, and strike cap 112. The outer shaft 108 is now free to move relative to the inner shaft 110 in response to striking on the strike cap 112. In this illustrated embodiment, the locking mechanism 118 can be moved from the locked position to the unlocked position after the suture 144 is tensioned and held by the suture holding mechanism, however, the locking mechanism 118 can be moved from the locked position to the unlocked position before the suture 144 is tensioned and held by the suture holding mechanism.

[0085] With the distal end of the inner shaft 110 positioned within the bone hole 150 and the locking mechanism 118 in the unlocked position, the anchor 102 is advanced distally into the bone hole 150 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 of the inserter 100. As shown in FIG. 25 , 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, thereby moving the anchor 102 distally relative to the inner shaft 110 and advancing it distally into the bone hole 150. The anchor 102 is positioned subcortically, for example, by about 1 mm or another amount, in the embodiment shown in FIG. 25 , such that it is positioned quasi-flush within the bone 152. The striking cap 112 may be struck one or more times to fully advance the anchor 102 into the bone hole 150. The bushing 108k may include an indicator, e.g., a laser line thereon, a groove formed therein, or the like, configured to align with the outer surface 152e of the bone 152, such that when the anchor 102 is positioned quasi-flush within the bone 152, visualization of the anchor 102 within the bone hole 150 is prevented (at least before the inserter 100 is removed from the anchor 102), thereby providing a visual indication to the user that the anchor 102 has been fully advanced distally into the bone hole 150. The anchor 102 within the bone hole 150 captures the suture 144, e.g., a leg thereof, between the outer surface of the anchor 102 and the bone surface defining the bone hole 150.

[0086] 25-28 show various parts of the inserter tool 100 in the method simultaneously. FIG. 25 shows the anchor 102 fully advanced distally into the bone hole 150 caused by distal axial translation of the outer shaft 108. The outer shaft 108, e.g., its bushing 108k, abuts the proximal end 102p of the anchor 102. FIG. 26 shows that distal advancement of the outer shaft 108 advances the lever lock 142 distally, thereby moving it from its locked position to its unlocked position. FIG. 27 shows that distal advancement of the outer shaft 108 causes the handle's fingers 106n to seat in the outer shaft's locking slots 108s and then in the outer shaft's locking grooves 108r, sliding along the outer shaft 108 as the outer shaft 108 moves distally relative to the fingers 106n. FIG. 28 shows the distal surface of the striking cap abutting the locking feature 118 after striking cap 112 in the distal direction indicated by arrow 156 .

[0087] The suture 144 is still held by the suture retaining member, as shown in Fig. 28. The suture 144 may also be secured within the bone hole 150 by advancing the anchor 102 into the bone hole 150, thus releasing it from the suture retaining member, as shown in Fig. 29, where the suture 144 is no longer seated within the groove 107.

[0088] As shown in FIG. 25, which corresponds to the same state of the inserter tool 100 as FIG. 28, the distal portion of the inserter tool 100, including the inner shaft 110 and the suture holder 132, is positioned within the bone hole 150 and the inner lumen 102i of the anchor 102, with the anchor 102 and suture 144 secured within the bone hole 150. The retraction mechanism 136 is actuated to retract the inner shaft 110 (and the suture holder 132 fixedly attached thereto) proximally relative to the outer shaft 108, handle 106, and anchor 102 to remove the inserter tool 100 from within the anchor 102. To actuate the retraction mechanism 136, the lever handle 138 is moved relative to the inserter handle 106, as shown in FIGS. 30 and 31. FIG. 30 shows the lever handle 138 in an unactuated position, and FIG. 31 shows the lever handle 138 in an actuated position. The lever handle 138 in this illustrated embodiment is configured to pivot approximately 90° from the unactuated position to the actuated position. Those skilled in the art will appreciate that values ​​such as angular values ​​may not be exactly at a value, but are nevertheless considered to be approximately that value, either for one or more reasons such as manufacturing tolerances or sensitivity of measuring equipment. The lever handle 138 pivoting approximately 90° can provide a clear visual indication to the user that the retraction mechanism 136 has been actuated, since in the actuated position the lever handle 138 protrudes substantially perpendicular to the inserter handle 106. The lever handle 138 in this illustrated embodiment is curved at its proximal end, which indicates the direction in which the lever handle 138 should pivot to actuate the retraction mechanism.

[0089] 31 shows that the lever handle 138 in the actuated position is no longer mounted within the handle cavity 106v and that the lever handle mating feature no longer mates with the handle mating element 106e located within the cavity 106v. The lever handle 138 mounted within the cavity 106v may help reduce the profile of the proximal portion of the inserter tool 100 and / or help keep the lever handle 138 out of the way prior to actuation of the retraction mechanism 136.

[0090] The pin 138p of the lever handle rotates within the handle bore during actuation of the lever handle 138 as the lever handle 138 moves from its unactuated position (FIG. 30) to its actuated position (FIG. 31), with the handle 106 serving as a fulcrum for the pivoting of the lever handle. The lever handle 138 is in a fixed axial position relative to the handle 106 due to the pin 138p being seated in the handle bore, and therefore the lever handle 138 does not translate longitudinally when actuated. The yoke 140 of the retraction mechanism is not in a fixed position relative to the handle 106, and therefore the yoke 140, operably coupled to the lever handle 138, is free to translate longitudinally relative to the handle 106 in response to the pivoting of the lever handle 138. The yoke 140 slides proximally within the longitudinal channel 108c of the outer shaft as the lever handle 138 moves from its unactuated position to its actuated position, as described above. Thus, the inner shaft 110 (and the suture holder 132 fixedly attached thereto) correspondingly translates proximally relative to the outer shaft 108, handle 106, and anchor 102 to pull the inner shaft 110 (and the suture holder 132 fixedly attached thereto) out of the anchor 102.

[0091] Actuation of the retraction mechanism 136 causes the flexible member 130 to bend. The flexible member 130 in this illustrated embodiment is passive by being configured to automatically bend in response to a force applied thereto. As the retraction mechanism 136 is actuated, the flexible member 130 encounters the sealed passage 134 and the suture 144 in the suture retaining channel 116 as the inner shaft 110 and suture retainer 132 move longitudinally proximally relative to the anchor 102. As shown in FIG. 30 , the flexible member 130 bends in the direction of arrow 160 in response to a force applied thereto by the suture 144 as the flexible member 130 is pulled proximally with the inner shaft 110. Thus, as discussed above, the sealed passage 134 no longer exists and the flexible member 130 no longer provides a distal end of the sealed passage 134. Thus, after the inner shaft 110 and suture retainer 132 are removed from the anchor 102, the suture 144 can exit the suture retaining channel 116 from the open distal end thereof and remain within the bone hole 150, as shown in Figures 31 and 32. Figure 32 also illustrates that the flexible member 130 bends back to its resting configuration after passing proximally over the suture 144, because the suture 144 is no longer exerting a force on the flexible member 130 to encourage bending of the flexible member 130.

[0092] After the retraction mechanism 136 is actuated, the inserter tool 100 is translated longitudinally in the proximal direction and pulled axially along the longitudinal axis of the inserter tool 100, for example as shown by arrow 162 in Fig. 33, and removed from the patient's body with the anchor 102 and suture 144 remaining within the bone hole 150 and the legs of the suture 144 extending out of the bone hole 150. Figs. 34 and 35 show the anchor 102 and suture 144 secured within the bone hole 150 with tissue 146 coupled to the suture 144 and fixed in place relative to the bone 152.

[0093] The outer shaft 108 and inner shaft 110 of the inserter tool 100 of Figures 1-5 are straight. In other embodiments, the inserter tool can have curved outer and inner shafts. The outer and inner shafts of the inserter tool being curved at least in their distal portions can facilitate approach of the distal end of the inserter tool to a target site for implantation of an anchor releasably coupled to the inserter tool, where severe constraints of the patient's anatomy at the joint can make the target site difficult to approach.

[0094] 36-39 show one embodiment of an inserter tool 200 having a curved outer shaft 208 and inner shaft 210. The inserter tool 200 is for knotless anchor insertion in soft tissue repair surgical procedures and is similar to the inserter tool 100 of FIGS. 1-5 except for the curvature of the outer and inner shafts 208, 210, and is configured to insert an anchor 102 into a patient's bone, for example to secure soft tissue to the bone, and includes a handle 206, an outer shaft 208 extending distally from the handle 206 and including a bushing 208k, an inner shaft 210 extending distally from the handle 206 and including a notch formed therein that defines a suture retaining channel, and an inner shaft 210 extending distally from the handle 206 and including a bushing 208k. 36-39 , a suture retaining member in the form of an elastomeric cleat 209 fixedly attached to the handle 206 and a groove 207 defined by the handle 206, a strike cap 212 extending proximally from the handle 206, a locking mechanism 218 configured to lock the outer shaft 208 in place relative to the inner shaft 210 when the locking mechanism 218 is in the locked position, and a retraction mechanism 236 configured to cause the inserter tool 200 to be removed from within the anchor 102. The retraction mechanism 236 is the same as the retraction mechanism 136 described above, e.g., configured as a lever and including a lever handle 238, a yoke (hidden in FIGS. 36-39 ), and a lever lock (hidden in FIGS. 36-39 ). The inserter tool 200 is shown in Figures 36-39 coupled to the anchor 102 of Figures 1-7, but may be similarly used with other anchors in a manner similar to that described above with respect to the anchor 102 and the inserter tool 100. Figures 36-40 show the inserter 200 in an initial configuration.

[0095] The inserter tool 200 includes an indicator configured to indicate to a user the direction of the curvature of the outer and inner shafts, for example, when the curvature of the outer and inner shafts is not visible inside the patient. In the illustrated embodiment, the elastomeric cleat 209 and the handle 206 cooperate as the indicator. The handle 206 is curved outward toward the elastomeric cleat 209. The curvature of the handle 206 is curved in the same direction as the outer shaft 208 and the inner shaft 210. Other embodiments of the indicator are further described, for example, in the aforementioned U.S. Patent Publication No. 2021 / 0338223, published November 4, 2021, entitled "Knotless Anchor Insertion."

[0096] Figures 36 and 37 show the inserter 200 releasably coupled to the loading aid 122 of Figures 3-5. However, similar to that described above with respect to the inserter 100 and loading aid 122 of Figures 3-5, the inserter 200 of Figures 40 and 41 may be used in conjunction with another loading aid or no loading aid at all.

[0097] The curved outer shaft 208 in this illustrated embodiment is flexible, unlike the straight outer shaft 108 of the inserter tool 100 of FIGS. 1-5. In other embodiments, the curvature of the inserter outer and inner shafts can be fixed. The flexible outer shaft 208 facilitates translation of the outer shaft along the curved inner shaft 210. As shown in FIGS. 36-41, the distal portion of the outer shaft 208 includes a plurality of slits 208t formed therein configured to facilitate bending of the outer shaft 208. The plurality of slits 208t in this illustrated embodiment includes two rows of crescent-shaped slits 208t, but another number of rows can be provided and / or the slits 208t can have another shape. The flexibility of the curved outer shaft 208 can be provided in other ways. For example, instead of including a plurality of slits, the curved outer shaft 208 can include a plurality of score marks formed in the outer shaft 208. In another example, the curved outer shaft 208 can include a thinner section of material at its distal portion such that the sidewall of the outer shaft is thinner than along the remainder of the outer shaft.

[0098] The retraction mechanism 136, 236 of the inserter tools 100, 200 of Figures 1-5 (inserter 100) and 36-39 (inserter 200), respectively, is configured as a lever. However, as noted above, the retraction mechanism of the inserter tool can have other configurations. For example, the retraction mechanism can be configured as a rack and pinion mechanism. In another example, the retraction mechanism can be configured as a lead screw mechanism.

[0099] 42 and 43 show an embodiment of an inserter tool 300 including a retraction mechanism 336 configured as a rack and pinion mechanism. The inserter tool 300 is for knotless anchor insertion in soft tissue repair surgical procedures and is similar to the inserter tool 100 of FIGS. 1-5 except for the configuration of the retraction mechanism 336, e.g., configured to insert an anchor into a patient's bone to secure soft tissue to the bone, and includes a handle 306, an outer shaft 308 extending distally from the handle 306 and including a bushing (not shown in FIGS. 42 and 43), an inner shaft 310 extending distally from the handle 306 and including a notch formed therein that defines a suture retaining channel (not shown in FIGS. 42 and 43), and a sealing passageway 316 extending distally from the handle 306 that defines a suture retaining channel (not shown in FIGS. 42 and 43) that cooperates with the inner shaft 310 to form a sealing passageway 316. 7, a suture retaining member in the form of a groove 307 defined by a handle 306 and an elastomeric cleat 309 fixedly attached to the handle 306, a strike cap 312 extending proximally from the handle 306, a locking mechanism 318 configured to lock the outer shaft 308 in place relative to the inner shaft 310 when the locking mechanism 318 is in a locked position, and a retraction mechanism 336 configured to cause the inserter tool 300 to be removed from within the anchor (not shown in FIGS. 42 and 43). The anchor can be the anchor 102 of FIG. 7, or can be another anchor as described herein.

[0100] The retraction mechanism 336 includes a handle 338, a rack 340, and a base 342. The retraction mechanism handle 338 is configured to be moved by a user to actuate the retraction mechanism 336. Similar to the lever handle 136, the retraction mechanism handle 338 is disposed partially exterior to the inserter handle 306 and partially interior to the inserter handle 306. The rack 340 and base 342 are disposed interior to the inserter handle 306.

[0101] The retraction mechanism handle 338 includes a pair of opposed pins 338p configured to mount and rotate within opposed holes defined by the inserter handle 306, similar to the pins 138p of the lever handle 138. The retraction mechanism handle 338 also includes a pinion 338n in the form of a spur gear operably coupled to a rack 340, the teeth of the pinion 338n being engaged with the teeth of the rack 340. Movement of the retraction mechanism handle 338 rotates the pinion 338n relative to the inserter handle 306, which moves the rack 340 due to the engagement of the teeth.

[0102] The rack 340 includes a pair of opposing rails (hidden in FIGS. 42 and 43) configured to be mounted in opposing longitudinal channels formed in the outer shaft 108, similar to the rails 140r of the yoke 140 configured to be mounted in opposing longitudinal channels 108c formed in the outer shaft 308 described above. Each of the rails of the rack is configured to be mounted in one of the pair of opposing grooves of the inner shaft 310, similar to the rails 140r of the yoke mounted in the groove 110g of the inner shaft described above. While the inner shaft 310 is disposed within the inner lumen of the outer shaft, the rails of the rack 340 extend through the longitudinal channels of the outer shaft and are configured to be mounted within the grooves of the inner shaft. The rails of the rack 340 are configured to slide proximally within the respective longitudinal channels of the outer shaft 308 in response to actuation of the retraction mechanism 336. Because the rails of the rack 340 are seated within grooves in the inner shaft 310, proximal movement of the rack 340 is configured to cause corresponding longitudinal movement of the inner shaft 310 (and suture holder fixedly attached thereto) in a proximal direction relative to the outer shaft 308, the inserter handle 306, and the anchor releasably coupled to the inserter 300. The inner shaft 310 (and suture holder fixedly attached thereto) can thus be removed from within the anchor by moving it proximally from the anchor in response to actuation of the retraction mechanism 336. The outer shaft 308 is configured as a stop that stops proximal movement of the rack 340 when the rack 340, e.g., its rails, abuts the proximal end of the outer shaft's longitudinal channel.

[0103] Retraction mechanism 336 is configured to move between an initial, unactuated position and an actuated position, similar to retraction mechanism 136 described above.

[0104] The locking base is fixedly attached to the push tube 308 by being mounted in a pair of opposing grooves in the outer shaft 308, similar to the lever lock 142 mounted in a pair of opposing grooves 108g in the outer shaft 108 described above. Distal movement of the push tube 308 is thus configured to cause corresponding longitudinal movement of the base 342 in the distal direction, moving the base 342 distally. Thus, the locking mechanism 318 configured to lock the push tube 308 as described herein is also configured to lock the base 342.

[0105] The outer shaft 308 in this illustrated embodiment includes a pair of opposing locking slots and a pair of opposing locking grooves 308r formed therein, similar to the pair of opposing slots 108s and pair of opposing grooves 108g of the outer shaft 108 described above. The inserter handle 306 in this illustrated embodiment includes a pair of opposing fingers therein, similar to the inserter handle 106 described above. As above, the fingers seated in the locking slots are configured to help hold the outer shaft 308 in its proximal position prior to striking the strike cap 312 to distally advance the outer shaft 308, and the fingers are each configured to be releasably seated in one of the outer shaft's locking grooves 308r, e.g., in response to a strike of the strike cap 312, after the outer shaft 308 has advanced distally to distally advance the anchors.

[0106] In this illustrated embodiment, the retraction mechanism handle 338 is configured to pivot approximately 90° from the inactivated position to the activated position. Varying the pitch diameter of the spur gear 338n will change the pivot angle of the retraction mechanism handle 338 if a different pivot angle is desired. For example, the pitch diameter of the spur gear 338n can be altered such that the retraction mechanism handle 338 is configured to pivot approximately 180° from the inactivated position to the activated position. A retraction mechanism handle 338 configured to pivot approximately 180° may make it easier for a user to hold the handle 306 of the inserter tool 300 after activation of the retraction mechanism because the retraction mechanism handle 338 will be configured to be at its lowest profile relative to the handle 306 in each of the activated and inactivated positions of the retraction mechanism.

[0107] The outer shaft 308 and inner shaft 310 of the inserter tool 300 may be straight, similar to the outer shaft 108 and inner shaft 110 of the inserter 100 of Figures 1-5, or may be curved, similar to the outer shaft 208 and inner shaft 210 of the inserter 200 of Figures 36-39.

[0108] The inserter 300 of Figures 42 and 43 may be used in conjunction with the loading aid 122, in conjunction with a different loading aid, or in conjunction with no loading aid at all.

[0109] 44 and 45 show an embodiment of an inserter tool 400 including a retraction mechanism configured as a lead screw mechanism. The inserter tool 400 is for knotless anchor insertion in soft tissue repair surgical procedures and is similar to the inserter tool 100 of FIGS. 1-5 except for the configuration of the retraction mechanism 436, e.g., configured to insert an anchor into a patient's bone to secure soft tissue to the bone, and includes a handle 406, an outer shaft 408 extending distally from the handle 406 and including a bushing (not shown in FIGS. 44 and 45), an inner shaft 410 extending distally from the handle 406 and including a notch formed therein that defines a suture retaining channel (not shown in FIGS. 44 and 45), and an inner shaft 412 extending distally from the handle 406 and including a bushing (not shown in FIGS. 44 and 45). 45 ), a suture retaining member (not shown in FIGS. 44 and 45 ), a striking cap (not shown in FIGS. 44 and 45 ) extending proximally from the handle 406, a locking mechanism (not shown in FIGS. 44 and 45 ) configured to lock the outer shaft 408 in place relative to the inner shaft 410 when the locking mechanism 418 is in the locked position, and a retraction mechanism configured to cause the inserter tool 400 to be removed from within the anchor (not shown in FIGS. 44 and 45 ). The anchor can be anchor 102 of FIG. 7 or can be another anchor as described herein.

[0110] 44-47, the retraction mechanism includes a ring actuator 438, a lead screw 440, and a guide 442. The ring actuator 438 is configured to be moved by a user to actuate the retraction mechanism, similar to the lever handles 138, 238 and retraction mechanism handle 338 described above. The ring actuator 438 is disposed circumferentially around the handle 406 on the exterior side of the handle 406. The lead screw 440 and guide 442 are disposed within the handle 406.

[0111] The ring actuator 438 is operatively coupled to the lead screw 440, with teeth 438t of the ring actuator 438 engaging teeth 440t of the lead screw 440. Movement of the ring actuator 438 rotates the lead screw 440 relative to the handle 406, which rotates the lead screw 440 due to the engagement of the teeth 438t, 440t.

[0112] The proximal and distal ends 440p, 440d of the lead screw 440 are rotatably attached to the handle 406. Thus, the lead screw 440 cannot translate proximally or distally relative to the handle 406, but can rotate relative to the handle 406. The helical threads 440h of the lead screw 440 are threadably engaged with the threads of the guide 442 (hidden in FIGS. 44 and 45). The guide 442 is fixedly attached to the inner shaft 410, as described further below. Rotation of the lead screw 440 causes the guide 442 to move longitudinally in the proximal direction due to the engagement of the helical threads 440h of the lead screw 440 with the threads of the guide 442. Thus, the inner shaft 410 attached to the guide 442 also moves proximally.

[0113] The guide 442 includes a pair of opposing rails (hidden in FIGS. 44 and 45 ) configured to be mounted within opposing longitudinal channels formed in the outer shaft 108, similar to the rails 140r of the yoke 140 configured to be mounted within opposing longitudinal channels 108c formed in the outer shaft 408 described above. The rails of the guide are each configured to be mounted within one of a pair of opposing grooves of the inner shaft 410, similar to the rails 140r of the yoke mounted within the groove 110g of the inner shaft described above. While the inner shaft 410 is disposed within the inner lumen of the outer shaft, the rails of the guide 440 extend through the longitudinal channels of the outer shaft and are configured to be mounted within the grooves of the inner shaft. The rails of the guide 440 are configured to slide proximally within their respective longitudinal channels of the outer shaft 408 in response to actuation of the retraction mechanism. The rails of the guide 440 are seated within grooves in the inner shaft 410 such that proximal movement of the guide 440 causes corresponding longitudinal movement of the inner shaft 410 (and suture holder fixedly attached thereto) in a proximal direction relative to the outer shaft 408, handle 406, and anchor that is releasably coupled to the inserter 400. The inner shaft 410 (and suture holder fixedly attached thereto) can thus be removed from within the anchor by moving it proximally from the anchor in response to actuation of the retraction mechanism. The outer shaft 408 is configured as a stop that stops proximal movement of the guide 440, e.g., when its rails abut the proximal end of the outer shaft's longitudinal channel.

[0114] The guide 442 is configured as a stop that is configured to prevent the ring actuator 438 from being moved relative to the handle 406, and thus prevent the guide 440 and inner shaft 410 (and the suture retainer fixedly attached thereto) from moving relative to the handle 406. Engagement of the helical threads 440h of the lead screw 440 with the threads of the guide 442 prevents longitudinal translation of the guide 442, and therefore the outer shaft 408 attached thereto, except in response to rotation of the ring actuator 438.

[0115] The handle 406 can include a pair of opposing fingers 406n similar to the fingers 106n of the handle 105 described above, and the outer shaft 408 can include a pair of opposing locking slots 408 formed therein and a pair of opposing locking grooves formed therein, similar to the pair of opposing slots 108s and the pair of opposing grooves 108g of the outer shaft 108 described above.

[0116] The outer shaft 408 and inner shaft 410 of the inserter tool 400 may be straight, similar to the outer shaft 108 and inner shaft 110 of the inserter 100 of Figures 1-5, or may be curved, similar to the outer shaft 208 and inner shaft 210 of the inserter 200 of Figures 36-39.

[0117] The inserter 400 of Figures 44 and 45 may be used with the loading aid 122, with a different loading aid, or with no loading aid at all.

[0118] 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.

[0119] 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.

[0120] [Embodiment] (1) A surgical system, comprising: an anchor configured to be implanted in bone; 1. An inserter tool comprising: an outer shaft configured to push the anchor distally along a longitudinal axis of the inserter tool; an inner shaft positioned within the outer shaft and within the anchor, a distal end of the inner shaft positioned distal to the outer shaft and the anchor, the distal end of the inner shaft configured to releasably couple to a suture; an inserter tool comprising: a retraction mechanism configured to be actuated to move the inner shaft proximally along the longitudinal axis of the inserter tool relative to the outer shaft and the anchor; A system comprising: (2) The system of embodiment 1, wherein the retraction mechanism is configured as a lever. (3) The system of embodiment 2, wherein the retraction mechanism comprises a lever handle operably coupled to the inner shaft and configured to be moved relative to the outer shaft and the anchor, thereby moving the inner shaft proximally relative to the outer shaft and the anchor. (4) The system of embodiment 3, wherein the retraction mechanism further comprises a locking portion configured to prevent the lever handle from moving relative to the outer shaft and the anchor before the outer shaft pushes the anchor distally. (5) The system of embodiment 4, wherein the outer shaft pushing the anchor distally is configured to move the locking portion from a locked position in which the locking portion prevents the lever handle from moving relative to the outer shaft and the anchor, to an unlocked position in which the locking portion allows the lever handle to move relative to the outer shaft and the anchor.

[0121] (6) The system described in embodiment 1, wherein the retraction mechanism is configured as a rack and pinion mechanism. (7) The system of embodiment 1, wherein the retraction mechanism is configured as a lead screw mechanism. (8) The system of embodiment 1, wherein the retraction mechanism includes a lock configured to prevent the retraction mechanism from being actuated before the outer shaft pushes the anchor distally. (9) The inserter tool further comprises a handle, the handle including a retention mechanism configured to hold the outer shaft in a fixed position relative to the handle during the actuation of the retraction mechanism; 2. The system of claim 1, wherein the inner shaft is also moved proximally relative to the handle by actuation of the retraction mechanism. (10) the inserter tool further comprises a handle configured to be positioned outside a patient's body with the distal end of the inner shaft positioned within a hole in the bone; the outer shaft extends distally from the handle; the inner shaft extends distally from the handle; 2. The system of claim 1, wherein the retraction mechanism is configured to be positioned outside the patient's body with the distal end of the inner shaft positioned within the hole in the bone.

[0122] (11) the inserter tool has a sealed passage configured to seat a suture therethrough and to releasably couple the inner shaft to the suture; The system of embodiment 1, wherein actuation of the retraction mechanism is configured to automatically unfold a flexible member of the inserter tool in response to the inner shaft moving proximally relative to the outer shaft and the anchor, thereby opening the sealed passage. (12) further comprising a suture installed through the sealed passage; The system of embodiment 11, wherein the suture is installed through the sealed passage prior to actuation of the retraction mechanism and prior to the distal end of the inner shaft being positioned within the hole in the bone, and is installed through the sealed passage after the outer shaft pushes the anchor distally such that the anchor captures the suture between an outer surface of the anchor and a wall of the hole in the bone. (13) A surgical method comprising: positioning a distal end of an inner shaft of an inserter tool within a bone hole, the distal end of the inner shaft being releasably coupled to a suture, whereby the suture is also positioned within the bone hole; moving an outer shaft of the inserter tool axially and distally relative to the inner shaft, thereby sliding an anchor along the inner shaft and positioning the anchor within the bone hole such that the anchor captures the suture between an outer surface of the anchor and a wall of the bone hole; after said moving the outer shaft axially and distally, actuating a retraction mechanism of the inserter tool, thereby moving the inner shaft axially and proximally relative to the outer shaft and the anchor such that the inner shaft is removed from the bone hole and the anchor and the suture remain within the bone hole. (14) The method of claim 13, wherein the retraction mechanism is configured as a lever. (15) The method of claim 13, wherein the retraction mechanism is configured as a rack and pinion mechanism.

[0123] (16) The method of claim 13, wherein the retraction mechanism is configured as a lead screw mechanism. (17) prior to said axially and distally moving said outer shaft, said inserter tool having a sealed passage in which said suture is seated; 14. The method of claim 13, wherein the actuation of the retraction mechanism also causes a flexible member of the inserter tool to move relative to the outer shaft and the anchor, bending the sealed passageway open. (18) striking a striking cap of the inserter tool to cause the axial and distal movement of the outer shaft; 14. The method of claim 13, wherein striking the striking cap moves a locking portion of the retraction mechanism from a locked position in which the locking portion prevents the retraction mechanism from being actuated to an unlocked position in which the locking portion allows the retraction mechanism to be actuated. (19) The method of claim 18, wherein a retention mechanism on the inserter tool handle holds the outer shaft in a fixed position relative to the handle during the actuation of the retraction mechanism. (20) The inserter tool comprises a handle positioned outside a patient's body with the distal end of the inner shaft positioned within the bone hole; the outer shaft extends distally from the handle; the inner shaft extends distally from the handle; 14. The method of claim 13, wherein the retraction mechanism is positioned outside the patient's body with the distal end of the inner shaft positioned within the bone hole.

[0124] (21) A surgical method comprising: Positioning a distal end of an inner shaft of an inserter tool and a flexible member of the inserter tool within a bone hole; moving an outer shaft of the inserter tool axially and distally relative to the inner shaft, thereby moving an anchor axially and distally, thereby positioning the anchor within the bone hole such that it captures the suture between an outer surface of the anchor and a wall of the bone hole; actuating a retraction mechanism of the inserter tool after said axially and distally moving the outer shaft, thereby moving the inner shaft and the flexible member axially and proximally relative to the outer shaft and the anchor such that the inner shaft and the flexible member are removed from the bone hole and the anchor and the suture remain within the bone hole, the flexible member expanding during said axially and proximal movement of the flexible member; A method comprising: (22) The method of claim 21, wherein the retraction mechanism is configured as a lever, a rack and pinion mechanism, or a lead screw mechanism.

Claims

1. 1. A surgical system comprising: an anchor configured to be implanted in a bone; 1. An inserter tool comprising: an outer shaft configured to push the anchor distally along a longitudinal axis of the inserter tool; an inner shaft positioned within the outer shaft and within the anchor, a distal end of the inner shaft positioned distal to the outer shaft and the anchor, the distal end of the inner shaft configured to releasably couple to a suture; an inserter tool comprising: a retraction mechanism configured to be actuated to move the inner shaft proximally along the longitudinal axis of the inserter tool relative to the outer shaft and the anchor; A system comprising:

2. The system of claim 1 , wherein the retraction mechanism is configured as a lever.

3. 3. The system of claim 2, wherein the retraction mechanism comprises a lever handle operably coupled to the inner shaft and configured to be moved relative to the outer shaft and the anchor, thereby moving the inner shaft proximally relative to the outer shaft and the anchor.

4. 4. The system of claim 3, wherein the retraction mechanism further comprises a stop configured to prevent the lever handle from moving relative to the outer shaft and the anchor before the outer shaft pushes the anchor distally.

5. 5. The system of claim 4, wherein the outer shaft pushing the anchor distally is configured to move the lock from a locked position in which the lock prevents the lever handle from moving relative to the outer shaft and the anchor, to an unlocked position in which the lock allows the lever handle to move relative to the outer shaft and the anchor.

6. The system of claim 1 , wherein the retraction mechanism is configured as a rack and pinion mechanism.

7. The system of claim 1 , wherein the retraction mechanism is configured as a lead screw mechanism.

8. The system of claim 1 , wherein the retraction mechanism includes a stop configured to prevent the retraction mechanism from being actuated before the outer shaft pushes the anchor distally.

9. the inserter tool further comprises a handle including a retention mechanism configured to hold the outer shaft in a fixed position relative to the handle during the actuation of the retraction mechanism; The system of claim 1 , wherein the inner shaft is also moved proximally relative to the handle by actuation of the retraction mechanism.

10. the inserter tool further comprising a handle configured to be positioned outside a patient's body with the distal end of the inner shaft positioned within a hole in the bone; the outer shaft extends distally from the handle; the inner shaft extends distally from the handle; The system of claim 1 , wherein the retraction mechanism is configured to be positioned outside the body of the patient with the distal end of the inner shaft positioned within the hole in the bone.

11. the inserter tool has a sealed passageway configured to seat a suture therethrough and to releasably couple the inner shaft to the suture; 2. The system of claim 1, wherein the actuation of the retraction mechanism is configured to automatically spread a flexible member of the inserter tool in response to the inner shaft moving proximally relative to the outer shaft and the anchor, thereby opening the sealed passage.

12. the suture being installed through the sealed passage; 12. The system of claim 11, wherein the suture is installed through the sealed passage prior to actuation of the retraction mechanism and prior to the distal end of the inner shaft being positioned within the hole in the bone, and is installed through the sealed passage after the outer shaft pushes the anchor distally such that the anchor captures the suture between an outer surface of the anchor and a wall of the hole in the bone.

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