Threaded Knotless Suture Anchor

Abstract

A variety of exemplary devices, systems, and methods are provided for knotless suture anchoring systems. Generally, the suture anchor system is configured for knotless suture anchor insertion in soft tissue repair surgical procedures. An inserter tool is configured to insert the anchor and implant into a patient's bone to secure the soft tissue to the bone. A suture is releasably coupled to a distal eyelet of the inserter tool, captured by an implant advanced along the inner shaft of the shaft, and anchored in the bone hole by the suture anchor. The distal eyelet and implant are aligned with one another to position, capture, and secure the suture in the bone hole.

Description

[Technical Field]

[0001] The present disclosure relates generally to knotless suture anchors. [Background technology]

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

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

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

[0005] Generally, devices, systems, and methods for knotless suture anchor technology are provided.

[0006] In one aspect, a suture anchor system is provided, which in one embodiment includes a cannulated suture anchor having at least one driven mechanism and at least one bone-engaging mechanism disposed on an outer surface thereof. The cannulated inserter member has a lumen extending therethrough and is configured to be removably disposed within the lumen of the suture anchor. The inserter member has at least one drive mechanism disposed on the inserter member and configured to engage the driven mechanism of the suture anchor. The suture anchor system further includes a saddle implant distal to the suture anchor. The saddle implant includes at least one alignment mechanism disposed within its lumen. The saddle implant includes a distal end having a suture seating groove. The saddle implant is attached distally adjacent to the suture anchor and configured to be rotatable relative to the suture anchor. The suture anchor system further includes an inner shaft configured to be removably disposed within the lumen of the inserter member. The inner shaft has at least one alignment feature on its outer surface and a distal eyelet secured to a distal end of the inner shaft, the distal eyelet having an opening and configured to be rotationally fixed relative to the saddle implant and rotatable relative to the suture anchor.

[0007] The surgical system can be varied in a variety of ways, for example, the alignment feature of the saddle implant can include two flat sides and two rounded sides.

[0008] In another example, the suture seating groove of the saddle implant can be a saddle-shaped feature having a base and two distally extending protrusions, each distally extending protrusion having a flat, distally facing surface.

[0009] In yet another example, the saddle implant can be removably mounted onto the inner shaft.

[0010] In yet another example, the eyelet can be defined by two arms. The arms can have a tapered shape.

[0011] In another example, the eyelets may be formed from a flexible material.

[0012] In yet another example, the eyelet may be removable through the lumen of the saddle insert and suture anchor.

[0013] In yet another example, the outer contour of the eyelet can correspond to the geometry of the inner surface of the saddle insert and the outer surface of the inner shaft.

[0014] In another example, the eyelets can be configured to release the suture upon retraction of the inner shaft.

[0015] In yet another example, the suture anchor system can also include a handle having multiple parts, and the handle can have a cleat on one of the multiple parts, and the cleat can maintain a predetermined distance from the grommet during insertion.

[0016] In yet another example, the suture anchor system can also include a threading tab. The threading tab can include a clip configured to be attached to the inserter member.

[0017] In another example, the bone engaging features disposed on the outer surface of the cannulated suture anchor can include threads. The threads can include two different thread configurations.

[0018] In another aspect, one embodiment provides a method for attaching soft tissue to bone, the method comprising securing at least one surgical suture to the soft tissue to be reattached to the bone. The method further comprises passing a suture limb of the at least one surgical suture through an eyelet of a suture anchor system, the eyelet extending from an inner shaft disposed within a suture anchor structure having an inserter member with an internal lumen extending therethrough within which the inner shaft is disposed, a cannulated suture anchor mounted on the inserter member, and a saddle implant mounted on the inner shaft distally adjacent to the suture anchor. The method further comprises positioning the inner shaft within a bone hole adjacent to the soft tissue to be reattached to the bone. The method further comprises tensioning the surgical suture to securely engage the soft tissue with the bone. The method further comprises driving the suture anchor and the saddle implant into the bone hole to engage the bone while maintaining the alignment of the saddle implant and the eyelet relative to one another. The method further includes releasing the surgical suture from the eyelet.The method further includes removing the inner shaft.

[0019] The surgical method may be varied in any number of ways. For example, the method may further include securing the surgical suture to a cleat on the handle of the suture anchor system. The method may further include maintaining tension on the surgical suture throughout insertion. The method may further include maintaining a predetermined distance between the cleat and the eyelet throughout insertion.

[0020] In another example, the method may further include capturing a surgical suture with the saddle implant.

[0021] In yet another example, releasing the surgical suture from the eyelet may include passing the suture between two arms of the eyelet.

[0022] In yet another example, releasing the surgical suture from the eyelet may include bending the arms of the eyelet.

[0023] In another example, driving the suture anchor and the saddle implant can include rotating the suture anchor and translating the saddle implant distally. [Brief explanation of the drawings]

[0024] The present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1A] FIG. 1 is a perspective view of an embodiment of a knotless suture anchoring system including a knotless suture anchor and a delivery tool. [Figure 1B] FIG. 1B is a cross-sectional view of the knotless suture anchoring system of FIG. 1A. [Figure 2] 1B is a perspective view of a distal portion of the knotless suture anchoring system of FIG. 1A with the cannulated suture anchor removed from the hexagonal portion of the shaft of the delivery tool; FIG. [Figure 3A] FIG. 1B is a perspective view of a distal portion of the knotless suture anchoring system of FIG. 1A with a cannulated suture anchor and saddle implant mounted thereon; [Figure 3B] 1B is a perspective view and a series of cross-sectional views of a distal portion of the knotless suture anchoring system of FIG. 1A. FIG. [Figure 4A] 1B is a series of perspective views of the knotless suture anchoring system of FIG. 1A during the process of inserting the suture anchor and saddle implant. [Figure 4B] 1B is a series of perspective views of the knotless suture anchoring system of FIG. 1A during the process of inserting the suture anchor and saddle implant. [Figure 4C] 1B is a series of perspective views of the knotless suture anchoring system of FIG. 1A during the process of inserting the suture anchor and saddle implant. [Figure 5A] FIG. 10 is a perspective view of another embodiment of a knotless suture anchoring system. [Figure 5B] FIG. 5B is a cross-sectional view of the knotless suture anchoring system of FIG. 5A. [Figure 6]5B is a perspective view and a series of cross-sectional views of a distal portion of the knotless suture anchoring system of FIG. 5A. FIG. [Figure 7] FIG. 5B is a perspective view of a distal portion of the knotless suture anchoring system of FIG. 5A having a threading tab mounted thereon; [Figure 8A] FIG. 5B is a perspective view of the knotless suture anchoring system of FIG. 5A with the threading tab positioned thereon and a bone hole created adjacent the tissue to be repaired. [Figure 8B] FIG. 5B is a perspective view of the knotless suture anchoring system of FIG. 5A with suture material attached to tissue passing therethrough. [Figure 8C] FIG. 5B is a perspective view of the knotless suture anchoring system of FIG. 5A with the suture material pulled through the distal eyelet. [Figure 8D] FIG. 5B is a perspective view of the knotless suture anchoring system of FIG. 5A with its distal portion inserted into a bone hole. [Figure 8E] FIG. 5B is a perspective view of the knotless suture anchoring system of FIG. 5A with its distal portion inserted into a bone hole and a desired suture tension applied. [Figure 8F] FIG. 5B is a perspective view of the cannulated suture anchor and saddle implant system of FIG. 5A, with the suture anchor being driven into a bone hole. [Figure 8G] FIG. 5B is a perspective view of the cannulated suture anchor and saddle implant of the system of FIG. 5A within the bone hole after the central shaft of the inserter tool has been removed. [Figure 8H] FIG. 5B is a perspective view of the secured cannulated suture anchor and saddle implant of the system of FIG. 5A after the inserter tool has been removed. DETAILED DESCRIPTION OF THE INVENTION

[0025] 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 understand that the devices, systems, and methods detailed herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that 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.

[0026] Furthermore, in this disclosure, like-named components of embodiments generally have similar characteristics, and therefore, in particular embodiments, every feature of each like-named component will not necessarily be 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 equivalent dimensions to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend, at least, on the anatomical structure of the subject within which the systems and devices are to be used, the size and shape of the components with which the systems and devices are to be used, and the method and procedure for which the systems and devices are to be used.

[0027] A variety of exemplary devices, systems, and methods are provided for knotless suture anchoring systems. Generally, an inserter tool is configured for knotless anchor insertion in a soft tissue repair surgical procedure. The inserter tool is configured to insert the anchor and implant into a patient's bone to secure the soft tissue to the bone. The suture coupled to the soft tissue is secured to the bone by being trapped between the outer surface of the anchor and the bone surface defining the hole in the bone in which the anchor is positioned. The suture enters the hole along the outer surface of the anchor, passes between the protrusions of the saddle implant, and exits the hole along the outer surface of the anchor, allowing it to be secured in place without the need to tie the suture. Knotting can be time-consuming and / or difficult to perform during surgery due to the small suture diameter, the limited working area in the joint space, the wet surgical environment, and / or limited visualization at the surgical site due to the challenging angles and tight nature of the joint space.

[0028] The inserter tool is configured to releasably couple the suture, suture anchor, and saddle implant to the inserter tool for inserting the suture, suture anchor, and saddle implant into the bone hole. The inserter tool is configured to position the suture within the bone hole before the suture anchor and implant are secured thereto. In an exemplary embodiment, the inserter tool includes a distal eyelet configured to releasably hold the suture therein, and the saddle implant includes a pair of protrusions configured to seat the suture therein. The distal eyelet and saddle implant are configured to cooperate with one another to orient the suture relative to the saddle implant and the inserter tool before the saddle implant and anchor are secured within the bone hole. The anchor and implant may be advanced together into position relative to the bone where the anchor and implant will be secured after the implant captures the suture from the distal eyelet. The inserter tool is configured to move relative to the anchor and saddle implant such that the saddle implant is configured to capture the suture from the distal eyelet of the inserter tool, thereby allowing the suture to be tensioned and positioned within the bone hole before the saddle implant and anchor secure the suture within the bone hole.

[0029] The inserter tool is configured to advance the suture anchor into the bone hole by rotating the inserter tool so that the threads of the suture anchor engage the bone and advance the suture anchor distally into the bone hole. The saddle implant abuts the distal end of the anchor so that the saddle implant translates distally along the inner shaft as the anchor is advanced by rotation. After the suture anchor is inserted into the bone, the inserter tool is configured to be longitudinally translated proximally so that the inserter tool is removed from the patient's body while the anchor, implant, and sutures remain in the bone. Separating the inserter tool from the sutures, implant, and suture anchor by longitudinally translating the inserter tool along its longitudinal axis may take less time and / or require the user to apply less force than other methods of separating the tool from an implanted anchor, including rotating the tool about its longitudinal axis. Unlike longitudinal translation of the inserter tool for removal, rotation of the tool for removal can cause the anchor to rotate and / or result in unintended off-axis loading, which can prevent the anchor from being firmly positioned in the bone and / or cause damage to the suture and / or anchor.

[0030] 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.

[0031] 1A-4C illustrate one embodiment of a knotless suture anchor fixation system 100 (also referred to herein as a "fixation device" or "fixation system"). Generally, fixation system 100 is configured to insert a suture anchor 110 and a saddle implant 112 into a patient's bone to secure soft tissue to the bone. The fixation process is illustrated in FIGS. 8A-8H. An inner lumen extends through suture anchor 110 and saddle implant 112 so that suture anchor 110 and saddle implant 112 are cannulated. A plurality of bone-engaging surface features 312 (shown in detail in FIG. 3A) are configured to engage bone to retain suture anchor 110 within the bone, for example, to engage bone surfaces defining a bone hole within which suture anchor 110 is positioned. Saddle implant 112 is removably attached to an inner shaft 114 of knotless suture anchor fixation system 100. In the embodiments disclosed herein, the inner shaft 114 is shown as a solid shaft. In other embodiments, the inner shaft 114 may have a lumen disposed therein. A distal eyelet 116 is positioned at the distal end of the inner shaft 114 and is configured to retain suture material therein.

[0032] The fixation system 100 includes an inserter tool having a rotatable knob 102 and a handle assembly 104. The handle assembly 104 includes an outer handle 126, a cleat 106, a threaded inner handle piece 122, and a toothed component 124. The outer handle 126 is configured to be held by hand during use of the inserter tool of the fixation system 100. In a robotic surgical implementation, the outer handle 126 may be held by a mechanical member, such as a tool holder, of the robotic surgical system. The fixation system 100 further includes an inserter tool having an inserter member 108. An inserter shaft 118 passing through the inserter member 108 operably connects the inner shaft 114 with the toothed component 124 of the handle assembly 104. The handle assembly 104 includes the cleat 106 configured to releasably hold suture material thereon at a desired tension during a fixation procedure. The cleat 106 of the handle assembly 104 maintains a distance from the distal eyelet 116 as the rotatable knob 102 rotates. This distance maintenance allows the tension on the suture held by the distal eyelet 116 to be selected by the clinician by tethering the suture to the cleat 106. Maintaining suture tension is further discussed with respect to FIG. 4 below. The handle assembly 104 moves relative to the carrier 128 as the knob 102 is rotated and the inner shaft 114 is retracted toward the knob 102.

[0033] The handle assembly 104 includes a toothed component 124 and a threaded inner handle piece 122 that couples with the toothed component 124 and an outer handle 126. The inserter shaft 118 has a proximal portion that fits into a slot in the toothed component 124. Rotating the knob while holding the outer handle 126 advances the suture anchor 110, retracts the inserter shaft 118, and moves the outer handle 126 proximally. The teeth of the toothed component 124 interact with threads in the threaded inner handle piece 122, driving translation of the inserter shaft 118 at the same rate as insertion of the suture anchor 110. A proximal extension 132 of the toothed component 124 extends into the outer handle 126 within a slot 130 in the knob 102.

[0034] 1B, twisting the rotatable knob 102 moves the outer handle 126 and the threaded inner handle piece 122 relative to one another. Twisting the rotatable knob 102 also retracts the inner shaft 114, moving the outer handle 126 toward the rotatable knob 102. The outer handle 126, on which the cleat 106 is disposed, maintains a distance from the distal eyelet 116 as the rotatable knob 102 rotates. This distance maintenance allows the tension on the suture held by the distal eyelet 116 to be selected by the clinician by tethering the suture to the cleat 106. The cleat 106 and maintaining suture tension are further discussed with respect to FIG. 4 below.

[0035] 2 shows a perspective view of the distal end of the fixation system 100 with the suture anchor 110 and saddle implant 112 pushed distally toward the distal eyelet 116. The inserter member 108 has a portion 120 that has a smaller outer diameter than the remainder of the inserter member 108 and abuts the hexagonal portion 200 (also referred to herein as the "hexagonal portion") of the inserter member 108. The suture anchor 110 has an inner lumen with a hexagonal internal geometry (forming the driven mechanism) so that the suture anchor 110 can be seated on and driven by the hexagonal portion 200 (the drive mechanism), as shown in FIG. 3A. The portion 120 of the cannulated inserter member 108 has an outer diameter that is larger than the hexagonal inner diameter of the suture anchor 110 so that the suture anchor 110 cannot slide proximally over the portion 120 of the inserter member 108. Inner shaft 114 and distal eyelet 116 have outer diameters that are smaller than the inner diameters of suture anchor 110 and saddle implant 112, respectively, so that suture anchor 110 and saddle implant 112 slide distally over inner shaft 114 and distal eyelet 116 (including the arms of distal eyelets 202a and 202b). The diameters of each component are shown in more detail in FIG. 3B.

[0036] Referring to FIG. 3A , the inner shaft 114 has a flat surface 308 and a curved surface 310 and extends within the cannulated inserter member 108. The distal eyelet 116 is secured to the distal end of the inner shaft 114 and has an outer contour with two flat sides and two curved surfaces that mirror the outer contour of the inner shaft 114 so that the saddle implant 112 can slide over the distal eyelet 116 and capture the suture held therein during insertion. The distal eyelet 116 has multiple arms 202 a, 202 b extending distally and forming an opening 314 therebetween. While the embodiment of FIGS. 1A-4C shows the opening 314 of the distal eyelet 116 formed by two arms, alternative embodiments may use any suitable number of arms, such as three arms, four arms, etc., depending on the material and geometry selected for the arms. As mentioned above, cannular inserter member 108 has a hexagonal portion 200 configured to seat suture anchor 110. Suture anchor 110 has a lumen extending therethrough that is correspondingly hexagonal such that rotation of hexagonal portion 200 of cannular inserter member 108 drives rotation of suture anchor 110.

[0037] FIG. 3A is a perspective view of the distal portion of the knotless suture anchor fixation system of FIG. 1A with a cannulated suture anchor and saddle implant mounted thereon. While the bone-engaging surface features 312 can take a variety of suitable forms, in the exemplary embodiment, they comprise threads that wrap circumferentially around the suture anchor 110 along the longitudinal length of the suture anchor 110. The bone-engaging surface features 312 are further configured to engage the suture to bone to aid in securing the suture to the bone. The suture anchor 110 includes two portions of a thread. On the proximal side, multiple threads begin at different locations around the suture anchor 110. The four thread starters are positioned circumferentially around the suture anchor 110, offset 90 degrees from one another. Two of these threads terminate at a proximal portion of the suture anchor 110, while the remaining two threads run more distally and terminate at a distal portion of the suture anchor 110. As a result, the number of bone-engaging features 312 per unit length of the anchor 110 is greater in the proximal portion of the anchor, and such relatively higher resolution may be beneficial for engagement with bones that are generally stiffer. The number of bone-engaging features 312 per unit length of the anchor 110 is lower in the distal portion of the anchor, and such relatively lower resolution may be beneficial for engagement with bones that are generally less stiff.

[0038] The suture anchor 110 and saddle implant 112 can be absorbable or non-absorbable. The suture anchor 110 and saddle implant 112 can be made from a variety of materials, including absorbable or non-absorbable polymers such as polyetheretherketone (PEEK), polylactic acid or polylactide (PLA), BIOCRYL®, BIOCRYL® RAPIDE®, polyglycolic acid, polycaprolactone, or blends of such polymers, or other absorbable or non-absorbable materials such as titanium, magnesium, bioglass, ceramic, carbon fiber, stainless steel, etc. The suture anchor 110 and saddle implant 112 can be formed by a variety of techniques, including machining, molding, metal injection molding, overmolding, or post-molding processes such as post-molding machining. The suture anchor 110 and saddle implant 112 can be formed from the same or different materials and can be made using the same or different techniques.

[0039] The saddle implant 112 is positioned distal to the suture anchor 110 and can rotate relative to it. In use, the suture anchor 110 is driven by the hexagonal portion 200 and rotates as it is driven into bone. The saddle implant 112 is configured to maintain its rotational position relative to the inner shaft 114, such that neither the saddle implant 112 nor the inner shaft 114 rotate with the suture anchor 110 and hexagonal portion 200. The saddle implant 112 has a base 302 and protrusions 304 a, 304 b. The protrusions 304 a, 304 b extend along a curved side 310 of the inner shaft 114. The protrusions 304 a, 304 b and the base 302 form a suture seating groove 306 configured to capture suture material therein from the opening 314 in the distal eyelet 116. The protrusions 304a, 304b can have flat distal end faces and sloping sides extending between the base 302 and the distal end faces of the protrusions 304a, 304b. The shape of the protrusions 304a, 304b and base 302 form a saddle-shaped feature.

[0040] An opening 314 in the distal eyelet 116 is formed between the arms 202a, 202b. The arms 202a, 202b can have a tapered shape such that the height of each arm at its distal tip is less than the height of the inner shaft 114, where the height of the inner shaft is the distance from one flat surface of the inner shaft 114 to the opposite flat surface. The arms 202a, 202b can also have a curved outer shape that matches the curved side of the inner shaft 114 from which they protrude. At the distal end of the distal eyelet 116, the arms 202a, 202b can overlap one another such that the hook shape formed on each arm 202a, 202b extends beyond the midline of the cross-section of the fixation device 100 (see cross-section shown in FIG. 3B ) and stacks on top of one another to form the opening 314. This overlap serves to retain the suture material within the distal eyelet 116 after it is captured within the suture seating groove of the saddle implant during the insertion process and until it is released by the arms 202a, 202b. The insertion process is shown and described below with respect to Figures 8A-8H.

[0041] The distal eyelet 116 can be made from any of a variety of materials, such as a polymer such as polyetheretherketone (PEEK), or other materials such as titanium, nitinol, magnesium, ceramic, carbon fiber, stainless steel, etc. The distal eyelet can be made by a variety of techniques, such as machining, molding, metal injection molding, overmolding, or a post-molding process such as post-molding machining. The distal eyelet 116 can be formed of the same or different materials as the suture anchor 110 and saddle implant 112 and can be made using the same or different techniques.

[0042] 3B shows five cross sections, labeled A-E, of the knotless suture anchoring device 100 at various locations along the device. Cross section A shows the inserter member 108 and inner shaft 114. At this location along the inserter member 108, the proximal portion of the inner shaft 114 is shown, which has a wider diameter than the distal portion of the inner shaft 114 so that the inner shaft 114 can mate with the inserter shaft 118. Proximal to cross section A, the inner shaft 114 forms a cup shape into which the inserter shaft 118 fits.

[0043] Section B shows section 120 surrounding inner shaft 114. At this location, inner shaft 114 has a cross section with two flat sides and two curved sides. Alternating flat surfaces 308 and curved surfaces 310 form the outer contour of inner shaft 114.

[0044] Section C shows the hexagonal exterior shape and circular profile of the inner cannula of hexagonal portion 200. Inner shaft 114 passes through and can rotate relative to the inner cannula of hexagonal portion 200. Suture anchor 110 has a hexagonal interior geometry such that suture anchor 110 is configured to seat on and be driven by hexagonal portion 200.

[0045] Section D shows the saddle implant 112 seated on the inner shaft 114. The saddle implant has a flat-round-flat-round inner geometry to match the outer geometry of the inner shaft 114.

[0046] Cross-section E shows that the saddle implant 112 and distal eyelet 116 have the same flat-circular-flat-circular outer cross-sectional shape that is configured to allow the saddle implant 112 to slide over the distal eyelet 116 and capture a suture held therein. The suture seating groove 306 of the saddle implant 112 is configured to align with the opening 314 of the distal eyelet 116 so that as the saddle implant 112 passes over the distal eyelet 116, suture material passing through the opening 314 (i.e., from the top to the bottom of cross-section E) is captured between the protrusions 304 a, 304 b of the saddle implant 112.

[0047] 1A in a starting position. In this starting position, the suture material passing through distal eyelet 116 is secured to cleat 106 by the surgeon. The surgeon can secure the suture material at a tension appropriate for the procedure being performed. The tension at which the suture material is secured to the cleat is substantially maintained throughout insertion of suture anchor 110. Maintaining tension on the suture material is achieved because cleat 106 and distal eyelet 116 maintain a constant distance D from each other throughout the procedure.

[0048] After the suture material is secured to the cleat 106, the surgeon turns the knob 102 and begins to thread the suture anchor 110 into the bone hole. As the suture anchor 110 is advanced, the knob moves distally to the second position shown in FIG. 4B , shortening the overall length of the knotless suture anchor fixation system 100. As the knob 102 moves distally, the distance D between the cleat 106 and the distal eyelet 116 remains constant. Thus, tension on the suture material secured to the cleat 106 is maintained. The outer handle 126 slides relative to the knob 102 as the toothed component rotates with the knob 102. As the knob 102 is rotated, the inserter member 108 and hex portion 200 are rotated, causing the inner shaft 114 to translate proximally. The suture anchor 110, seated on the hexagonal portion 200, is rotated so that the bone-engaging surface features 312 engage the bone, securing the suture anchor 110 within the bone. The distal end of the suture anchor 110 contacts the base 302 of the saddle implant 112. The suture anchor 110 is rotated, moving it distally into the bone hole, and the inner shaft 114 is translated proximally, moving the saddle implant 112 distally into the bone hole.

[0049] As shown in FIG. 4C , as the knob 102 is further rotated, the outer handle 126 and inner shaft 114 continue to translate proximally. The inserter member 108 continues to rotate, driving the suture anchor 110 into the bone hole. As the inner shaft 114 is retracted, the saddle implant 112 moves toward the distal eyelet 116. The suture seating groove 306 of the saddle implant 112 maintains alignment with the opening 314 of the distal eyelet 116 as the saddle implant 112 passes over the distal eyelet 116, such that the suture material passing through the distal eyelet extends between the two prongs 304 a, 304 b of the saddle implant 112. Tension on the suture material is maintained as the distance D continues to be maintained throughout the insertion process. The knotless suture anchoring device 100 is in its shortest configuration when the outer handle 126 is in the third position of FIG. 4C, with the inner shaft 114 and distal eyelet 116 moved to their proximal-most positions and the knob 102 moved to its distal-most position.

[0050] 5A-6 illustrate another embodiment of a knotless suture anchor fixation system 500 (also referred to herein as a "fixation device" or "fixation system"). The fixation system 500 includes a knob 502 for advancing a suture anchor 510 and a saddle implant 512 into a bone hole. The saddle implant 512 is seated on an inner shaft 514 and includes protrusions along the curved side of the inner shaft 514. A distal eyelet 516 is attached to the distal end of the inner shaft 514. The knotless suture anchor fixation system 500 has a cannulated inserter member 508 that rotates when the knob 502 is rotated. Referring to FIG. 5B, the inner shaft 114 extends proximally from the distal eyelet 516 into a toothed component 518.

[0051] 6 shows four cross sections, labeled A-D, of the knotless suture anchoring system 500 at various locations along the device. Cross section A shows the inserter member 508 and inner shaft 514. The inserter member 508 has a circular outer profile and a circular inner profile. The inner shaft 514 has two curved sides and two flat sides that alternate to form a flat-curved-flat-curved outer profile. The flat-curved-flat-curved profile is an alignment feature of the inner shaft 514 that allows for slidable engagement of the saddle implant 512. The curved sides of the outer profile of the inner shaft 514 allow the inner shaft 514 to rotate relative to the inserter member 508.

[0052] Cross-section B is taken at a position where the suture anchor 510 seats on the hexagonal portion 600 of the inserter member 508. The suture anchor 510 has a threaded outer profile and a hexagonal inner profile. The hexagonal inner profile of the suture anchor 510 allows the suture anchor 510 to be driven by the hexagonal portion 600 of the inserter member 508 when the inserter member 508 is rotated by rotation of the knob 502. The inner shaft 514 is configured to rotate relative to the hexagonal portion 600 of the inserter member 508.

[0053] Cross-section C is taken at the location where the saddle implant 512 is seated on the inner shaft 514. The base of the saddle implant 512 has a circular outer contour and a flat-curved-flat-curved inner contour that is the alignment feature of the saddle implant 512 and corresponds to the outer contour of the inner shaft 514, allowing for slidable engagement between the saddle implant 512 and the inner shaft 514. The corresponding contours on the interior of the saddle implant 512 and the outer contour of the inner shaft 514 allow the suture anchor 510 to rotate and be driven into the bone hole while the saddle implant 512 and the inner shaft 514 do not rotate with the suture anchor 510. The corresponding contours on the interior of the saddle implant 512 and the outer contour of the inner shaft 514 allow for alignment of the suture seating grooves with the openings of the distal eyelets 516. The suture anchor 510 can be seen behind the saddle implant 512. The distal end surface of the suture anchor 510 abuts the proximal end surface of the saddle implant 512, such that force is transmitted between the suture anchor 510 and the saddle implant 512, allowing the saddle implant 512 to be advanced into the bone hole in front of the suture anchor 510 during use.

[0054] Cross-section D is taken across the distal eyelet 516. The distal eyelet 516 has two arms 602a, 602b that extend distally within the same cross-sectional flat-curved-flat-curved profile of the inner shaft 514. The distal eyelet 516 has a cross-sectional shape that is no larger than the cross-section of the inner shaft 514 so that the saddle implant 512 can slide over the distal eyelet 516 to receive suture material. In cross-section D, protrusions 604a, 604b on the saddle implant 512 that extend toward the distal eyelet can be seen.

[0055] FIG. 7 is a perspective view of the distal portion of the knotless suture anchoring system of FIG. 5A with a threading tab 700 mounted thereon. The threading tab 700 includes clips 706a, 706b that attach the threading tab 700 to the inserter member 508 of the knotless suture anchoring system 500. The threading tab 700 further includes a suture loop 702 configured to allow a suture material to be threaded therethrough. The suture loop 702 is configured to be flexible so that the suture loop 702 can reform its loop shape after being threaded through and through the distal eyelet 516. The suture loop 702 may be made from any suitable material, including, but not limited to, metal, plastic, etc. The relatively large size of the suture loop 702 allows for easy passage of the suture material through the suture loop 702. Threading tab 700 has a grip 704, including indentations and ridges, configured to be easily grasped by a surgeon performing a suture anchoring procedure to remove threading tab 700 from inserter member 508 or to hold and manipulate the position of threading tab 700 during the procedure. Use of threading tab 700 is illustrated in Figures 8A and 8B below.

[0056] FIG. 8A is a perspective view 800 of a setup for a procedure to anchor tissue 802 to bone 804 using knotless suture anchoring system 500 of FIG. 5A. While the procedure is generally applicable to use of knotless suture anchoring system 100, the procedure will be described with respect to system 500 for illustrative purposes. A bone hole 806 has been created in bone 804 adjacent to tissue 802 to be repaired. A suture 808 is threaded through tissue 802 to be repaired. Knotless suture anchoring system 500 is provided for a clinician to perform the repair procedure. The suture 808 is threaded through the suture loop 702 of threading tab 700, and threading tab 700 is removed from inserter member 508.

[0057] 8B is a perspective view of the knotless suture anchoring system 500 of FIG. 5A showing a suture 808 attached to tissue being threaded through a threading tab 700 attached to the knotless suture anchoring system 500. The suture 808 is also pulled through the distal eyelet 516 by removing the threading tab 700 from the inserter member 508 of the anchoring system 500 and pulling the suture loop 702 of the threading tab 700 through the distal eyelet. The threading tab 700 can be used to pull the free end 810 of the suture 808 through the distal eyelet 516, as indicated by arrow 812.

[0058] Figure 8C is a perspective view of the knotless suture anchoring system 500 of Figure 5A with the suture 808 pulled through the distal eyelet 516. After the clinician threads the suture 808 through the distal eyelet 516 using the threading tab 700 shown in Figures 8A-8B, the clinician pulls the free end 810 of the suture 808 through the distal eyelet. Figure 8D is a perspective view of the knotless suture anchoring system 500 of Figure 5A inserted into a bone hole 806. The clinician inserts the distal end of the fixation device 500 into the bone hole 806 so that the distal eyelet 516 is positioned therein. The suture 808 extends from the tissue 802 downward into the bone hole 806, through the distal eyelet 516, and back out of the bone hole 806, such that the free end 810 is accessible and the suture 808 can be manipulated by the clinician. Referring to FIG. 8E , the clinician applies tension, represented by arrow 816, to the suture 808, pulling the tissue 802, represented by arrow 818, toward the bone hole 806. The clinician selects the appropriate tension for the procedure to secure the tissue in a desired position proximate the bone hole 806. In a procedure using an embodiment of a knotless suture anchor fixation system, such as the fixation device 100 of FIG. 1A including cleats 106, the clinician secures the suture 808 to the cleats 106 and maintains the selected tension for the remainder of the procedure. In some cases, the clinician may align the opening of the distal eyelet 516 so that the suture material will advance through the opening at a desired angle relative to the tissue 802. For example, one of the flat surfaces of the inner shaft 514 may be positioned to face the tissue 802, so that the suture material will advance in a generally straight line from the tissue 802 into the opening.

[0059] After the desired tension is applied to the suture 808, the inserter member 508 of the knotless suture anchor fixation system 500 is rotated by turning the knob 502. The rotation is represented by arrow 820. The rotation causes the bone-engaging threads on the suture anchor 510 to grip the bone, advancing the suture anchor 510 into the bone hole 806. As the suture anchor 510 is advanced distally via rotation of the inserter member 508, the distal end face of the suture anchor 510 transfers force to the saddle implant 512, advancing the saddle implant 512 into the bone hole 806. The saddle implant 512 has a flat proximal end face that abuts the distal end face of the suture anchor 510. Unlike the suture anchor 510, the saddle implant 512 does not rotate as it moves distally into the bone hole 806. The saddle implant 512 is seated on the inner shaft 514 and is configured to slide relative thereto due to corresponding contours on the inner lumen of the saddle implant 512 and the exterior of the inner shaft 514 .

[0060] As shown in Figure 8F, as the saddle implant 512 is advanced over the distal eyelet 516, the suture 808 becomes positioned between the prongs 604a, 604b of the saddle implant 512 (shown in Figure 6). As the saddle implant 512 continues to advance over the distal eyelet 516, the suture 808 contacts the base of the saddle implant 512 (see base 302 of saddle implant 112 in Figure 3A). As the distal eyelet 516 moves proximally with the base of the saddle implant 512 contacting the suture 808 within the suture seating groove, the suture 808 moves distally within the opening of the distal eyelet 516.

[0061] 8F , as the arms 602 a, 602 b of the distal eyelet 516 move proximally with the retraction of the inner shaft 514, they reach a position where the ends of the arms 602 a, 602 b are flush with the base of the saddle implant 512. The arms 602 a, 602 b of the distal eyelet 516 begin to bend when the suture 808, which is contacting the base of the saddle implant 512, begins to exert a force on the arms 602 a, 602 b of the distal eyelet 516 as the distal eyelet 516 is retracted through the cannula of the saddle implant 512. The arms 602 a, 602 b reach a point where the force exerted by the suture 808 on the arms 602 a, 602 b is sufficient to bend them wide enough to allow the suture 808 to release the arms 602 a, 602 b through them. 8G, the suture 808 is held within a suture seating groove in a saddle implant 512 and anchored within the bone hole by a suture anchor 510. The suture anchor 510 maintains tension on the suture 808 to hold the tissue 802 in place.

[0062] 8H, after securing the suture anchor 510, saddle implant 512, and suture 808 within the bone hole 806, the remainder of the knotless suture anchoring device 500 is removed from the bone hole as represented by arrow 822. The free ends of the suture 808 can be trimmed by the clinician if desired.

[0063] In other embodiments, various combinations of handles and shafts disclosed herein may be used. For example, the handle 104 of the embodiment of the fixation device 100 shown in FIG. 1A may be combined with the inserter member 508 and inner shaft 514 to create an alternative configuration of the knotless suture anchoring device. In another example, the handle 504 of the embodiment of the fixation device 500 shown in FIG. 5A may be combined with the inserter member 108 and inner shaft 114 to create another alternative configuration of the knotless suture anchoring device.

[0064] Those skilled in the art will recognize 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.

[0065] 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 can be made within the spirit and scope of the claims without departing from the overall scope of the disclosure.

[0066] [Embodiment] (1) A suture anchor system, comprising: a cannulated suture anchor having at least one driven mechanism and at least one bone engaging mechanism disposed on an outer surface thereof; a cannulated inserter member having a lumen extending therethrough and configured to be removably disposed within the lumen of the suture anchor, the inserter member having at least one drive mechanism disposed thereon and configured to engage the driven mechanism of the suture anchor; a saddle implant distal to the suture anchor, the saddle implant including at least one alignment feature disposed within a lumen thereof and a distal end having a suture seating groove, the saddle implant mounted distally adjacent the suture anchor and configured to be rotatable relative to the suture anchor; an inner shaft configured to be removably positioned within the lumen of the inserter member, the inner shaft having at least one alignment feature on an outer surface thereof and a distal eyelet secured to the distal end of the inner shaft, the distal eyelet having an opening and configured to be rotationally fixed relative to the saddle implant and rotatable relative to the suture anchor. (2) A suture anchor system as described in embodiment 1, wherein the alignment mechanism of the saddle implant includes two flat sides and two rounded sides. (3) A suture anchor system as described in embodiment 1, wherein the suture seating groove is a saddle-shaped mechanism. (4) A suture anchor system as described in embodiment 3, wherein the saddle-shaped mechanism has a base and two distally extending protrusions, each distally extending protrusion having a flat distally facing surface. (5) A suture anchor system as described in embodiment 1, wherein the saddle implant is removably attachable onto the inner shaft.

[0067] (6) A suture anchor system as described in embodiment 1, wherein the eyelet is defined by two arms. (7) The suture anchor system of embodiment 6, wherein the arms have a tapered shape. (8) The suture anchor system of embodiment 1, wherein the eyelet is formed of a flexible material. (9) A suture anchor system according to embodiment 1, wherein the eyelet is removable through the inner lumen of the saddle insert and the suture anchor. (10) A suture anchor system according to embodiment 1, wherein the outer contour of the eyelet corresponds to the geometric shape of the inner surface of the saddle insert and the outer surface of the inner shaft.

[0068] (11) The suture anchor system of embodiment 1, wherein the eyelet is configured to release the suture upon retraction of the inner shaft. (12) The suture anchor system of embodiment 1, further comprising a handle having multiple components. (13) The suture anchor system of claim 12, further comprising a cleat on one of the plurality of components. (14) The suture anchor system of embodiment 13, wherein the cleat mechanism maintains a predetermined distance from the eyelet during insertion. (15) The suture anchor system of embodiment 1, further comprising a threading tab.

[0069] (16) The suture anchor system of embodiment 15, wherein the threading tab comprises a clip configured to be attached to the inserter member. (17) The suture anchor system of claim 1, wherein the bone-engaging feature disposed on the outer surface of the cannulated suture anchor includes a screw thread. (18) The suture anchor system of embodiment 17, wherein the threads include two different thread configurations. (19) A method of attaching soft tissue to bone, said method comprising: anchoring at least one surgical suture to the soft tissue to be reattached to the bone; passing a suture limb of the at least one surgical suture through an eyelet of a suture anchor system, the eyelet extending from an inner shaft disposed within a suture anchor structure having an inserter member with a lumen extending therethrough within which the inner shaft is disposed, a cannulated suture anchor mounted on the inserter member, and a saddle implant mounted on the inner shaft distally adjacent to the suture anchor; placing the inner shaft within the bone hole adjacent the soft tissue to be reattached to bone; applying tension to the surgical suture to securely engage the soft tissue with bone; driving the suture anchor and the saddle implant into the bone hole to engage the bone while maintaining alignment of the saddle implant and the eyelet relative to one another; Releasing the surgical suture from the eyelet; and removing the inner shaft. (20) The method of claim 19, further comprising anchoring a surgical suture to a cleat on a handle of the suture anchor system.

[0070] 21. The method of claim 20, further comprising maintaining tension on the surgical suture throughout insertion. (22) The method of claim 20, further comprising maintaining a predetermined distance between the cleat and the eyelet during insertion. (23) The method of embodiment 19, further comprising capturing the surgical suture with the saddle implant. (24) The method of embodiment 19, wherein releasing the surgical suture from the eyelet comprises passing the suture between two arms of the eyelet. (25) The method of claim 19, wherein releasing the surgical suture from the eyelet comprises bending the arms of the eyelet.

[0071] (26) The method of embodiment 19, wherein driving the suture anchor and the saddle implant comprises rotating the suture anchor and translating the saddle implant distally.

Claims

1. 1. A suture anchor system comprising: a cannulated suture anchor having at least one driven mechanism and at least one bone engaging mechanism disposed on an outer surface thereof; a cannulated inserter member having a lumen extending therethrough and configured to be removably disposed within the lumen of the suture anchor, the inserter member having at least one drive mechanism disposed thereon and configured to engage the driven mechanism of the suture anchor; a saddle implant distal to the suture anchor, the saddle implant including at least one alignment feature disposed within a lumen thereof and a distal end having a suture seating groove, the saddle implant mounted distally adjacent the suture anchor and configured to be rotatable relative to the suture anchor; an inner shaft configured to be removably positioned within the lumen of the inserter member, the inner shaft having at least one alignment feature on an outer surface thereof and a distal eyelet secured to the distal end of the inner shaft, the distal eyelet having an opening and configured to be rotationally fixed relative to the saddle implant and rotatable relative to the suture anchor.

2. The suture anchor system of claim 1 , wherein the alignment feature of the saddle implant includes two flat sides and two rounded sides.

3. The suture anchor system of claim 1 , wherein the suture seating groove is a saddle-shaped feature.

4. 4. The suture anchor system of claim 3, wherein the saddle-shaped feature has a base and two distally extending prongs, each distally extending prong having a flat distally facing surface.

5. The suture anchor system of claim 1 , wherein the saddle implant is removably mountable onto the inner shaft.

6. The suture anchor system of claim 1 , wherein the eyelet is defined by two arms.

7. The suture anchor system of claim 6 , wherein the arms have a tapered shape.

8. The suture anchor system of claim 1 , wherein the eyelet is formed of a flexible material.

9. The suture anchor system of claim 1 , wherein the eyelet is removable through the lumen of the saddle insert and the suture anchor.

10. The suture anchor system of claim 1 , wherein an outer contour of the eyelet corresponds to the geometry of an inner surface of the saddle insert and an outer surface of the inner shaft.

11. The suture anchor system of claim 1 , wherein the eyelet is configured to release the suture upon retraction of the inner shaft.

12. The suture anchor system of claim 1 further comprising a handle having multiple parts.

13. The suture anchor system of claim 12 further comprising a cleat on one of the plurality of components.

14. The suture anchor system of claim 13 , wherein the cleat mechanism maintains a predetermined distance from the eyelet during insertion.

15. The suture anchor system of claim 1 further comprising a threading tab.

16. The suture anchor system of claim 15, wherein the threading tab comprises a clip configured to be attached to the inserter member.

17. The suture anchor system of claim 1 , wherein the bone-engaging features disposed on the outer surface of the cannulated suture anchor include threads.

18. The suture anchor system of claim 17, wherein the threads include two different thread configurations.

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