Screw-in knotless suture anchor

Abstract

Various exemplary devices, systems, and methods are provided for knotless suture anchor securement. In general, a suture anchor system is configured for knotless suture anchor insertion in a soft tissue repair surgical procedure. The insert tool is configured to insert the anchor and implant into a bone of a patient to secure soft tissue relative to the bone. A suture is releasably coupled to a distal aperture of the insert tool and captured by an implant advanced along an inner axis of the shaft and secured into the bone hole by a suture anchor. The distal aperture and implant are aligned with each other to position, capture, and secure the suture in the bone hole.

Description

Technical Field

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

[0002] A variety of injuries and conditions require the repair of soft tissue damage, or the reattachment of soft tissue to bone and / or surrounding tissue. For example, once healthy tissue is torn from the bone, such as the tearing of labrum from the glenoid (shoulder instability), it is often necessary to reattach the tissue to the bone by surgery to allow healing in the correct position. A plurality of devices and methods for performing these surgical repairs have been developed. Some of the more successful methods include the use of suture fixing members (such as suture anchors), which generally include an anchor body with a suture attachment feature and a tissue or bone engagement feature for keeping the suture anchor in or near the tissue or bone. Depending on the specific injury, repair can be performed using one or more suture anchors connected to one or more sections of the suture or interconnected by one or more sections of the suture.

[0003] When tearing occurs in the substance of a single type of tissue, surgery may also be required.Sutures may also be used in combination with one or more suture anchors to repair such tissue tearing.Sutures may be fastened to suture anchors and to tissue using knots tied by surgeons during the repair procedure or using "knotless" devices and methods, in which one or more anchors and one or more sutures may be connected and tensioned without the surgeon needing to tie knots during surgery.Knotless anchoring is particularly useful for minimally invasive surgery (such as endoscopic repair or arthroscopic repair), in which surgeons use tools inserted through small diameter cannulas, endoscopic tubes, or otherwise percutaneously inserted to remotely manipulate the sutures at the surgical site, which may make the knotting process difficult and cumbersome. In addition, the knot itself may stimulate surrounding tissues. However, although knotless anchors can be very effective in reattaching soft tissue to bone, due to the smaller size of the anchors and the patient's anatomical structure, this may make it difficult to locate the anchors and insert them into the bone holes. Additionally, visualization of the foramen can be difficult due to the challenging angles and narrow nature of the joint space.

[0004]

[0006] Therefore, there remains a need for improved devices, systems, and methods for knotless anchors. Summary of the invention

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

[0006] In one aspect, a suture anchor system is provided, in one embodiment, the suture anchor system includes: a hollow suture anchor having at least one driven feature and at least one bone engagement feature, the at least one bone engagement feature being disposed on the outer surface of the hollow suture anchor. The hollow insert member has an inner cavity extending therethrough and is configured to be removably disposed in the inner cavity of the suture anchor. The insert member has at least one drive feature disposed thereon, the at least one drive feature being configured to engage with the driven feature of the suture anchor. The suture anchor system also includes a saddle-shaped implant located distally of the suture anchor. The saddle-shaped implant includes at least one alignment feature disposed in its inner cavity. The saddle-shaped implant includes a distal end having a suture placement groove. The saddle-shaped implant is configured to be mounted distally adjacent to the suture anchor and to be rotatable relative to the suture anchor. The suture anchor system also includes an inner shaft configured to be removably disposed in the inner cavity of the insert member. The inner shaft has at least one alignment feature on its outer surface and a distal eyelet fixed at its distal end. The distal eyelet has an opening and is configured to be rotationally fixed relative to the saddle implant and rotatable relative to the suture anchor.

[0007] The surgical system may be varied in any number of ways. For example, the alignment feature of a saddle-shaped implant may include two flat sides and two rounded sides.

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

[0009] For yet another example, a saddle shaped implant can be removably mounted on the inner shaft.

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

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

[0012] For yet another example, the eyelet can be removed through the lumen of the saddle insert and suture anchor.

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

[0014] For another example, the eyelet can be configured to release the suture when the inner shaft is retracted.

[0015] For yet another example, the suture anchor system can also include a handle having a plurality of pieces. The handle can have a clamp on one of the plurality of pieces. During insertion, the clamp can maintain a predetermined distance from the eyelet.

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

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

[0018] On the other hand, a method for attaching soft tissue to bone is provided, in one embodiment, the method comprising fixing at least one surgical suture to the soft tissue to be reattached to the bone. The method also includes passing the suture branch of the at least one surgical suture through the eyelet of the suture anchor system, the eyelet extending from the inner shaft disposed in the suture anchor structure, the suture anchor structure having: an insert member having an inner cavity extending therethrough, the inner shaft disposed in the inner cavity; a hollow suture anchor mounted on the insert member; and a saddle implant mounted on the inner shaft adjacent to the suture anchor distally. The method also includes placing the inner shaft in the bone hole adjacent to the soft tissue to be reattached to the bone. The method also includes tensioning the surgical suture to securely engage the soft tissue with the bone. The method also includes driving the suture anchor and the saddle implant into the bone hole to engage with the bone while maintaining the saddle implant and the eyelet aligned relative to each other. The method also includes releasing the surgical suture from the eyelet. The method also includes removing the inner shaft.

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

[0020] For another example, the method may further include capturing the surgical suture using the saddle implant.

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

[0022] For yet another example, releasing the surgical suture from the eyelet may include bending an arm of the eyelet.

[0023] For another example, actuating the suture anchor and the saddle implant can include rotating the suture anchor and translating the saddle implant distally. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The present disclosure will be more fully understood through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0025] Figure 1A is a perspective view of an embodiment of a knotless suture anchor fixation system including a knotless suture anchor and a delivery tool;

[0026] Figure 1B yes Figure 1A A cross-sectional view of a knotless suture anchor fixation system;

[0027] Figure 2 yes Figure 1A A perspective view of a distal portion of a knotless suture anchor fixation system of FIG. 1 , wherein a hollow suture anchor exits from a hexagonal portion of a shaft of a delivery tool;

[0028] Figure 3A yes Figure 1A A perspective view of a distal portion of a knotless suture anchor fixation system with a hollow suture anchor and a saddle implant mounted thereon;

[0029] Figure 3B yes Figure 1A A perspective view and a series of cross sections of a distal portion of a knotless suture anchor fixation system;

[0030] FIG. 4A to FIG. 4C yes Figure 1A A series of perspective views of a knotless suture anchor fixation system during the procedure of inserting a suture anchor and a saddle implant;

[0031] Figure 5A is a perspective view of another embodiment of a knotless suture anchor fixation system;

[0032] Figure 5B yes Figure 5A A cross-sectional view of a knotless suture anchor fixation system;

[0033] Figure 6 yes Figure 5A A perspective view and a series of cross sections of a distal portion of a knotless suture anchor fixation system;

[0034] Figure 7 The one on which the threader tab is installed Figure 5A A perspective view of a distal portion of a knotless suture anchor fixation system;

[0035] Fig. 8A yes Figure 5AA perspective view of a knotless suture anchor fixation system of claim 1, wherein a threader tab is mounted on the knotless suture anchor fixation system and a bone hole is formed adjacent to the tissue to be repaired;

[0036] Figure 8B yes Figure 5A A perspective view of a knotless suture anchor fixation system in which a suture material is passed through tissue and attached to the tissue;

[0037] Figure 8C yes Figure 5A A perspective view of a knotless suture anchor fixation system with suture material being pulled through a distal eyelet;

[0038] Fig.8D yes Figure 5A A perspective view of a knotless suture anchor fixation system with a distal portion thereof inserted into a bone hole;

[0039] Fig. 8E yes Figure 5A a perspective view of a knotless suture anchor fixation system of , wherein a distal portion of the knotless suture anchor fixation system is inserted into a bone hole and a desired suture tension is applied;

[0040] Figure 8F yes Figure 5A A perspective view of a hollow suture anchor and a saddle implant of the system, wherein the suture anchor is driven into a bone hole;

[0041] Figure 8G yes Figure 5A A perspective view of a hollow suture anchor and a saddle implant of the system in a bone hole after removal of a central shaft of an inserter tool;

[0042] Figure 8H After removing the insert tool Figure 5A Perspective view of the system's fixed hollow suture anchor and saddle implant. DETAILED DESCRIPTION

[0043] Certain exemplary embodiments will now be described to provide a comprehensive 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. It will be understood by those skilled in the art that the devices, systems and methods specifically described herein and illustrated in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features illustrated or described in conjunction with an exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0044] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, each feature of each component with similar names is not necessarily fully set forth. In addition, to the extent that linear or circular dimensions are used in the description of 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 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 anatomy of the subject in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used.

[0045] Various exemplary devices, systems and methods for knotless suture anchor fixation are provided. Generally speaking, an inserter tool is configured for knotless anchor insertion in soft tissue repair surgical procedures. The inserter tool is configured to insert the anchor and implant into the patient's bone to fix the soft tissue relative to the bone. The suture connected to the soft tissue is fixed relative to the bone by being stuck between the outer surface of the anchor and the bone surface that defines the hole in the bone where the anchor is located. The suture is inserted into the bone hole along the outer surface of the anchor, passes between the protrusions of the saddle-shaped implant, and leaves the bone hole along the outer surface of the anchor, thereby allowing the suture to be fixed in place without the need for knotting. Due to the small diameter of the suture, the limited working area of ​​the joint space, the humid surgical environment, and / or the limited visualization at the surgical site due to the challenging angles and the narrow nature of the joint space, knotting may be time-consuming and / or difficult to perform during surgery.

[0046] The insert tool is configured to releasably couple each of a suture, a suture anchor, and a saddle-shaped implant thereto, and is releasably coupled to the insert tool by the suture, the suture anchor, and the saddle-shaped implant to insert the suture, the suture anchor, and the saddle-shaped implant into the bone hole. The insert tool is configured to position the suture in the bone hole before the suture anchor and the implant are fixed in the bone hole. In an exemplary embodiment, the insert tool includes a distal eyelet, which is configured to releasably retain the suture therein, and the saddle-shaped implant includes a pair of protrusions, which are configured to place the suture therein. The distal eyelet and the saddle-shaped implant are configured to cooperate with each other to orient the suture relative to the saddle-shaped implant and the insert tool before the saddle-shaped implant and the anchor are fixed in the bone hole. The anchor and implant can be advanced together into a position relative to the bone where they will be fixed after the implant captures the suture from the distal eyelet. The inserter tool is configured to move relative to the anchor and saddle implant so that the saddle implant is configured to capture the suture from the distal eyelet of the inserter tool. Thus, the suture can be tensioned and positioned in the bone hole before the saddle implant and anchor secure the suture in the bone hole.

[0047] The inserter tool is configured to advance the suture anchor into the bone hole by rotating the inserter tool so that the thread of the suture anchor is stuck in the bone and the suture anchor is advanced into the bone hole in the distal direction. The saddle implant abuts the distal end of the anchor so that when the anchor is advanced via rotation, the saddle implant translates distally along the inner axis. After the suture anchor has been inserted into the bone, the inserter tool is configured to translate longitudinally in the proximal direction to be removed from the patient, while the anchor, implant and suture remain in the bone. Disengaging the inserter tool from suture, implant and suture anchor by longitudinally translating the inserter tool along the longitudinal axis of the inserter tool is less time-consuming and / or may require less force applied by the user than other methods (including rotating the tool around its longitudinal axis) of disengaging the tool from the implanted anchor. Unlike translating the inserter tool longitudinally for removal, rotating the tool for removal may risk rotating the anchor and / or inadvertent off-axis loading, which may cause the anchor to become less securely positioned in the bone and / or may cause damage to the suture and / or anchor.

[0048] The systems, devices, and methods described herein are suitable for use in a variety of soft tissue repair surgical procedures, such as for use in tissue repair surgical procedures at a joint, such as a shoulder, knee, or hip.

[0049] Figures 1A to 4COne embodiment of a knotless suture anchor fixation system 100 (also referred to herein as a "fixation device" or "fixation system") is illustrated. Generally speaking, the fixation system 100 is configured to insert a suture anchor 110 and a saddle implant 112 into a patient's bone to fix soft tissue relative to the bone. The fixation process is as follows FIG. 8A to FIG. 8H The lumen extends through the suture anchor 110 and the saddle implant 112 so that the suture anchor 110 and the saddle implant 112 are cannulated. The plurality of bone engaging surface features 312 (at Figure 3A The saddle implant 112 is configured to engage the bone to retain the suture anchor 110 in the bone, for example, engaging the surface of the bone that defines the hole in the bone in which the suture anchor 110 is located. The saddle implant 112 is removably mounted on the inner shaft 114 of the knotless suture anchor fixation system 100. In the embodiments disclosed herein, the inner shaft 114 is depicted as a solid shaft. In other embodiments, the inner shaft 114 can have an inner cavity disposed therein. The distal eyelet 116 is positioned at the distal end of the inner shaft 114 and is configured to retain the suture material therein.

[0050] The fixing 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 clamp 106, a threaded inner handle member 122, and a toothed member 124. The outer handle 126 is configured to be held by hand during use of the inserter tool of the fixing system 100. In a specific implementation of robotic surgery, the outer handle 126 can be held by a mechanical member (such as a tool holder) of the robotic surgical system. The fixing system 100 also includes an inserter tool having an inserter member 108. The inserter shaft 118 that advances through the inserter member 108 functionally connects the inner shaft 114 to the toothed member 124 of the handle assembly 104. The handle assembly 104 includes a clamp 106 that is configured to releasably hold the suture material thereon with a desired tension during the fixing process. As the rotatable knob 102 is turned, the clamp 106 of the handle assembly 104 maintains a distance from the distal eyelet 116. This distance maintenance allows the clinician to select the tension on the suture held by the distal eyelet 116 by tying the suture to the clamp 106. Maintenance of suture tension is discussed further below with respect to FIG. 4. As the knob 102 is turned and the inner shaft 114 is retracted toward the knob 102, the handle assembly 104 moves relative to the carrier 128.

[0051] The handle assembly 104 includes a toothed member 124 and a threaded inner handle member 122 that interfaces with the toothed member 124 and the outer handle 126. The inserter shaft 118 has a proximal portion that fits into the slot of the toothed member 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 member 124 interact with the threads in the threaded inner handle member 122 and advance the inserter shaft 118 in translation at the same rate as the insertion of the suture anchor 110. The proximal extension 132 of the toothed member 124 extends within the slot 130 in the knob 102 and extends into the outer handle 126.

[0052] Reference Figure 1B , twisting the rotatable knob 102 causes the outer handle 126 and the threaded inner handle member 122 to move relative to each other. Twisting the rotatable knob 102 also causes the inner shaft 114 to retract and the outer handle 126 to move toward the rotatable knob 102. When the rotatable knob 102 is turned, the outer handle 126, on which the clamp 106 is disposed, is maintained at a distance from the distal eyelet 116. This distance maintenance allows the clinician to select the tension on the suture held by the distal eyelet 116 by tying the suture to the clamp 106. The clamp 106 and the maintenance of the suture tension are further discussed below with respect to FIG. 4.

[0053] Figure 2 A perspective view of the distal end of the fixation system 100 is shown, with the suture anchor 110 and the saddle implant 112 being pushed distally toward the distal eyelet 116. The insert member 108 has a portion 120 having a smaller outer diameter than the remainder of the insert member 108 and abutting a hexagonal portion 200 (also referred to herein as the "hexagonal portion") of the insert member 108. The suture anchor 110 has an inner lumen with a hexagonal internal geometry (forming a driven feature) such that the suture anchor 110 can be seated on and driven by the hexagonal portion 200 (driving feature), as shown in FIG. Figure 3A . Portion 120 of the hollow insert member 108 has an outer diameter that is larger than the inner hexagonal diameter of the suture anchor 110, so that the suture anchor 110 cannot slide proximally over portion 120 of the insert member 108. The inner shaft 114 and the distal eyelet 116 each have an outer diameter that is smaller than the inner diameter of the suture anchor 110 and the saddle implant 112, so that the suture anchor 110 and the saddle implant 112 slide distally over the inner shaft 114 and the distal eyelet 116 (including the arms of the distal eyelets 202a and 202b). The diameter of each component is Figure 3B is shown in more detail in .

[0054] Reference Figure 3A, the inner shaft 114 has a flat surface 308 and a curved surface 310 and extends into the hollow insert member 108. The distal eyelet 116 is fixed to the distal end of the inner shaft 114 and has an outer profile having two flat sides and two curved surfaces that are mirror images of the outer profile 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 a plurality of arms 202a, 202b extending distally and forming an orifice 314 therebetween. Figures 1A to 4C In the embodiment of the present invention, the orifice 314 of the distal eyelet 116 is formed by two arms, but any suitable number of arms may be used in alternative embodiments, such as three arms, four arms, etc., depending on the material and geometry selected for the arms. As described above, the hollow insert member 108 has a hexagonal portion 200 on which the suture anchor 110 is configured to rest. The suture anchor 110 has an inner cavity extending therethrough that is correspondingly hexagonal in shape, such that rotation of the hexagonal portion 200 of the hollow insert member 108 drives rotation of the suture anchor 110.

[0055] Figure 3A yes Figure 1A 10 is a perspective view of the distal portion of a knotless suture anchor fixation system of 10, wherein a hollow suture anchor and a saddle implant are mounted on the distal portion. The bone engaging surface features 312 can be various suitable forms, but in an exemplary embodiment, they include threads that are wound around the suture anchor 110 circumferentially along the longitudinal length of the suture anchor 110. The bone engaging surface features 312 are also configured to engage the suture against the bone to help fix the suture relative to the bone. The suture anchor 110 includes two parts of threads. On the proximal side, a plurality of threads start at different positions around the circumference of the suture anchor 110. Four thread starts are positioned 90 degrees offset from each other circumferentially around the suture anchor 110. Two of these threads terminate in the proximal portion of the suture anchor 110, while the remaining two threads continue to extend distally and terminate in the 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 higher in the proximal portion of the anchor, where such relatively higher resolution may be beneficial for engagement with bones of generally higher stiffness. The number of bone engaging features 312 per unit length of the anchor 110 is lower in the distal portion of the anchor, where such relatively lower resolution may be beneficial for engagement with bones of generally lower stiffness.

[0056] The suture anchor 110 and the saddle implant 112 may be absorbable or non-absorbable. The suture anchor 110 and the saddle implant 112 may be made of any of a variety of materials, such as absorbable or non-absorbable polymers such as polyetheretherketone (PEEK), polylactic acid or polylactide (PLA), Polyglycolic acid, polycaprolactone, or blends of such polymers; or other materials, absorbable or non-absorbable, such as titanium, magnesium, bioglass, ceramic, carbon fiber, stainless steel, etc. The suture anchor 110 and the saddle implant 112 can be formed by a variety of techniques, such as by machining, molding, metal injection molding, overmolding, or by a post-molding process, such as post-molding machining. The suture anchor 110 and the saddle implant 112 can be formed of the same or different materials and can be made using the same or different techniques.

[0057] The saddle implant 112 is positioned distally of the suture anchor 110 and can rotate relative to the suture anchor 110. In use, the suture anchor 110 is driven by the hexagonal portion 200 and rotates when it is driven into the bone. The saddle implant 112 is configured to maintain its rotational position relative to the inner shaft 114, and neither the saddle implant 112 nor the inner shaft 114 rotates with the suture anchor 110 and the hexagonal portion 200. The saddle implant 112 has a base 302 and protrusions 304a, 304b. The protrusions 304a, 304b extend along the curved side 310 of the inner shaft 114. The protrusions 304a, 304b and the base 302 form a suture placement groove 306, which is configured to capture suture material from the orifice 314 of the distal eyelet 116. The protrusions 304a, 304b may have a flat distal side and an angled side extending between the base 302 and the distal side of the protrusions 304a, 304b. The shape of the protrusions 304a, 304b and the base 302 forms a saddle feature.

[0058] The aperture 314 of the distal eyelet 116 is formed between the arms 202a, 202b. The arms 202a, 202b may have a tapered shape such that the height of each arm at the distal tip of the arm is less than the height of the inner shaft 114, the height of the inner shaft being the distance from one flat side to the opposite flat side of the inner shaft 114. The arms 202a, 202b may also have a curved outer shape that conforms to the curved side of the inner shaft 114 from which the arms protrude. At the distal end of the distal eyelet 116, the arms 202a, 202b may overlap each other so that the hook-shaped extension formed in each arm 202a, 202b passes through the midline of the cross-section of the fixation device 100 (see Figure 3B) and stacked on top of each other to form an orifice 314. This overlap helps to retain the suture material within the distal eyelet 116 until it is released by the arms 202a, 202b after being captured in the suture placement groove of the saddle implant during the insertion process. FIG. 8A to FIG. 8H The insertion process is shown and discussed.

[0059] The distal eyelet 116 can be made of any of a variety of materials, such as, for example, 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 formed by a variety of techniques, such as by machining, molding, metal injection molding, overmolding, or by 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 the saddle implant 112, and can be made using the same or different techniques as the suture anchor and the saddle implant.

[0060] Figure 3B Five cross-sections, labeled A through E, of the knotless suture anchor fixation device 100 are shown at different locations along the device. Cross-section A shows the insert member 108 and the inner shaft 114. At this location along the insert member 108, the proximal portion of the inner shaft 114 is shown as having a wider diameter than the distal portion of the inner shaft 114 so that the inner shaft 114 can interface with the insert shaft 118. Proximal to cross-section A, the inner shaft 114 forms a cup into which the insert shaft 118 fits.

[0061] Cross section B shows the portion 120 around the inner shaft 114. At this location, the inner shaft 114 has a cross section with two flat sides and two curved sides. The alternating flat surfaces 308 and curved surfaces 310 form the outer contour of the inner shaft 114.

[0062] Cross section C shows the hexagonal outer shape and circular profile of the inner tube of the hexagonal portion 200. The inner shaft 114 passes through the inner tube of the hexagonal portion 200 and can rotate relative to the inner tube of the hexagonal portion 200. The suture anchor 110 has a hexagonal inner geometry such that the suture anchor 110 is configured to be seated on the hexagonal portion 200 and driven thereby.

[0063] Cross section D shows the saddle shaped implant 112 seated on the inner shaft 114. The saddle shaped implant has a flat-round-flat-round inner geometry to match the outer geometry of the inner shaft 114.

[0064] Cross section E shows that the saddle implant 112 and the distal eyelet 116 have the same flat-round-flat-round outer cross-sectional shape, so that the saddle implant 112 is configured to slide over the distal eyelet 116 and capture the suture held therein. The suture placement groove 306 of the saddle implant 112 is configured to align with the orifice 314 of the distal eyelet 116, so that when the saddle implant 112 passes over the distal eyelet 116, the suture material passing through the orifice 314 (i.e., from the top to the bottom of the cross section E) is captured between the protrusions 304a, 304b of the saddle implant 112.

[0065] Figure 4A is at the starting position Figure 1A 1. A front view of a knotless suture anchor fixation system of FIG. 1. In this starting position, the surgeon secures the suture material through the distal eyelet 116 to the clamp 106. The surgeon can secure the suture material with a tension appropriate for the procedure being performed. The tension with which the suture material is secured to the clamp is substantially maintained throughout the insertion process of the suture anchor 110. Maintenance of the tension of the suture material is achieved because the clamp 106 and the distal eyelet 116 remain at a constant distance D from each other throughout the process.

[0066] After the suture material has been secured to the clamp 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 Figure 4B , and shortens the overall length of the knotless suture anchor fixation system 100. When the knob 102 moves distally, the distance D between the clamp 106 and the distal eyelet 116 remains constant. In this way, the tension on the suture material fixed to the clamp 106 is maintained. When the toothed component is rotated with the knob 102, the outer handle 126 slides relative to the knob 102. When the knob 102 rotates, the insert member 108 and the hexagonal portion 200 rotate and the inner shaft 114 translates proximally. The suture anchor 110 disposed on the hexagonal portion 200 is rotated and the bone engaging surface feature 312 engages the bone to fix the suture anchor 110 in the bone. The distal end of the suture anchor 110 contacts the base 302 of the saddle implant 112. As the suture anchor 110 is rotated, moving it distally into the bone hole, and the inner shaft 114 is translated proximally, the saddle implant 112 is moved distally into the bone hole.

[0067] like Figure 4CAs shown in , when the knob 102 is further turned, the outer handle 126 and the inner shaft 114 continue to translate proximally. The insert member 108 continues to rotate and drives the suture anchor 110 into the bone hole. When the inner shaft 114 retracts, the saddle implant 112 moves toward the distal eyelet 116. The suture placement groove 306 of the saddle implant 112 remains aligned with the orifice 314 of the distal eyelet 116, so that when the saddle implant 112 passes over the distal eyelet 116, the suture material passing through the distal eyelet extends between the two protrusions 304a, 304b of the saddle implant 112. When the distance D is continuously maintained throughout the insertion process, the tension on the suture material is maintained. When the outer handle 126 is in Figure 4C When in the third position in FIG. 1 , the knotless suture anchor fixation device 100 is in its shortest configuration, wherein the inner shaft 114 and the distal eyelet 116 are moved to their most proximal positions and the knob 102 is moved to its most distal position.

[0068] FIG. 5A to FIG. 6 Another embodiment of a knotless suture anchor fixation system 500 (also referred to herein as a "fixation device" or "fixation system") is shown. 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 a protrusion 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 hollow insert member 508 that rotates when the knob 502 is rotated. Referring to Figure 5B , the inner shaft 114 extends proximally from the distal eyelet 516 into the toothed component 518.

[0069] Figure 6 Four cross-sections, labeled A to D, of the knotless suture anchor fixing system 500 at different locations along the device are shown. Cross-section A shows the insert member 508 and the inner shaft 514. The insert 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 the saddle-shaped implant 512 to slidably engage. The curved sides of the outer profile of the inner shaft 514 allow the inner shaft 514 to rotate relative to the insert member 508.

[0070] Cross section B is taken at a location where the suture anchor 510 is located on the hexagonal portion 600 of the insert 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 insert member 508 when the insert 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 insert member 508.

[0071] Cross section C is taken at the position where the saddle implant 512 is placed 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, which is the alignment feature of the saddle implant 512 and corresponds to the outer contour of the inner shaft 514, thereby allowing the saddle implant 512 and the inner shaft 514 to be slidably engaged. The corresponding contour of the interior of the saddle implant 512 and the outer contour of the inner shaft 514 allow the suture anchor 510 to rotate to 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 contour of the interior of the saddle implant 512 and the outer contour of the inner shaft 514 allow the suture placement groove to align with the orifice of the distal eyelet 516. It can be seen that the suture anchor 510 is behind the saddle implant 512. The distal surface of the suture anchor 510 abuts the proximal surface of the saddle implant 512 so that force can be transmitted between the suture anchor 510 and the saddle implant 512 to advance the saddle implant 512 into the bone hole in front of the suture anchor 510 during use.

[0072] Cross section D is taken at a location through 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. Because the distal eyelet 516 has a cross-sectional profile that is no larger than the cross section of the inner shaft 514, the saddle implant 512 can slide over the distal eyelet 516 and receive suture material. In cross section D, projections 604a, 604b extending toward the distal eyelet on the saddle implant 512 can be seen.

[0073] Figure 7 The threader tab 700 is mounted thereon. Figure 5A500. The threader tab 700 includes clips 706a, 706b that attach the threader tab 700 to the insert member 508 of the knotless suture anchor fixing system 500. The threader tab 700 also includes a sewing ring 702 that is configured to be threaded with suture material. The sewing ring 702 is configured to be flexible so that the sewing ring 702 can pass through the distal eyelet 516 and re-form a ring shape after passing through the distal eyelet. The sewing ring 702 can be made of any suitable material (including but not limited to metal, plastic, etc.). The relatively large size of the sewing ring 702 allows the suture material to easily pass through the sewing ring 702. The threader tab 700 has a grip 704 including a notch and ridges configured to be easily grasped by a surgeon performing a suture anchor fixation procedure to remove the threader tab 700 from the inserter member 508 or to maintain and manipulate the position of the threader tab 700 during the procedure. The use of the threader tab 700 is described below. Fig. 8A and Figure 8B Shown in.

[0074] Fig. 8A Is used for Figure 5A 800 of a procedure for fixing a tissue 802 to a bone 804 using the knotless suture anchor fixation system 500. Although the process is generally applicable to the use of the knotless suture anchor fixation system 100, the process is described for the system 500 for exemplary purposes. A bone hole 806 is formed in a bone 804 proximate to the tissue 802 to be repaired. A suture 808 is passed through the tissue 802 to be repaired. The knotless suture anchor fixation system 500 is provided for a clinician to perform a repair procedure. The suture 808 is passed through the suture loop 702 of the threader tab 700, and the threader tab 700 is removed from the inserter member 508.

[0075] Figure 8B yes Figure 5A 500, wherein a suture 808 attached to tissue is threaded through a threader tab 700 attached to the knotless suture anchor fixation system 500. By removing the threader tab 700 from the insert member 508 of the fixation system 500 and pulling the suture loop 702 of the threader tab 700 through the distal eyelet, the suture 808 is also pulled through the distal eyelet 516. The threader 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.

[0076] Figure 8C yes Figure 5A A perspective view of a knotless suture anchor fixation system 500 is shown with a suture 808 being pulled through the distal eyelet 516. FIG. 8A to FIG. 8B After the threader tab 700 is shown threading the suture 808 through the distal eyelet 516, the clinician pulls the free end 810 of the suture 808 through the distal eyelet. Fig.8D is inserted into the bone hole 806 Figure 5A 806, through the distal eyelet 516, and back out of the bone hole 806 so that the free end 810 is accessible and the suture 808 can be manipulated by the clinician. Fig. 8E , the clinician applies tension (indicated by arrow 816) on suture 808, and this tension pulls tissue 802 toward bone hole 806 (indicated by arrow 818). The clinician selects the appropriate tension for this procedure to secure the tissue at the desired location proximate bone hole 806. Figure 1A In a procedure of an embodiment of a fixture 100 including a clamp 106, the clinician secures the suture 808 to the clamp 106 to maintain the selected tension during the remainder of the procedure. In some cases, the clinician can align the orifice of the distal eyelet 516 so that the suture material travels through the orifice at a desired angle relative to the tissue 802. For example, one of the flat surfaces of the inner shaft 514 can be positioned to face the tissue 802 so that the suture material can be advanced from the tissue 802 in a generally straight line and into the orifice.

[0077] After the desired tension is applied to the suture 808, the insert member 508 of the knotless suture anchor fixation system 500 is rotated by rotating the knob 502. The rotation is represented by arrow 820. The rotation causes the bone engaging threads on the suture anchor 510 to grab the bone and advance the suture anchor 510 into the bone hole 806. When the suture anchor 510 is advanced distally via the rotation of the insert member 508, the distal surface of the suture anchor 510 transmits force to the saddle implant 512 to advance the saddle implant 512 into the bone hole 806. The saddle implant 512 has a flat proximal surface that abuts the distal surface of the suture anchor 510. Unlike the suture anchor 510, the saddle implant 512 does not rotate when it is moved distally into the bone hole 806. The saddle implant 512 is located on the inner shaft 514 and is configured to slide relative to the inner shaft due to the corresponding contours of the inner cavity of the saddle implant 512 and the exterior of the inner shaft 514 .

[0078] When the saddle implant 512 is advanced over the distal eyelet 516, as shown in FIG. Figure 8FAs shown, the suture 808 is positioned between the protrusions 604a, 604b of the saddle-shaped implant 512 (eg, 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 Figure 3A When the distal eyelet 516 moves proximally and the base of the saddle-shaped implant 512 contacts the suture 808 in the suture placement groove, the suture 808 moves distally in the orifice of the distal eyelet 516.

[0079] When the arms 602a, 602b of the distal eyelet 516 move proximally as the inner shaft 514 retracts, as shown in FIG. Figure 8F As shown, a position is reached where the ends of the arms 602a, 602b are flush with the base of the saddle implant 512. The arms 602a, 602b of the distal eyelet 516 begin to bend as the suture 808 contacting the base of the saddle implant 512 begins to exert a force on the arms 602a, 602b of the distal eyelet 516 as the distal eyelet 516 is retracted through the cannula of the saddle implant 512. The arms 602a, 602b will reach a point where the force exerted on the arms 602a, 602b by the suture 808 is sufficient to bend the arms 602a, 602b wide enough for the suture 808 to pass between the arms and be released. Figure 8G As shown, suture 808 is retained in the suture placement groove of saddle implant 512 and secured in the bone hole by suture anchor 510. Suture anchor 510 maintains tension on suture 808 to hold tissue 802 in place.

[0080] Reference Figure 8H After the suture anchor 510, saddle implant 512, and suture 808 are secured in the bone hole 806, the remainder of the knotless suture anchor fixture 500 is removed from the bone hole, as indicated by arrow 822. The free end of the suture 808 may be trimmed as desired by the clinician.

[0081] In other embodiments, various combinations of handles and shafts disclosed herein may be used. For example, Figure 1A The handle 104 of the embodiment of the fixation device 100 shown in FIG. 5 can be combined with the insert member 508 and the inner shaft 514 to produce an alternative configuration of a knotless suture anchor fixation device. In another example, Figure 5A The handle 504 of the embodiment of the fixation device 500 shown in FIG. 1 may be combined with the inserter member 108 and the inner shaft 114 to create another alternative configuration of a knotless suture anchor fixation device.

[0082] Those skilled in the art will know other features and advantages of these devices, systems and methods based on the above embodiments. Therefore, the present disclosure should not be limited to what has been specifically shown and described, unless otherwise indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety for all purposes.

[0083] The present disclosure has been described above by way of example only in the context of the overall disclosure provided herein. It should be understood that modifications may be made within the spirit and scope of the claims without departing from the overall scope of the present disclosure.

Claims

1. A suture anchor system, comprising: a hollow suture anchor having at least one follower feature and at least one bone engaging feature disposed on an outer surface of the hollow suture anchor; a hollow 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 feature disposed thereon, the at least one drive feature configured to engage the driven feature of the suture anchor; a saddle-shaped implant distal to the suture anchor, the saddle-shaped implant comprising at least one alignment feature disposed in an inner cavity of the saddle-shaped implant, a distal end portion having a suture placement groove, wherein the saddle-shaped implant is configured to be mounted distally adjacent to the suture anchor and rotatable relative to the suture anchor; and An inner shaft configured to be removably disposed within the inner cavity of the insert member, the inner shaft having at least one alignment feature located on its outer surface and a distal eyelet fixed at its distal end, the distal eyelet having an opening and configured to be rotationally fixed relative to the saddle implant and capable of rotation relative to the suture anchor.

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

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

4. The suture anchor system of claim 3, wherein: The saddle feature has a base and two distally extending projections, each distally extending projection having a flat distally facing surface.

5. The suture anchor system of claim 1, wherein: The saddle implant can be removably mounted on 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 arm has a tapered shape.

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

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

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

11. The suture anchor system of claim 1 , wherein: The eyelet is configured to release the suture when the inner shaft is retracted.

12. The suture anchor system of claim 1, further comprising a handle having a plurality of pieces.

13. The suture anchor system of claim 12, further comprising a clamp located on one of the plurality of members.

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

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

16. The suture anchor system of claim 15, wherein: The threader tab includes a clip configured to attach to the inserter member.

17. The suture anchor system of claim 1, wherein: The bone engaging feature disposed on the outer surface of the hollow suture anchor includes threads.

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

19. 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; 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 construct having: an insert member having a lumen extending therethrough, the inner shaft disposed within the lumen; a hollow suture anchor mounted on the insert member; and a saddle implant mounted on the inner shaft distally adjacent to the suture anchor; placing the inner shaft in the bone hole adjacent to the soft tissue to be reattached to the bone; Tensioning the surgical suture to firmly join the soft tissue to the bone; driving the suture anchor and the saddle implant into the bone hole to engage bone while maintaining alignment of the saddle implant and the eyelet relative to one another; releasing the surgical suture from the eyelet; as well as Remove the inner shaft.

20. The method of claim 19, further comprising securing a surgical suture to a clamp located on a handle of the suture anchor system.

21. The method of claim 20, further comprising maintaining tension on the surgical suture throughout the insertion process.

22. The method of claim 20, further comprising maintaining a predetermined distance between the clamp and the eyelet throughout the insertion process.

23. The method of claim 19, further comprising capturing the surgical suture using the saddle implant.

24. The method according to claim 19, wherein: Releasing the surgical suture from the eyelet includes passing the suture between two arms of the eyelet.

25. The method of claim 19, wherein: Releasing the surgical suture from the eyelet includes flexing the arms of the eyelet.

26. The method of claim 19, wherein: Driving the suture anchor and the saddle implant includes rotating the suture anchor and translating the saddle implant distally.

Images