Knotless instability device and method for soft tissue repair

Abstract

To provide knotless suture anchors and methods for affixing soft tissue to a bone.SOLUTION: One exemplary embodiment of a suture anchor includes an insertion rod, a distal tip member removably coupled to a distal end of the insertion rod, the distal tip member having a suture engagement feature configured to have a plurality of suture limbs slidably coupled to the tip member, and a proximal main member having an elongated cylindrical body with one or more bone-engaging features disposed on its outer surface and a longitudinal lumen extending from a proximal end to a distal end. The suture anchor can also include two suture limb holding surfaces to maintain two suture limbs at a distance from each other. Other exemplary embodiments and methods for affixing soft tissue to a bone are also provided.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] This disclosure relates to devices and methods for fixing soft tissue to bone, and more specifically to knotless suture anchors and methods for use in performing soft tissue repair. [Background technology]

[0002] Many surgical procedures involve placing implants in bone. For example, in cases where soft tissue injury results in partial or complete detachment of soft tissue (e.g., ligaments and / or tendons) from the associated bone, reattachment of the detached soft tissue to the bone may be necessary. In such cases, surgical procedures involving bone implants may be used to reattach the soft tissue to the bone. A common type of bone implant used in soft tissue repair is a suture anchor combined with a suture. For example, the soft tissue can be attached to a suture, which can be tied to a suture anchor placed in the bone to which the soft tissue is attached, or otherwise secured by the suture anchor. The suture anchor can be implanted in the bone by being driven directly into it, or it can be fixed in a pre-formed or existing hole in the bone.

[0003] A knotless suture anchor is a type of suture anchor designed so that the surgeon does not need to tie any knots during the procedure. For example, some knotless suture anchors fix the suture limb (strand) to the bone by trapping the suture limb between the inner surface of the hole and the outer surface of the suture anchor. A knotless suture anchor can be a single-component suture anchor. Alternatively, a knotless suture anchor can be a multi-component system, which includes, for example, an insertion rod, a suture engagement member, and a suture anchor member, the insertion rod first guides the suture engagement member into the hole in the bone, carries a portion of the suture limb into the hole, and then fixes the inserted portion of the suture limb to the bone by inserting it into the hole of the suture anchor member.

[0004] One challenge posed by currently available knotless suture anchors is the inability to properly manipulate the suture limb during soft tissue repair procedures. Proper manipulation of the suture limb during soft tissue repair procedures is important for several reasons. For example, before fully inserting the suture anchor into the bone, it may be necessary to manipulate the suture limb to ensure proper tension is applied to the suture limb attached to the soft tissue in order to properly position the soft tissue relative to the bone. Improper manipulation of the suture limb can result in insufficient or excessive tension being applied to the suture limb before anchor implantation. Furthermore, the frictional force holding the suture limb to the bone can be significantly reduced when the suture limbs cross, resulting in insufficient retention of the suture limb. Therefore, it may be necessary to manipulate the suture limb to ensure that the portion of the suture limb trapped between the bone tunnel surface and the suture anchor surface does not cross. Such insufficient retention of the suture limb can cause the suture limb to slide (or otherwise deviate) from its intended fixation position. [Overview of the project] [Problems that the invention aims to solve]

[0005] Therefore, it is desirable to provide an apparatus and method for use in soft tissue repair that enables improved manipulation of the suture limb, in order to ensure that appropriate tension is applied to the suture limb and that the portion of the suture limb fixed between the bone and the suture anchor does not cross. [Means for solving the problem]

[0006] Generally, devices and methods for fixing soft tissue to bone are provided. The devices and methods may also be adapted for use in fixing one or more objects, such as bone fragments or tissues, among other surgical procedures, and may also be adapted to pull out two or more tissues together so that they can be fixed in a desired location.

[0007] In one exemplary embodiment, the suture implantation assembly includes an insertion rod, a distal tip member detachably coupled to the insertion rod, and a proximal main member. The distal tip member has a suture engagement feature configured to slidably accommodate a plurality of suture limbs. The proximal main member has an elongated cylindrical body with one or more bone engagement features disposed on its outer surface. The proximal main member also includes a longitudinal lumen extending from the proximal end to the distal end. The proximal main member is slidably positioned on the insertion rod by having an insertion rod detachably disposed through the longitudinal lumen. The proximal main member is proximal to the distal tip member, and the proximal main member is configured to allow the plurality of suture limbs slidably coupled to the distal tip member to pass through at least a portion of the elongated cylindrical body in the proximal direction, from a first position on the elongated cylindrical body to a second position on the elongated cylindrical body. The first position is closer to the distal end of the elongated cylindrical body than the second position. One of the distal tip member and the proximal main member includes a first suture rim retaining surface formed on the first side of the central longitudinal axis extending to the center through the longitudinal lumen from the projection image, and a second suture rim retaining surface formed inside it on the second side of the central longitudinal axis from the projection image, the second side facing the first side with respect to the central longitudinal axis. A portion of the first suture rim retaining surface closest to the proximal end of the distal tip member is positioned separately from a portion of the second suture rim retaining surface closest to the proximal end of the distal tip member. The first rim of a plurality of suture rims slidably coupled to the distal tip member can be positioned in contact with the portion of the first suture rim retaining surface closest to the proximal end of the distal tip member, and the second rim of a plurality of suture rims slidably coupled to the distal tip member can be positioned in contact with the portion of the second suture rim retaining surface closest to the proximal end of the distal tip member. As a result, the first and second suture rims are maintained at a certain distance apart from each other.

[0008] The first suture limb retaining surface may include a first bore, and the second suture limb retaining surface may include a second bore. The first and second bores may lie on the first and second sides of the central longitudinal axis. Alternatively, the first suture limb retaining surface may be part of a first lobe, and the second suture limb retaining surface may be part of a second lobe. The first and second lobes may be parts of a single bore. Furthermore, the nearest portions of the first and second lobes may lie on the first and second sides of the central longitudinal axis.

[0009] In some embodiments, the first suture rim retaining surface and the second suture rim retaining surface can be located on the distal tip member, while in some embodiments, the first suture rim retaining surface and the second suture rim retaining surface can be located on the proximal main member. In the latter case, the first suture rim retaining surface and the second suture rim retaining surface may be part of at least one opening formed in the proximal main member. In some such embodiments, the most distal end of the opening may be located at the most distal end of the proximal main member, which can form a location into which the first suture rim and the second suture rim can enter the at least one opening and slidably connect to the first suture rim retaining surface and the second suture rim retaining surface.

[0010] In some other embodiments, the first suture rim retaining surface and the second suture rim retaining surface are part of at least one opening formed in the proximal main member, such that the distal end of the opening is positioned at the distal end of the proximal main member. As a result, a location is created in which the first suture rim and the second suture rim can enter the at least one opening and slidably bond to the first suture rim retaining surface and the second suture rim retaining surface.

[0011] One or more projections may be positioned radially outward from the outer surface of the distal portion of the proximal main member. The projection(s) may be configured such that at least one portion of the first suture rim retaining surface and the second suture rim retaining surface is positioned proximal to the relatively planar surface when a relatively planar surface positioned close to the bore entry point engages with the distal end(s) of the projection(s). As a result, at least one of the first or second rims of a plurality of suture rims slidably coupled to the respective first and second retaining surfaces may remain slidable relative to the respective first and second retaining surfaces. In some such embodiments, the distal end of at least one of the one or more projections may taper radially outward as the projection extends toward the proximal end of the proximal main member.

[0012] The flared portion can be positioned at the proximal end of the proximal main member. The combination of the flared portion and any portion of one or more bone engagement surfaces formed on the flared portion may have a diameter larger than the diameter formed by the combination of the proximal main member distal to the flared portion and one or more bone engagement surfaces positioned on the outer surface of the proximal main member.

[0013] An exemplary embodiment of a surgical procedure for fixing tissue to bone includes tying a suture to tissue such that two suture limbs extend from the tissue, and tying each of the two suture limbs to one or more suture engagement features such that the two suture limbs are slidably positioned to one or more suture engagement features of the distal tip member of a suture anchor. The method further includes inserting the distal tip member into a bore formed in the bone, and passing the two suture limbs from one or more suture engagement features of the distal tip member into and through at least a portion of the proximal main member of the suture anchor. The two suture limbs are positioned such that the first limb of the two suture limbs engages with a first surface defining a portion of at least one opening formed in one of the distal tip member and the proximal main member, located on the first side of the central longitudinal axis extending centrally through a suture anchor from the projection image, and the second limb of the two suture limbs engages with a second surface defining a portion of at least one opening formed in one of the distal tip member and the proximal main member, located on the second side of the central longitudinal axis opposite to the first side from the projection image, so that the first and second limbs are maintained at a certain distance apart from each other on opposite sides of the central longitudinal axis. The method further includes applying tension to at least one of the two suture limbs to pull the tissue toward the bone and advancing the proximal main member distally toward the distal tip member, thereby locking the two suture limbs, and thus the location of the tissue attached to the bone, in place relative to the bone.

[0014] In some embodiments, at least one opening may be formed within the distal tip member, and one or more suture engagement features may include at least one opening. In some such embodiments, coupling each of two suture limbs to one or more suture engagement features of the distal tip member may also include engaging the first limb with a first surface of at least one opening and engaging the second limb with a second surface of at least one opening. In some alternative embodiments, at least one opening is formed in the proximal main member. In some such embodiments, the operation of coupling each of two suture limbs to one or more suture engagement features of the distal tip member may occur before the operation of passing the two suture limbs from one or more suture engagement features of the distal tip member to at least a portion of the proximal main member of the suture anchor.

[0015] The operation of inserting the distal tip member into a bore formed in the bone may include advancing the insertion rod to which the distal tip member is attached toward the bore formed in the bone. In some such embodiments, the proximal main member may be slidably positioned on the insertion rod. Advancing the proximal main member distally toward the distal tip member to lock the position of the two suture limbs may include inserting the proximal main member into the bone bore so that surface engagement features formed on the outer surface of the elongated body engage with the bone surface defining the bore.

[0016] In some embodiments, the surgical procedure may also involve moving the proximal principal member toward the bore formed in the bone until one or more projections positioned on the proximal principal member engage with the bone adjacent to the bore, so that the proximal principal member cannot advance further toward the bore without an additional amount of force being applied to it. The engagement of one or more projections with the bone creates a gap between the proximal principal member and the proximal edge of the bore, thereby accommodating the movement of the suture rims toward the first and second surfaces. The gap is eliminated by advancing the proximal principal member distally toward the distal tip member to lock the two suture rims into place.

[0017] An exemplary embodiment of a suture anchor includes an elongated anchor body, one or more bone engagement surfaces, and at least one lateral opening formed on the outer surface. More specifically, the elongated anchor body includes a proximal end, a distal end, and a longitudinal lumen extending through the length of the elongated anchor body from the distal end to the proximal end. The distal tip portion associated with the distal end of the suture anchor is tapered, such that the diameter defined at the distal end by the outer surface of the elongated anchor body is smaller than the diameter defined at the proximal end of the distal tip portion by the outer surface of the elongated anchor body. One or more bone engagement surfaces are positioned on the outer surface of the elongated anchor body and configured to engage with bone. At least one lateral opening is formed on the outer surface of the elongated anchor body and communicates directly with the longitudinal lumen so that a suture limb can pass through the lateral opening into the longitudinal lumen. The proximal end of at least one lateral opening has a shape such that at least two distinct suture guide paths are formed. The at least two distinct suture guide paths include a first suture guide path positioned on a first side of the central longitudinal axis extending from the projection image through at least one lateral opening, and a second suture guide path positioned on a second side of the central longitudinal axis from the projection image, the second side facing the first side.

[0018] In some embodiments, the shape of at least one side opening may include a scalloped portion. In some such embodiments, the at least one side opening may include a distal portion containing a channel and a proximal portion containing a scalloped portion. The scalloped portion may include a first guide path and a second guide path.

[0019] The anchor may also comprise one or more protrusions disposed radially outwardly from the outward-facing surface of the distal portion of the suture anchor. At least one of the protrusions is configured such that when a relatively planar surface disposed proximate to a bore entry location engages the distal end of the at least one protrusion, at least a portion of at least one of the first suture guide path and the second suture guide path is disposed proximal of the relatively planar surface, whereby a suture limb passed through a side opening and into the longitudinal lumen can be slidably coupled to and slidable relative to the respective first suture guide path and second suture guide path.

[0020] In some embodiments, the distal end of the at least one protrusion may taper radially outwardly as the protrusion extends toward the proximal end of the suture anchor. The protrusion may further comprise a proximal end that does not taper radially outwardly as the protrusion extends toward the proximal end of the suture anchor.

[0021] The flared portion may be disposed at the proximal end of the elongated body. The combination of the flared portion and any portion of one or more bone-engaging surfaces formed on the flared portion may have a larger diameter than the diameter formed by the combination of the elongated anchor body distal to the flared portion and one or more bone-engaging surfaces disposed on the outer surface of the elongated anchor body. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] [Figure 1A] It is a front view of an exemplary embodiment of a suture anchor. [Figure 1B] It is a rear view of the suture anchor of FIG. 1A. [Figure 1C] It is an isometric view of the suture anchor of FIG. 1A. [Figure 1D] It is another isometric view of the suture anchor of FIG. 1A. [Figure 2A]Figure 1A is a cross-sectional view of a suture anchor taken along line AA when the anchor is positioned within the bore of the bone. [Figure 2B] Figure 1A is a cross-sectional view of a suture anchor taken along line AA when the anchor is positioned within the bore of the bone. [Figure 3A] This is a front view showing another exemplary embodiment of a suture anchor. [Figure 3B] Figure 3A is a dorsal view of the suture anchor. [Figure 3C] Figure 3A is an isometric view of the suture anchor. [Figure 3D] This is another isometric view of the suture anchor shown in Figure 3A. [Figure 4] Figure 3A is a cross-sectional view of the suture anchor taken along line BB before the anchor was fully inserted into the bore within the bone. [Figure 5A] This is a front view of yet another exemplary embodiment of a suture anchor. [Figure 5B] Figure 5A is a dorsal view of the suture anchor. [Figure 5C] Figure 5A is an isometric view of the suture anchor. [Figure 5D] This is another isometric view of the suture anchor shown in Figure 5A. [Figure 6] This is a perspective view of the suture anchor shown in Figure 5A, which is currently in use. [Figure 7A] This is a front view of another exemplary embodiment of a suture anchor. [Figure 7B] Figure 7A is a rear view of the suture anchor. [Figure 7C] This is a cross-sectional front view of yet another exemplary embodiment of a suture anchor, where the cross-section is taken along the same line CC as the anchor in Figure 7A. [Figure 8] Figure 7A shows a cross-sectional view of the suture anchor taken along line CC before the anchor was fully inserted into the bore within the bone. [Figure 9A] This is a front view of another exemplary embodiment of a suture anchor. [Figure 9B] Figure 9A is a dorsal view of the suture anchor. [Figure 9C] Figure 9A is an isometric view of the suture anchor. [Figure 9D] This is another isometric view of the suture anchor shown in Figure 9A. [Figure 10] Figure 9A is a cross-sectional view of the suture anchor taken along line DD after the anchor has been fully inserted into the bore of the bone. [Figure 11A] This is a perspective view of yet another exemplary embodiment of a suture anchor. [Figure 11B] Figure 11A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 12A] This is a perspective view of another exemplary embodiment of a suture anchor. [Figure 12B] Figure 12A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 13A] A perspective view of another embodiment of the suture anchor. [Figure 13B] Figure 13A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 14A] A perspective view of another embodiment of the suture anchor. [Figure 14B] Figure 14A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 15A] This is a perspective view of yet another exemplary embodiment of a suture anchor. [Figure 15B] Figure 15A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 16A] This is a perspective view of another exemplary embodiment of a suture anchor. [Figure 16B] Figure 16A is a perspective view of a suture anchor in which the suture rim is slidably bonded to the suture-holding surface of the suture anchor. [Figure 17]This is a schematic side view of another exemplary embodiment of a suture anchor. [Figure 18] This is a schematic side view of another exemplary embodiment of a suture anchor. [Figure 19A] This is a schematic side view of yet another exemplary embodiment of a suture anchor. [Figure 19B] This is a schematic side view of another exemplary embodiment of a suture anchor. [Figure 20A] This is a schematic diagram of yet another exemplary embodiment of a suture anchor. [Figure 20B] This is a schematic side view of another exemplary embodiment of a suture anchor. [Figure 21] This is a schematic side view of yet another exemplary embodiment of a suture anchor. [Figure 22A] This is a schematic side view of the suture anchor shown in Figure 19A, which is currently in use. [Figure 22B] This is a schematic side view of the suture anchor shown in Figure 19A, which is currently in use. [Figure 23] This is a schematic side view of another exemplary embodiment of a suture anchor in use. [Modes for carrying out the invention]

[0023] Specific exemplary embodiments are described below to provide an overall understanding of the structure, function, manufacture, and principles of use of the apparatus and methods disclosed herein. One or more of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatus and methods described 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 relation to one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are included within the scope of the invention.

[0024] Furthermore, in this disclosure, components bearing similar reference numerals in embodiments generally have similar characteristics, and therefore, in a particular embodiment, the characteristics of each component bearing similar reference numerals are not necessarily fully described. Furthermore, to the extent that linear or circular dimensions are used in the description of the disclosed apparatus and method, such dimensions are not intended to limit the types of shapes that may be used with such apparatus and method. Those skilled in the art will recognize that it is readily possible to determine dimensions equivalent to such linear and circular dimensions for any geometric shape. The dimensions and shape of the apparatus, and its components, may depend at least on the anatomical form of the patient in whom the apparatus will be used, the dimensions and shape of the components in which the apparatus will be used, and the methods and procedures in which the apparatus will be used. The drawings provided herein are not necessarily to scale, and at least some of them are schematic illustrative diagrams that will enable those skilled in the art to recognize, in consideration of the teachings herein and their knowledge in the art, how the illustrated embodiments will be sized, dimensional, and used in the context of surgical procedures.

[0025] Generally, devices and methods for fixing soft tissue to bone are provided. Generally, the devices and methods enable fixing soft tissue to bone using sutures coupled to suture anchors without tying knots or otherwise tying the sutures to fix the soft tissue in place to the bone. As illustrated in some embodiments described herein, the suture anchors may include two or more components, sometimes described as a suture implantation assembly comprising multiple components.

[0026] The device includes features configured to improve suture handling during the implantation of suture anchors, thereby resulting in improved soft tissue fixation to the tissue. Specifically, the device has features that allow tension to be applied to the suture strand before the suture anchor is fully inserted into the anchor-receiving bone hole that locks the suture rim, and features that help the user prevent unintended and / or accidental "crossing" of the suture rim in a portion of the suture rim that is fixed and / or locked between the inner surface of the bone hole and the outer surface of the suture anchor. Although the device and method disclosed herein are for fixing soft tissue to bone, the method and device can be used in other medical procedures for fixing various objects to each other.

[0027] In one exemplary embodiment, as shown in Figures 1A to 1D, the suture anchor 100 may include a substantially cylindrical elongated body 110 extending along a longitudinal axis L1 from a proximal end 110p to a distal end 110d. The distal end 110d may more commonly be part of the distal portion of the elongated body 110, which includes a tapered distal portion 110t and a notched portion 110c. A longitudinal lumen 120 may extend from the distal portion of the elongated body 110 to the proximal end 110p. As shown, the lumen 120 may be centrally located, through which the longitudinal axis L1 extends, and the lumen 120 may be coaxial with the cylindrical elongated body 110 of the suture anchor 100, but other configurations are also possible. As shown in Figure 2A, the proximal portion of the lumen 120 may have a larger diameter than the distal portion, which may be useful for accommodating the distal end of an inserter or other inserting device for the suture anchor 100. As will be discussed in more detail below, the notch 110c helps define the plane of the distal side opening 140d and provides access to the suture engagement feature 130. In the illustrated embodiment, the notch 110c has an elongated curved profile, as best illustrated in Figures 1A and 1C, but other configurations are also possible.

[0028] The external surface of the elongated body 110 may include one or more bone engagement features 150. In the illustrated embodiment, the bone engagement features 150 include a plurality of radially extending projections or ribs formed on the external surface of the suture anchor 100, but those skilled in the art will recognize other suitable bone engagement features that may be used in a context that helps the elongated body 110 to be firmly positioned within the bone. One such non-limiting example is provided in Figure 19A, where the bone engagement feature includes a single corkscrew-shaped thread 1450. Those skilled in the art will understand that modifications may be made to the geometric shape of the bone engagement features 150 to increase the compressive force applied between the bone engagement features 150 of the bone anchor 100 and the internal surface or wall 71 of the bone hole 70, such as a bone engagement feature 150 having dimensions that may be larger than the diameter of the bone hole 70 at its widest portion. Similarly, those skilled in the art will understand that the geometric shape of the bone engagement feature 150 may be modified to help prevent unintended removal of the suture anchor 100 (i.e., proximal movement of the suture anchor 100 after it has been inserted into the bone hole 70), thereby ensuring that the suture anchor 100 remains in the bone hole 70 and the suture rim 180 engages with the bone 75.

[0029] The distal portion of the elongated body 110 may also include a suture engagement feature 130. The suture engagement feature 130 may be described as being located within a lumen 120, where the lumen 120 extends from the distal end 110d to the proximal end 110p, and the suture engagement feature 130 is located within the length of the lumen 120. The lumen 120 may be coaxial with the elongated body 110. Alternatively, the lumen 120 may be described as terminating at the location of the distal lateral opening 140d, and then terminating at the location of a separate lumen substantially aligned with the lumen 120, and located below the suture engagement feature. While any interpretation may be appropriate, for ease of reference, this example shows a lumen 120 extending to the distal end 110d. Furthermore, both interpretations could involve openings formed on the surfaces of the distal end 110d and proximal end 110p of the cylindrical, elongated body 110.

[0030] The suture engagement feature 130 may be a structure to which a suture rim, such as the suture rim 180 shown in Figures 2A-2B, can be slidably coupled. In some embodiments, as shown in Figure 1C, the suture engagement feature 130 may include a bridge member (e.g., a saddle or pulley-like member). In an illustrated, non-limiting embodiment of the bridge member in Figure 1C, the suture engagement feature includes a rod-like member that extends substantially across the central longitudinal axis L1 of the suture anchor 100 from one side to the opposite side of the inner surface of the longitudinal lumen 120 of the suture anchor 100. The suture engagement feature 130 can improve suture manipulation during surgical procedures (e.g., adjusting the tension of the suture rim to position soft tissue associated with the suture rim in bone, as will be described in more detail with respect to Figures 2A-2B). More specifically, in the illustrated embodiment, the bridge member forming the suture engagement feature 130 provides a “pulley-like” feature that allows the suture to slide easily around it during use. Those skilled in the art will understand that the suture engagement feature 130 may include, but not limited to, other morphological and structural features, including such suture engagement features as described herein with respect to at least Figures 4, 7A, and 14A. Access to the suture engagement feature 130 may be provided by a notch 110c, which in turn provides access by a distal opening 140d and a longitudinal lumen 120.

[0031] At least one lateral opening 140p, 140d may be formed on the outer surface of the elongated anchor body 110. The illustrated embodiment includes two lateral openings, the distal lateral opening 140d located above the suture engagement feature 130 and relative to the proximal body 110, and the proximal lateral opening 140p located below the proximal end 110p and relative to the proximal body 110. More specifically, the distal lateral opening 140d is defined by the upper surface 130t of the suture engagement feature 130 and the nearest surface 110ct of the notch 110c. In a profile diagram as illustrated by Figure 1A, the resulting distal lateral opening 140d may have a door-like shape. In the embodiment, as clearly illustrated by Figures 2A and 2B, the nearest surface 110ct can function as a suture rim retaining surface, as the suture rim can engage with the surface in use. Alternatively, the nearest surface 110ct does not necessarily have to hold the surface if, for example, the suture engagement feature 130 is positioned so that the suture limb passes through and thereby does not actually engage with the nearest surface 110ct.

[0032] The proximal lateral opening 140p is formed through the anchor body 110. In the illustrated embodiment, it has an elongated ellipse shape. More generally, one or more lateral openings 140p, 140d can communicate directly with the longitudinal lumen 120, and with sutures positioned on, around, or otherwise associated with the suture engagement feature 130, the sutures can pass through one or more of the lateral openings 140p, 140d and the longitudinal lumen 120. Furthermore, those skilled in the art will understand that other sizes, shapes, and configurations of the openings 140p, 140d, or other lateral openings provided in the anchor, may be used without departing from the spirit of the present disclosure. Other suitable terms for the lateral openings 140p, 140d may include slots, eyelets, or keyways in other descriptions, shapes, sizes, and configurations.

[0033] As clearly shown in Figures 2A and 2B, such direct communication between the distal opening 140d, the longitudinal lumen 120, and the proximal opening 140p allows the suture rim 180, shown as two rims, to pass through the distal opening 140d, through the longitudinal lumen 120, into the suture anchor 100, and exit the suture anchor through the proximal opening 140p before reaching the proximal end 110p of the elongated body 110. This configuration can help provide additional compression for shorter lengths, as the suture rim 180 can be confined by the proximal portion of the anchor 100, as illustrated in Figure 2B, showing the outer surface of the body 110 between the upper part of the proximal opening 140p and the terminal portion of the proximal end 110p.

[0034] As shown in Figures 2A and 2B, the suture anchor 100 can be sized and shaped to fit into and be fixed to a corresponding bone hole or bore 70 formed within the bone 75. The bone hole 70 may be a pre-drilled or existing bore within the bone 75 designed to receive the suture anchor 100. As described and illustrated herein, the bone hole 70 may provide a surface 71, and the suture rim 180 can be positioned between the surface 71 of the bone hole 70 (e.g., the inner surface of the bone hole 70) and the outer surface of the suture anchor 100, which is shown to include a bone engagement feature 150.

[0035] In some embodiments, the suture anchor 100 may include a distal opening 140d and a proximal opening 140p, while in other embodiments, only the distal opening 140d may be present. In some cases, the suture can pass through an opening 120p defined by the longitudinal lumen 120 at the proximal end 110p of the body 110. One example is illustrated with respect to Figures 9A to 10, in which the suture anchor 500 includes only a distal opening 540d and does not include a separate proximal opening, and the suture 580 passes through an opening 520p of the longitudinal lumen 520, which will be described in more detail below. Additional lateral openings may be formed within the main body 110 as desired, providing alternative passages or routes through which sutures can be passed in and out of the anchor 100, communicating with and / or not communicating with the bone surface 71 defined by the bone 75 forming the bone hole 70. As a result, there are many different configurations in which various portions of the suture limb can be confined between the main body 110 and the bone surface 71 over various lengths within the bone hole 70.

[0036] The bone engagement feature 150 can also function as a suture engagement feature in addition to, or instead of, the suture engagement feature 130. As shown in Figure 2B, the bone engagement feature 150 can improve the fixation, or other locking or fastening, of the suture rim 180 to the bone 75 by increasing the holding force that fixes the suture rim 180 in place by the anchor 100. For example, increasing the length of the portion of the suture rim 180 that is in contact with the suture anchor 100 and / or the surface 71 of the bone hole 70 can increase the total friction between the suture anchor 100 and the suture rim 180, and / or between the suture rim 180 and the bone hole surface 71. The fixation of the suture rim 180 between the anchor 100 and the surface 71 can be further enhanced by the shape and size of the bone engagement feature 150, so that the shape and size of the bone engagement feature 150 can further strengthen the fixation of the anchor 100 to the bone 75.

[0037] In some embodiments, the distal tip portion 110t of the suture anchor 100 can be tapered (for example distally toward the central axis L1) such that the diameter defined by the outer surface of the distal end 110d of the body 110 is smaller than the diameter defined by the outer surface of the body 110 at the proximal end 110tp of the distal tip portion 110t, and / or the diameter of the bone hole 70 into which the anchor 100 is inserted. Since the distal end 110d of the elongated body 110 has a smaller diameter than the diameter of the bone hole 70, such a tapered distal tip portion 110t of the suture anchor 100 can facilitate the insertion of the suture anchor 100 into the bone hole 70 by facilitating the user to insert the distal tip portion 110t of the suture anchor 110 into the bone hole 70. Furthermore, illustrated curvatures in alternative embodiments, which may be more linear and angled but have a straight surface, can assist in initiating the insertion of the anchor 100 into the bone hole 70.

[0038] Figures 2A and 2B serve to illustrate one non-limiting exemplary embodiment of a surgical procedure that can be performed using a suture anchor 100 to fix tissue 90 to bone 75. The suture limb 180 may be bonded to or otherwise engaged with the tissue 90 intended to be fixed to bone 75. This can be achieved, for example, by inserting one or both ends of the suture limb 180 through the tissue 90, as shown. In other non-limiting cases, this may include wrapping one or both suture limbs 180 around the tissue 90. After being bonded to the tissue 90 or otherwise associated with the tissue, the suture limb 180 may extend from the tissue 90 and be manipulated toward the anchor 100. In the illustrated embodiment, the suture limb 180 extends from the tissue 90, passes through the distal opening 140d to the suture anchor 100, and is slidably bonded to or otherwise associated with the suture engagement feature 130. The suture rim 180 can easily slide against the suture engagement feature. The rim 180 can then extend proximal from the suture engagement feature 130 through at least a portion of the longitudinal lumen 120. As shown, the rim 180 extends through the lumen 120 and exits the anchor 100 through the proximal lateral opening 140p. Alternatively, they can pass through the longitudinal lumen 120 at the terminal portion of the proximal end 110p of the body 110 (i.e., the terminal or proximal terminal).

[0039] In particular, in the illustrated embodiment, both suture limbs 180 follow the same path, but in other embodiments, they can take different paths, one passing through the longitudinal lumen 120 at the terminal portion of the proximal end 110p of the body 110, while the other passes through the proximal lateral opening 140p. In a further non-limiting embodiment, one limb may extend proximal through at least a portion of the longitudinal lumen 120 by passing through the distal lateral opening 140d around the suture engagement feature 130, while the other limb may be positioned around the distal end 110d of the body 110 (through the distal lateral opening 140d) and may pass proximal upward around the opposing outer surfaces of the body 110 (if it passes through the distal lateral opening 140d), and then exit the longitudinal lumen 120 at the terminal portion of the distal end 110d of the body 110. In at least some cases, three or more suture limbs may be used, which may take the same or different paths around and / or through the anchor 100 without departing from the spirit of the present disclosure. These and other configurations may typically be set up before inserting the anchor 100 into the bone hole 70, or before inserting at least the portion of the anchor 100 including the distal opening 140d into the bone hole 70, so that the opening 140d is easily accessible and the suture limb 180 can easily slide against it.

[0040] Once the suture limb 180 is bonded to the tissue 90 and the suture anchor 100, the anchor can be inserted into the bone hole 70, or, if at least partially inserted, into the bone hole 70, as shown in Figure 2A, it can be more completely inserted. Once the anchor 100 is inserted into the bone hole 70 and the distal opening 140d is positioned within the bone, it becomes more difficult to manipulate the suture limb 180. Insertion also causes the tissue 90 to be pulled toward the bone hole 70 as the suture limb 180 is pulled distally into the bone hole 70, so that the tissue 90 is trapped between the anchor 100 and the surface 71 of the bone 75 defining the bone hole 70. Therefore, some aspects of the desired manipulation of the tissue 90 and / or suture limb 180 relative to the anchor 100 should be performed before the distal opening 140d is positioned within the bone hole 70 and before it becomes more difficult to slide the suture limb 180 relative to the anchor 100. For example, it may be desirable to apply tension to the suture limb 180 before insertion to slide the suture limb 180 against the anchor 100, thereby drawing the tissue 90 toward the anchor 100.

[0041] Figure 2B illustrates the anchor 100 after it has been fully inserted into the bone hole 70. Insertion can be performed using any technique for positioning the anchor in the bone hole, including but not limited to driving, screwing, or pushing. As shown, the suture limb 180 is fixed to the anchor 100 by being trapped between the anchor 100 and the surface 71 defining the bone hole 70. As discussed above, the engagement of the anchor 100 and the suture limb 180 by the surface 71 occurs over the substantial length of the outer surface of the body 110 (over the entire exposed length of the outer surface, as shown in Figure 2B), while the engagement of the anchor 100 and the suture limb 180 by the surface 71 may occur over the length of the outer surface of the body 110 opposite the anchor at the proximal end 110p, since the suture limb 180 exits from the proximal opening 140p. The bone engagement feature 150 helps to provide fixation between these two. As the anchor 100 is further positioned within the bone tunnel 70, the tissue 90 is pulled toward the bone tunnel 70 and therefore toward the bone 75.

[0042] Figures 3A to 4 illustrate another embodiment of the suture anchor 200. The anchor 200 is similar to anchor 100 in that it includes an elongated body 210 having a proximal end 210p and a distal end 210d extending along its longitudinal axis L2, a tapered distal portion 210t, a longitudinal lumen 220 extending through it, a suture engagement feature 230 (Figure 4) located in the distal portion of the body 210 within the lumen 220, a proximal opening 240p and a distal opening 240d, and a bone engagement feature 250. The illustrated embodiment differs from anchor 100 in that, at least in that there is no notch formed in the distal portion of the body 210, the distal opening 240d has a more circular shape compared to the proximal opening 240p, and the position of the distal opening 240 facing the suture engagement feature 230 is different. Finally, as clearly illustrated by Figure 4, the suture limb 280 can pass through the distal opening 240d, extend distally toward the suture engagement feature 230, then extend around it, and subsequently extend proximal upward through the longitudinal lumen 220, and then exit through the proximal opening 240p. Due to the shape of the distal opening 240d and the absence of a notch, at least in this embodiment, the distance the suture limb 280 travels from the distal opening 240d to the suture engagement feature 230 is longer than the similar distance the suture limb 180 travels from the distal opening 140d to the suture engagement feature 130 of the anchor 100. Otherwise, the configuration and operation of the anchor 200 are similar to those of the anchor 100, as can be seen by those skilled in the art in consideration of this disclosure and the drawings, unless otherwise noted or understood to be different. In the illustrated embodiment of Figure 4, the anchor 200 does not engage the suture limb 280 along its entire length, but does engage the suture limb 280 along its entire length above the distal opening 240d, which qualifies as the substantial length of the anchor 200. One advantage of the suture anchor 200 is that, compared to the anchor 100, the distal end 210d has more material, allowing it to provide additional strength and resilience, which can be beneficial, for example, when the anchor 200 is inserted out-of-axis into a bone tunnel.This configuration makes the distal end 210d less susceptible to damage.

[0043] Figures 5A to 6 illustrate yet another embodiment of the suture anchor 300. The anchor 300 is similar to the aforementioned anchor (in particular, for example, anchor 100) in that it includes an elongated body 310 having a proximal end 310p and a distal end 310d extending along a longitudinal axis L3, a notched portion 310c, a tapered distal portion 310t, a longitudinal lumen 320 extending through it, a suture engagement feature 330 located within the distal portion of the body 310 in the lumen 320, a proximal opening 340p and a distal opening 340d, and a bone engagement feature 350. The illustrated embodiment is included to show an additional feature located on the outer surface of the anchor body 310, namely at least one projection 355, which is shown as a boss feature. The projections 355 are formed on opposing sides of the outer surface of the anchor body 310 and can project radially outward from the body 310. Any number of projections can be used, and their configuration relative to the body 310 can vary. The projections 355 have a longitudinal dimension (extending longitudinally as defined herein) that can provide some stability when the anchor is placed in a bone hole or bore 270 formed in the bone 275.

[0044] The projections 355 are configured to facilitate the manipulation of the suture rim 380 before the suture anchor 300 is fully inserted. For example, as illustrated in Figures 5A to 6, the projections 355 are configured such that at least a portion of the lateral opening 340d is positioned proximal to the proximal edge 270p of the bone hole 270 when a relatively planar surface positioned close to the entry point of the bone hole (i.e., the proximal edge 270p of the bone hole 270) engages with the distal end of at least one projection 355, thereby allowing the suture rim 380 to pass through the lateral opening 340d into the longitudinal lumen 320. As a result, the suture rim 380 can remain slidably coupled to the suture engagement feature 330, and can be manipulated because they are not yet trapped and are compressed between the bone engagement feature 350 of the body 300 and the surface (not shown) of the bone 275 forming the bone hole 270. This configuration is achieved in the illustrated embodiment by the projection 355 tapering radially outward as it extends toward the proximal end 310p of the body 310. As shown, the proximal end of the projection 355 cannot be tapered radially outward, i.e., the tapered configuration cannot extend along the entire longitudinal length of the projection 355. In some embodiments, the projection 355 can maintain at least a portion of the lateral opening 340d adjacent to the proximal edge 270p of the bone hole 270 by providing a physical obstruction that holds the suture anchor 300 in a partially inserted position into the bone hole 270. Applying additional force distal to the suture anchor 300 overcomes the physical obstruction and allows the suture anchor 300 to be fully inserted into the bone hole 270.

[0045] As will be discussed in more detail in other embodiments, the surgical procedure may include the step of applying tension to at least one of the two suture rims 380 to pull the tissue 290 toward the bone 275. The projection 355 can serve to ensure that the suture rim 380 remains slidable toward the anchor 300, such as by means of the suture engagement feature 330, while the anchor 300 is partially positioned within the bone hole 270, and therefore the projection 355 can assist in this operation during the surgical procedure. The suture rim 380 is not yet tightened between the outer surface of the body 310 and the surface defining the bone hole 270, thus allowing the suture rim 380 to be subjected to the desired tension application. Once the desired tension application is performed, the anchor 300 can be inserted into the bone hole 270 in a manner similar to that provided above or in other methods known to those skilled in the art. Therefore, the projection 355, while not an overall barrier, provides an obstruction for inserting the anchor 300 into the bone hole 270, which, if desired, helps position the anchor 300 in the bone hole 270 while manipulating the suture limb 380 and the tissue 290 associated therewith before finally fixing the position of the anchor 300 within the bone hole 270.

[0046] Figures 7A-7B and 8 illustrate another embodiment of the suture anchor 400. The anchor is similar to the aforementioned anchor (in particular, for example, anchor 100) in that it includes an elongated body 410 having a proximal end 410p and a distal end 410d extending along a longitudinal axis L4, a notched portion 410c, a tapered distal portion 410t, a longitudinal lumen 420 extending through it, a proximal opening 440p and a distal opening 440d, and a bone engagement feature 450. The illustrated embodiments include, to illustrate at least one embodiment in which there are no separately located suture engagement features, and to illustrate a configuration in which the proximal end 410p includes a flared portion 450f, wherein in the flared portion 450f, the diameter of the bone engagement feature(s) 450 at the proximal end is increased compared to the diameter of one or more bone engagement features 450 located more distally along the length of the anchor body 410.

[0047] As illustrated in Figure 8, if there is no separately positioned suture engagement feature, the suture limb 480 attached to the tissue 390 for pulling the tissue 390 toward the bone 375 is passed through the distal opening 440d, engages with the upper surface 410ct of the notch 410c, extends proximal through the lumen 420, and can exit through the proximal opening 440p (alternatively, one or more limbs can be passed through the longitudinal lumen 420 at the terminal portion of the proximal end 410p of the body 410). The upper surface 410ct of the notch 410c, which is also the surface defining the distal opening 440d, can function as a suture engagement feature, allowing the suture limb 480 to slide against the upper surface 410ct before the anchor 400 is fully implanted in the bone 375. As in other embodiments, once the anchor 400 is fully positioned within the bone hole 370 formed in the bone 375, the suture limb 380 can be confined between the outer surface of the body 410 and the surface 371 of the bone 375 defining the bone hole 370. Although this configuration is not illustrated, a similar configuration is provided with respect to the suture anchor 500 described below with respect to Figure 10. The anchor 500 also includes a flared portion at its nearest end, and therefore additional details regarding the flared portion 450f of the anchor 400 are described in more detail below with respect to the anchor 500.

[0048] Figure 7C illustrates an alternative configuration of the suture anchor 400' having a flared portion 450f'. The suture anchor 400' includes several feature parts of the suture anchor 400, such as a flared portion 450f' corresponding to the flared portion 450f, and several feature parts of the suture anchor 200, such as a more circular distal opening 440d' having a suture engagement feature part 430' arranged similarly to the equivalent feature part 230 of the suture anchor 200. Features such as the elongated body 410' having a proximal end 410p' and a distal end 410d' extending along the longitudinal axis L4', a tapered distal portion 410t', a longitudinal lumen 420', a proximal lateral opening 440p and a distal lateral opening 440d', and a bone engagement feature 450' are features seen in anchor 400', similarly found in many of the other embodiments described above, including anchors 400 and 200. Figure 7C specifically labels the difference between the diameter 450fd' of the flared portion 450f and the diameter 450d' of the bone engagement feature 450'. In some embodiments, the flared portion 450f' may have a diameter in the range of about 3 percent to about 20 percent larger than the diameter of the bone engagement feature located further distal to the anchor, or in the range of about 3 percent to about 10 percent larger than the diameter of the bone engagement feature located further distal to the anchor.

[0049] Figures 9A to 10 illustrate yet another embodiment of the suture anchor 500. The anchor here is similar to the anchor previously described (in particular, for example, anchor 100) in that it includes an elongated body 510 having a proximal end 510p and a distal end 510d extending along its longitudinal axis L5, a notched portion 510c, a tapered distal portion 510t, a longitudinal lumen 520 extending through it, a distal lateral opening 540d, a bone engagement feature 550, and a flared portion 550f located at the proximal end 510p. The illustrated embodiment shows an embodiment without the proximal lateral opening and is included to illustrate the impact of the flared portion 550f when the anchor 500 is implanted in a bone hole 470 formed in the bone 475. Furthermore, similar to the anchor 400, the upper surface 510ct of the notched portion 510c, which is also the surface defining the distal opening 540d, can function as a suture engagement feature, allowing the suture limb 580 to slide against the upper surface 510ct before the anchor 500 is fully implanted into the bone 475.

[0050] As shown in Figure 10, since there is no proximal opening, the suture rim 580 can extend from the tissue 490 through the distal opening 540d, engage with the upper surface 510ct of the notch 510c, and extend proximal through the longitudinal lumen 520 until the rim 580 exits the lumen 520 at the terminal portion of the proximal end 510p of the anchor body 510. As in other embodiments, the suture rim 580 can be captured between the outer surface of the body 510 and the surface 471 of the bone 475 defining the bone hole 470 by fully inserting the anchor 500 into the bone hole 470. However, unlike some other embodiments, as shown in the flared engagement section 550fs of Figure 10, the flared portion 550f can form a more stable fixation between the suture rim 580 and the anchor 500, at least in part, by the increased surface area for engaging the suture rim 580 resulting from the larger diameter of the flared portion 550f, and thus by the increased length of the suture rim 580 engaged by the flared portion 550f. In particular, while other methods may exist to improve retention, extending the anchor to do so is usually undesirable as it would occupy additional depth in the bone where implantation occurs. On the other hand, the use of the flared portion 550f increases the compressive force between the anchor 500 and the bone 475, i.e., the retaining force of the anchor 500, without replacing much additional bone with the anchor.

[0051] Figures 11A to 24 provide various suture anchor configurations, which allow for easier separation and control of the sutures. These may include configurations in which special surface features are formed on the body and / or distal portion of the anchor.

[0052] Figures 11A and 11B illustrate an exemplary embodiment of a suture anchor 600 having features designed to assist in controlling the placement, position, and / or movement of sutures. While the aforementioned embodiments are also useful in controlling the placement, position, and / or movement of sutures, rather, the suture anchor 600 includes a specific design in the anchor body 610 that allows multiple suture rims to be separated from each other for easier identification, while still allowing and controlling the desired slidable movement between the suture rims and the anchor.

[0053] Some embodiments of the anchor 600 are similar to the aforementioned anchors (in particular, for example, anchor 100) in that they include an elongated body 610 having a proximal end 610p and a distal end 610d extending along a longitudinal axis L6, a notched portion 610c, a tapered distal portion 610t, a longitudinal lumen 620 extending through it, a distal opening 640d, and a bone engagement feature 650. The illustrated embodiments differ from anchor 100 in that at least their distal opening 640d is specifically designed to provide two different surfaces 640d1, 640d2 (i.e., suture engagement surfaces or suture retention surfaces) that can receive the retaining suture limbs 680a, 680b, and thus these surfaces 640d1, 640d2 allow the suture limbs 680a, 680b to be separated from each other. Surfaces 640d1, 640d2, sometimes referred to as lobes (or branched lobes, the branching of which is obtained from the longitudinal axis L6), can be formed by the upper surface 610ct of the notched portion 610c and can provide pathways for suture limbs 680a, 680b. As illustrated, the notched portion 610c can have a Y-shaped configuration with lobes 640d1, 640d2 forming the upper portion of the Y-shaped configuration (i.e., the “arms” of the Y-shaped configuration), and a stem of the Y-shaped configuration extending from lobes 640d1, 640d2 to the distal end 610d of the body 610. Alternative shapes and / or configurations of the surface of the distal lateral opening are provided with respect to embodiments described later, and different shapes and / or configurations provide alternative retaining surfaces, forces, and pathways for the suture limbs associated therewith.

[0054] More specifically with respect to the anchor 600 in Figures 11A and 11B, the surfaces 640d1 and 640d2 are positioned on either side of the longitudinal axis L6. As shown, the surfaces 640d1 and 640d2 are curved toward each other opposite the longitudinal axis L6, are symmetrical, and form a scalloped structure or portion of the distal opening 640. As a result, at least two suture paths are formed, each on the opposing side of the longitudinal axis L6. As shown in Figure 11B, the two suture rims 680a and 680b can be separated, with one suture rim, indicated as rim 680a, engaging with surface 640d1, and the other suture rim, indicated as rim 680b, engaging with surface 640d2. This allows the rims 680a and 680b to be easily separated, identified, and retained relative to the anchor 600 at a certain distance apart. One advantage of such a configuration is the improved ease of handling of the suture limbs 680a and 680b when positioning them through the distal lateral opening 640d and through the longitudinal lumen 620, so that both limbs 680a and 680b can be inserted through the same terminal 640dt of the lateral opening 640d, which is also the terminal of the lumen 620. Separate lobes 640d1 and 640d2 that hold the two suture limbs 680a and 680b at a certain distance apart can reduce the possibility of intersection of the suture limbs fixed between the suture anchor and the bone hole during surgery. The illustrated configuration, and other configurations, may help prevent overlap of the suture limbs. Overlap of suture limbs can adversely affect the anchor's ability to hold the suture in the desired position.

[0055] Figures 12A and 12B illustrate another embodiment of the suture anchor 700. The anchor 700 is similar to the aforementioned anchors (in particular, for example, anchor 600) in that it includes an elongated body 710 having a proximal end 710p and a distal end 710d extending along a longitudinal axis L7, a notched portion 710c, a tapered distal portion 710t, a longitudinal lumen 720 extending through it, a distal lateral opening 740d, and a bone engagement feature 750. The illustrated embodiment is included to show an alternative configuration of the notched portion. As shown, the notched portion 710c includes surfaces 740d1 and 740d2, which have a more rectangular or window-like configuration compared to surfaces 640d1 and 640d2. Surfaces 740d1 and 740d2 can function as suture engagement surfaces of anchor 700 in the absence of separately located suture engagement features (e.g., suture engagement features 130, 330, and 430'). More specifically, as shown in the figure, surfaces 740d1 and 740d2 are positioned substantially across the longitudinal axis L7 of anchor body 710. The use and purpose of surfaces 740d1 and 740d2 are the same as those of surfaces 640d1 and 640d2. Thus, as shown in Figure 12B, the first suture limb 780a can be coupled to surface 740d1 or, if not, associated with it, and the second suture limb 780b can be coupled to surface 740d2 or, if not, associated with it, thereby keeping the two suture limbs 780a and 780b separate from each other. In the illustrated embodiment, the two surfaces 740d1 and 740d2 are located on either side of the longitudinal axis L7, but other configurations are also possible.

[0056] Figures 13A and 13B illustrate yet another embodiment of the suture anchor 800. The anchor 800 is similar to the aforementioned anchors (in particular, for example, anchor 600) in that it includes an elongated body 810 having a proximal end 810p and a distal end 810d extending along its longitudinal axis L8, a notched portion 810c, a tapered distal portion 810t, a longitudinal lumen 820 extending through it, a distal lateral opening 840d, and a bone engagement feature portion 850. Similar to anchors 400, 400', and 500, it also includes a flared portion 850f, which can serve the same purpose as the flared portions 450f, 450f', and 550f. The illustrated embodiments are included to show yet another alternative configuration of the notched portion. As illustrated, the notch 810c includes a shelf 840d1 which can engage the suture rim without the presence of a separately positioned suture engagement feature. The surface of shelf 840d1 can substantially traverse the longitudinal axis L8, allowing the suture rims 880a, 880b to engage with shelf 840d1, as shown in Figure 13B, so that the suture rim engages with other surfaces formed by the notch in other embodiments provided herein. The illustrated configuration may help to provide separation of the suture rims 880a, 880b at the corners 840dc1, 840dc2 of shelf 840d1 located on either side of the longitudinal axis L8. In some embodiments, the corners 840dc1, 840dc2 may include other configurations that allow divots, grooves, scallops, or suture rims 880a, 880b to be more easily separated from each other and held in their desired positions or in close proximity to them in the corners 840dc1, 840dc2.

[0057] Figures 14A and 14B illustrate another embodiment of the suture anchor 900. The anchor 900 is similar to the aforementioned anchors (in particular, for example, anchor 600) in that it includes an elongated body 910 having a proximal end 910p and a distal end 910d extending along a longitudinal axis L9, a notched portion 910c, a tapered distal portion 910t, a longitudinal lumen 920 extending through it, a distal lateral opening 940d, and a bone engagement feature 950. The illustrated embodiment is included to show another alternative configuration of the notched portion. More specifically, the cut portion 910c extends entirely through the volume of the anchor 900 and becomes a distal lateral opening 940d extending through the entire diameter of the anchor 900. As illustrated, the shape of the distal lateral opening 940d on the opposing surfaces of the anchor body 910 is symmetrical, but various shapes of the notches and distal openings provided herein can be mixed and matched, and / or other shapes and configurations can be utilized to form the distal lateral opening 940d, as well as other configurations. As described in previous embodiments, the upper surface 910ct of the notch 910c may be configured to further assist in separating and / or holding the suture limbs 980a, 980b apart.

[0058] Figures 15A and 15B illustrate yet another embodiment of the suture anchor 1000. The anchor 1000 has a longitudinal axis L 10It is similar to the anchor described above (in particular, anchor 600, for example) in that it includes an elongated body 1010 having a proximal end 1010p and a distal end 1010d extending along a certain line, a notched portion 1010c, a tapered distal portion 1010t, a longitudinal lumen 1020 extending through it, a distal lateral opening 1040d, and a bone engagement feature 1050. The illustrated embodiments are included to illustrate yet another alternative configuration of the notched portion. More specifically, the notched portion 1010c includes opposing longitudinal surfaces 1010c1, 1010c2, which have a diameter that changes between the upper surface 1010ct of the notched portion 1010c and the distal end 1010d. This causes the distal lateral opening 1040d to narrow to its narrowest position 1011, and then expands again until the surfaces 1010c1 and 1010c2 reach the distal end 1010d. As shown in the figure, the opposing longitudinal surfaces 1010c1 and 1010c2 are aligned along the longitudinal axis L 10 They are symmetrically opposed to each other. Similar to the notch 910c, the notch 1010c can extend completely through the volume of the anchor 1000 and form a distal lateral opening 1040d that extends through the entire diameter of the anchor 1000. Thus, the opposing longitudinal surfaces 1010c1 and 1010c2 of the notch 1010c are formed on both sides of the anchor body 1010. As shown in Figure 15B, the configuration of the anchor 1000 can enhance the retention of the suture limbs 1180a and 1180b to the distal lateral opening 1040d.

[0059] Figures 16A and 16B illustrate another embodiment of the suture anchor 1100. The anchor 1100 is located along the longitudinal axis L 11This is similar to the aforementioned anchors (in particular, anchor 200, for example) in that it includes an elongated body 1110 having a proximal end 1110p and a distal end 1110d extending along a certain line, a tapered distal portion 1110t, a longitudinal lumen 1120 extending through it, a distal lateral opening 1140d, and a bone engagement feature 1150. The illustrated embodiment is included to show a configuration in which the distal lateral opening 1140d extends to the opposite side of the anchor body 1110 but does not extend all the way to the distal end 1110d. As shown, the distal lateral opening 1140d has a substantially elliptical shape or cross-section and extends from one side of the anchor body 1110 to the opposite side of the anchor body 1110. As shown in Figure 16B, the two suture limbs 1180a and 1180b are positioned through opposing sides 1140da and 1140db of the distal lateral opening 1140d, respectively, and can pass through the longitudinal lumen 1120. As with other embodiments, alternative embodiments may include one or more other lateral openings, such as a proximal lateral opening (not shown), and one or both suture limbs 1180a and 1180b can pass through such openings instead of, or in addition to, passing through the longitudinal lumen 1120 at the proximal end 1110p of the body 1110.

[0060] Figure 17 illustrates yet another embodiment of the suture anchor 1200. The anchor 1200 has a longitudinal axis L 12It is similar to the aforementioned anchors (in particular, anchor 100, for example) in that it includes an elongated body 1210 having a proximal end 1210p and a distal end 1210d extending along a certain line, a tapered distal portion 1210t, a longitudinal lumen 1220 extending through it, and a bone engagement feature portion 1250. Somewhat similar to anchor 600 in Figures 11A-11B, the illustrated embodiments include an anchor 1200 that includes two separately formed surfaces for the purpose of distinguishing, holding, or otherwise separately identifying two or more suture limbs. More specifically, as illustrated, anchor 1200 includes two distal lateral openings 1240d1, 1240d2, which are separated by a longitudinal wall 1241 extending to the distal end 1210d, thereby forming branching passages within anchor 1200. In the illustrated embodiment, the longitudinal wall 1241 is along the longitudinal axis L 12 Although it extends along the longitudinal lumen, those skilled in the art will recognize that it does not necessarily form two equally sized distal openings 1240d1, 1240d2, and / or two or more such walls may be provided in other embodiments, and that they may be located in other positions. The longitudinal wall 1241 may, but does not have to, extend into part or all of the longitudinal lumen 1200. This configuration clearly defines the positions through which the suture rims 1280a, 1280b can pass. In the illustrated embodiment, suture rim 1280a passes through the distal opening 1240d1 and upward through the longitudinal lumen 1220 before exiting the lumen 1220 at its proximal end 1210p, and suture rim 1280b passes through the distal opening 1240d2 and similarly upward through the longitudinal lumen 1220 before exiting the lumen 1220 at its proximal end 1210p. As in other embodiments, in alternative configurations, one or both of the suture rims 1280a, 1280b can exit the longitudinal lumen 1220 through one or more other lateral openings (not shown) formed within the anchor body 1210.

[0061] Figure 18 illustrates another embodiment of the suture anchor 1300. The anchor 1300 has a longitudinal axis L 13It is similar to the anchor described above (in particular, for example, anchor 1200) in that it includes an elongated body 1310 having a proximal end 1310p and a distal end 1310d extending along a certain line, a tapered distal portion 1310t, a longitudinal lumen 1320 extending through therethrough, two distal lateral openings 1340d1, 1340d2, longitudinal walls 1341, 1340d2 extending to the distal end 1310d and separating the two distal lateral openings 1340d1, and a bone engagement feature portion 1350. The illustrated embodiment includes to show a configuration in which the elongated body 1310 can be separated into a proximal portion or proximal main member 1310a and a plurality of parts, such as a distal portion or distal tip member 1310b. As illustrated, an insertion rod 1360 may be provided to assist in implanting a suture anchor 1300 during a surgical procedure. The combination of the anchor 1300 and the rod 1360 can be considered a suture anchor insertion assembly. In the illustrated embodiment, the distal portion 1310b of the anchor body 1310 can be mounted on the distal end 1360d of the insertion rod, and the proximal portion 1310a of the anchor body 1310 is slidably positioned on the rod 1360 and can translate along the rod 1360 to selectively couple with the distal portion 1310b. Any number of known techniques for mating one component with another can be used to mat the proximal portion 1310a with the distal portion 1310b. One advantage provided by this configuration is that it may be easier to control the suture tension compared to other embodiments provided herein that do not separate the fixation to the two parts or components.

[0062] Figures 19A and 19B illustrate two embodiments of a suture anchor insertion assembly, which include both of two further embodiments of suture anchors 1400, 1400' and insertion rods 1460, 1460'. Each anchor 1400, 1400' has its longitudinal axis L 14 , L 14an elongated body 1410, 1410' having proximal ends 1410p, 1410p' and distal ends 1410d, 1410d' extending along '; a tapered distal portion 1410t, 1410t'; a longitudinal lumen 1420, 1420' extending therethrough; a bone engaging feature 1450, 1450'; and a separable proximal portion or proximal main member 1410a, 1410a' and a distal portion or distal tip member 1410b, 1410b' of the elongated body 1410, 1410', and is similar to the aforementioned anchor (in particular, for example, anchor 1300). In the illustrated embodiment, the longitudinal lumens 1420, 1420' extend through the proximal main members 1410a, 1410a' but do not extend through the distal tip members 1410b, 1410b', although in other embodiments, the longitudinal lumens 1420, 1420' may extend through part or all of the distal tip members 1410b, 1410b'. The anchor 1400 is also similar to the anchor 1300 in that its distal portion 1410b includes two distal side openings 1440d1, 1440d2, while the anchor 1400' is similar to the anchor 600 of Figures 11A-11B in that it includes one distal side opening 1440d' having different inner surfaces 1440d1', 1440d2' (i.e., suture engaging surfaces) formed therein in a Y-shaped configuration. Accordingly, similar to the surfaces 640d1', 640d2 of the anchor 600, the surfaces 1440d1', 1440d2' may be identified as lobes or scallops of the single opening 1440d'. In both embodiments, the surfaces 1440d1, 1440d2 of the respective distal side openings 1440d1, 1440d2 and the surfaces 1440d1', 1440d2' of the distal side opening 1440d' are positioned on the longitudinal axis L 14 , L 14 ' symmetrically on opposite sides of .

[0063] As illustrated, the distal tip members 1410b, 1410b' may be removably fitted to the distal ends 1460d, 1460d' of the insertion rods 1460, 1460', and the proximal main members 1410a, 1410a' may be slidably disposed along the rods 1460, 1460', but those skilled in the art will understand that other configurations may be used for inserting the separable portions of the anchor body without departing from the spirit of the present disclosure. The insertion rods 1460, 1460' can be disengaged from the distal tip members 1410b, 1410b' during a surgical procedure, such as after the distal tip members 1410b, 1410b' are positioned in a desired location within a bore formed in the bone, and / or after the proximal main members 1410a, 1410a' have been inserted and fixed to the distal tip members 1410b, 1410b'. In particular, embodiments such as the assemblies in Figures 19A and 19B are schematic illustrative diagrams, and those skilled in the art will understand that components including, but not limited to, the insertion rods 1460 and 1460' can have many different configurations, including larger and smaller diameters, shapes, lengths, etc.

[0064] The bone engagement feature 1450 in Figure 19A differs from the bone engagement feature 1450' in Figure 19B, in that the bone engagement feature 1450 includes a single corkscrew-like thread extending radially around the outer surface of the elongated body 1410, compared to the projection or rib forming the bone engagement feature 1450'. In either case, as with the bone engagement features of the various embodiments provided herein, the bone engagement features 1450, 1450' help facilitate the secure engagement of the proximal main members 1410a, 1410a' in a bone hole or bore formed within a bone hole. As described elsewhere in this specification, suture limbs 1480a, 1480b, 1480a', 1480b' are passed through distal lateral openings 1440d1, 1440d2, 1440d', through longitudinal luminals 1420, 1420', and out of luminals 1120, 1120' at the proximal ends 1410p, 1410p' of the main body 1410, 1410', or one or more other lateral openings (not shown), where they can be captured between bone engagement features 1450, 1450' and the bone surface forming a bore in the bone, respectively. The bone engagement features 1450, 1450' can provide frictional force to the suture rims 1480a, 1480b, 1480a', 1480b' configured to be fixed to the surgical site by anchors 1400, 1400', and can also provide additional surface area, thereby allowing the rims 1480a, 1480b, 1480a', 1480b' to engage when the anchors 1400, 1400' are implanted into bores formed in the bone. Similar to the suture anchor 1300 in Figure 18, one advantage provided by the configuration of the suture anchors 1400, 1400' in Figures 19A and 19B is that it may be easier to control the suture tension compared to other embodiments provided herein that do not separate the fixation to two parts or components.

[0065] Figures 20A and 20B illustrate two further embodiments of the suture anchor insertion assembly, including two further embodiments of suture anchors 1500, 1500' and insertion rods 1560, 1560'. Each anchor 1500, 1500' is oriented along the longitudinal axis L 15 , L 15It is similar to the anchors described above (in particular, for example, anchors 1400, 1400') in that it includes elongated bodies 1510, 1510' having proximal ends 1510p, 1510p' and distal ends 1510d, 1510d' extending along ', tapered distal portions 1510t, 1510t', longitudinal lumens 1520, 1520' extending through them, bone engagement features 1550, 1550', and separable proximal portions or proximal main members 1510a, 1510a' and distal portions or distal tip members 1510b, 1510b' of the elongated bodies 1510, 1510'. Similar to the longitudinal lumens 1420, 1420', the longitudinal lumens 1520, 1520' extend through the proximal main members 1510a, 1510a' and may or may not extend into at least some portions of the distal tip members 1510b, 1510b'. The configuration of the distal lateral openings 1540d1, 1540d2, 1540d' is also similar, except that the openings themselves are not completely enclosed, and can be described as grooves. The openings 1540d1, 1540d2, 1540d' have distal ends 1540de1, 1540de2, 1540de' that are themselves open, and they are aligned along the longitudinal axis L 15 , L 15By moving substantially parallel to the grooves, the suture limbs 1580a, 1580b, 1580a', 1580b' are made able to pass through the open distal end and come into contact with the grooves 1540d1, 1540d2, 1540d'. In the illustrated embodiment, schematic diagrams of bones 1475, 1475' are provided, illustrating how the distal end members 1510b, 1510b' can engage with the bone to close the openings 1540d1, 1540d2, 1540d'. However, during use, the openings 1540d1, 1540d2, and 1540d' can remain open at their distal ends, for example, if appropriate tension is applied to the associated suture limbs 1580a, 1580b, 1580a', and 1580b', so as not to fall, or, if not, to the surfaces 1540d1, 1540d2, and 1540d' of the opening 1540d', more specifically, to the surfaces 1540d1 and 1540d2 of the opening 1540d'. Similar to the suture anchor 1300 in Figure 18 and the suture anchors 1400, 1400' in Figures 19A and 19B, one of the advantages provided by the configuration of the suture anchors 1500, 1500' in Figures 20A and 20B is that it may be easier to control the suture tension compared to other embodiments provided herein that do not separate the fastening to two parts or components.

[0066] Figure 21 illustrates yet another embodiment of a suture anchor insertion assembly, including a suture anchor 1600 and an insertion rod 1660. The anchor 1600 has a longitudinal axis L 16It is similar to the anchors described above (in particular, for example, anchors 1500, 1500') in that it includes an elongated body 1610 having a proximal end 1610p and a distal end 1610d extending along a certain line, a tapered distal portion 1610t, a longitudinal lumen 1620 extending through it, a bone engagement feature 1650, and a separable proximal portion or proximal main member 1610a and distal portion or distal tip member 1610b of the elongated body 1610. The illustrated embodiment is included to illustrate a non-limiting embodiment in which a feature designed to more easily separate or retain or identify the suture limb is formed at another location beyond the distal tip member when the anchor includes multiple components. More specifically, in the illustrated embodiment, equivalents of grooves 1540d1', 1540d2' are formed in the proximal main member 1610a. As illustrated, surfaces 1640d1, 1640d2 of the distal lateral opening 1640d can be formed on the distal end 1610ad of the proximal main member 1610a, and surfaces 1640d1, 1640d2 forming a lobe or scallop are configured to receive and hold suture limbs 1680a, 1680b. In the illustrated embodiment, the portion of the rod 1660 passing through the opening 1640d is removed to facilitate viewing of the distal lateral opening 1640d. Furthermore, the distal tip member 1610b may also include one or more distal lateral openings, as shown in the second distal lateral opening 1640d'. Therefore, in some cases, such as the illustrated embodiments, the suture limbs 1680a, 1680b may pass through the second distal lateral opening 1640d' of the distal tip member 1610b, across the surfaces 1640d1, 1640d2 formed on the proximal main member 1610a, and through at least a portion of the longitudinal lumen 1620 before exiting the lumen 1620 at the proximal end 1610p of the elongated body 1610, or through another lateral opening (not shown). In other embodiments, the suture limbs 1680a, 1680b may not pass through any portion of the distal tip member 1610b.Furthermore, similar to the suture anchor 1300 in Figure 18, the suture anchors 1400 and 1400' in Figures 19A and 19B, and the suture anchors 1500 and 1500' in Figures 20A and 20B, one of the advantages provided by the configuration of the suture anchor 1600 in Figure 21 is that it may be easier to control the suture tension compared to other embodiments provided herein that do not separate the fastening to two parts or components.

[0067] While this disclosure has already provided several non-limiting examples of disclosed anchors and assemblies used in conjunction with surgical procedures, further procedures will be well understood by those skilled in the art based on the features and descriptions of various anchor embodiments, and Figures 22A–22B provide further non-limiting examples of surgical procedures utilizing the devices and assemblies disclosed herein, more specifically, the assembly including anchor 1400 and rod 1460 of Figure 19A.

[0068] The process may include joining the suture limbs 1480a, 1480b to the tissue 1390 by passing the suture limbs 1480a, 1480b through the tissue 1390 and / or by wrapping the suture limbs 1480a, 1480b around the tissue 1390. The limbs 1480a, 1480b can then be passed through the respective distal lateral openings 1440d1, 1440d2 formed in the distal tip member 1410b. The limbs 1480a, 1480b can then be passed upward through the longitudinal lumen 1420 formed in the proximal main member 1410a, and the limbs 1480a, 1480b exit the proximal main member 1410a at the proximal end 1410p of the elongated body 1410. In embodiments including other lateral openings, one or more rims 1480a, 1480b may exit through the lateral openings instead of, or in addition to, exiting through the proximal end 1410p of the main body 1410. The distal end member 1410b may be positioned within a bore or hole 1370 formed in the bone 1375 to which the tissue 1390 is fixed. This can be achieved, for example, by using a rod 1460 to insert the distal end member 1410b into the surgical site.

[0069] After the distal tip member 1410b is positioned in its desired location, such as when the distal end 1410d of the main body 1410 contacts the distal end of the bone hole 1370, the proximal main member 1410a can be lowered by sliding the rod 1460 so that it abuts against the distal tip member 1410b, as illustrated in Figure 22B. They can be fixedly joined together using any technique known to those skilled in the art, if desired. As the proximal main member 1410a enters the bone hole 1370, at least portions of the suture limbs 1480a, 1480b can be engaged by both the bone engagement feature 1450 and the surface 1371 of the bone 1375 defining the hole 1370. This occurs in the three-dimensional abstract of the viewer-oriented figure in Figure 22, similar to how the bone engagement feature portion 150 of the anchor 100 in Figure 2B engages with the surface 71 of the bone 75 defining the suture limb 180 and bone hole 70 between them. The insertion of the proximal main member 1410a toward the distal tip member 1410b can be in a locking configuration, in which the suture limbs 1480a, 1480b are locked in place with respect to the anchor 1400 and bone 1375, and then the tissue 1390 is locked in place with respect to the anchor 1400 and bone 1375. This can occur after the proximal main member 1410a and the distal tip member 1410b are connected, or at some point before that if the proximal main member 1410a is sufficiently deep into the bone hole 1370. The rod 1460 can be disengaged from the distal tip member 1410b after the proximal main member 1410a has been positioned as desired. In other embodiments, the rod 1460 may not be used to assist in inserting the proximal main member 1410a, in which case it may be removed before advancing the proximal main member 1410a distally toward the distal tip member 1410b.

[0070] The suture limbs 1480a, 1480b can be operated to pull the tissue 1390 toward the anchor 1400, and therefore toward the bone 1375. Alternatively, or additionally, the suture limbs 1480a, 1480b can be sufficiently tensed to allow the tissue 1390 to be pulled toward the bone 1375 by advancing the proximal main member 1410a distal end member 1410b distally. Furthermore, while the illustrated embodiment provides associating the suture limbs 1480a, 1480b with the anchor 1400 before insertion, the suture limbs 1480a, 1480b can be associated with at least some portion of the anchor 1400 after at least a portion of the anchor 1400 has been implanted in the bore 1370. For example, the suture limbs 1480a and 1480b can be coupled to the distal lateral openings 1440d1 and 1440d2 before the distal tip member 1410b is inserted into the bore 1370, but can be passed through the longitudinal lumen 1420 after the distal tip member 1410b has been inserted into the bore 1370. Those skilled in the art will understand that most of the steps provided in conjunction with the surgical methods described herein can be performed in a different order without departing from the spirit of this disclosure.

[0071] Figure 23 illustrates another non-limiting embodiment of a suture anchor insertion assembly and its use. The suture anchor insertion assembly includes a suture anchor 1700 and an insertion rod 1760. The anchor 1700 has a longitudinal axis L 17It is similar to the aforementioned anchor (in particular, for example, anchor 1600) in that it includes an elongated body 1710 having a proximal end 1710p and a distal end 1710d extending along a certain direction, a tapered distal portion 1710t, a longitudinal lumen 1720 extending through it, a bone engagement feature 1750, a separable proximal portion or proximal main member 1710a and distal portion or distal tip member 1710b of the elongated body 1710, a distal lateral opening 1740d formed in the proximal main member 1710a having surfaces 1740d1, 1740d2, and a second distal lateral opening 1740d' formed in the distal tip member 1710b. An illustrated embodiment is included to illustrate a second embodiment, in which the projection 1755 is formed on the outer surface of the anchor body 1710 for similar reasons as the projection 355 of the anchor 300 illustrated in Figures 5A-6, and more specifically, on the proximal main member 1710a. As shown, the projection 1755 is formed on the opposing surface of the body 1710. The projection 1755 can engage with the upper surface 1675t of the bone 1675, thereby enabling the manipulation of the suture limbs 1780a, 1780b with respect to the anchor 1700 and associated tissue 1690. More specifically, the suture limbs 1780a and 1780b can slide through the longitudinal lumen 1720 of the main body 1710, in contact with the surfaces 1740d1 and 1740d2 of the distal opening 1740d, before applying sufficient force to overcome the obstruction caused by the projection 1755. Even after the proximal main member 1710a has advanced toward the distal tip member 1710b into the bore 1670 formed in the bone 1675, several operations of the suture limbs 1780a and 1780b relative to the anchor 1700 may be possible.

[0072] Various embodiments of suture anchors and insertion assemblies provided herein enable improved suture tension and, furthermore, maximize the suture retention force associated with the resulting suture tension. This is at least in part due to the various configurations of the lateral openings (e.g., particularly the proximal lateral opening 140p and the distal lateral opening 140d), the suture engagement features (e.g., particularly the suture engagement feature 130), and the bone engagement features (e.g., particularly the bone engagement feature 150), as well as the way in which the suture limb interacts with the various configurations during the surgical procedure. Once implantation occurs, the associated suture limb is also firmly held by being captured by the outer surface of the anchor and the bone surface defining the bone hole into which the anchor is implanted. The various embodiments also facilitate the implantation procedure for the aforementioned reasons related to tension, and by making it easier to hold, separate, and / or identify the suture, for example, by specially configured distal lateral openings (e.g., particularly the distal lateral opening 640d).

[0073] Those skilled in the art will recognize further features and advantages of the present disclosure based on the embodiments described above. Therefore, the present disclosure and related inventions are not limited to what is specifically shown and described, except as indicated by the appended claims. For example, to the extent that the disclosure provided herein describes devices and methods used in conjunction with soft tissue repair, those skilled in the art may apply these disclosures to other surgical procedures requiring suture retention to bone, to other anatomical structures, and at other locations in the body, without departing from the spirit of the disclosure. Furthermore, although the devices and methods provided herein are generally intended for surgical techniques, at least some of these devices and methods may be used in applications outside the surgical field. Those skilled in the art will also understand that various features and / or elements of different embodiments of the present disclosure can be combined in various ways. Unless it is clearly physically impossible to achieve, one or more features from one embodiment may be combined with one or more features from one or more other embodiments. Furthermore, insofar as a particular embodiment illustrates a side opening that extends only partially through the volume of the anchor or entirely through the volume of the anchor, those skilled in the art will recognize that such a configuration can be modified, as needed, to allow the opening to extend entirely through the volume or the anchor, or only partially through the volume of the anchor.

[0074] [Implementation Method] (1) A suture implantation assembly, Insertion rod and A distal tip member, detachably coupled to the distal end of the insertion rod, having a suture engagement feature configured such that a plurality of suture rims are slidably coupled to it, A proximal main member comprises an elongated cylindrical body having one or more bone engagement features arranged on its outer surface and a longitudinal lumen extending from the proximal end to the distal end, wherein the proximal main member is slidably positioned on the insertion rod, which is detachably positioned through the longitudinal lumen, and the proximal main member is located proximal to the distal tip member, and the proximal main member is configured to allow a plurality of suture limbs slidably coupled to the distal tip member to pass through at least a portion of the elongated cylindrical body in the proximal direction from a first position on the elongated cylindrical body to a second position on the elongated cylindrical body, wherein the first position is closer to the distal end of the elongated cylindrical body than the second position, One of the distal tip member and the proximal main member has a first suture rim retaining surface formed internally on a first side of the central longitudinal axis extending to the center through the longitudinal lumen from the projection image, and a second suture rim retaining surface formed internally on a second side of the central longitudinal axis opposite to the first side from the projection image, wherein a portion of the first suture rim retaining surface closest to the proximal end of the distal tip member is located separately from a portion of the second suture rim retaining surface closest to the proximal end of the distal tip member. Therefore, a suture implantation assembly in which the first rim of the plurality of suture rims slidably coupled to the distal tip member may be positioned in contact with the portion of the first suture rim holding surface closest to the proximal end of the distal tip member, and the second rim of the plurality of suture rims slidably coupled to the distal tip member may be positioned in contact with the portion of the second suture rim holding surface closest to the proximal end of the distal tip member, and the first suture rim and the second suture rim are maintained at a certain distance apart from each other. (2) The suture implantation assembly according to Embodiment 1, wherein the first suture rim retaining surface comprises a first bore, and the second suture rim retaining surface comprises a second bore, and the first bore and the second bore are located on the first and second sides of the central longitudinal axis. (3) The suture implantation assembly according to Embodiment 1, wherein the first suture rim retaining surface is part of a first lobe, the second suture rim retaining surface is part of a second lobe, the first lobe and the second lobe are part of a single bore, and the nearest portions of the first lobe and the second lobe are on the first and second sides of the central longitudinal axis. (4) The suture implantation assembly according to Embodiment 1, wherein the first suture rim retaining surface and the second suture rim retaining surface are located on the distal tip member. (5) The suture implantation assembly according to Embodiment 1, wherein the first suture rim retaining surface and the second suture rim retaining surface are located on the proximal main member.

[0075] (6) The suture implantation assembly according to Embodiment 5, wherein the first suture rim retaining surface and the second suture rim retaining surface are part of at least one opening formed in the proximal main member, so that the distal end of the opening is located at the distal end of the proximal main member, thereby forming a location into which the first suture rim and the second suture rim can enter the at least one opening in order to slidably bond to the first suture rim retaining surface and the second suture rim retaining surface. (7) The suture implantation assembly according to Embodiment 1, further comprising one or more projections radially outward from the outer surface of the distal portion of the proximal main member, wherein at least one of the projections is configured such that when a relatively planar surface located close to the bore entry point engages with the distal end of the at least one projection, at least a portion of at least one of the first suture rim retaining surfaces and the second suture rim retaining surfaces is located proximal to the relatively planar surface, so that at least one of the first or second rims of the plurality of suture rims slidably coupled to the respective first and second retaining surfaces remains slidable relative to the respective first and second retaining surfaces. (8) The suture implantation assembly according to Embodiment 7, wherein the distal end of at least one projection is tapered radially outward as the projection extends toward the proximal end of the proximal main member. (9) The proximal main member further comprises a flared portion located at the proximal end, The suture implantation assembly according to Embodiment 8, wherein the combination of the flared portion and any portion of the one or more bone engagement surfaces formed on the flared portion has a diameter greater than the diameter formed by the combination of the proximal main member distal to the flared portion and the one or more bone engagement surfaces arranged on the outer surface of the proximal main member. (10) A surgical method for fixing tissue to bone, The suture is attached to the tissue such that two suture limbs extend from the tissue, Each of the two suture rims is connected to one or more suture engagement features such that the two suture rims are slidably positioned relative to one or more suture engagement features of the distal tip member of the suture anchor, The two suture rims are positioned to pass through at least a portion of the proximal main member of the suture anchor from one or more suture engagement features of the distal tip member, wherein the first rim of the two suture rims engages with a first surface defining a portion of at least one opening formed in one of the distal tip member and the proximal main member, located on the first side of the central longitudinal axis extending centrally through the suture anchor from the projection image, and the second rim of the two suture rims engages with a second surface defining a portion of at least one opening formed in one of the distal tip member and the proximal main member, located on the second side of the central longitudinal axis opposite to the first side from the projection image, so that the first rim and the second rim are maintained at a certain distance from each other on opposite sides of the central longitudinal axis. Inserting the distal tip member into a bore formed in the bone, To pull the tissue toward the bone, tension is applied to at least one of the two suture limbs, A method comprising advancing the proximal main member distally toward the distal tip member to lock the two suture rims in place, thereby causing the tissue to bond to the bone at a certain location.

[0076] (11) The at least one opening is formed within the distal tip member, and the one or more suture engagement features are provided with the at least one opening. The surgical method according to Embodiment 10, further comprising connecting each of the two suture rims to one or more suture engagement features of the distal tip member, by engaging the first rim with the first surface of the at least one opening and engaging the second rim with the second surface of the at least one opening. (12) The at least one opening is formed in the proximal main member, The surgical method according to Embodiment 10, wherein the operation of connecting each of the two suture limbs to one or more suture engagement features of the distal tip member occurs before the operation of passing the two suture limbs from the one or more suture engagement features of the distal tip member into and through at least a portion of the proximal main member of the suture anchor. (13) The surgical method according to Embodiment 10, wherein the action of inserting the distal tip member into a bore formed in the bone further includes advancing the insertion rod to which the distal tip member is attached toward the bore formed in the bone, and the proximal main member is slidably positioned on the insertion rod. (14) The surgical method according to Embodiment 10, further comprising advancing the proximal main member distally toward the distal tip member in order to lock the two suture rims into place, inserting the proximal main member into the bone hole so that a surface engagement feature formed on its outer surface engages with the bone surface defining the bore. (15) Further comprising moving the proximal main member toward the bore formed in the bone until one or more projections positioned on the proximal main member engage with the bone adjacent to the bore, wherein the proximal main member cannot advance further toward the bore without an additional amount of force being applied to the proximal main member, and the engagement of the one or more projections with the bone provides a gap between the proximal main member and the proximal edge of the bore to adapt to the movement of the suture rim toward the first and second surfaces, The surgical method according to Embodiment 10, wherein advancing the proximal main member distally toward the distal tip member in order to lock the two suture rims in place results in the elimination of the gap.

[0077] (16) A suture anchor, An elongated anchor body having a proximal end, a distal end, and a longitudinal lumen extending from the distal end to the proximal end along the length of the elongated anchor body, wherein the distal tip portion associated with the distal end of the suture anchor is tapered, and the diameter defined at the distal end by the outer surface of the elongated anchor body is smaller than the diameter defined at the proximal end of the distal tip portion by the outer surface of the elongated anchor body, One or more bone-engaging surfaces are arranged on the outer surface of the elongated anchor body and configured to engage with bone, The elongated anchor body comprises at least one lateral opening formed on the outer surface, which is in direct communication with the longitudinal lumen so that a suture rim can pass through the lateral opening and into the longitudinal lumen, A suture anchor wherein the proximal end of at least one lateral opening is shaped such that at least two separate suture guide paths are formed, and the at least two separate suture guide paths include a first suture guide path positioned on a first side of a central longitudinal axis extending through the at least one lateral opening from the projection image, and a second suture guide path positioned on a second side of the central longitudinal axis from the projection image, wherein the second side is opposite to the first side. (17) The surgical anchor according to embodiment 16, wherein the shape of the at least one side opening includes a scalloped portion. (18) The suture anchor according to Embodiment 17, wherein the at least one lateral opening comprises a distal portion including a channel and a proximal portion including the scallop portion, the scallop portion including the first guide path and the second guide path. (19) The suture anchor according to Embodiment 16, further comprising one or more projections radially outward from the outward-facing surface of the distal portion of the suture anchor, wherein at least one of the projections is configured such that when a relatively planar surface positioned close to the bore entry point engages with the distal end of the at least one projection, at least a portion of at least one of the first suture guide paths and the second suture guide path is positioned proximal to the relatively planar surface, so that a suture rim passing through the lateral opening and into the longitudinal lumen is slidably coupled to and slidable toward the respective first suture guide path and the second suture guide path. (20) The suture anchor according to embodiment 19, wherein the distal end of at least one projection is tapered radially outward as the projection extends toward the proximal end of the suture anchor.

[0078] (21) The slender anchor body further comprises a flared portion located at the proximal end, The suture anchor according to Embodiment 16, wherein the combination of the flared portion and any portion of the one or more bone engagement surfaces formed on the flared portion has a diameter larger than the diameter formed by the combination of the elongated anchor body distal to the flared portion and the one or more bone engagement surfaces arranged on the outer surface of the elongated anchor body.

Claims

1. A suture implantation assembly, Insertion rod and A distal tip member, detachably coupled to the distal end of the insertion rod, having a suture engagement feature configured such that a plurality of suture rims are slidably coupled to it, A proximal main member has an elongated cylindrical body comprising one or more bone engagement features arranged on its outer surface and a longitudinal lumen extending from the proximal end to the distal end, wherein the proximal main member is slidably positioned on the insertion rod, which is detachably disposed through the longitudinal lumen, and the proximal main member is located proximal to the distal tip member, and the proximal main member is configured to allow a plurality of suture limbs slidably coupled to the distal tip member to pass through at least a portion of the elongated cylindrical body in the proximal direction from a first position on the elongated cylindrical body to a second position on the elongated cylindrical body, wherein the first position is closer to the distal end of the elongated cylindrical body than the second position, The proximal main member has a first suture rim retaining surface formed internally on a first side of the central longitudinal axis extending centrally through the longitudinal lumen from the projection image, and a second suture rim retaining surface formed internally on a second side of the central longitudinal axis opposite to the first side from the projection image, wherein a portion of the first suture rim retaining surface closest to the proximal end of the distal tip member is located separately from a portion of the second suture rim retaining surface closest to the proximal end of the distal tip member. Therefore, the first rim of the plurality of suture rims slidably coupled to the distal tip member may be positioned in contact with a portion of the first suture rim holding surface closest to the proximal end of the distal tip member, and the second rim of the plurality of suture rims slidably coupled to the distal tip member may be positioned in contact with a portion of the second suture rim holding surface closest to the proximal end of the distal tip member, and the first rim and the second rim are held at a certain distance apart from each other. One or more protrusions are arranged radially outward from the outer surface of the distal portion of the proximal main member, and when at least one of the protrusions engages with a relatively planar surface located close to the entry point of the hole, at least a portion of at least one of the first suture rim retaining surface and the second suture rim retaining surface is positioned proximal to the relatively planar surface, so that at least one of the first rim or the second rim of the plurality of suture rims slidably coupled to the first suture rim retaining surface and the second suture rim retaining surface, respectively, remains slidable relative to the first suture rim retaining surface and the second suture rim retaining surface, respectively. A suture implantation assembly wherein the relatively planar surface is the outer surface of the hole, and the distal end of the at least one projection is the axial end face of the proximal main member at the distal end of the at least one projection.

2. The suture implantation assembly according to claim 1, wherein the first suture rim retaining surface comprises a first bore, and the second suture rim retaining surface comprises a second bore, and the first bore and the second bore are located on the first and second sides of the central longitudinal axis, respectively.

3. The suture implantation assembly according to claim 2, wherein the first bore and the second bore open at the distal end of the proximal main member and penetrate from the outer surface of the proximal main member to the longitudinal lumen.

4. The suture implantation assembly according to claim 1, wherein the first suture rim retaining surface and the second suture rim retaining surface are part of a single bore, and the nearest portions of the first suture rim retaining surface and the second suture rim retaining surface are located on the first and second sides of the central longitudinal axis, respectively.

5. The suture implantation assembly according to claim 4, wherein the single bore opens at the distal end of the proximal main member and penetrates from the outer surface of the proximal main member to the longitudinal lumen.

6. The suture implantation assembly according to claim 4, wherein the single bore is a first distal opening and the suture engagement feature is a second distal opening.

7. The suture implantation assembly according to claim 1, wherein the first suture rim retaining surface and the second suture rim retaining surface are part of at least one opening formed in the proximal main member, and the distal end of the opening is located at the distal end of the proximal main member, thereby forming a location into which the first rim and the second rim can enter the at least one opening in order to slidably bond to the first suture rim retaining surface and the second suture rim retaining surface.

8. The suture implantation assembly according to claim 1, wherein the distal end of the at least one projection is tapered radially outward as the projection extends toward the proximal end of the proximal main member.

9. The proximal main member further comprises a flared portion located at the proximal end, The suture implantation assembly according to claim 8, wherein the combination of the flared portion and any portion of one or more bone engagement surfaces formed on the flared portion has a diameter greater than the diameter formed by the combination of the proximal main member distal to the flared portion and one or more bone engagement surfaces arranged on the outer surface of the proximal main member.

10. The suture implantation assembly according to claim 1, wherein the proximal main member includes a first distal opening having the first suture rim retaining surface and the second suture rim retaining surface, and the suture engagement feature includes a second distal opening.

11. The suture implantation assembly according to claim 10, wherein the second distal opening extends from the first side of the distal tip member corresponding to the first side of the proximal main member to the second side of the distal tip member corresponding to the second side of the proximal main member.

12. The suture implantation assembly according to claim 1, wherein the outer diameter of the distal tip member is smaller than the diameter of the hole.

13. The suture implantation assembly according to claim 1, wherein the two protrusions are arranged at opposing positions on the outer surface.

Images