WO2017152026A1

WO2017152026A1 - Push-in anchor

Info

Publication number: WO2017152026A1
Application number: PCT/US2017/020617
Authority: WO
Inventors: Jon-Paul Rogers; Paul O'connor; Timothy Callahan
Original assignee: Smith & Nephew, Inc.
Priority date: 2016-03-03
Filing date: 2017-03-03
Publication date: 2017-09-08

Abstract

Embodiments of the invention include an anchoring system (1) and methods of inserting an anchor (100). Suture (300, 310) and soft tissue grafts (510) may be implanted with anchors (100) of some embodiments. Some anchor (100) embodiments may include instruments (200) and anchors (100) with openings and cavities in which structures to be implanted, such as soft tissue grafts (510), are protected while being manipulated relative to a bone (500) or other structure.

Description

PUSH-IN ANCHOR

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 62/303,019, filed March 3, 2016.

FIELD OF THE INVENTION

[0002] The present invention relates generally to the field of anchors, and more particularly relates to improved anchors and methods of inserting anchors that may envelope and protect structures attached with the anchors. Some embodiments may include a cooperating inserter that provides a cavity that may be aligned with a protected space in an anchor for structures attached with the anchors.

BACKGROUND

[0003] It is conventional to use tissue anchors to secure sutures, soft tissue grafts, or other components in tissue such as bone. For example, a blind hole or other tunnel in bone may be created in which one or more of a suture, soft tissue graft, or other component is to be coupled. A common, conventional technique is to insert an "interference screw" into a blind hole or bone tunnel with a suture, soft tissue graft, or other component. It is often difficult to insert the interference screw or other, conventional implant into the bone tunnel with the suture, soft tissue graft, or other component without lacerating, crushing, twisting, or otherwise harming the suture, soft tissue graft, or other component. Such a technique is particularly difficult where the anchor is a threaded anchor, which is often the case with prior art devices.

[0004] It would be advantageous to provide an anchoring system capable of securing a suture, soft tissue graft, or other component in a blind hole or other bone tunnel without imposing potentially damaging friction or stress on the suture, soft tissue graft, or other component. It may additionally be advantageous to provide an anchoring system that allows for adjustment of the suture, soft tissue graft, or other component after the anchor has been substantially fully inserted. Further, it may be advantageous to provide an anchor, an inserter, or an anchor and inserter combination that envelopes and protects the suture, soft tissue graft, or other component one or both of during insertion and after implantation.

SUMMARY

[0005] An embodiment of the invention is an anchoring system that includes an anchor and an inserter. The anchor of some embodiments includes an anchor body with a distal end, a proximal end, and a length between the distal end and the proximal end, and one or more anti-backout features along the length of the anchor body configured to resist proximal movement of the anchor when the anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the anchor. The anchor body may be cannulated along its length, and may include an opening through a side of the anchor body adjacent to at least one of the one or more anti-backout features along the length of the anchor body. The inserter of some embodiments includes a handle and a shaft coupled to the handle. The shaft may include a connecting mechanism configured to releasably couple with the anchor, and a cavity extending proximally from a distal end of the shaft that substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter.

[0006] Another embodiment of the invention is an anchor with an anchor body having a distal end, a proximal end, and a length between the distal end and the proximal end. Some embodiments of the anchor also include one or more anti- backout features along the length of the anchor body configured to resist proximal movement of the anchor when the anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the anchor. The anchor body may be cannulated along its length and may include an opening through a side of the anchor body adjacent to at least one of the one or more anti-backout features along the length of the anchor body.

[0007] An additional embodiment of the invention is a method of inserting a soft tissue graft into a bone that may include coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter. The act of coupling the sort tissue graft to an anchor and to an inserter may also include passing an anchor suture coupled to the soft tissue graft through an anchor suture hole near a distal end of the anchor, and pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, wherein following the act of pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is to be inserted. The method embodiment may also include inserting the anchor into the hole in the bone after the act of pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter and removing the inserter from the anchor.

[0008] Still another embodiment of the invention is a method of inserting a soft tissue graft into a bone that may include coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter. The act of coupling the soft tissue graft to an anchor and to an inserter may also include passing a first anchor suture coupled to the soft tissue graft through a first anchor suture hole near a distal end of the anchor, and passing a second anchor suture coupled to the soft tissue graft through a second anchor suture hole closer to a proximal end of the anchor than the first anchor suture hole. The act of coupling may also include pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter. Following the act of pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter, the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is to be inserted. Method embodiments may also include inserting the anchor into the hole in the bone after the act of pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter. Method embodiments may additionally include pulling the first anchor suture through the first anchor suture hole until the soft tissue graft is pulled more distally into the cannulation of the anchor, wherein the act of pulling the first anchor suture occurs after the act of inserting the anchor into the hole in the bone, and removing the inserter from the anchor.

[0009] Yet another embodiment of the invention is a method of inserting a soft tissue graft into a bone that may include coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter. The act of coupling the soft tissue graft to an anchor and to an inserter may also include initially passing an anchor suture coupled to the soft tissue graft through an anchor suture hole near a distal end of the anchor but initially not bringing the soft tissue graft into the cannulation of the anchor. Method embodiments may include inserting the anchor into the hole in the bone and pulling the anchor suture through the anchor suture hole after inserting the anchor into the hole in the bone until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, wherein the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is inserted while the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter. Method embodiments may additionally include removing the inserter from the anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

[00010] FIG. 1 is a perspective view of an embodiment of an anchoring system.

[00011] FIG. 2 is an enlarged perspective view of a distal end of the anchoring system of FIG. 1.

[00012] FIG. 3 is a side elevation view of an anchor of the anchoring system of FIG. 1. [00013] FIG. 4 is a side elevation view of an anchor of the anchoring system of

FIG. 1 of a side of the anchor adjacent to the side illustrated in FIG. 3.

[00014] FIG. 5 is a side elevation view of an anchor of the anchoring system of

FIG. 1 of a side of the anchor adjacent to the side illustrated in FIG. 4.

[00015] FIG. 6 is an enlarged perspective view of a distal end of an inserter of the anchoring system of FIG. 1.

[00016] FIG. 7 is a perspective view of the anchoring system of FIG. 1 that also includes stay sutures.

[00017] FIG. 8 is a perspective view of an opposite side of the anchoring system of FIG. 7 that also includes anchor sutures.

[00018] FIG. 9 is the enlarged perspective view of the distal end of the anchoring system shown in FIG. 2 that also illustrates an attached anchor suture and soft tissue graft.

[00019] FIG. 1 OA is a cross-sectional side elevation view of a distal end of the anchoring system of FIG. 1 with an attached anchor suture and soft tissue graft and with the anchor in position to be inserted in bone.

[00020] FIG. 10B is a cross-sectional side elevation view of the anchoring system as shown in FIG. 10A after insertion in bone.

[00021] FIG. 11 is the enlarged perspective view of the distal end of the anchoring system shown in FIG. 2 that also illustrates multiple attached anchor sutures and a soft tissue graft.

[00022] FIG. 12A is a cross-sectional side elevation view of a distal end of the anchoring system of FIG. 1 with multiple attached anchor sutures and a soft tissue graft and with the anchor in position to be inserted in bone. [00023] FIG. 12B is a cross-sectional side elevation view of the anchoring system as shown in FIG. 12A after insertion in bone.

[00024] FIG. 12C is a cross-sectional side elevation view of the anchoring system as shown in FIG. 12B with the soft tissue graft advanced further distally.

[00025] FIG. 13A is a cross-sectional side elevation view of a distal end of the anchoring system of FIG. 1 with an attached anchor suture and soft tissue graft and with the anchor in position to be inserted in bone.

[00026] FIG. 13B is a cross-sectional side elevation view of the anchoring system as shown in FIG. 13A after insertion in bone.

[00027] FIG. 13C is a cross-sectional side elevation view of the anchoring system as shown in FIG. 13B with the soft tissue graft advanced further distally.

DETAILED DESCRIPTION

[00028] The provisional application to which the present application claims priority was filed on the same day with U.S. Provisional Application No. 62/303,012, filed March 3, 2016, entitled VARIABLE LENGTH ANCHOR AND METHOD", which is hereby incorporated by reference in its entirety in the present application.

[00029] An embodiment of an anchoring system 1 and its component parts and methods of implementation are illustrated in FIGS. 1-13C. As shown in FIGS. 1, 2, 7-13C, the anchoring system 1 may include an anchor 100 and an inserter 200.

Various features of the anchor 100 are illustrated in combination in FIGS. 1-5, and 7- 13C. As specifically illustrated in FIGS. 2-5, the anchor 100 shown includes an anchor body with a distal end 101 , a proximal end 103, and a length between the distal end 101 and the proximal end 103. The illustrated embodiment also shows anti- backout features in the form of teeth 110 along the length of the anchor body. The teeth 110 shown are configured to resist proximal movement of the anchor 100 when the anchor 100 has been inserted in a hole 520 (FIGS. 10A, 10B, 12A-12C, and 13A- 13C) in a bone 500.

[00030] Embodiments of the invention may include an anchor body with a cross- sectional shape that has a larger diameter in a first direction and a relatively smaller diameter and a second direction. The term "diameter" is a straight line distance through an anchor from one side of the anchor to the other side of the anchor that passes through a cross-sectional central portion of the anchor. A "diameter" as used herein is not limited to an object with a circular or even rounded cross-section. For example and without limitation, the anchor 100 has a larger diameter illustrated laterally across FIGS. 3 and 5 and a smaller diameter illustrated laterally across FIG. 4. The smaller diameter may be transverse to the first direction such that when an anchor, such as the anchor 100, is inserted in a hole that is substantially the same diameter as the larger diameter, a first space exists in the direction of a first side of the smaller diameter through which a suture may be passed and a second space exists in a direction of a second side of the smaller diameter through which a soft tissue graft coupled to the suture may be passed. With the anchor 100 in the position illustrated in FIGS. 10B, 12B, 12C, 12B, and 13C, the larger diameter of the anchor 100 is engaged with a wall of the hole 520 to secure the anchor 100 relative to the bone 500. The second, transverse direction of the illustrated embodiment is substantially perpendicular to the first direction. However, in other embodiments the directions may not be substantially perpendicular but are transverse to some degree. The distal end 101 of the anchor body of the anchor 100 includes a portion that is substantially round with a diameter in all directions larger than the smaller diameter of the anchor 100. Other embodiments may or may not include a substantially round distal end portion. As used herein, a hole substantially the same diameter as the larger diameter is not considered to be an exact specification, particularly in light of the fact that holes in bone may be relatively imprecise or irregular.

[00031] The teeth 110 depicted may be resilient or flexible such that the teeth 110 flex away from the wall of the hole 520 (FIGS. 10A, 10B, 12A-12C, and 13A-13C) when the anchor 100 is inserted into the hole 520. These and other such teeth of some embodiments are resilient so that after flexed they are biased to return to their original shapes, thereby creating increased friction against the walls of holes 520 in which they are inserted. A resilient tooth may also include an angular edge, such as the angular edge 111 (FIGS. 2-5), that catches against the wall of the hole 520 if a proximal force is applied to the anchor 100. Anti-backout features of these or other embodiments may include barbs, hooks, spikes, or any other effective mechanism to resist backout of an anchor to which the features are attached. For example and without limitation, anti-backout elements may be triangular, square, pyramid shaped, shark's tooth shaped, and raked to any effective degree.

[00032] The anchor body of the anchor 100 depicted is cannulated along its length. As illustrated in FIG. 2, for example, a cannulation 120 extends from the distal end 101 of the anchor body to the proximal end 103 of the anchor body. Embodiments of the anchor body also include an opening 130 through a side of the anchor body adjacent to at least one of the one or more anti-backout features along the length of the anchor body, as particularly illustrated in FIGS. 2-4. In the illustrated

embodiment, the opening 130 is substantially as long as the anchor body.

Particularly, the opening 130 is as long as the anchor body excluding a conical tip 115 of the anchor body. In other embodiments, an opening may be significantly longer than half the length of the anchor body, like the opening 130, or may be only slightly longer than half of the length of the anchor. Still other embodiments may include relatively shorter openings. As illustrated in FIG. 4, the opening 130 is tapered to provide for a narrower implant diameter closer to the distal end 101 of the anchor body. This taper may be useful in providing greater graft contact distally with tissue in which the anchor is implanted while still providing a large contact area between the anchor 100 and the inserter 200 near the proximal end 103 of the anchor body.

[00033] The anchor body illustrated in FIGS. 2-5 and 7-13C includes a series of five anchor suture holes 106. The illustrated anchor suture holes 106 are transverse to the length of the anchor body and are created through a longitudinal side of the anchor body adjacent to the teeth 110. In some embodiments, there may be only one anchor suture hole 106 or there may be any other effective number or arrangement of anchor suture holes. A distal hole 108, as specifically illustrated in FIGS. 2 and 9-13C, may also serve as a suture anchor hole in some embodiments. The distal hole 108 depicted is also a portion of the cannulation 120 that extends from the distal end 101 of the anchor body to the proximal end 103 of the anchor body.

[00034] Some features of the inserter 200 are shown in combination in FIGS. 1, 2, and 6-13C. The inserter 200 of some embodiments includes a handle 210 and a shaft 220 coupled to the handle 210 wherein the shaft 220 includes a connecting mechanism configured to releasably couple with the anchor 100. In particular, the connecting mechanism illustrated includes a distal end 225 (FIGS. 2 and 6) of the shaft 220 that extends along and contacts a portion of the anchor 100. The proximal end 103 of the anchor body shown fits within a portion of the shaft 220 of the inserter 200 to form a part of the connecting mechanism between the anchor 100 and the inserter 200. More particularly, the proximal end 103 of the anchor body fits against a shoulder 227 to limit relative longitudinal movement between the anchor 100 and the inserter 200, and the proximal end 103 of the anchor body fits within a diameter of the distal end 225 of the shaft 220, as illustrated in FIGS. 1, 2, and 7-13C. In other embodiments, other portions of an anchor may be supported by portions of an inserter to facilitate insertion of an anchor. After the anchor 100 is inserted, the inserter 200, and particularly the distal end 22S of the shaft 220, may be removed from the anchor 100.

[00035] The inserter 200 illustrated in FIGS. 1, 7, and 8 also includes stay suture holders 230 and an anchor suture holder 240. The stay suture holders 230 and the anchor suture holder 240 are shown as conventional wraparound suture holders. However, in other embodiments any other effective mechanism may be used to secure sutures relative to an inserter. Stay sutures 330 are shown in FIGS. 7 and 8 removably coupling between the stay suture holders 230 and the anchor 100. The anchor 100 includes stay suture holes 109 (FIGS. 2, 4, 7, 9, and 11) through which one or more stay sutures 330 (FIGS. 7 and 8) may be passed to enable removable coupling between the anchor 100 and inserter 200. Coupling by use of the stay suture 330 is most clearly illustrated in FIG. 7 where the far stay suture 330 is shown transiting the stay suture hole 109 and a pass-through 209 such that both ends of the stay suture 330 are outside of the inserter and are available to be coupled around the stay suture holder 230. Pass-throughs 209 are illustrated in the shaft 220 of the inserter 200 in FIGS. 2, 6-9, and 11. Holes such as pass-throughs 209 may be provided on opposite sides of an inserter shaft, as shown in the illustrated

embodiment, or may include only a single pass-through. Other embodiments may include more than two pass-throughs in any functional arrangement. Stay sutures 330 have been omitted from FIGS. 1, 2, and 9-13C to provide clarity to other features being illustrated in those figures. As shown in FIG. 6, the shaft 220 of the inserter 200 also includes two suture notches 211 that provide for clearance of stay sutures 330 that pass through the stay suture holes 109 when the anchor 100 is seated in the inserter 200 in the illustrated embodiment. Any other effective connecting mechanism may be used to removably couple between an inserter and an anchor of this or other embodiments. [00036] The shaft 220 of the inserter 200 includes a cavity 223 extending proximally from the distal end 225 of the shaft 220, as shown in FIGS. 1, 2, and 6- 13C. The cavity 223 illustrated substantially aligns with the opening 130 through the side of the anchor body when the anchor 100 is coupled with the inserter 200, as depicted in FIGS. 1, 2, and 7-13C. The illustrated cavity 223 extends proximally from the distal end 225 of the shaft 220 a length that is longer than the anchor body of the anchor 100 of the anchoring system 1. In other embodiments, a cavity may be shorter than an anchor body of an anchor or may be to a greater or lesser degree longer.

[00037] The anchoring system 1 illustrated includes one or more anchor sutures 300, 310 (FIGS. 8-13C) configured to couple to a soft tissue graft, such as the soft tissue graft 510 illustrated in FIGS. 9-13C. Sutures of the anchoring system may be any type of suture, for example and without limitation, a monofilament, multistrand, or woven construct. A suture may be passed through an anchor while the anchor is outside of a patient's body, or may be passed when the anchor is in whole or in part within a joint or other subcutaneous portion of a patient's body. Use of the sutures 300, 310 will be described in more detail in association with method embodiments illustrated in FIGS. 9-13C. Any other effective structure, which may or may not include use of a suture, may be used to enable coupling of an anchor to an inserter in other embodiments.

[00038] A soft tissue graft 510 is illustrated in FIGS. 9-13C. The soft tissue graft of this or other embodiments may be a tendon, ligament, muscle, cartilage, or other tissue or synthetic material to be secured. In FIGS. 9-13C, the anchor suture 300 has been whipstitched to the soft tissue graft 510. In FIGS. 11-12B, the anchor suture 310 has additionally been whipstitched to the soft tissue graft 510. Each of the anchor sutures 300, 310 illustrated includes two strands or ends of the anchor sutures 300, 310. Other embodiments may include larger or smaller numbers of strands of suture. In other embodiments, graft tissue, a patient's tissue, or sutures of any type, or a combination of such elements may be used in combination with an anchor for anchoring.

[00039] An embodiment of the invention is a method of inserting a soft tissue graft, such as soft tissue graft 510, into a bone, such as illustrated bone 500. A suture, such as the anchor suture 300, 310 (FIGS. 8-13C) is provided for coupling to the soft tissue graft 510 for the illustrated embodiment. Method embodiments include the act of coupling the soft tissue graft 510 to the anchor 100 and to the shaft 220 of the inserter 200. The anchor 100 shown is cannulated by the cannulation 120 and includes an opening 130 through a side of the anchor body of the anchor 100. The inserter 200 depicted includes the shaft 220 with the cavity 223 extending proximally from the distal end 225 of the shaft 220. As shown in FIGS. 1, 2, 7, and 9-13C, the cavity 223 substantially aligns with the opening 130 through the side of the anchor body when the anchor 100 is coupled with the inserter 200.

[00040] The act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 in the embodiment illustrated in FIGS. 9-10B includes passing the anchor suture 300 coupled to the soft tissue graft 510 through an anchor suture hole near a distal end of the anchor 100. In particular, the anchor suture 300 in FIGS. 9-10B is passed through the distal hole 108 in the far distal tip of the anchor body of the anchor 100. In other embodiments, one or more of the anchor suture holes 106 near the distal end 101 of the anchor body may have the anchor suture 300 passed through them.

[00041] The act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 in the embodiment illustrated in FIGS. 9-10B also includes pulling the anchor suture 300 through the distal hole 108, which is in this instance the anchor suture hole, until the soft tissue graft 510 is pulled into the cannulation 120 of the anchor 100 and into the cavity 223 of the shaft 220 of the inserter 200, as illustrated in the position of the soft tissue graft 510 shown in FIGS. 10A and 10B. After coupling in this manner, the soft tissue graft 510 illustrated is within the anchor 100 and the inserter 200 such that the soft tissue graft 510 is substantially enveloped and protected from abrasion against a wall of a hole 520 in a bone 500 in which the anchor 100 is to be inserted. As used herein the term "substantially enveloped and protected" does not mean that there is not contact between the bone 500 and the soft tissue graft 510, rather it means that there is not sufficient contact to cause appreciable damage to the soft tissue graft 510 during an act of anchor insertion.

[00042] The illustrated method also includes inserting the anchor 100 into the hole 520 in the bone 500 after the act of pulling the anchor suture 300 through the distal hole 108. The result of inserting the anchor 100 into the hole 520 in the bone 500 after the act of pulling the anchor suture 300 through the distal hole 108 is illustrated in the progression between FIGS. 10A and 10B. As illustrated in FIG. 10B, some embodiments may include inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is substantially flush with a surface of the bone 500. As used with this and other embodiments herein, the term "substantially flush" means a proximal end may be slightly above or slightly below bone surface. Other embodiments may include inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is below a surface of the bone 500. In some embodiments, the act of inserting the anchor 100 into the hole 520 in the bone 500 includes applying substantially only an axial force along a longitudinal axis of the inserter 200. In some embodiments, for example, there would not be twisting force applied such as would be applied to screw in an anchor. Similarly, in such embodiments there would be no bending forces applied by moving the proximal end of an inserter laterally relative to a hole in which an anchor was being inserted. A longitudinal insertion path may assist a surgeon in protecting the soft tissue graft and sutures from damage and may lead to more precisely adjustable soft tissue graft tensioning. The act of insertion of some embodiments may include inserting an anchor into a preformed hole in bone, such as the hole 520, or may include forcing a self-penetrating anchor into a bone or other tissue.

[00043] The anchor suture 300 may be tied near the anchor distal hole 108 in some embodiments before the anchor 100 is inserted into the bone 500. In other embodiments, tension may be maintained in the anchor suture 300 by fixing the anchor suture 300 to the anchor suture holder 240 throughout the insertion, after which the anchor suture 300 may be tied off, cut off, routed as a continuation suture for another aspect of a procedure, or employed for any useful purpose.

[00044] Another act of some embodiments is to remove the inserter 200 from the anchor 100. In the illustrated embodiment, removal of the inserter 200 from the anchor 100 would include removal of the stay sutures 330. This could be accomplished by removing the stay sutures 330 from the stay suture holders 230 and pulling one end of each stay sutures 330 until the other end passed through the pass- through 209. Alternatively, the stay sutures 330 may be cut and both ends pulled proximally to remove the stay sutures from the anchor 100. With the stay sutures removed, the inserter 200 may be separated from the anchor 100. Other embodiments with other connecting mechanisms would be removed by other effective acts for those respective connecting mechanisms.

[00045] In still another embodiment of the invention, the act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 in the embodiment illustrated in FIGS. 11-12C includes passing the anchor suture 300, a first anchor suture in this embodiment, coupled to the soft tissue graft 510 through a first anchor suture hole near a distal end of the anchor 100. In particular, the anchor suture 300 in FIGS. 11- 12C is passed through the distal hole 108 in the far distal tip of the anchor body of the anchor 100. In other embodiments, one or more of the anchor suture holes 106 near the distal end 101 of the anchor body may have the anchor suture 300 passed through them. The act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 in the embodiment illustrated in FIGS. 11-12C includes passing the anchor suture 310, a second anchor suture in this embodiment, coupled to the soft tissue graft 510 through an anchor suture hole closer to a proximal end of the anchor 100 than the first anchor suture hole. In particular, the anchor suture 300 in FIGS. 11- 12C is passed through the most proximal of the anchor suture holes 106 in the anchor body of the anchor 100.

[00046] The act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 in the embodiment illustrated in FIGS. 11-12C also includes pulling the second anchor suture 310 through the second anchor suture hole, the most proximal anchor suture hole 106 in this example, until the soft tissue graft 510 is pulled partially into the cannulation 120 of the anchor 100 and into the cavity 223 of the inserter 200. Following the act of pulling the second anchor suture 310 through the second anchor suture hole 106 until the soft tissue graft 510 is pulled partially into the cannulation 120 of the anchor 100 and into the cavity 223 of the inserter 200, the soft tissue graft 500 is substantially enveloped and protected from abrasion against a wall of a hole 520 in the bone 500 in which the anchor is to be inserted (FIGS. 12A and 12B). As used herein the term "substantially enveloped and protected" does not mean that there is not contact between the bone 500 and the soft tissue graft 510, rather it means that there is not sufficient contact to cause appreciable damage to the soft tissue graft 510 during an act of anchor insertion.

[00047] The illustrated method also includes inserting the anchor 100 into the hole 520 in the bone 500 after the act of pulling the second anchor suture 310 through the second anchor suture hole 106 until the soft tissue graft 510 is pulled partially into the cannulation 120 of the anchor 100 and into the cavity 223 of the inserter 200. The result of inserting the anchor 100 into the hole 520 in the bone 500 is illustrated in the progression between FIGS. 12A and 12B. As illustrated in FIG. 12B, some embodiments may include inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is substantially flush with a surface of the bone 500. Other embodiments may include inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is below a surface of the bone 500. In some embodiments, the act of inserting the anchor 100 into the hole 520 in the bone 500 includes applying substantially only an axial force along a longitudinal axis of the inserter 200. In some embodiments, for example, there would not be twisting force applied such as would be applied to screw in an anchor. Similarly, in such embodiments there would be no bending forces applied by moving the proximal end of an inserter laterally relative to a hole in which an anchor was being inserted. A longitudinal insertion path may assist a surgeon in protecting the soft tissue graft and sutures from damage and may lead to more precisely adjustable soft tissue graft tensioning. The act of insertion of some embodiments may include insetting an anchor into a preformed hole in bone, such as the hole 520, or may include forcing a self-penetrating anchor into a bone or other tissue.

[00048] An act of the illustrated method embodiment of FIGS. 11-12C also includes pulling the first anchor suture 300 through the distal hole 108, which is in this instance the first anchor suture hole, until the soft tissue graft 510 is pulled more distally into the cannulation 120 of the anchor 100. This state of the soft tissue graft 510 is illustrated in the position of the soft tissue graft 510 being pulled from the position of FIG. 12B to the position of FIG. 12C. In some embodiments, the second suture 310 is at least partially released prior to the act of pulling the first anchor suture 300 through the distal hole 108 until the soft tissue graft 510 is pulled more distally into the cannulation 120 of the anchor 100. In other embodiments, tension may be maintained in the anchor sutures 300, 310 by fixing the anchor sutures 300, 310 to the anchor suture holder 240 throughout the insertion, after which the anchor suture 300 may be tied off, cut off, routed as a continuation suture for another aspect of a procedure, or employed for any useful purpose.

[00049] Another act of some embodiments is to remove the inserter 200 from the anchor 100. In the illustrated embodiment, removal of the inserter 200 from the anchor 100 would include removal of the stay sutures 330. This could be accomplished by removing the stay sutures 330 from the stay suture holders 230 and pulling one end of each stay sutures 330 until the other end passed through the pass- through 209. Alternatively, the stay sutures 330 may be cut and both ends pulled proximally to remove the stay sutures from the anchor 100. With the stay sutures removed, the inserter 200 may be separated from the anchor 100. Other embodiments with other connecting mechanisms would be removed by other effective acts for those respective connecting mechanisms.

[00050] In yet another embodiment of the invention, the act of coupling the soft tissue graft 510 to the anchor 100 and to the inserter 200 is illustrated in FIG. 13A and includes initially passing the anchor suture 300 coupled to the soft tissue graft 510 through an anchor suture hole near a distal end of the anchor 100. In particular, the anchor suture 300 in FIGS. 13A-13C is passed through the most distal of the anchor suture holes 106. In other embodiments, one or more of the other anchor suture holes 106 near the distal end 101 of the anchor body may have the anchor suture 300 passed through them, or the anchor suture hole may be the distal hole 108 in the far distal tip of the anchor body of the anchor 100. In the embodiment depicted in FIGS. 13A and 13B, the soft tissue graft 510 is not initially brought into the cannulation 120 of the anchor 100.

[00051] The illustrated method also includes inserting the anchor 100 into the hole 520 in the bone 500, as shown in FIG. 13B. The illustrated embodiment includes inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is substantially flush with a surface of the bone 500. Other embodiments may include inserting the anchor 100 until a proximal end 103 of the anchor body of the anchor 100 is below a surface of the bone 500. In some embodiments, the act of inserting the anchor 100 into the hole 520 in the bone 500 includes applying substantially only an axial force along a longitudinal axis of the inserter 200. In some embodiments, for example, there would not be twisting force applied such as would be applied to screw in an anchor. Similarly, in such embodiments there would be no bending forces applied by moving the proximal end of an inserter laterally relative to a hole in which an anchor was being inserted. A longitudinal insertion path may assist a surgeon in protecting the soft tissue graft and sutures from damage and may lead to more precisely adjustable soft tissue graft tensioning. The act of insertion of some embodiments may include inserting an anchor into a preformed hole in bone, such as the hole 520, or may include forcing a self-penetrating anchor into a bone or other tissue.

[00052] The progression between FIGS. 13B and 13C illustrates an act of pulling the anchor suture 300 through the most distal of the anchor suture holes 106 after inserting the anchor 100 into the hole 520 in the bone 500. The anchor suture 300 shown in FIG. 13C has been pulled until the soft tissue graft 510 is pulled into the cannulation 120 of the anchor body of the anchor 100 and into the cavity 223 of the shaft 220 of the inserter 200. While pulling the anchor suture 300 in this manner, the soft tissue graft 510 illustrated is within the anchor 100 and the inserter 200 such that the soft tissue graft 510 is substantially enveloped and protected from abrasion against a wall of a hole 520 in a bone 500 in which the anchor 100 is inserted. As used herein the term "substantially enveloped and protected" does not mean that there is not contact between the bone 500 and the soft tissue graft 510, rather it means that there is not sufficient contact to cause appreciable damage to the soft tissue graft 510 during an act of anchor insertion.

[00053] The anchor suture 300 may be tied near the most distal of the anchor suture holes 106 in some embodiments after the anchor 100 is inserted into the bone 500 and the anchor suture 300 is pulled to move the soft tissue graft 510 distally. A set length of the anchor suture 300 may be maintained by fixing the anchor suture 300 to the anchor suture holder 240 throughout a portion of a surgical procedure, after which the anchor suture 300 may be tied off, cut off, routed as a continuation suture for another aspect of a procedure, or employed for any useful purpose.

[00054] Another act of some embodiments is to remove the inserter 200 from the anchor 100. In the illustrated embodiment, removal of the inserter 200 from the anchor 100 would include removal of the stay sutures 330. This could be

accomplished by removing the stay sutures 330 from the stay suture holders 230 and pulling one end of each stay sutures 330 until the other end passed through the pass- through 209. Alternatively, the stay sutures 330 may be cut and both ends pulled proximally to remove the stay sutures from the anchor 100. With the stay sutures removed, the inserter 200 may be separated from the anchor 100. Other embodiments with other connecting mechanisms would be removed by other effective acts for those respective connecting mechanisms.

[00055] An embodiment of the invention is an anchor including at least an anchor body with a distal end, a proximal end, and a length between the distal end and the proximal end; and one or more anti-backout features along the length of the anchor body configured to resist proximal movement of the anchor when the anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the anchor. The anchor body may be cannulated along its length. The anchor body may include an opening through a side of the anchor body adjacent to at least one of the one or more anti-backout features along the length of the anchor body. The anchor body may include a distal hole through the distal end of the anchor body. The one or more anti-backout features may include a tooth. The tooth may be resilient and configured to be flexed away from a wall of the hole when the anchor is inserted into the hole, and wherein the resilient tooth includes an angular edge that catches against the wall of the hole if a proximal force is applied to the anchor. The opening may be longer than half the length of the anchor body. The opening may be substantially as long as the anchor body. The anchor body may include an anchor suture hole transverse to the length of the anchor body through a side of the anchor body adjacent to the one or more anti-backout features along the length of the anchor body. The anchor body may include one or more additional anchor suture holes to provide alternate suture attachment locations.

[00056] An embodiment of the invention is a method of inserting a soft tissue graft into a bone that includes at least the acts of coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter, the act of coupling the soft tissue graft to an anchor and to an inserter also including at least passing an anchor suture coupled to the soft tissue graft through an anchor suture hole near a distal end of the anchor, and pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, wherein following the act of pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is to be inserted. The method also including at least inserting the anchor into the hole in the bone after the act of pulling the anchor suture through the anchor suture hole until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter; and removing the inserter from the anchor. The act of passing an anchor suture coupled to the soft tissue graft through a hole near a distal end of the anchor may also include passing the anchor suture through a distal hole in a far distal tip of the anchor. The act of passing an anchor suture coupled to the soft tissue graft through a hole near a distal end of the anchor may also include passing the anchor suture through one or more anchor suture holes in a side of the anchor near the distal end of the anchor. The act of inserting the anchor into the hole in the bone may also include inserting the anchor until a proximal end of the anchor is substantially flush with a surface of the bone. The act of inserting the anchor into the hole in the bone may also include inserting the anchor until a proximal end of the anchor is below a surface of the bone. The act of inserting the anchor into the hole in the bone may also include applying substantially only an axial force along a longitudinal axis of the inserter.

[00057] An embodiment of the invention is a method of inserting an anchor into a bone including at least coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter, the act of coupling the soft tissue graft to an anchor and to an inserter also including at least passing a first anchor suture coupled to the soft tissue graft through a first anchor suture hole near a distal end of the anchor, passing a second anchor suture coupled to the soft tissue graft through a second anchor suture hole closer to a proximal end of the anchor than the first anchor suture hole, and pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter, wherein following the act of pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter, the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is to be inserted. The method also including at least inserting the anchor into the hole in the bone after the act of pulling the second anchor suture through the second anchor suture hole until the soft tissue graft is pulled partially into the cannulation of the anchor and into the cavity of the inserter; pulling the first anchor suture through the first anchor suture hole until the soft tissue graft is pulled more distally into the cannulation of the anchor, wherein the act of pulling the first anchor suture occurs after the act of inserting the anchor into the hole in the bone; and removing the inserter from the anchor. The act of passing a first anchor suture coupled to the soft tissue graft through a first anchor hole near a distal end of the anchor may include passing the first anchor suture through a distal hole in a far distal tip of the anchor. The act of passing a first anchor suture coupled to the soft tissue graft through a first anchor hole near a distal end of the anchor may include passing the first anchor suture through one or more anchor suture holes in a side of the anchor near the distal end of the anchor. The act of inserting the anchor into the hole in the bone may include inserting the anchor until a proximal end of the anchor is substantially flush with a surface of the bone. The act of inserting the anchor into the hole in the bone may include inserting the anchor until a proximal end of the anchor is below a surface of the bone. The act of inserting the anchor into the hole in the bone includes applying substantially only an axial force along a longitudinal axis of the inserter. The method may also include at least partially releasing the second suture prior to pulling the first anchor suture through the first anchor suture hole until the soft tissue graft is pulled more distally into the cannulation of the anchor.

[00058] An embodiment of the invention is a method of inserting a soft tissue graft into a bone including at least coupling the soft tissue graft to an anchor and to an inserter, wherein the anchor is cannulated and includes an opening through a side of the anchor body, wherein the inserter includes a cavity extending proximally from a distal end of the inserter, and wherein the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter, the act of coupling the soft tissue graft to an anchor and to an inserter also comprising initially passing an anchor suture coupled to the soft tissue graft through an anchor suture hole near a distal end of the anchor but initially not bringing the soft tissue graft into the cannulation of the anchor; inserting the anchor into the hole in the bone; pulling the anchor suture through the anchor suture hole after inserting the anchor into the hole in the bone until the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter, wherein the soft tissue graft is substantially enveloped and protected from abrasion against a wall of a hole in the bone in which the anchor is inserted while the soft tissue graft is pulled into the cannulation of the anchor and into the cavity of the inserter; and removing the inserter from the anchor. The act of passing an anchor suture coupled to the soft tissue graft through a hole near a distal end of the anchor may include passing the anchor suture through a distal hole in a far distal tip of the anchor. The act of passing an anchor suture coupled to the soft tissue graft through a hole near a distal end of the anchor may include passing the anchor suture through one or more anchor suture holes in a side of the anchor near the distal end of the anchor. The act of inserting the anchor into the hole in the bone may include inserting the anchor until a proximal end of the anchor is substantially flush with a surface of the bone. The act of inserting the anchor into the hole in the bone may include inserting the anchor until a proximal end of the anchor is below a surface of the bone. The act of inserting the anchor into the hole in the bone may include applying substantially only an axial force along a longitudinal axis of the inserter.

[00059] Various embodiments of a system wholly or its components individually may be made from any biocompatible material. For example and without limitation, materials may include in whole or in part: non-reinforced polymers, reinforced polymers, metals, ceramics, adhesives, reinforced adhesives, and combinations of these materials. Reinforcing of polymers may be accomplished with carbon, metal, or glass or any other effective material. Examples of biocompatible polymer materials include polyamide base resins, polyethylene, Ultra High Molecular Weight (UHMW) polyethylene, low density polyethylene, polymethylmethacrylate (PMMA), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), a polymeric hydroxyethylmethacrylate (PHEMA), and polyurethane, any of which may be reinforced. Example biocompatible metals include stainless steel and other steel alloys, cobalt chrome alloys, zirconium, oxidized zirconium, tantalum, titanium, titanium alloys, titanium-nickel alloys such as Nitinol and other superelastic or shape- memory metal alloys. The material of some embodiments of the anchor or its components may include a resorbable material, which over time is incorporated into a patient's tissue in which the device is implanted. Effective resorbable materials of some embodiments provide an adequate level of strength and stiffness for a time frame that exceeds that expected for tissue healing. After healing, such devices may be completely or otherwise significantly absorbed by a patient's body. The biological performance for some embodiments, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer. A non-limiting list of synthetic and natural biodegradable polymers includes polyglycolide,

polyhydroxobutyrate, chitosan, hyaluronic acid, and hydrogels. Poly(2-hydroxyethyl- methacrylate) and poly(ethylene glycol) may be used, as may poly(L-lactide) (PLA). REGENESORB is a trade named resorbable polymer material that may be used and includes D,L-polylactid acid. Embodiments of the anchor may be made via a molding process or other process known to one of skill in the art. The internal and external surfaces of embodiments of the distal anchor component may be formed during a molding process or may be formed by drilling or machining. Sutures or other similar components of the invention may be single strand, woven, braided, or any combination thereof from any of these or other biocompatible materials. The sutures or other similar components may be any effective natural or synthetic material and may be a use or combination of materials well-known in the art. Sutures or other similar components of various embodiments may be resorbable or not resorbable.

[00060] Terms such as proximal, distal, along, near, far, below, and the like have been used relatively herein. However, such terms are not limited to specific coordinate orientations, distances, or sizes, but are used to describe relative positions referencing particular embodiments. Such terms are not generally limiting to the scope of the claims made herein. Any embodiment or feature of any section, portion, or any other component shown or particularly described in relation to various embodiments of similar sections, portions, or components herein may be

interchangeably applied to any other similar embodiment or feature shown or described herein.

[00061] While embodiments of the invention have been illustrated and described in detail in the disclosure, the disclosure is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are to be considered within the scope of the disclosure.

Claims

What is claimed is:

1. An anchoring system comprising :

an anchor comprising:

an anchor body with a distal end, a proximal end, and a length between the distal end and the proximal end, and

one or more anti-backout features along the length of the anchor body configured to resist proximal movement of the anchor when the anchor has been inserted in a hole with a diameter equal to or less than a maximum diameter of the anchor,

wherein the anchor body is cannulated along its length, and wherein the anchor body includes an opening through a side of the anchor body adjacent to at least one of the one or more anti-backout features along the length of the anchor body; and

an inserter comprising:

a handle, and

a shaft coupled to the handle;

wherein the shaft includes a connecting mechanism configured to releasably couple with the anchor, and

wherein the shaft includes a cavity extending proximally from a distal end of the shaft and the cavity substantially aligns with the opening through the side of the anchor body when the anchor is coupled with the inserter.

2. The anchoring system of claim 1 wherein anchor body includes a distal hole through the distal end of the anchor body.

3. The anchoring system of claim 1 wherein the one or more anti-backout features includes a tooth.

4. The anchoring system of claim 3 wherein the tooth is resilient and is configured to be flexed away from a wall of the hole when the anchor is inserted into the hole, and wherein the resilient tooth includes an angular edge that catches against the wall of the hole if a proximal force is applied to the anchor.

5. The anchoring system of claim 1 wherein the opening is longer than half the length of the anchor body.

6. The anchoring system of claim 1 wherein the opening is substantially as long as the anchor body.

7. The anchoring system of claim 1 wherein the anchor body includes an anchor suture hole transverse to the length of the anchor body through a side of the anchor body adjacent to the one or more anti-backout features along the length of the anchor body.

8. The anchoring system of claim 7 wherein the anchor body includes one or more additional anchor suture holes to provide alternate suture attachment locations.

9. The anchoring system of claim 1 wherein the connecting mechanism includes a stay suture capable of removably coupling between the inserter and the anchor.

10. The anchoring system of claim 1 wherein the connecting mechanism includes a distal end of the shaft that extends along and contacts a portion of the anchor to couple with the anchor.

11. The anchoring system of claim 1 wherein the cavity extends proximally from the distal end of the shaft a length that is longer than the anchor body of the anchor of the anchoring system.

12. The anchoring system of claim 1 wherein the shaft includes a pass- through from the cavity to an exterior of the shaft large enough for a stay suture to be passed.

13. The anchoring system of claim 1 , further comprising a first anchor suture configured to couple to the anchor and to couple to a soft tissue graft.

14. The anchoring system of claim 13, further comprising a second anchor suture configured to couple to the anchor at a location offset from the first anchor suture and to couple to the soft tissue graft.

15. The anchoring system of claim 1 wherein the anchor body includes a side with reduced material thickness on the side of the anchor body opposite from the opening through a side of the anchor body.

16. The anchoring system of claim IS wherein the reduced material thickness is a reduction in the material of one or more of the anti-backout features.