COUNTER-TORQUE IMPLANT

TECHNICAL FIELD

[0001] Implants for joint or bone fusion, and instrumentation for preparing a joint or bones to receive an im plant are disclosed. The implants disclosed may be used to compress and/or provide torsional stability to a joint, osteotomy, fracture, or interface between two bodies, at least two bones, at least two bone portions, or at least two objects. The implants disclosed may be used in joint fusion procedures, fracture repair, osteotomies, or other situations where is it desirable to compress and/or provide rotational stability to two tissue portions. Each implant may also be referred to as a bone staple, clip, plate, fastener, a nd/or plug, and may include one or more integrated anti-torque features.

[0002] The disclosed technology includes a n implant element, a plug, that is implanted in the joint or interface so that a portion of the implant element protrudes into each bone fragment. The plug resists forces such as shear and rotation at the joint or interface. The plug may be a stand alone implant or it may be combined with other implant elements, such as staples, plates, and the like. When combined, the plug may be a separate part or integrally formed with the other implant element(s). The plug does not interfere with dynamic compression provided by a staple because it is not restrained in the plane of compression, and in some examples it may lie out of the plane of compression.

BACKGROUND

[0003] Successful bone fusion relies upon stable initial fixation of two or more bone fragments or pieces. Until fusion is achieved, one or more im plants must stabilize the bone fragments against relative translation and/or rotation in response to forces acting across the joint or interface between the bone fragments.

SUMMARY

[0004] The various systems and methods of the present technology have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available implants or clips and corresponding instrument systems. The systems and methods of the present technology may provide enhanced rotational stability across a joint, osteotomy, fracture, or other interface between two bone portions.

[0005] To achieve the foregoing, and in accordance with the technology as embodied and broadly described herein, an aspect of the technology includes an implant to aid in fusion of a joint between a first body and a second body, the implant including: a clip implantable into the first and second bodies to provide compression across the joint, the clip including: a bridge extending from a first clip end to a second clip end; first and second bone engaging members projecting from the bridge, the first bone engaging member having a first distal free end and the second bone engaging member having a second distal free end, the first and second distal free ends implantable in the first and second bodies, respectively; wherein the clip is bendable from a first state in which the first and second distal free ends converge toward one another, and a second state in which the first and second distal free ends do not converge toward one another; and a plug insertable into the joint between the first and second bodies to prevent rotation of the first body relative to the second body, the plug including a head, a body and a tip.

[0006] Embodiments of this aspect may include one or more of the following attributes. The plug includes a channel formed in the head to receive the clip bridge. At least a portion of the plug body includes a rectangular cross-section to prevent rotation of the first body relative to the second body.

[0007] Another aspect of the technology includes an implant, including: a plug having a first end, a second end, and a plug body extending therebetween, wherein the plug is implantable into a joint between a first body and a second body, wherein the positioning of the plug in the joint provides resistance to one or more forces acting with respect to the joint.

[0008] Embodiments of this aspect may include the following attribute. The forces include shear and/or rotational forces.

[0009] Yet another aspect of the technology includes a device to aid in fusion of a joint between at least a first body and a second body, the device including: an implant implantable into the first and second bodies to provide compression across the joint, the implant including: a bridge extending from a first end to a second end; at least one bone engaging member; and a keel integrally formed with the implant, the keel being insertable into the joint between the first and second bodies to additionally resist joint forces between the first body and the second body.

[0010] Embodiments of this aspect may include one or more of the following attributes. The device of claim 6, wherein at least a portion of the plug body includes a rectangular cross-section to prevent rotation of the first body with respect to the second body. The implant further includes a spacer, wherein the spacer is joined to the plug. The implant includes a first bone engaging member and a second bone engaging member, the first bone engaging member having a first distal free end and the second bone engaging member having a second distal free end, the first and second distal free ends implantable in the first and second bodies, respectively.

[0011] Yet another aspect of the technology includes an implant including: a bridge, a first bone engaging member, a second bone-engaging member, and a plug; wherein the bridge includes a length, a height, and a thickness, wherein the bridge length extends along a length direction between a first end and an opposite second end, wherein the bridge height extends along a height direction between a bone-facing surface and an opposite upper surface, wherein the bridge thickness extends along a thickness direction between a front surface and a n opposite back surface; wherein the first bone-engaging member extends from the first end from the bone- facing surface and includes a thickness along the thickness direction; wherein the second bone- engaging member extends from the second end from the bone-facing surface and includes a thickness along the thickness direction; wherein the plug extends from the bone-facing surface between the first and second bone-engaging members and includes a thickness along the thickness direction, wherein the plug thickness is less than the first bone-engaging member thickness or the second bone-engaging member thickness.

[0012] Embodiments of this aspect may include the following attribute. The plug connects only to the bridge bone-facing surface.

[0013] Yet another aspect of the technology includes an implant including: a bridge, a first bone engaging member, a second bone-engaging member, and a plug; wherein the bridge includes a length, a height, and a thickness, wherein the bridge length extends along a length direction between a first end and an opposite second end, wherein the bridge height extends along a height direction between a bone-facing surface and an opposite upper surface, wherein the bridge thickness extends along a thickness direction between a front surface and a n opposite back surface, wherein the length direction and the height direction define a bridge plane; wherein the first bone-engaging member extends from the first end from the bone-facing surface in the bridge plane; wherein the second bone-engaging member extends from the second end from the bone-facing surface in the bridge plane; wherein the plug extends from the bone-facing surface between the first and second bone-engaging members in the bridge plane and includes a length along the length direction a nd a height along the height direction.

[0014] Embodiments of this aspect may include the following attribute. The plug connects only to the bridge bone-facing surface. [0015] Yet another aspect of the technology includes a method for stabilizing a first bone portion relative to a second bone portion, wherein the first bone portion abuts the second bone portion at an interface between the first and second bone portions, the method including: preparing a first hole extending into the first bone portion; preparing a second hole extending into the second bone portion substantially parallel to the first hole, wherein the first and second holes are on either side of the interface; preparing a third hole extending into the first and second bone portions substantially parallel to the first hole, wherein a transverse cross section of the third hole is elongated in a direction extending across the interface; providing a first implant including an elongated bridge, a first leg extending from a first end of the bridge and terminating in a first free end, and a second leg extending from a second end of the bridge and terminating in a second free end, wherein the first implant is movable between a free state, in which the first and second legs converge as they extend from the bridge toward the first and second free ends, and an insertion state, in which the first implant is elastically deformed so that the first and second legs are substantially parallel to each other; providing a second implant including an elongated body terminating in an enlarged head, wherein the body has a non-circular transverse cross section; while the first implant is in the insertion state, inserting the first leg into the first hole and inserting the second leg into the second hole; permitting the first implant to move toward the free state; and inserting the second implant body into the third hole.

[0016] Embodiments of this aspect may include one or more of the following attributes. The first and second holes lie in a first plane. The third hole lies in the first plane. The second implant body is inserted into the third hole before inserting the first and second legs of the first implant into the first and second holes, respectively; and inserting the bridge of the first implant in a slot that extends across the head of the second implant. The second implant is integrally formed with the first implant. The third hole is spaced apart from the first plane.

[0017] These and other features and advantages of the present technology will become more fully apparent from the following description and appended claims, or may be learned by the practice of the technology as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Exemplary embodiments of the technology will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. U nderstanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the scope of the technology, the exemplary embodiments will be described with additional specificity and detail through use of the accompanying drawings in which:

[0019] FIG. 1A is an isometric view of an implant comprising a compression bone staple and an independent plug with the staple in a relaxed state; FIG. IB is a front view of the implant with the staple in an elastically deformed state; and FIG. 1C is a front view of the impla nt with the staple in the relaxed state;

[0020] FIG. 2A is a front view of the staple of FIG. 1A in the relaxed state; and FIG. 2B is an isometric view of the staple of FIG. 1A in the relaxed state;

[0021] FIG. 3A is an isometric view of the plug of FIG. 1A; FIG. 3B is a front view of the plug of FIG. 1A; FIG. 3C is a side view of the plug of FIG. 1A, the plug rotated 90° with respect to FIG. 3B; and FIG. 3D is an isometric view of an alternative embodiment of a plug;

[0022] FIG. 4A is an isometric view of a drill guide for use with the implant of FIG. 1A; FIG. 4B is a front view of the drill guide of FIG. 4A; FIG. 4C is a top detail view of a guide portion of the drill guide of FIG. 4A; and FIG. 4D is an isometric detail view of the guide portion of the drill guide of FIG. 4A;

[0023] FIG. 5A is an isometric view of a joint between a first bone portion and a second bone portion, and pilot holes drilled into the joint and bone portions; FIG. 5B is an isometric view of the joint of FIG. 5A with the plug of FIG. 1A inserted into the joint; and FIG. 5C is an isometric view of the joint of FIG. 5A with the plug and clip of FIG. 1A inserted into the pilot holes;

[0024] FIG. 6A is a front view of an implant comprising a compression bone staple having an integrated anti-torque plug with the staple in a relaxed state; FIG. 6B is an isometric view of the implant of FIG. 6A; and FIG. 6C is a back view of the implant of FIG. 6A with the staple in an elastically deformed state;

[0025] FIG. 7A is a front view of another embodiment of an implant comprising a compression bone staple and an integrated anti-torque plug with the staple in a relaxed state; and FIG. 7B is an isometric view of the staple of FIG. 7A;

[0026] FIG. 8A is a top view of a joint between a first bone portion and a second bone portion, and pilot holes drilled into the joint and bone portions; FIG. 8B is an isometric view of the joint of FIG. 8A, with the plug of FIG. 3D implanted in the joint; and FIG. 8C is an isometric view of the joint of FIG. 8A with the implant of FIG. 6A and the independent anti-torque plug of FIG. 3D inserted into the joint; [0027] FIG. 9A is an isometric view of an implant including a clip and an interbody spacer; and FIG. 9B is an isometric view of the implant of FIG. 9A with the clip joined to the spacer;

[0028] FIG. 10A is a side view of another embodiment of an implant comprising a compression bone staple and two integrated anti-torque plugs with the staple in an elastically deformed state; FIG. 10B is an isometric view of the implant of FIG. 10A and another interbody spacer; and FIG. IOC is an isometric view of the interbody spacer of FIG. 10B joined to the implant of FIG. 10A;

[0029] FIG. 11A is an anterior view of an implant including a spacer and two clips, implanted together in a tibiotalar joint; FIG. 11B is an oblique view of the implant and tibiotalar joint of FIG. 11B; FIG. 11C is an isometric view of the implant of FIG. 11A; and FIG. 11D is an exploded isometric view of the implant of FIG. 11A;

[0030] FIG. 12A is an isometric anterior view of an implant including a spacer and two clips, implanted together in an intervertebral joint; FIG. 12B is an isometric view of the implant of FIG.

12A; and FIG. 12C is an exploded isometric view of the implant of FIG. 12A;

[0031] FIG. 13 is a top view of another embodiment of an implant including an anti-torque

Plug;

[0032] FIG. 14 is a top view of another embodiment of an implant including an anti-torque Plug;

[0033] FIG. 15A is an inferior isometric view of an implant include a plate with an anti-torque plug; FIG. 15B is a top view of the implant of FIG. 15A; FIG. 15C is a front view of the implant of FIG. 15A; and FIG. 15D is a partially exploded view of the implant of FIG. 15A;

[0034] FIG. 16A is a front view of another embodiment of an implant including an anti-torque plug; FIG. 16B is an isometric view of the implant of FIG. 16A; and FIG. 16C is another isometric view of the implant of FIG. 16A;

[0035] FIG. 17A is a front view of another implant comprising a compression bone staple having an integrated anti-torque plug; FIG. 17B is an isometric view of the implant of FIG. 17A; FIG. 17C is a bottom view of the implant of FIG. 17A; and FIG. 17D is a bottom oblique view of the implant of FIG. 17A;

[0036] FIG. 18A is an isometric view of a drill guide for use with the implant of FIG. 17A; FIG. 18B is a front view of the drill guide of FIG. 18A; FIG. 18C is a top detail view of a guide portion of the drill guide of FIG. 18A; and FIG. 18D is an isometric detail view of the guide portion of the drill guide of FIG. 18A; [0037] FIG. 19A is an isometric view of a drill for use with the drill guide of FIG. 18A; and FIG. 19B is a bottom oblique view of the drill of FIG. 19A;

[0038] FIG. 20A is an exploded isometric view of a handle and a punch guide body of a punch guide for use with the implant of FIG. 17A; and FIG. 20B is another exploded isometric view of the handle and punch guide body of FIG. 20A from a different direction;

[0039] FIG. 21A is an isometric view of a punch for use with the punch guide of FIG. 20A; and FIG. 21B is another isometric view of the punch of FIG. 21A from a different direction;

[0040] FIG. 22A is a front view of an implant inserter; FIG. 22B is a side view of the implant inserter of FIG. 22A; FIG. 22C is a front cross-sectional view of the implant inserter of FIG. 22A, taken along section line 22C-22C of FIG. 22B; FIG. 22 D is a side cross-sectional view of the implant inserter of FIG. 22A, taken along section line 22D-22D of FIG. 22A; FIG. 22E is an exploded isometric view of the implant inserter of FIG. 22A; and FIG. 22F is another exploded isometric view of the implant inserter of FIG. 22A from a different direction;

[0041] FIG. 23 is an isometric view of a joint between a first bone portion and a second bone portion;

[0042] FIG. 24 is an isometric view of the joint of FIG. 23 with the drill guide of FIG. 18A positioned over the joint and the drill of FIG. 19A inserted through the drill guide;

[0043] FIG. 25 is an isometric view of the joint of FIG. 24 with holes drilled in the first and second bone portions;

[0044] FIG. 26 is an isometric view of the joint of FIG. 25 with the assembled punch guide of FIG. 20A engaged in the holes in the first and second bone portions;

[0045] FIG. 27 is an isometric view of the joint and punch guide of FIG. 26 with the punch of FIG. 21A inserted through the punch guide;

[0046] FIG. 28 is an isometric view of the joint of FIG. 27 with a slot punched into the first and second bone portions and extending across the joint;

[0047] FIG. 29 is an isometric view of the joint of FIG. 28 with the implant of FIG. 17A coupled to the implant inserter of FIG. 22A, the implant in an insertion state;

[0048] FIG. 30 is an isometric view of the joint, implant, and implant inserter of FIG. 29 with the implant inserted into the holes and slot in the first and second bone portions;

[0049] FIG. 31 is a bottom oblique view of the implant of FIG. 17A coupled to the implant inserter of FIG. 22A; [0050] FIG. 32 is an isometric view of the joint and implant of FIG. 30 after disconnecting the implant inserter from the implant; and

[0051] FIG. 33 is a cross-sectional view of the joint and implant of FIG. 32

DETAILED DESCRIPTION

[0052] Exemplary embodiments of the technology will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the technology, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the apparatus, system, and method is not intended to limit the scope of the invention, as claimed, but is merely representative of exemplary embodiments of the technology.

[0053] The phrases "connected to," "coupled to" and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase "fluid communication" refers to two features that are connected such that a fluid within one feature is able to pass into the other feature.

[0054] The word "exem plary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

[0055] Standard medical planes of reference and descriptive terminology are employed in this specification. While these terms are commonly used to refer to the human body, certain terms are applicable to physical objects in general.

[0056] A standard system of three mutually perpendicular reference planes is employed. A sagittal plane divides a body into right and left portions. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. A mid-sagittal, mid-coronal, or mid-transverse plane divides a body into equal portions, which may be bilaterally symmetric. The intersection of the sagittal and coronal planes defines a superior-inferior or cephalad-caudal axis. The intersection of the sagittal and transverse planes defines an anterior-posterior axis. The intersection of the coronal and transverse planes defines a medial-lateral axis. The superior-inferior or cephalad-caudal axis, the anterior-posterior axis, and the medial-lateral axis are mutually perpendicular.

[0057] Anterior means toward the front of a body. Posterior means toward the back of a body. Superior or cephalad means toward the head. Inferior or caudal means toward the feet or tail. Medial means toward the midline of a body, particularly toward a plane of bilateral symmetry of the body. Lateral means away from the midline of a body or away from a plane of bilateral symmetry of the body. Axial means toward a central axis of a body. Abaxial means away from a central axis of a body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. Proximal means toward the trunk of the body. Proximal may also mean toward a user or operator. Distal means away from the trunk. Distal may also mean away from a user or operator. Dorsal means toward the top of the foot. Plantar means toward the sole of the foot. Varus means deviation of the distal part of the leg below the knee inward, resulting in a bowlegged appearance. Valgus means deviation of the distal part of the leg below the knee outward, resulting in a knock-kneed appearance.

[0058] In this specification, "substantially" means ± 20% for linear dimensions and ± 20° for angular dimensions.

[0059] In this specification, the terms "keel" and "plug" are used interchangeably to refer to a feature that extends into or across a joint or other interface between two bone portions.

[0060] Referring to FIGS. 1A-1C and 5C, an implant 100 includes a plug 150 and a clip 200. It is appreciated that the plug 150 and clip 200 may be used together as implant 100; however, each may also be used independently. One or more implants 100, clips 200, and/or plugs 150 may be implanted in a single procedure, for example to join two bone portions together.

[0061] Referring to FIGS. 2A and 2B, the clip 200 includes bone engaging members 202 and 204 which may be integral to a clip bridge 206, also referred to as a clip body. The bone engaging members 202 and 204 may be referred to as legs or fixation elements. I n other embodiments within the scope of the disclosure, a clip may include more than two bone engaging mem bers; or alternatively may include openings for one or more independent fasteners in lieu of integrated bone engaging members. The bone engaging member 202 extends from a left end 230 of the clip bridge 206 and the bone engaging member 204 extends from an opposite right end 232 of the clip bridge 206. Bone engaging member 202 has a proximal end 234 attached to the left end 230 of the clip bridge 206 and an opposite distal end 236 which is a free end. Bone engaging member 204 has a proximal end 238 attached to the right end 232 of the clip bridge 206 and an opposite distal end 240 which is a free end. Clip bridge 206 has an upper or proximal surface 208 and a lower surface 210. The lower surface 210 may be referred to as a bone facing surface or distal surface. Bone engaging member 202 extends from the lower surface 210 beside bone engaging member 204. The bone engaging members 202 and 204 may have features 212 that may improve bone purchase or improve pull out strength of the clip 200 from bone or soft tissue. The features 212 may be referred to as teeth or serrations. The features 212 are shown on facing sides of the bone engaging members 202, 204 but may be on any or all sides of the bone engaging members. The clip 200 may have projections or other connecting means 214 and 216 for connection with a means of insertion. The connecting means 214, 216 may be referred to as tabs, ears, protrusions, wings, retainers, connection features, or retaining members. The connecting means 214 and 216 are shown extending sideways outwardly from the left and right ends 230, 232 of the bridge 206, respectively, along a longitudinal direction established by the bridge. In other embodiments, the connecting means may project perpendicularly with respect to the bridge. The connecting means 214 and 216 may have lower surfaces 218 and 220 respectively that may releasably engage with a means of insertion that may allow an inserter or other means of insertion to be side loading, top loading or pivotably loaded. For example, an inserter for clip 200 may be side loading or pivotably loading. The lower surfaces 218, 220 may be referred to as bone facing surfaces or distal surfaces. Referring to FIG. 2A, the lower surfaces 218, 220 are proximally spaced apart from, or proximally offset from, from the lower surface 210 toward the upper surface 208. The dashed extension lines 210' and 210" in FIG. 2A show the level of the lower surface 210 versus the lower surfaces 218, 220.

[0062] A means of insertion may maintain the clip 200 in a first configuration thereby allowing a second configuration once an inserter is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state, as seen in FIG. IB. The second configuration may be a free state or an implanted state, as seen in FIGS. 1A, 1C, and 2A. The means of insertion may utilize features similar to connecting means 214 and 216 in combination with other surfaces such as top surface 208. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific clip device configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 214, may be used on the entire clip or portions of a clip to create or maintain a particular configuration of a clip. For example, a tab such as 214 and top surface, such as 208 may be used to maintain one side of a clip or one leg of a clip in a particular configuration. When disassembled, that leg may have a configuration that is different from or the same as the configuration of the rest of the clip.

[0063] Referring to FIGS. 2A-2B, the clip 200 is shown in the free state, or relaxed state, which is the shape of the clip 200 when no external forces are acting upon the clip 200, other than gravity; the clip 200 experiences no elastic or plastic deflection or deformation. I n the free state, the bone engaging members 202 and 204 converge as they extend away from the bridge 206 so that the distal ends 236, 240 are closer together than are the proximal ends 234, 238. An angle 222 is formed between the converging bone engaging members 202 and 204 in the free state. The angle 222 opens toward the bridge 206. The angle 222 may be referred to as a free state angle.

[0064] Referring to FIGS. 1A-1C and 3A-3C, plug 150 extends between a proximal or first end 154 and a distal or second end 156, along a longitudinal axis 158. A plug head 160 is at the first end 154, separated from a plug tip 162 by a plug body 152. The plug head 160 may include a slot or channel 164 shaped to complementarily receive the clip bridge 206, the channel flanked by opposing first and second rails 166, 168. From a superior or top down perspective, the plug head 160 may have a circular perimeter, whereas the body 152 is generally rectangular in cross- section, in order to prevent rotation of the plug 150 once inserted. The thickness of the body 152, perpendicular to the slot 164, may be the same as or similar to the thickness of the bridge 206 and/or bone engaging members 202, 204 of the clip 200 in the same direction (front-back), or the body 152 may be thicker or thinner than the clip 200. Preferably, the body 152 is thinner than the bone engaging members 202, 204. The plug tip 162 is tapered to facilitate insertion into bone. One or more sides of the plug body 152 and/or tip 162 may include features 170 that may improve bone purchase. The features 170 may be referred to as teeth or serrations. The features 170 are shown on opposing sides of the plug body 152 and tip 162, but may be on any or all sides. I n an embodiment, features 170 may be absent. In other embodiments, the cross-sectional shape of the body may be rectangular, triangular, round, double-barrel or another shape.

[0065] Referring to FIGS. 4A-4D, a drill guide 300 may be employed to prepare pilot holes for implant 200 in a joint 2 between a first bone 4 and a second bone 6. The joint 2 may be an actual anatomical joint, an osteotomy, a fracture, or an interface between the first and second bones 4, 6. Drill guide 300 may include a handle portion 302 and a guide portion 304; some embodiments may exclude the handle portion 302. The guide portion 304 includes a guide bar 310 from which one or more guide elements may depend. In the embodiment depicted, guide portion 304 includes first and second single hole guide elements 312, 314 which flank a multi- hole guide element 316. Of course, other embodiment of the drill guide 300 can include any number and arrangement of guide elements; and in other embodiments the guide elements may not depend from the guide bar. Guide element 312 surrounds and supports a first lumen 322; guide element 314 surrounds and supports a second lumen 324, and guide element 316 surrounds and supports a third lumen 326. All the guide elements may include pointed or tapered tips to facilitate engagement with bone or tissues during the drilling procedure. Guide element 316 includes a wedge 318 which may be aligned with a joint 2 to control placement of the pilot holes with respect to the joint 2, during a drilling procedure.

[0066] In the embodiment depicted, the first and second lumens 322, 324 are circular in a transverse cross section, and each are shaped to guide a drill for drilling a single bore. The third lumen 326 includes three overlapping lumens 327, 328, 329. In a transverse cross section, the third lumen 326 has the shape of three overlapping circles, which may be called a "snowman shape." The elongated transverse shape of the third lumen 326 allows a single drill to be used to create a pilot hole large enough to receive the plug 150. I n other embodiments, the third lumen may have an oval, circular, figure eight, rectangular, or other shape cross-sectional shape which provides a line to line or interference fit between the lumen and the plug upon insertion of the plug. In the embodiment shown, the first, second and third lumens 322, 324, 326 are co-planar. In other embodiments, one or more of the lumens may be out of the plane of the others.

[0067] Referring to FIGS. 4A-5C, a method of insertion of implant 100 is described. Drill guide 300 is positioned adjacent the first and second bone portions 4, 6, with guide portion 304 spanning the joint 302. The guide portion 304 may be impacted, with wedge 318 positioned in joint 2. Wedge 318 may be pressed, impacted or otherwise aligned into the joint 2, to ensure proper alignment of the drill guide with respect to the joint 2, and may ensure that the pilot holes are centered with respect to the joint line. Pilot holes 352, 354, and 356 are drilled into the bone portions 4, 6 and joint 2. Residual material 358, which may be in the form of ridges, may be left in pilot hole 356. This residual material may create interference for the plug 150 providing a tight fit of the plug in the pilot hole 356. [0068] Referring to FIG. 5B, plug 150 is inserted into the pilot hole 356 and in contact with bone portions 4, 6. Thus positioned in the joint, the plug provides stability to the joint, and provides resistance to forces acting on the joint, including shear and rotational forces. Head 160 of the plug is oriented so that channel 164 is approximately perpendicular to the joint 2, and is aligned in the same plane with outboard pilot holes 352, 354. Referring to FIG. 5C, clip 200 is inserted with bridge 206 approximately perpendicular to the joint 2. During the insertion procedure, a means of insertion such as an instrument may flex clip 200 toward the insertion state to urge leg distal ends 236, 240 away from one another. Bone engaging member 202 is inserted in pilot hole 352, and bone engaging member 204 is inserted in pilot hole 354. Clip bridge 206 is received in channel 164, preventing rotation of the clip 200 once inserted, and preventing rotation of the bone portions 4, 6 relative to one another.

[0069] In an alternative embodiment shown in FIG. 3D, a plug 180 includes a head 190 which lacks a channel. When implant into a joint as described above, plug 180 may be offset from the plane of corresponding implant 200, as shown in FIGS. 8B and 8C. Drill guide 300 may be used to prepare an offset pilot hole 366. Plug 180 may be implanted independently as a stand-alone implant, or may be implanted with a staple such as clip 200 or others disclosed herein. I n another embodiment, plug 150 may be implanted to be offset from the plane of clip 200. Whether implanted independently into a joint, or with a clip 200, the plug 180 may provide torsional stability, preventing rotation of the bone portions 4, 6 relative to one another, and/or preventing shear forces from acting upon the joint.

[0070] In other embodiments within the scope of the disclosure, plug 150 may be implanted with another corresponding implant such as a bone plate. The plug and bone plate combination may be implanted across a joint between two bones, bodies or devices to resist rotation of the bodies about the joint. The bone plate may have two or more openings for fasteners, and a feature to cooperatively connect with plug 150.

[0071] Referring to FIGS. 6A-6C, a clip 1100 includes an integrated anti-torque plug 1150. Clip 1100 and other clips disclosed herein may also be referred to as a fastener, staple, or implant. Anti-torque plug 1150 and other anti-torque features disclosed herein may also be referred to as a tab, keel, post, or implant. FIGS. 7A-7B show an alternate embodiment of an implant; clip 1200 includes an integrated anti-torque plug 1250 which has a chisel-shaped tip. FIG. 3D shows an independent anti-torque plug 180. One or more clips 1100, 1200, plates and/or plugs 180 disclosed herein may be implanted in a single procedure, for example to join two bone portions together.

[0072] Referring to FIGS. 6A and 6B, the clip 1100 includes bone engaging members 1102 and 1104 which may be integral to a clip bridge 1106, also referred to as a clip body. The bone engaging members 1102 and 1104 may be referred to as legs. In other embodiments within the scope of the disclosure, a clip may include more than two bone engaging members; or alternatively may include openings for one or more independent fasteners in lieu of the bone engaging members. In other embodiments of the disclosure, the implant 1100 may be more similar to a plate. The bone engaging member 1102 extends from a left end 1130 of the clip bridge 1106 and the bone engaging member 1104 extends from an opposite right end 1132 of the clip bridge 1106. Bone engaging member 1102 has a proximal end 1134 attached to the left end 1130 of the clip bridge 1106 and an opposite distal end 1136 which is a free end. Bone engaging member 1104 has a proximal end 1138 attached to the right end 1132 of the clip bridge 1106 and an opposite distal end 1140 which is a free end. Clip bridge 1106 has at least one upper or proximal surface 1108 and at least one lower or distal surface 1110. The lower surface 1110 may be referred to as a bone facing surface. Bone engaging mem ber 1102 extends from the lower surface 1110 beside bone engaging member 1104. The bone engaging members 1102 and 1104 may have features 1112 that may improve bone purchase or improve pull out strength of the clip 1100 from bone or soft tissue. The features 1112 may be referred to as teeth or serrations. The features 1112 are shown on facing sides of the bone engaging members 1102, 1104 but may be on any or all sides of the bone engaging members. The clip 1100 may have projections or other connecting means 1114 and 1116 for connection with a means of insertion. The connecting means 1114, 1116 may be referred to as tabs, ears, protrusions, wings, retainers, or retaining members. The connecting means 1114 and 1116 are shown extending sideways outwardly from the left and right ends 1130, 1132 of the bridge 1106, respectively, along a longitudinal direction established by the bridge. I n other embodiments, the connecting means may project perpendicularly with respect to the bridge. The connecting means 1114 and 1116 may have lower or distal surfaces 1118 and 1120 respectively that may releasably engage with a means of insertion that may allow an inserter or other means of insertion to be side loading, top loading or pivotably loaded. For example, an inserter for clip 1100 may be side loading or pivotably loading. The lower surfaces 1118, 1120 may be referred to as bone facing surfaces. Referring to FIG. 6A, the lower surfaces 1118, 1120 are proximally spaced apart from, or proximally offset from, from the lower surface 1110. The dashed extension lines 1110' and 1110" in FIG. 6A show the level of the lower surface 1110 versus the lower surfaces 1118, 1120.

[0073] An integrated anti-torque plug 1150 projects distal ly from the lower surface 1110 of bridge 1106. I n the embodiment depicted, a single plug 1150 is centered between bone engaging members 1102, 1104; in other embodiments the plug may be off-center relative to the members 1102, 1104, and/or a plurality of plugs may be included. The plug may also be connected to the implant 1100 in more than one location along the lower surface 1110 of bridge 1106. Plug 1150 includes a neck portion 1152 where the plug is joined to bridge 1106, a body 1154, and a tip 1156. Neck portion 1152 may be formed as a waist having a reduced width with respect to the plug body 1154 as shown in FIGS. 6A-6C; in other embodiments the neck portion 1152 may be wider than or equal in width with respect to the plug body 1154. Preferably, plug 1150 is connected to the clip 1100 only via the bridge 1106, and not along the bone engaging members 1102, 1104. Plug 1150 may be rectangular in cross-section and includes four sides 1160, 1162, 1164, 1166. The plug thickness between sides 1160 and 1166 may be less than, the same as, similar to, or greater than the thickness of the bridge 1106 and/or bone engaging members 1102, 1104 of the clip 1100 in the same direction (front-back). Preferably, the plug thickness between sides 1160 and 1166 is less than the thickness of the bone engaging members 1102, 1104 in the same direction. The plug tip 1156 may be tapered on at least two sides 1162, 1164 with respect to the plug body to facilitate insertion into a joint. The plug sides 1160, 1162, 1164, 1166 may be smooth as seen in FIGS. 6A-6C; in other embodiments one or more plug sides may include teeth, serrations, or other surface roughening. In other embodiments, the plug may have a differently shaped cross-section. The plug does not preclude compression of the bone segments by the bone engaging members 1102, 1104, at least because the plug is oriented in a plane coplanar with, or parallel to, the plane of the bridge 1106 and bone engaging members 1102, 1104 of the clip 1100.

[0074] A means of insertion may maintain the clip 1100 in a first configuration thereby allowing a second configuration once an inserter is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state, as seen in FIGS. 6C. The second configuration may be a free state or an implanted state, as seen in FIGS. 6A and 6B. The means of insertion may utilize features similar to connecting means 1114 and 1116 in combination with other surfaces such as top surface 1108. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific clip device configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 1114, may be used on the entire clip or portions of a clip to create or maintain a particular configuration of a clip. For example, a tab such as 1114 and top surface, such as 1108 may be used to maintain one side of a clip or one leg of a clip in a particular configuration. When disassembled, that leg may have a configuration that is different from or the same as the configuration of the rest of the clip.

[0075] Referring to FIGS. 6A-6B, the clip 1100 is shown in the free state, or relaxed state, which is the shape of the clip 1100 when no external forces are acting upon the clip 1100, other than gravity; the clip 1100 experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members 1102 and 1104 converge as they extend away from the bridge 1106 so that the distal ends 1136, 1140 are closer together than are the proximal ends 1134, 1138. An angle 1122 is formed between the converging bone engaging members 1102 and 1104 in the free state. The angle 1122 opens toward the bridge 1106. The angle 1122 may be referred to as a free state angle.

[0076] Referring to FIGS. 7A-7B, an alternative embodiment of an implant with an integrated anti-torque plug is shown. Clip 1200 includes a first bone-engaging member 1202, a second bone- engaging member 1204, a bridge 1206, and an integrated anti-torque plug 1250. The descriptions of the bone engaging members, bridge and anti-torque plug of clip 1100 are applicable to clip 1200. In addition, the descriptions of the free state, the elastically deformed state, and means of insertion of clip 1100 are also applicable to clip 1200. The anti-torque plug 1250 of clip 1200 includes neck 1252 and body 1254 portions, as described for clip 1100. A tip portion 1256 of clip 1200 is tapered on all four sides with respect to the body 1254, to form a chisel or wedge sha pe. Other embodiments may include tip portions having other taper shapes in which one or more sides of the tip is tapered with respect to the body. I n other embodiments, the taper may extend along one or more body portion sides.

[0077] Referring to FIG. 3D, an independent anti-torque plug 180 extends between a proximal or first end 182 and a distal or second end 184, along a longitudinal axis 186. A plug head 190 is at the first end 182, separated from a plug tip 188 by a plug body 192. From a superior or top down perspective, the plug head 190 may have a circular perimeter, whereas the body 192 is generally rectangular in cross-section, in order to prevent rotation of the plug 180 once inserted. The plug tip 188 is tapered to facilitate insertion into bone. One or more sides of the plug body 192 and/or tip 188 may include features 194 that may improve bone purchase. The features 194 may be referred to as teeth or serrations. The features 194 are shown on opposing sides of the plug body 192 and tip 188, but may be on any or all sides. In an embodiment, features 194 may be absent. In other embodiments, the cross-sectional shape of the body 192 may be rectangular, triangular, round, double-barrel or another shape. One or more plugs 180 may be implanted independently in a joint to prevent rotation of the bones or bodies about the joint, and/or one or more plugs 180 may be implanted in conjunction with any of the clips disclosed herein, as in FIG. 8C, to provide additional joint stability.

[0078] Referring to FIGS. 4A-4D, the drill guide 300 may be employed to prepare pilot holes for implants 180, 1100, 1200 or any impla nt disclosed herein, in a joint 2 between a first bone 4 and a second bone 6. The joint 2 may be an actual anatomical joint, an osteotomy, a fracture, or an interface between the first and second bones 4, 6. Drill guide 300 may be used to prepare a joint for implantation of any of the implants disclosed herein. Other instrumentation may be used to prepare a site to receive one or more of the implants described herein, including punches, drills, saws, sawblades, or any other instrument capable of creating an opening through the tissue, bone or joint material.

[0079] Referring to FIGS. 4A-4D and 8A-8C, a method of insertion of implant 1100 is described. It is understood that the method of insertion may employed for any of the implants described herein. Drill guide 300 is positioned adjacent the first and second bone portions 4, 6, with guide portion 304 spanning the joint 2. The guide portion 304 may be impacted, with wedge 318 positioned in joint 2. Wedge 318 may be pressed, im pacted or otherwise aligned into the joint 2, to ensure proper alignment of the drill guide with respect to the joint 2, and may ensure that the pilot holes are centered with respect to the joint line. Pilot holes 352, 354, and 356 are drilled into the bone portions 4, 6 and joint 2. Residual material 358, which may be in the form of ridges, may be left in pilot hole 356. This residual material may create interference for the plug 1150 providing a tight fit of the plug in the pilot hole 356. If desired, another pilot hole 366 may be created for implantation of an independent anti-torque plug 180. Pilot hole 366 may be drilled in joint 2, and may be offset from pilot holes 352, 354, and 356.

[0080] Referring to FIG. 8C, clip 1100 is inserted into the pilot holes 352, 354, 356, with bridge 1106 approximately perpendicular to the joint 2. During the insertion procedure, a means of insertion such as an instrument may flex clip 1100 toward the insertion state to urge leg distal ends 1136, 1140 away from one another. Bone engaging member 1102 is inserted into pilot hole 352, bone engaging member 1104 is inserted into pilot hole 354, and plug 1150 is inserted into the joint, in pilot hole 356 and in contact with bone portions 4, 6. Thus positioned in the joint, the plug 1150 provides stability to the joint, and provides resistance to forces acting on the joint, including shear and rotational forces. Before or after insertion of clip 1100, an auxiliary independent anti-torque plug 180 may be implanted in optional pilot hole 366. The plug 180 may be oriented so that features 70 are approximately perpendicular to the joint 2, in order to provide an interference fit with any residual material in pilot hole 366. Plug 180 may be offset from the plane of the bone engaging members 1102, 1104 and plug 1150 of clip 1100.

[0081] Clips disclosed herein may also be implanted in combination with a spacer or other interbody device. Referring to FIGS. 9A and 9B, implant 1400 includes a clip 1500 and a spacer 1450. The description of clip 1100 may apply to clip 1500, with the exception that clip 1500 includes a plug 1550 having neck portion 1552 which may be greater to or equal in width to the body of the plug. Spacer 1450 includes a body 1452, and may have one or more fenestrations 1454 for insertion of bone graft material and/or for bone in-growth. Spacer 1450 also includes a slot 1456 shaped to receive a plug such as plug 1550, and may form an interference fit with neck 1552 when joined with the plug as shown in FIG. 9B. I n a method of implantation, spacer 1450 may be joined to clip 1500, and the resultant impla nt 1400 may be implanted as a unit. Alternately, spacer 1450 may be implanted into a prepared joint space first, and then clip 1500 may be implanted, with slot 1456 receiving plug 1550.

[0082] Referring to FIGS. lOA-lOC, implant 1600 includes a clip 1700 and a spacer 1650. The description of clip 1100 may apply to clip 1700, with the exception that clip 1700 includes two anti-torque plugs 1750, 1770. Each anti-torque plug 1750, 1770 may include a neck portion 1752, 1772 which may taper outward from the neck to the clip bridge 1706. Spacer 1650 includes a body 1652, and may have one or more fenestrations 1654 for insertion of bone graft material and/or for bone in-growth. Spacer 1650 also includes slots 1656, 1658 shaped to receive plugs 1750, 1770, which may form an interference fit when the spacer 1650 joined with the plugs as shown in FIG. IOC. I n a method of implantation, spacer 1650 may be joined to clip 1700, and the resultant implant 1600 may be implanted as a unit into a joint between two bodies, for example two bones. Alternately, spacer 1650 may be implanted into a prepared joint space first, and then clip 1700 may be implanted, with slots 1656, 1658 receiving plugs 1750, 1770. When implanted as described, the inner or medial facing surfaces of plugs 1750, 1770 interfere with spacer 1650, and the outer or lateral facing surfaces of plugs 1750, 1770 interfere with the bone(s) in which they are implanted. This may prevent rotation or counteraction forces between the bone(s) and the implant, while also preventing rotation of the bones with respect to one another.

[0083] Referring to FIGS. 11A-12C, additional examples of implants comprising clips and spacers are shown. FIGS. 11A and 11B depict an implant 1800 implanted into a tibiotalar joint between a tibia 8 and a talus 10. FIGS. 11C and 11D illustrate that implant 1800 comprises two clips 1500 in combination with a spacer 1850. FIG. 12A depicts an impla nt 1900 implanted into an intervertebral joint between a first vertebra 12 and a second vertebra 14. FIGS. 12B and 12C illustrate that implant 1900 comprises two clips 1500 in combination with a spacer 1950.

[0084] Referring to FIG. 13, another embodiment of an implant with an associated keel is shown. Implant 2000 includes implant body 2006, and keel 2050 which projects away from implant body 2006. Implant 2000 may include one or more bone engagement features 2002, 2004 to fasten the implant 2000 to bone, tissue, and/or another device. Bone engagement features 2002, 2004 may be integrated into implant body 2006, for example as posts, legs, or pins; or may be separate fasteners such as screws. The implant 2000 may include a first configuration which is an elastically deformed state for insertion, and a second configuration which is a relaxed or free state when implanted, as described above for implants 1100, 1200. In the embodiment shown, the keel 2050 has a star-shaped cross-sectional shape, with four flanges or lobes 2052, 2054, 2056, 2058 protruding from a central keel body 2060. A distal tip of the keel may be tapered to facilitate introduction into a joint. The keel 2050 may be integrally formed with the implant body 2006 as one piece, or may be a separate entity joined to the implant body before or during implantation. Implant 2000 may be implanted according to the methods described above for implants 1100, 1200. When implanted in a joint, the flanges 2052, 2054, 2056, 2058 can have an interference fit with the surrounding joint tissues, to resist rotation and shear forces around the joint.

[0085] Referring to FIG. 14, another embodiment of an implant with an associated keel is shown. Implant 2100 includes implant body 2106, and keel 2150 which projects away from implant body 2106. Implant 2100 may include one or more bone engagement features 2102, 2104 to fasten the implant 2100 to bone, tissue and/or another device. Bone engagement features 2102, 2104 may be integrated into implant body 2106, for example as posts, legs, or pins; or may be separate fasteners such as screws. The implant 2100 may include a first configuration which is an elastically deformed state for insertion, and a second configuration which is a relaxed or free state when implanted, as described above for implants 1100, 1200. In the embodiment shown, the keel 2150 includes four longitudinal edges 2152, 2154, 2156, 2158 projecting from a central keel body 2160. A distal tip of the keel may be tapered to facilitate introduction into a joint. The keel 2150 may be integrally formed with the implant body 2106 as one piece, or may be a separate entity joined to the implant body before or during implantation. I mplant 2100 may be implanted according to the methods described above for implants 1100, 1200. When implanted in a joint, the edges 2152, 2154, 2156, 2158 can have an interference fit with the surrounding joint tissues, to resist rotation and shear forces acting on the joint.

[0086] Referring to FIGS. 15A-15D, another embodiment of an im plant with an associated keel is shown. Implant 2200 includes a plate 2206 and a keel 2250. The plate 2206 depicted includes openings for a plurality of bone screws 2280 for fastening the plate 2206 across a joint between two bones or bodies. In other embodiments, fasteners may be formed integrally with the plate 2206. In the embodiment depicted, the keel 2250 is received in a slot 2202 in the plate and projects inferiorly below the plate. In other embodiments, the keel may be formed integrally with the plate, as shown for implants 1100, 1200. I n a method of implantation, drill guide 300 may be used to create a pilot hole for keel 2250 in a joint 2 between first second bodies 4, 6. Plate 2206 may be oriented perpendicular to the joint and fastened to the bodies 4, 6 with fasteners 2280. Keel 2250 may be inserted through slot 2202 and into the joint 2. Keel 2250 may be fastened to the plate 2206. In other methods of implantation, keel 2250 may be joined to the plate 2206 before implantation. The keel 2250 may be replaced by implant 1100, 1200, 1500, 1700, 2000, or 2100. It is appreciated that within the scope of the disclosure, other shapes or configurations of plates may include an integrated or associated keel.

[0087] It is appreciated that in other embodiments of the disclosure, keels 1150, 1250, 2060, 2160, 2250 and other keels disclosed herein may have other shapes, including but not limited to square, rectangular, triangular, star, and/or irregular or asymmetric. The keels disclosed herein may also have rounded shapes, if they are sufficiently sized to provide an interference fit with the surrounding tissues or bodies in which they are implanted, in order to resist rotation and shear forces.

[0088] Referring to FIGS. 16A-16C, another embodiment of a n im plant with an integrated counter-torque feature is shown. I mplant 2300 includes first and second bone engagement members 2302, 2304 and an implant body 2306. The implant 2300 may include a first configuration which is an elastically deformed state for insertion, and a second configuration which is a relaxed or free state when implanted, as described above for implants 1100, 1200. The implant 2300 includes protrusion 2350 which projects inferiorly from the implant body 2306. I mplant 2300 may be implanted into a joint, as described previously for implants 1100, 1200. Protrusion 2350 is received in joint 2 and may form an interference fit in a prepared pilot hole, and the bone engagement members 2302, 2304 may provide compression across the joint. The protrusion 2350 may provide stability to the joint and resist rotation and shear forces acting on the joint.

[0089] Referring to FIGS. 17A-17D, another implant or clip 2400 includes an integrated anti- torque plug 2450. Clip 2400 and other clips disclosed herein may also be referred to as a fastener, staple, or implant. Anti-torque plug 2450 and other anti-torque features disclosed herein may also be referred to as a tab, keel, post, or implant. One or more clips 2400 may be implanted in a single procedure, for example to join two bone portions together.

[0090] Referring to FIGS. 17A and 17B, the clip 2400 includes bone engaging members 2402 and 2404 which may be integral to a clip bridge 2406, also referred to as a clip body. The bone engaging members 2402 and 2404 may be referred to as legs. In other embodiments within the scope of the disclosure, a clip may include more than two bone engaging members; or alternatively may include openings for one or more independent fasteners in lieu of the bone engaging members. In other embodiments of the disclosure, the implant 2400 may be more similar to a plate. The bone engaging member 2402 extends from a left end 2430 of the clip bridge 2406 and the bone engaging member 2404 extends from an opposite right end 2432 of the clip bridge 2406. Bone engaging member 2402 has a proximal end 2434 attached to the left end 2430 of the clip bridge 2406 and an opposite distal end 2436 which is a free end. Bone engaging member 2404 has a proximal end 2438 attached to the right end 2432 of the clip bridge 2406 and an opposite distal end 2440 which is a free end. Clip bridge 2406 has at least one upper or proximal surface 2408 and at least one lower or distal surface 2410. The lower surface 2410 may be referred to as a bone facing surface. Bone engaging mem ber 2402 extends from the lower surface 2410 beside bone engaging member 2404. The bone engaging members 2402 and 2404 may have features 2412 that may improve bone purchase or improve pull out strength of the clip 2400 from bone or soft tissue. The features 2412 may be referred to as teeth or serrations. The features 2412 are shown on facing sides of the bone engaging members 2402, 2404 but may be on any or all sides of the bone engaging members. The clip 2400 may have projections or other connecting means 2414 and 2416 for connection with a means of insertion. The connecting means 2414, 2416 may be referred to as tabs, ears, protrusions, wings, retainers, or retaining members. The connecting means 2414 and 2416 are shown extending sideways outwardly from the left and right ends 2430, 2432 of the bridge 2406, respectively, along a longitudinal direction established by the bridge. I n other embodiments, the connecting means may project perpendicularly with respect to the bridge. The connecting means 2414 and 2416 may have lower or distal surfaces 2418 and 2420 respectively that may releasably engage with a means of insertion that may allow an inserter or other means of insertion to be side loading, top loading or pivotably loaded. For example, an inserter for clip 2400 may be side loading or pivotably loading. The lower surfaces 2418, 2420 may be referred to as bone facing surfaces. Referring to FIG. 17A, the lower surfaces 2418, 2420 are proximally spaced apart from, or proximally offset from, from the lower surface 2410. The dashed extension lines 2410' and 2410" in FIG. 17A show the level of the lower surface 2410 versus the lower surfaces 2418, 2420.

[0091] An integrated anti-torque plug 2450 projects distal ly from the lower surface 2410 of bridge 2406. I n the embodiment depicted, a single plug 2450 is centered between bone engaging members 2402, 2404; in other embodiments the plug may be off-center relative to the members 2402, 2404, and/or a plurality of plugs may be included. The plug may also be connected to the implant 2400 in more than one location along the lower surface 2410 of bridge 2406. Plug 2450 includes a neck portion 2452 where the plug is joined to bridge 2406, a body 2454, and a tip 2456. Neck portion 2452 may be formed as a waist having a reduced width with respect to the plug body 2454 as shown in FIGS. 17A-17D; in other embodiments the neck portion 2452 may be wider than or equal in width with respect to the plug body 2454. Preferably, plug 2450 is connected to the clip 2400 only via the bridge 2406, and not along the bone engaging members 2402, 2404. Plug 2450 may be rectangular in cross-section and includes four sides 2460, 2462, 2464, 2466. The plug thickness between sides 2460 and 2466 may be less than, the same as, similar to, or greater than the thickness of the bridge 2406 and/or bone engaging members 2402, 2404 of the clip 2400 in the same direction (front-back). Preferably, the plug thickness between sides 2460 and 2466 is less than the thickness of the bridge and bone engaging members 2402, 2404 in the same direction, as seen best in FIGS. 17C-17D. The plug tip 2456 may be tapered on at least two sides 2462, 2464 with respect to the plug body to facilitate insertion into a joint. The plug sides 2460, 2462, 2464, 2466 may be smooth as seen in FIGS. 17A-17D; in other embodiments one or more plug sides may include teeth, serrations, or other surface roughening. In other embodiments, the plug may have a differently shaped cross-section. The plug does not preclude compression of the bone segments by the bone engaging members 2402, 2404, at least because the plug is oriented in a plane coplanar with, or parallel to, the plane of the bridge 2406 and bone engaging members 2402, 2404 of the clip 2400, as shown in FIG. 17C.

[0092] A means of insertion may maintain the clip 2400 in a first configuration thereby allowing a second configuration once an inserter is disassembled from the implant. The first configuration may be an elastically deformed state, for example an insertion state. The second configuration may be a free state or an implanted state, as seen in FIG. 17A. The means of insertion may utilize features similar to connecting means 2414 and 2416 in combination with other surfaces such as top surface 2408. This combination of means of insertion may be used to maintain one or more features or arms or projections in a particular configuration. This combination of means of insertion may create a bending modality, such as a three point or four point bend, to maintain a specific clip device configuration or combination of configurations. A combination of surfaces and means of insertion, such as connecting means 2414, may be used on the entire clip or portions of a clip to create or maintain a particular configuration of a clip. For example, a tab such as 2414 and top surface, such as 2408 may be used to maintain one side of a clip or one leg of a clip in a particular configuration. When disassembled, that leg may have a configuration that is different from or the same as the configuration of the rest of the clip.

[0093] Referring to FIGS. 17A-17B, the clip 2400 is shown in the free state, or relaxed state, which is the shape of the clip 2400 when no external forces are acting upon the clip 2400, other than gravity; the clip 2400 experiences no elastic or plastic deflection or deformation. In the free state, the bone engaging members 2402 and 2404 converge as they extend away from the bridge 2406 so that the distal ends 2436, 2440 are closer together than are the proximal ends 2434, 2438. An angle 2422 is formed between the converging bone engaging members 2402 and 2404 in the free state. The angle 2422 opens toward the bridge 2406. The angle 2422 may be referred to as a free state angle.

[0094] Referring to FIGS. 18A-18D, a drill guide 2500 may be employed to prepare pilot holes for implant 2400 in a joint 2 between a first bone 4 and a second bone 6. The joint 2 may be an actual anatomical joint, an osteotomy, a fracture, or an interface between the first and second bones 4, 6. Drill guide 2500 may include a handle portion 2502 and a guide portion 2504; some embodiments may exclude the handle portion 2502. The guide portion 2504 includes a guide bar 2510 from which one or more guide elements may depend. In the embodiment depicted, guide portion 2504 includes first and second single hole guide elements 2512, 2514. Other embodiments of the drill guide 2500 can include any number and arrangement of guide elements corresponding to a particular implant or clip, or set of implants; and in other embodiments the guide elements may not depend from the guide bar. Guide element 2512 surrounds and supports a first lumen 2522 and guide element 2514 surrounds and supports a second lumen 2524. All the guide elements may include pointed or tapered distal tips to facilitate engagement with bone or tissues during the drilling procedure.

[0095] In the embodiment depicted, the first and second lumens 2522, 2524 are circular in a transverse cross section, and each is shaped to guide a drill for drilling a single bore. In the embodiment shown, the first and second lumens 2522, 2524 are co-planar. In other embodiments, one or more of the lumens may be out of the plane of the others.

[0096] Referring to FIGS. 19A-19B, a drill bit 2550 may be used with the drill guide 2500 to prepare pilot holes for implant 2400. The drill bit 2550 extends between a distal end 2552 and a proximal end 2554. The distal end 2552 includes a cutting portion 2556 with side and/or end cutting flutes. The proximal end 2554 includes a torque coupling portion 2558 for connection to a powered or manual torque source, such as an electric drill or a T-handle. The drill bit 2550 is shown with an optional intermediate portion 2560 with an outer diameter that is larger than the outer diameter of the cutting portion 2556 and smaller than the outer diameter of the torque coupling portion 2558. The drill bit 2550 may include one or more depth marks and/or depth stops and/or indicia. For example, a shoulder 2562 between the cutting portion 2556 and the intermediate portion 2560 may serve as a depth mark or depth stop. Another depth mark 2564 is shown in the intermediate portion 2560 proximal to the shoulder 2562. The shoulder 2562 and/or depth mark 2564 may align with, or may make contact with, a corresponding feature of the drill guide 2500. For example, the depth mark 2564 may align with the proximal side of the guide bar 2510 to indicate that the drill bit 2550 has been advanced to the proper depth.

[0097] Referring to FIGS. 20A-20B, a punch guide 2600 may include a punch guide body 2602 and a handle 2604. The punch guide 2600 is illustrated in exploded views in FIGS. 20A-20B and operatively assem bled in FIGS. 26A-27B.

[0098] The punch guide body 2602 may be a generally rectangular sha pe with a distal side 2606, a proximal side 2608, a handle-facing side 2610, a left side 2612, and a right side 2614. A lumen 2616 extends through the punch guide body 2602 between the distal and proximal sides 2606, 2608. The lumen 2616 may have a transverse cross section that is elongated in a left-right direction as shown. The cross sectional shape may be rectangular, oval, snowman, or another shape. An oval shape is shown. The lumen 2616 may be centered in the left-right width of the punch guide body 2602. Bilateral pegs 2618, 2620 extend distally from the distal side 2606 to the left and right of the lumen 2616. The pegs 2618, 2620 may have distal tapered or pointed tips as shown in FIG. 20B. A boss 2622 may extend obliquely outwardly and proximally from the handle- facing side 2610. The boss 2622 may be centered in the left-right width of the punch guide body 2602. An internally threaded hole 2624 may extend into the boss 2622.

[0099] The handle 2604 may be a generally cylindrical shaft that extends between a distal end 2626 and a proximal end 2628. The distal end 2626 may include an externally threaded distal tip portion 2630 with threads that are complementary to the internal threads in the hole 2624 of the punch guide body 2602. The proximal end 2628 may function as a handle.

[00100] The punch guide 2600 may be assembled by threading the distal tip portion 2630 into the internally threaded hole 2624. In use, the punch guide body 2602 and handle 2604 are fixed together.

[00101] Referring to FIGS. 21A-21B, a punch 2650 may be used with the punch guide 2600 to prepare a slot to receive the plug 2450 of the clip 2400. The punch 2650 extends between a distal end 2652 and a proximal end 2654. The punch 2650 may include four portions or segments along its distal-proximal length. A first portion 2656 may extend proximally from the distal end 2652. The first portion 2656 may have an elongated cross sectional shape that is complementary to the cross sectional shape of the lumen 2616 of the punch guide 2600. The distal-most aspect of the first portion 2656 may be sharpened or pointed to penetrate bone. Two points 2658, 2660 are shown, with a distal sharp concave profile between the points. A second portion 2662 may extend proximally from the first portion 2656. The second portion 2662 may have the same cross sectional shape as the first portion, outwardly offset so that the second portion is wider and/or thicker tha n the first portion. A third portion 2664 may extend proximally from the second portion 2662. The third portion 2664 may have a cross sectional shape that is similar to, or different from, the cross sectional shapes of the first and second portions 2656, 2662, and which may be outwardly offset so that the third portion is wider and/or thicker than the second portion. The third portion 2664 is shown with a rectangular cross sectional shape. A transverse hole 2666 may extend through the thickness of the punch 2650 in the third portion 2664. A fourth portion 2668 may extend proximally from the third portion 2664. The fourth portion 2668 may have a circular cross sectional shape that is outwardly offset so that the fourth portion is wider and/or thicker than the third portion 2664. The third and fourth portions 2664, 2668, together or separately, may function as a handle. The fourth portion 2668 may function as a strike platform to impact the punch 2650 distal ly into bone or proximally out of bone.

[00102] In an alternate embodiment, the punch guide 2600 and punch 2650 may be combined together in a single instrument. In one example of this embodiment, the punch guide body 2602, handle 2604, and punch 2650 may be formed together as a unitary part. In this example, the feature corresponding to the punch 2650 may be equivalent to the first portion 2656 shown in FIGS. 21A, 21B, and 27B, which is the portion that protrudes distal ly from the punch guide body 2602 between the pegs 2618, 2620.

[00103] Referring to FIGS. 22A-22F, an inserter 2700 may be used with any of the implants or clips disclosed herein. The inserter 2700 may include a body 2702, a ram 2704, a ram pin 2706, a knob 2708, a shaft 2710, and a knob pin 2712. The ram 2702 and the ram pin 2706 may be coupled together as a ram sub-assembly 2714. The knob 2708, the shaft 2710, and the knob pin 2712 may be coupled together as a shaft sub-assembly 2716.

[00104] The body 2702 extends between a distal end 2718 and a proximal end 2720. The body 2702 may be a generally plate-like part that is wider at the distal end 2718 and narrower at the proximal end 2720. The distal-most aspect of the body 2702 may include two jaws or hooks 2722, 2724 that face each other across a shallow alcove 2726. The hooks 2722, 2724 include proximal surfaces 2728, 2730, respectively. The hook 2722 includes a front wall 2732 and the hook 2724 includes a back wall 2734. A notch 2736 extends proximally from a central portion of the alcove 2726. A first slot 2738 extends through the body 2702 proximal to the notch 2736 along a front- back direction. The slot 2738 is elongated along a proximal-distal direction. A second slot 2740 extends through the body 2702 proximal to the slot 2738 along the front-back direction. The slot 2740 is elongated along the proximal-distal direction. The second slot 2740 is longer than the first slot 2738 in the proximal-distal direction and is wider than the first slot 2738 in the left-right direction. A first central longitudinal hole 2742 extends proximally into the body 2702 from the distal end 2718 to the slot 2740. The slot 2738 and the hole 2742 intersect at right angles. A second central longitudinal hole 2744 extends distally into the body 2702 from the proximal end 2720 to the slot 2740. The hole 2744 may be internally threaded. The body 2702 may be thickened in the vicinity of the hole 2744 so as to adequately support the hole 2744 under expected loads.

[00105] The ram 2704 extends between a distal end 2750 and a proximal end 2752. The ram 2704 includes a distal head 2754, which may be generally rectangular as shown. As seen best in FIGS. 22A and 22C, the distal-most aspect of the head 2754 may be convex in a front or back view. A shaft 2756 extends proximally from the head 2754. The shaft 2756 may have a circular cross section as shown. The outer diameter of the shaft 2756 may be similar to the thickness of the head 2754 in a front-back direction, and may be less than the width of the head in a left-right direction. A transverse hole 2758 extends through the shaft 2756 near the proximal end 2752.

[00106] The ram 2702 and the ram pin 2706 may be coupled together to form the ram subassembly 2714 by inserting the ram pin through the hole 2758.

[00107] The knob 2708 may be a generally rectangular part which may be contoured to match the proximal end 2720 of the body 2702. A central longitudinal hole 2760 may extend through the knob in a proximal-distal direction. A transverse hole 2762 may extend through the knob in a front-back direction.

[00108] The shaft 2710 extends between a distal end 2770 and a proximal end 2772. The shaft 2710 may include three portions or segments along its distal-proximal length. A first portion 2774 extends proximally from the distal end 2770, has a circular cross section, and a smooth outer surface. A second portion 2778 extends proximally from the first portion 2774 and has external threads 2780. The minor diameter of the external threads may be greater than the outer diameter of the first portion 2774. A third portion 2782 extends proximally from the second portion 2778 to the proximal end 2720, has a circular cross section, and a smooth outer surface. The outer diameter of the third portion 2782 may be similar to the minor diameter of the external threads 2780. A transverse hole 2784 extends through the third portion 2782 near the proximal end 2772.

[00109] The knob 2708, the shaft 2710, and the knob pin 2712 may be coupled together to form the shaft sub-assembly 2716 by inserting the third portion 2782 of the shaft 2710 into the hole 2760 of the knob 2708, aligning the transverse holes 2762, 2784, and inserting the knob pin 2712 through the holes 2762, 2784.

[00110] The inserter 2700 may be assembled by inserting the shaft 2756 of the ram 2704 into the hole 2742 of the body 2702, aligning the transverse hole 2758 with the first slot 2738, and inserting the ram pin 2706 through the slot 2738 and hole 2758; and by inserting the first portion 2774 of the shaft 2710 into the hole 2744 of the body 2702 and advancing the shaft distally relative to the body until the first portion enters the hole 2742 and the external threads 2780 engage the internal threads of the hole 2744. The head 2754 may be at least partially received in the notch 2736. Referring to FIGS. 22C and 22D, the distal end 2770 of the shaft 2710 directly contacts the proximal end 2752 of the ram 2704, but the two parts are not otherwise mechanically connected.

[00111] When the inserter 2700 is operatively assembled, the ram 2704 is free to translate proximal-distal relative to the body 2702 within the constraint provided by the ram pin 2706 in the slot 2738, but the ram is prevented from rotating about its shaft 2756 relative to the body by the ram pin in the slot. The shaft sub-assembly 2716 engages the body 2702 via the external threads 2780 engaged with the internal threads of the hole 2744. Thus the shaft sub-assembly rotates and translates simultaneously relative to the body. The shaft sub-assembly 2716 is removable from the assembled body 2702, ram 2704, and ram pin 2706, which is advantageous at least for cleaning. Turning the knob 2708 clockwise advances the shaft sub-assembly 2716 distally, which pushes the ram sub-assembly 2714 distally. Turning the knob 2708 counterclockwise moves the shaft sub-assembly proximally, which permits the ram sub-assembly to move proximally under an external force such as the elastic force of a clip bridge or the force of gravity. However, the distal end 2770 of the shaft 2710 is not mechanically coupled to the proximal end 2752 of the ram 2704 in a way that enables the shaft sub-assembly 2716 to pull the ram sub-assembly 2714 proximally.

[00112] The inserter 2700 may be coupled to any implant or clip disclosed herein. Clip 2400 will be used as an example. A method of coupling the inserter 2700 to the clip 2400 may include any or all of the following steps in any order: rotating the knob 2708 counterclockwise; rotating the shaft 2710 counterclockwise; rotating the shaft sub-assembly 2714 clockwise; moving the ram 2704 proximally; moving the ram sub-assembly 2714 proximally; positioning the upper surface 2408 of the bridge 2406 of the clip 2400 against the distal-most aspect of the ram 2704; orienting the bridge 2406 relative to the body 2702 so that the front wall 2732 is in front of the connecting means 2414 and the back wall 2734 is in back of the connecting means 2416; orienting the bridge 2406 relative to the body 2702 so that the longitudinal direction established by the bridge is oblique to the left-right direction between the hooks 2722, 2724; rotating the body 2702 clockwise; sliding the hooks 2722, 2724 under the connecting means 2414, 2416; rotating the knob 2708 clockwise; rotating the shaft 2710 clockwise; rotating the shaft sub-assembly 2714 clockwise; moving the ram 2704 distally relative to the body 2702; moving the ram sub-assembly 2714 distally relative to the body 2702; and contacting the upper surface 2408 of the bridge 2406 of the clip 2400 with the distal-most aspect of the ram 2704. [00113] The inserter 2700 may be disconnected from the implant 2400 at least by reversing the assembly steps.

[00114] When the implant 2400 and the inserter 2700 are operatively assembled, the inserter 2700 may be actuated to move the implant 2400 between the free state and an elastically deformed state. Referring to FIG. 22C, clockwise rotation of the knob 2708, the shaft 2710, or the shaft sub-assembly 2716 causes the ram 2704 or the ram sub-assembly 2714 to move distally relative to the body 2702 against the static resistance or support of the hooks 2722, 2724 or other static support feature(s). This causes the bridge 2406 to elastically deform in three or four point bending, which causes the bone engaging members 2402, 2404 to spread apart. Counterclockwise rotation of the knob 2708, the shaft 2710, or the shaft sub-assembly 2716 causes the ram 2704 or the ram sub-assembly 2714 to move proximally relative to the body 2702, reducing the proximal force of the hooks 2722, 2724 on the connecting means 2414, 2416. This allows the implant 2400 to relax toward the free state.

[00115] A surgical method for stabilizing first and second bone fragments may include any or all of the following steps in any order: assembling the punch guide 2600; assembling the inserter 2700; assembling the implant 2400 and the inserter 2400; actuating the inserter 2400; moving the ram 2704 or the ram sub-assembly 2714 distally relative to the body 2702; moving the implant 2400 from the free state to an elastically deformed state; moving the bone engaging members 2402, 2404 from a distally-converging state to a parallel state; creating a first hole in a first bone fragment; creating a second hole in a second bone fragment; creating a third hole in the first and second bone fragments; inserting the left bone engaging member 2402 in the first hole; inserting the right bone engaging member 2404 in the second hole; inserting the plug 2450 in the third hole; seating the lower surface 2410 against a surface of the first or second bone fragment; releasing the inserter 2700; moving the ram 2704 or the ra m sub-assembly 2714 proximally relative to the body 2702; moving the implant 2400 from the elastically deformed state toward the free state; moving the bone engaging members 2402, 2404 from a parallel state toward a distally-converging state; and disconnecting the inserter 2700 from the implant 2400.

[00116] Creating the first and second holes may include the steps of: positioning the guide element 2512 of the drill guide 2500 against the first bone fragment; positioning the guide element 2514 against the second bone fragment so that the guide elements 2512, 2514 are on either side of an interface between the first and second bone fragments; inserting the drill bit 2550 through the first lumen 2522 of the drill guide 2500; rotating the drill bit 2550 to form the first hole in the first bone fragment; inserting the drill bit 2550 through the second lumen 2524; and rotating the drill bit 2550 to form the second hole in the second bone fragment.

[00117] Creating the third hole in the first and second bone fragments may include the steps of: inserting the peg 2618 of the punch guide 2600 in the first hole; inserting the peg 2620 in the second hole; inserting the first portion 2656 of the punch 2650 in the lumen 2616 of the punch guide 2600; advancing the punch 2650 in the lumen 2616; impacting the punch; and abutting the third portion 2664 of the punch 2650 against the proximal side 2608 of the punch guide body 2602.

[00118] FIG. 23 shows a joint 2 between a first bone 4 and a second bone 6.

[00119] FIG. 24 shows the steps of positioning the guide element 2512 of the drill guide 2500 against the first bone fragment 4; positioning the guide element 2514 against the second bone fragment 6 so that the guide elements 2512, 2514 are on either side of an interface 2 between the first and second bone fragments 4, 6; and inserting the drill bit 2550 through the first lumen 2522 of the drill guide 2500; rotating the drill bit 2550 to form the first hole in the first bone fragment 4.

[00120] FIG. 25 shows the joint 2 after creating first and second holes 2492, 2494 in the first and second bone fragments 4, 6.

[00121] FIGS. 26A and 26B show the steps of inserting the peg 2618 of the punch guide 2600 in the first hole 2492; and inserting the peg 2620 in the second hole 2494.

[00122] FIGS. 27A and 27B show the steps of inserting the first portion 2656 of the punch 2650 in the lumen 2616 of the punch guide 2600; advancing the punch 2650 in the lumen 2616; impacting the punch; and abutting the third portion 2664 of the punch 2650 against the proximal side 2608 of the punch guide body 2602.

[00123] FIG. 28 shows the joint 2 after creating the third hole 2496 in the first and second bone fragments 4, 6.

[00124] FIG. 29 shows the steps of assembling the implant 2400 and the inserter 2400; actuating the inserter 2400; moving the ram 2704 or the ram sub-assembly 2714 distal ly relative to the body 2702; moving the implant 2400 from the free state to an elastically deformed state; moving the bone engaging members 2402, 2404 from a distally-converging state to a parallel state; inserting the left bone engaging member 2402 in the first hole 2492; and inserting the right bone engaging member 2404 in the second hole 2494. [00125] FIG. 30 shows the steps of inserting the plug 2450 in the third hole 2496; and seating the lower surface 2410 against a surface of the first or second bone fragment. FIG. 31 is an oblique detail view of the distal end of the inserter 2700 coupled to the implant 2400.

[00126] FIGS. 32 and 33 show the implant 2400 fully seated in the bone fragments 4, 6.

[00127] The implants or clips disclosed herein may be made from nitinol, titanium, stainless steel, polymers including PEEK, or any material providing the elastic properties to allow the clip to provide compression across the joint. The plugs disclosed herein may be made from PEEK, titanium, stainless steel, allograft, UH MWPE or any other biocompatible material suitable to resist joint forces for a time. Additionally, any of these materials could be coated with osteoconductive coatings/surface treatments such as hydroxyapatite, trabecular metal, porous beads, and/or nanotubes, among others. It is appreciated that the use of the implants disclosed herein is not limited to bone; any of the implants, clips, or plugs described herein may be implanted into other tissues or materials.

[00128] The terms "upper" and " lower", and "top" and "bottom", "front", "side", and "rear" are used as relative terms herein for ease of description and understanding. It is understood that in embodiments of the disclosure, upper and lower entities may be reversed, as may top and bottom, front and rear.

[00129] Any methods disclosed herein includes one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.

[00130] Reference throughout this specification to "an embodiment" or "the embodiment" means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment.

[00131] Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

[00132] Recitation in the claims of the term "first" with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. §112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the technology.

[00133] While specific embodiments and applications of the present technology have been illustrated and described, it is to be understood that the technology is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present technology disclosed herein without departing from the spirit and scope of the technology.