System for bone fixation using nail locked to entire-peripheral fastening anchor, and method

Abstract

To provide a system for fixing a bone by using an intramedullary nail which is locked to an entire-peripheral fastening anchor having a bushing and a lock member, and a method.SOLUTION: An exemplary system may comprise an arbitrary combination of a nail, one or a plurality of bushings, one or plurality of lock members, an apparatus for guiding the attachment of the bushing, at least one drill, and a driver attached to the bushing. The apparatus defines a guide shaft, and may take a constitution in which the guide shaft is connected to a bone while traversing the bone and extending. The apparatus may be used for guiding the drill, the bushing and / or the lock member into the bone along the guide shaft. The nail may be constituted so as to stay along a medullary canal of the bone, the nail thereby penetrates the bushing, and the lock member may be constituted so as to lock the nail to the bushing.SELECTED DRAWING: Figure 43

Description

[Technical field]

[0001] CROSS-REFERENCE TO PRIORITY APPLICATIONS This application is based on and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62 / 569,955, filed October 9, 2017, which is incorporated by reference herein for all purposes. [Background technology]

[0002] Intramedullary (IM) nails are internal fixation devices that can be placed along the medullary canal of a fractured bone. The nail acts as a splint inside the bone to keep the bone segments aligned as healing occurs. A standard double-locking nail defines multiple openings near its opposing ends to accept screws that lock both ends of the nail to the bone. However, some bones, such as the fibula and ulna, are too narrow to accept a standard nail without excessive boring. For these bones, an elongated single-locking nail may be installed instead. A single-locking nail has a head that defines an opening for the screw and a shaft that is too narrow to accept the screw. Thus, one end of the nail (the head) is locked to the bone, while the other end (the shaft) remains unlocked. If the fracture is at a location within the shaft, the nail may allow movement of the bone segments with respect to each other. In this type of fracture, the bone can be more effectively stabilized if the surgeon had the option to further lock the shaft to the bone.

[0003] US Patent No. 5,399,633 proposes a nail-based fixation system in which the nail passes through and is locked to the fastener. More specifically, the system utilizes a mounting fixture that must move in a linear path as the nail advances into the bone until the tip of the nail is inside the fastener hole. However, this system is not suitable for forming non-linear and / or flexible nail shafts at a distance substantially away from the nail's entry site into the bone. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 7,785,326 [Patent Document 2] U.S. Patent Application Serial No. 15 / 728,247 Summary of the Invention [Means for solving the problem]

[0005] The present disclosure provides systems and methods for fixing a bone using an intramedullary nail locked to an encircling anchor comprising a bushing and a locking member. An exemplary system may include any combination of a nail, one or more bushings, one or more locking members, an instrument for guiding installation of the bushing, at least one drill, and a driver for attachment to the bushing. The instrument may define a guide axis and be configured to be coupled to the bone such that the guide axis extends across the bone. The instrument may be used to guide the drill, bushing, and / or locking member into the bone along the guide axis. The nail may be configured to be placed along the medullary canal of the bone such that the nail passes through the bushing and the locking member is configured to lock the nail to the bushing. [Brief description of the drawings]

[0006] [Figure 1] FIG. 1 illustrates an anterior view of a fractured left fibula (shown in phantom) fixed with an intramedullary nail engaged with a circumferential fastening anchor, but omitting fasteners to the posterior region of the nail, in accordance with aspects of the present disclosure. [Diagram 2] FIG. 2 is a lateral view of the fractured left fibula of FIG. 1 taken with the nail and circumferential fastening anchor installed as in FIG. 1 . [Diagram 3] FIG. 2 is a partial isometric view of the nail and perimeter fastening anchor of FIG. 1 taken around the anchor. [Figure 4]2 is a partial view of the fibula, nail, and anchor of FIG. 1 taken generally about the area indicated in FIG. 1 showing a longitudinal cross-section of the fibula. [Diagram 5] 5 is a partial cross-sectional view of the nail and anchor of FIG. 1 taken along line 5-5 of FIG. 4. [Figure 6] FIG. 2 is a side view of a bushing of the anchor of FIG. 1. [Figure 7] 7 is another side view of the bushing of FIG. 1 taken along line 7-7 of FIG. 6. [Figure 8] 8 is an end view of the bushing of FIG. 1 taken along line 8-8 of FIG. 6. [Figure 9] 9 is a cross-sectional view of the bushing of FIG. 1 taken along line 9-9 of FIG. 6. [Figure 10] 1 taken along line 10-10 of FIG. 8. FIG. [Figure 11] 2 is a side view of the locking member of the anchor of FIG. 1. [Figure 12] FIG. 2 is a proximal end view of the locking member of FIG. 1. [Figure 13] 13 is a cross-sectional view of the locking member of FIG. 1 taken along line 13-13 of FIG. 12. [Figure 14] 2 illustrates a set of bushings and corresponding locking members that may be included in the fixation system of FIG. 1 to facilitate attachment of the nail to regions of bone having different local widths. [Figure 15] FIG. 2 is a partial cross-sectional view of the fibula of FIG. 1 taken after the fibula has been bicortically hollowed out to prepare the bone to receive a bushing. [Figure 16] 16 is another partial cross-sectional view of the fibula of FIG. 1 taken similarly to FIG. 15 except that a bushing is embedded within the fibula. [Figure 17]1 , with the nail partially shown and the bushing shown in cross section similar to FIG. 9 , taken as the tip of the nail passes through the side opening of the bushing, illustrating how the tip offset and rotation of the nail can work together to correct for misalignment between the tip and the side opening, thereby allowing the tip to enter the bushing correctly. [Figure 18] 1 , with the nail partially shown and the bushing shown in cross section similar to FIG. 9 , taken as the tip of the nail passes through the side opening of the bushing, illustrating how the tip offset and rotation of the nail can work together to correct for misalignment between the tip and the side opening, thereby allowing the tip to enter the bushing correctly. [Figure 19] 1 , with the nail partially shown and the bushing shown in cross section similar to FIG. 9 , taken as the tip of the nail passes through the side opening of the bushing, illustrating how the tip offset and rotation of the nail can work together to correct for misalignment between the tip and the side opening, thereby allowing the tip to enter the bushing correctly. [Figure 20] 1 , with the nail partially shown and the bushing shown in cross section similar to FIG. 9 , taken as the tip of the nail passes through the side opening of the bushing, illustrating how the tip offset and rotation of the nail can work together to correct for misalignment between the tip and the side opening, thereby allowing the tip to enter the bushing correctly. [Figure 21] FIG. 2 is a partial anterior view of the fibula of FIG. 1 taken during preparation of the fibula to receive the bushing of FIG. 1 and showing an exemplary instrument attached in part to the fibula with a wire member and positioned to guide a stepped drill, shown as a fragment, into the fibula, according to an embodiment of the present disclosure. [Figure 22] 22 is a top view of the instrument of FIG. 21 taken without the guide portion of the instrument and with the jaws of the instrument in a closed configuration. [Figure 22A] FIG. 22 is a partial view of the device of FIG. 21 showing a portion of the gauge of the device. [Figure 23] 23 is another top view of the instrument of FIG. 21 taken as in FIG. 22 but with the jaws of the instrument in an open configuration. [Figure 24] 23 is a partial top view of the instrument of FIG. 21 taken in the same manner as FIG. 22 about the fulcrum and coupling assembly of the instrument. [Diagram 25] 23 , taken around the fulcrum and coupling assembly of the instrument. FIG. 24 is another partial top view of the instrument of FIG. 21 . [Figure 26] FIG. 22 is a top view of the instrument of FIG. 21 with the cortex and medullary canal of the fibula shown diagrammatically in phantom outline. [Figure 27] 26 and showing an exemplary trajectory that the instrument may follow as it guides the tip of the wire member into and / or through the bone to further bond the instrument to the bone, thereby stabilizing the instrument on the bone. [Figure 28] 28 is a schematic diagram corresponding to FIG. 27 but showing different exemplary trajectories that the instrument may follow as it guides the tip of the wire member into and / or through the bone to stabilize the instrument. [Figure 29] FIG. 22 is a schematic diagram of a pair of fluoroscopic images showing a partial axial portion of the fibula and nail of FIG. 1 and the guide tube of the instrument of FIG. 21 as viewed along the axis defined by the guide tube anterior (left) and posterior (right) where the position of the tube improves alignment of the tube with the nail. [Figure 30A] FIG. 22 is an isometric view of the guide portion and holder of the instrument of FIG. 21 taken apart from the remainder of the instrument and in a locked configuration that prevents rotation of the guide portion relative to the holder. [Figure 30B] FIG. 30B is a partial isometric view of the guide portion and holder of FIG. 30A taken with the guide portion in an unlocked configuration that allows rotation of the guide relative to the holder. [Figure 30C]FIG. 30B is another partial isometric view of the guide portion and holder of FIG. 30A taken after rotation of the guide portion relative to the holder (compare FIG. 30B) while the guide portion is still in an unlocked configuration. [Diagram 31] 31 is a cross-sectional view of the guide portion and holder of FIG. 30A taken generally along line 31-31 of FIG. 30A and showing in phantom an alternative locking position of the guide portion. [Diagram 32] 32 is a cross-sectional view of the guide portion and holder of FIG. 30A taken generally along line 32-32 of FIG. 30A. [Figure 33A] 22 is an isometric view of another exemplary guide portion and holder for the instrument of FIG. 21 taken separate from the remainder of the instrument and in a locked configuration that prevents movement of the guide portion relative to the holder, according to an embodiment of the present disclosure. [Figure 33B] FIG. 33B is another isometric view of the guide portion and holder of FIG. 33A, taken similarly to FIG. 33A, except that the holder is fragmentary and the guide portion is retracted to provide an unlocked configuration. [Figure 33C] FIG. 33B is another isometric partial view of the guide portion and holder of FIG. 33A taken similar to FIG. 33B except that the guide portion has been rotated and is in a retracted, unlocked configuration. [Diagram 34] 34 is a cross-sectional view of the guide portion and holder of FIG. 33A taken generally along line 34-34 of FIG. 33A. [Diagram 35] 35 is another cross-sectional view of the guide portion and holder of FIG. 33A taken generally along line 35-35 of FIG. 33A. [Diagram 36] 22 is an isometric view of yet another exemplary guide portion and holder for the instrument of FIG. 21 , taken separate from the remainder of the instrument, according to an embodiment of the present disclosure. [Figure 37] FIG. 37 is an exploded partial view of the guide portion and holder of FIG. 36. [Figure 38] 38 is a cross-sectional view of the guide portion of FIG. 36 taken generally along line 38-38 of FIG. 36. [Figure 39]FIG. 15 is an isometric view of an example driver for the bushing of FIG. [Diagram 40] 40 is an exploded view of the driver of FIG. 39 with one of the bushings of FIG. 14 aligned with the driver. [Diagram 41] 40 is a partial view of the driver sleeve of FIG. 39 showing the protrusions taken around the tip of the sleeve and mating with complementary recesses in each bushing. [Diagram 42] 42 is a cross-sectional view of the driver of FIG. 39 taken generally along line 42-42 of FIG. 40 through a handle portion of the driver. [Diagram 43] FIG. 2 is an exploded view of another exemplary perimeter fastening anchor for the nail-based fastening system of FIG. 1 according to an embodiment of the present disclosure. [Diagram 44] 44 is a side view of the bushing of the anchor of FIG. 43 as viewed parallel to the through axis defined by the lateral opening of the bushing. [Diagram 45] FIG. 45 is a side view of the bushing of FIG. 44 taken perpendicular to the through axis of the transverse opening. [Figure 46] FIG. 44 is a side view of the locking member of the anchor of FIG. 43. [Figure 47] 47 is a partial cross-sectional view of the anchor of FIG. 43 taken generally along line 47-47 of FIG. 43 where the anchor is circumferentially fastened and locked to the distal region of the intramedullary nail of FIG. 1. FIG. [Figure 48] 48 is a cross-sectional view of the anchor of FIG. 43 in an initial assembly stage, taken generally along line 48-48 of FIG. 43, in which the tip region of the intramedullary nail of FIG. 1 has penetrated the bushing of the anchor and the locking member of the anchor has advanced in an axial opening of the bushing by translation only and has not yet threadedly engaged with the bushing. [Figure 49] 49 is another cross-sectional view of the anchor and nail of FIG. 48 taken similarly to FIG. 48 except that the anchor is in an intermediate assembly stage formed by rotational (threaded) advancement of the locking member into the axial opening of the bushing and pushed part way into the distal end of the lateral opening of the bushing. [Figure 50]49, except that the locking member has been fully advanced into a seated position locking the nail into the bushing. FIG. 49 is another cross-sectional view of the anchor and nail of FIG. [Figure 51] FIG. 13 is a top view of another exemplary instrument for guiding installation of a bushing of a circumferential nail fastening anchor, according to aspects of the present disclosure. [Figure 52] FIG. 52 is a view of the guide portion and holder of the instrument of FIG. 51 taken separately from the clamp portion of the instrument. [Diagram 53] 53 is a partial cross-sectional view of the guide portion and holder of FIG. 52 taken generally along line 53-53 of FIG. 52. [Figure 54] 54 is another cross-sectional view of the guide portion and holder of FIG. 52 taken generally along line 54-54 of FIG. 53. [Figure 55] FIG. 1 is a side view of an exemplary near-cortex drill for use in a two-drill procedure to hollow out bone to receive a bushing, where the near-cortex drill is configured to be guided into the bone using any of the guide instruments disclosed herein. [Figure 56] FIG. 56 is a side view of an exemplary far-cortex drill that can be used with the near-cortex drill of FIG. 55 in a two-drill procedure to hollow out bone to receive a bushing. [Figure 57] FIG. 57 is a partial cross-sectional view of a bone showing how the drill of FIGS. 55 and 56 can sequentially drill holes of different diameters to receive correspondingly sized areas of a bushing. [Figure 58] FIG. 57 is a partial cross-sectional view of a bone showing how the drill of FIGS. 55 and 56 can sequentially drill holes of different diameters to receive correspondingly sized areas of a bushing. [Figure 59] FIG. 57 is a partial cross-sectional view of a bone showing how the drill of FIGS. 55 and 56 can sequentially drill holes of different diameters to receive correspondingly sized areas of a bushing. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] The present disclosure provides systems and methods for fixing bone using an intramedullary nail locked to a circumferential fastening anchor comprising a bushing and a locking member. An exemplary system may comprise any combination of a nail, one or more bushings, one or more locking members, an instrument for guiding installation of the bushing, at least one drill, and a driver for attachment to the bushing. The instrument may define a guide axis and be configured to be coupled to the bone such that the guide axis extends across the bone. The instrument may be used to guide the drill, bushing, and / or locking member into the bone along the guide axis. The nail may be configured to be placed along the medullary canal of the bone such that the nail passes through the bushing and the locking member is configured to lock the nail to the bushing.

[0008] An exemplary system for bone fixation is provided. The system may include an instrument, a bushing, a nail, and a locking member. The instrument may have a pair of jaws configured to engage opposing sides of the diaphysis of a long bone. The jaws may be coupled to a guide portion defining a guide axis. The guide axis may extend across the diaphysis when the jaws engage the diaphysis. The instrument may be configured to maintain the guide in a central plane that is between the jaws and equidistant from the jaws when the jaws open and close. The bushing may be configured to be placed laterally in the bone along the guide axis. The nail may be configured to be placed along the medullary canal of the bone such that the nail passes through the bushing. The locking member may be configured to lock the nail to the bushing. In some embodiments, the instrument may be configured to allow the guide axis to be adjustably offset from the central plane if necessary. In some embodiments, the instrument may be configured to couple a guide instrument to the bone through a wire member into / through the bone. For example, the tips of the pair of wire members may be guided in non-parallel trajectories through the bone to stabilize the instrument on the bone. In some embodiments, the instrument may include a gauge configured to measure the local width of the bone and optionally indicate whether the local width is sufficient for secure installation of the bushing. In some embodiments, the bushing may form a step configured to impede advancement of the bushing when the step contacts the far cortex of the bone. The bushing may also form a post that projects distally from the step. In some embodiments, the nail may have an offset tip configured to allow adjustment of alignment of the nail with the lateral opening of the bushing when the nail is rotated about its long axis.

[0009] An exemplary method of fixating a bone is provided, in which opposing sides of the bone may be engaged with jaws of an instrument having a guide portion defining a guide axis. The jaws may be coupled, or configured to be coupled, to the guide portion such that the guide axis remains in a central plane between and equidistant from the jaws as the jaws open and close. The bone may be cross-bored along the guide axis to drill at least one hole. A bushing may be placed into the bone at the at least one hole. A nail may be advanced along the medullary canal of the bone such that the nail passes through the bushing. The nail may be locked to the bushing.

[0010] Another exemplary method of fixing a bone is provided. In this method, the bone may be hollowed out along an axis to form a wider hole through the near cortex of the bone and a narrower hole in and / or through the far cortex of the bone. A bushing may be selected. The bushing may have a trailing end portion with a diameter corresponding to the wider hole and a leading end portion with a diameter corresponding to the narrower hole. The trailing end portion may form a step adjacent the leading end portion. The bushing may be driven as one piece into the hollowed out bone along an axis until contact between the step and the far cortex prevents further advancement of the bushing. A nail may be advanced along the medullary canal such that the nail penetrates the bushing. The nail may be locked into the bushing.

[0011] The disclosed systems and methods may provide any combination of the following features and advantages: Installation of the bushing may be more reliably performed using an instrument with a self-centering guide shaft. The jaws of the clamp may be inserted through an incision, under the soft tissue covering the opposing sides of the bone, and engage areas of the bone that are not visible to the surgeon. Thus, even if the surgeon cannot visually determine where the lateral center of the bone is, the self-centering configuration of the instrument can ensure that the guide shaft will cut across the bone and be very close to the lateral center. The systems and methods can also ensure that the tip of the nail inside the bone is aligned with the lateral opening defined by the bushing, even when the nail is flexible / curved and / or the bushing is positioned away from the nail's entry site. The nail successfully mates with the bushing when the nail's trajectory intersects with the lateral opening of the bushing. The systems and methods can properly position the guide shaft along which the bushing is installed. For example, the instrument defining the guide shaft may be self-centering on the bone as described above and / or may allow off-center movement of the guide shaft, if necessary, while the instrument remains attached to the bone. The instrument may be coupled to the bone with one or more wire members in addition to or instead of using the jaws of the instrument. (The jaws may thus be omitted from the instrument design.) These systems and methods may mount or be configured to mount the bushing along the guide shaft such that the bushing has an optimal position along the guide shaft. For example, the bushing may have a step that stops the advancement of the bushing through contact with the far cortex of the bone to set the position of the bushing along the guide shaft. This configuration may place the distal end of the lateral opening very close to the far cortex. The lateral opening may be elongated (forming a slot) parallel to the long axis of the bushing, such that the lateral opening substantially spans (across the canal) the medullary canal when the bushing is mounted in the bone. In some embodiments, the size of the side opening may be selected by choosing a bushing from a set of bushings having respective side openings of different lengths (measured parallel to the long axis of the bushing).The width of the side opening may be substantially maximized through the use of a bevel, which may be formed in part by a protrusion on the bushing, to more securely interface the nail with the bushing.

[0012] Further aspects of the present disclosure are described in sections: (I) Overview of the Implanted Components of the Fixation System, (II) Anchors, (III) Offset Tip Nails, (IV) Instruments, (V) Drivers, (VI) Methods of Fixing Bones, (VII) System Component Configurations, and (VIII) Examples.

[0013] I. Overview of the embedded components of the fastening system This section provides an overview of exemplary embedded components for the fixation system 50 of the present disclosure. See Figures 1-5.

[0014] 1 and 2 show a fixation assembly 52 of a fixation system implanted in a left fibula 54 having a fracture 56 in the diaphyseal region 58 of the bone. The fixation assembly may include an intramedullary nail 60 that spans at least one fracture 56 and passes through an anchor 62 for the nail. The anchor may surround the nail and engage the nail to attach the nail to the bone. The nail 60 may be configured to be longitudinally disposed within the bone, and in particular within its medullary canal 64, with the long axes of the nail and bone substantially aligned with one another (e.g., parallel and / or coincident). The anchor 62 may be embedded laterally (e.g., bicortically) within the bone and span the medullary canal in a crosswise manner. The anchor may alternatively be described as an implant or, in some embodiments, as an external fastener (i.e., external to the nail).

[0015] The nail 60 may be elongated and have a trailing region 66 and a leading region 68, each of which may also be elongated. The trailing region 66 and the leading region 68 may be adjacent to one another or separated by an intermediate region of the nail. The regions 66, 68 may form opposing leading and trailing ends of the nail and may be formed integrally with one another. The leading region may have a smaller diameter (e.g., a smaller average or maximum diameter) than the trailing region. Thus, the leading region may be described as the stem and the trailing region as the head of the nail. The leading region may be configured to enter the medullary canal as the nail is inserted therein. The nail may taper or have a stepwise reduction in diameter at one or more locations along its length. The leading region 68 may comprise an elongated lockable section that is uniform in diameter and size according to a lateral opening of the anchor. The anchor may be locked to the nail over a continuous range of locations along the lockable section. The lockable section may have any suitable length, such as at least about 5%, 10%, or 20% of the length of the nail, among others.

[0016] To fix the fibula 54, the nail may be attached to bone fragments 70, 72 (also described as bone segments) of the fibula 54 (or another bone) located on opposite sides of the fracture 56. The trailing end region 66 of the nail may define one or more lateral openings 74 (such as through holes or blind holes) to receive a fastener (such as a threaded fastener (e.g., a screw)) that attaches the trailing end region to the bone fragment 70 and / or end region 76 of the bone. Each opening 74 may or may not include female threads complementary to the male threads of the fastener. In narrow bones, such as the fibula, the tip region 68 may be too thin to define an opening, such as a hole, for receiving a fastener without compromising the strength of the nail. The anchors 62 disclosed herein attach the tip region 68 of the nail 60 to the bone fragment 72 and / or diaphyseal region 58 of the bone to stabilize the fibula 54 and promote osteosynthesis at the fracture site.

[0017] The nail 60 may be straight or may have a preformed radial curvature, for example, as shown at 78. Thus, the nail may define a longitudinal axis 80 that is straight or non-straight. The nail may also have sufficient flexibility, particularly in the tip region 68, such that the nail is deformed as it is placed into the medullary canal of the bone so that the nail follows the longitudinal shape of the medullary canal.

[0018] The anchor may be elongated but substantially shorter than the nail, for example the nail may be at least 5 or 10 times the length of the anchor and / or its bushing.

[0019] The anchor 62 may be introduced into the fibula 54 laterally, within the diaphyseal region 58 of the bone. The anchor may be placed into the bone along an axis transverse to, such as substantially perpendicular to, the long axis of the bone. In the illustrated embodiment, the anchor 62 may be introduced from the anatomical lateral side of the fibula 54 and advanced along the central lateral axis of the bone, although in other embodiments the anchor 62 may be introduced from the appropriate side of the fibula or other bone.

[0020] 3-5 show the anchor 62 and its relationship to the nail 60 and fibula 54 in more detail. The anchor 62 may comprise an assembly of a bushing 82 and a locking member 84 that are separate and attached to one another. The bushing may be interchangeably referred to as a housing. The bushing 82 may define a cavity 86 into which at least a portion of the lockable section 88 of the nail 60 and at least a portion or all of the locking member 84 may be received. The lockable section 88 may be cooperatively clamped by the bushing 82 and the locking member 84 to lock the nail to the bushing / anchor (see FIG. 5). For example, the bushing 82 may define a female thread 90 and the locking member 84 may be a set screw having a complementary male thread 92, or vice versa, providing a threaded engagement between the bushing and the locking member. (Elongation of either thread may also occur due to material deformation when the fixation system is installed. See Example 1.)

[0021] The locking member 84 may be rotated to adjust its axial position within the bushing, advancing a tip 94 of the locking member such that the nail section 88 may be gripped firmly on the opposing side with the tip 94 and an inner wall region 96 of the bushing 82 to lock the nail into the anchor. The inner wall region may be complementary to the nail (e.g., cylindrical in shape). The locking member may be configured to be fully disposed inside the bushing 82 when the nail is locked into the bushing, with the rear end of the locking member being flush or recessed with respect to the bushing.

[0022] The tip 94 of the locking member 84 and / or the inner wall region 96 of the bushing 82 may be structured to further prevent slippage of the locked nail. One or both may have a protruding feature that may be configured, in one embodiment, to indent the surface of the nail 60 as the nail becomes tightly clamped. For example, the tip 94 may form a distal protruding rim or spike that is centered on the long axis of the locking member (see Section II and Example 1 in Section VIII), and / or the inner wall region 96 may define one or more proximal protruding ridges, bumps, spikes, etc. that contact the nail. To facilitate deformation of the nail by the protruding features, the nail may be formed from a softer material than the bushing 82 and / or the locking member 84. In an exemplary embodiment, the nail may be formed from titanium or a titanium alloy, and the bushing and / or the locking member may be formed from, among other things, a cobalt-chromium alloy (interchangeably referred to as a cobalt-chromium alloy).

[0023] The bushing 82 may have a rear end portion 98 and a tip portion 100 that are arranged coaxially with respect to one another and are each centered on the longitudinal axis 102 of the bushing (see FIG. 4). The rear end portion 98 may extend to a rear end 104 of the bushing and the tip portion 100 may extend to a tip 105 of the bushing. The bushing may be unitary (only one component part) and / or may be configured to be attached as a unit. The rear end portion 98 and the tip portion 100 may be integrally formed with one another. In other embodiments, the rear end portion and the tip portion may be formed spaced apart and rigidly attached to one another. The rear end portion and the tip portion may be adjacent to one another.

[0024] The trailing portion 98 is substantially wider than the distal portion 100, with the portions forming a body 106 and a post 108. For example, the trailing portion can have a diameter (e.g., average diameter) that is greater than the diameter (e.g., average diameter) of the distal portion. In some embodiments, the average diameter of the trailing portion can be at least about 1.5, 2, 2.5, or 3 times the average diameter of the distal portion. Each portion can be substantially cylindrical, as shown in the illustrated embodiment. The post can stabilize the bushing to prevent it from wobbling in the bone.

[0025] The rear end portion 98 may form a step 110 at its distal end (see FIGS. 4 and 5). The step may be formed by an abrupt termination to the body portion 106, as in the illustrated embodiment, or by a gradual linear or non-linear decrease in diameter of the body portion 106, as shown by the dashed line at 112 in FIG. 4. Thus, the step may be planar, lying in a plane oriented perpendicular to the longitudinal axis 102, conical, or rounded (e.g., spherical) in profile, among other things (again, see Example 1 in Section VIII). The step may form an angle (e.g., maximum or average angle) of at least about 50, 60, 70, or 80° with the longitudinal axis 102 (and / or the strut 108) such that the step is configured to act as a stop when the bushing is installed.

[0026] The trailing portion 98 and the distal portion 100 may be at different distances from each other, with the lengths measured parallel to the long axis 102. These different lengths may correspond to different locations and functions of each portion within the bone, as illustrated with the fibula 54 shown in cross section in FIG. 4. The cortex 116 of the fibula 54 forms a shell of dense compact bone around the medullary canal 64 in which the nail 60 is located. The laterally spaced regions of the cortex 116 near and far from the entry site of the bushing 82, respectively, are described as the near cortex 118 (proximal to the site) and the far cortex 120 (distal to the site). The trailing portion 98 may be located only partially within the near cortex 118 and may cross-straddle the medullary canal 64. The step 110 may be configured to contact the far cortex 120 to stop the advancement of the bushing into the bone upon installation. The trailing end of the trailing portion may be recessed, flush, or protruding with respect to the exterior of the bone. The tip portion 100 of the bushing may penetrate and / or pass through the far cortex 120, as in the illustrated embodiment where a rounded tip of the tip portion 100 protrudes from the far cortex, and may be located at least primarily within the far cortex 120, or at least primarily within the far cortex and / or outside the bone. In other embodiments, the tip may be sharp or blunt, among other things.

[0027] The bushing 82 may be configured to attach to the near cortex 118, the far cortex 120, or both cortices. The trailing end portion 98 and / or the tip portion 100 may have at least one radial projection configured to attach the portion to the bone by engagement, such as threading, with a corresponding region of the cortex. Each radial projection may include or form, for example, at least one thread, tooth, fin, barb, annular ridge, axial ridge, and / or the like. In some embodiments, one or both portions 98, 100 may have one or more radial projections forming an external thread structure, which is any fastening structure corresponding to at least one continuous or segmented external thread. In the illustrated embodiment, the segmented external thread structure 121 is formed by radial projections 122 formed only on the trailing end portion 98, each radial projection defining a plurality of teeth 124, as described in more detail in Section II. In other embodiments, a male thread structure 121 having a more continuous configuration may be formed by one or more helical protrusions on the body portion 106 (see Example 1 in Section VIII) and / or a continuous / segmented male thread structure may be formed on the post 108.

[0028] The fibula is merely an example. Other suitable bones that may be fixed with the fixation systems disclosed herein may include long bones, particularly long bones having a narrow diaphyseal region, such as the ulna, although the fixation assemblies may be used with any suitable bone (e.g., radius, humerus, femur, tibia, clavicle, etc.). In the illustrated embodiment, the nail 60 enters the fibula 54 from the distal anatomical end of the bone and then the tip region 68 is attached to the proximal anatomical bone fragment 72. However, in other embodiments, the nail may be introduced into the bone from the proximal anatomical end and the tip region 68 may be attached to the distal anatomical bone fragment.

[0029] The terms "proximal" and "distal" have different meanings herein with respect to implants and bones. The terms "proximal" and "distal" as used to describe an implant or instrument mean closer to and farther from the site of entry into the bone and / or the surgeon at the time of installation or use, respectively, and often correspond to "rear" and "front," respectively. The terms "proximal" and "distal" as used to describe regions along a long bone mean closer to and farther from the site of attachment to the bone, respectively.

[0030] II. Anchor This section further describes additional aspects of an exemplary anchor 62 for the fixation system of the present disclosure, as well as an exemplary coaxial cortical bone to which the anchor may be attached. See Figures 6-16.

[0031] 6-10 show various views of the bushing 82 described above in Section I. As previously described, the bushing may have a proximal cylindrical body portion 106 and a distal post 108, which may or may not be cylindrical and / or axially elongated. The bushing may also have a plurality of external radial projections 122 formed on the body portion 106 that form male threads or are otherwise configured to limit removal of the bushing from the bone.

[0032] The body portion 106 may be hollow and define a gap 86 to allow the body portion to radially receive the nail 60 and axially receive the locking member 84 (see also FIGS. 3-5). More specifically, the gap 86 may include a lateral opening 126 intersecting the axial opening 128. The lateral opening is a through opening that passes laterally through the body portion (e.g., perpendicular to the longitudinal axis 102, such as radially through the body portion as a radial opening). The lateral opening may be formed in part by the interior wall region 96. The lateral opening 126 may be sized to allow the nail 60 to gradually advance longitudinally from its tip, through the body portion, until a lockable section of the tip region of the nail is partially disposed within the lateral opening and passes (e.g., radially) through the bushing 82. The transverse opening may be a slot elongated parallel to the longitudinal axis 102 to increase the size of the opening, thereby increasing the probability of successful entry of the tip of the nail into the bushing. The axial opening 128 may be sized to receive the locking member 84 and may define the female threads 90.

[0033] The lateral openings 126 may be tapered inwardly at one or both ends to form at least one inlet 130. The inlet further increases the target size of the opening, thereby increasing the probability of successful entry of the tip of the nail into the body of the bushing. In the illustrated embodiment, a pair of inlets 130 are defined by opposing lateral sides of the body 106. Each inlet 130 may be formed as a bevel 132, which may be a circumferential bevel as shown. At least a portion of at least one or each inlet / bevel may be formed by a radial protrusion (e.g., protrusion 122) on the body 106. The bevel may form any suitable acute angle with the through axis 134 of the opening 126, such as an angle greater than about 35, 40, or 45 degrees, among others. The increase in target size of the lateral openings caused by the bevels is illustrated in FIGS. 9 and 10. The bevel may increase the maximum width 136 of the opening (i.e., the width of the inlet, compared to the internal width 138) and / or may increase the maximum length 140 of the opening (i.e., the length of the inlet, compared to the internal length 142). In some embodiments, the internal width 138 may be at least about ½ the average diameter of the body portion 106 (ignoring any protrusions thereon). In some embodiments, the width 136 of the inlet 130 may be at least about 40% or 50% or more greater than the internal width 138 and / or may be at least about 75%, 80%, or 90% of the average diameter of the body portion 106 (as defined above). In some embodiments, the internal length 142 of the opening 126 and / or the length 140 of at least one or each inlet 130 may be greater than ½ the length of the body portion 106 measured parallel to the longitudinal axis 102.

[0034] The radial projections 122 may be described as wings (see FIG. 8). The projections may be spaced apart from one another around the circumference of the body and may be uniformly spaced apart. For example, the illustrated embodiment has four projections 122 spaced apart from one another by 90 degrees, defining an X-shape in the end face of the bushing. In other embodiments, the bushing may have a different number of projections 122, such as 2, 3, 5, or 6, among others. Each of the projections may be arranged linearly and axially on the body 106 parallel to the longitudinal axis 102, may be helical, or may have some other arrangement.

[0035] The body portion 106 may have teeth 124 formed laterally thereon, optionally also provided by the projections 122 (see FIG. 7). The teeth may be arranged in spaced columns 144, each extending parallel to the longitudinal axis 102, and the columns may be uniformly spaced from one another as described above for the projections 122. Teeth considered together may be arranged on the same helical path 146. The pitch (p) of the helical path (the distance between successive complete turns of the path) may be equal to the center-to-center spacing of adjacent teeth in the column. The columns of teeth may be axially offset from one another by a fraction of the pitch to place some or all of the teeth on the helical path. For example, with n uniformly spaced rows of teeth, the rows may be consecutively offset from one another by a distance of p / n. The axial column of teeth allows the bushing to be driven into the bone either axially / translationally (without substantial rotation), or by rotating the bushing (so that the teeth act as male threads), or both sequentially. In other embodiments, the teeth may be replaced with more complete male threads (see, for example, Example 1 in Section VIII).

[0036] The bushing 82 may have driver engagement structure formed internally, externally, and / or at its proximal (rear) end to facilitate translational and / or rotational impaction of the bushing into the bone. In the illustrated embodiment, the body portion 106 defines a pair of recesses 148 at its rear end. The recesses may be diagonally spaced from one another. Corresponding drivers are described in Section V below.

[0037] 11-13 show various views of the locking member 84, described above in Section I. The locking member may have a cylindrical diaphyseal 150 with external threads 92 formed thereon. The length of the locking member, measured parallel to the longitudinal axis 152, may be less than the length of the body portion 106 of the bushing 82, such as approximately equal to the length of the body portion 106 minus the cross-sectional diameter of the nail passing through the body portion minus the distance between the distal end of the body portion 106 and the inner wall region 96 of the body portion that engages the nail. This length may result in the proximal end of the locking member being flush or recessed with respect to the proximal end of the bushing when the locking member is operatively engaged with the nail.

[0038] The proximal end of the locking member 84 may define a driver engagement structure 154. In the illustrated embodiment, the structure 154 is a hexalobe recess, however, any suitable internal and / or external driver engagement structure may be present.

[0039] The distal end of the locking member 84 may define a protrusion 156 configured to engage the nail and optionally deform the nail. In the illustrated embodiment, the protrusion 156 surrounds a central recess 158 and the distal end of the locking member forms an annular protruding rim for engaging the nail.

[0040] FIG. 14 shows a set of bushings 82 and corresponding locking members 84 that may be included with the fixation system 50. This set of bushings allows the surgeon to select a suitable size of anchor for a given bone, and in particular for the particular region of the bone where the anchor is to be attached. The bushings have the same diameter, but differ in length from one another. The difference in length may be determined by the body portion 106 of each bushing. In other words, the body portions 106 may differ in length from one another, and the posts 108 may have the same length (and / or diameter) from one another. In the illustrated embodiment, the posts 108 are identical to one another. The lateral openings 126 may differ in length between the bushings 82, measured parallel to the major axis 102, in direct relation to the differing lengths of the bushings 82 and / or the body portions 106. By increasing the length of the openings 126 (and therefore the entrance 130), the target area for nail entry into the bushing is increased for bones with locally larger diameters. The elongated portal 130 may substantially span the medullary canal of the bone, which simplifies alignment of the tip of the nail with the portal.

[0041] The locking members 84 may have different lengths corresponding to the different lengths of the body portions 106. Each locking member 84 may have a length that is approximately the length of the corresponding body portion 106 minus the diameter of the tip region of the nail that passes through the body portion, minus the distance between the distal end of the body portion 106 and the inner wall region 96 of the body portion that engages the nail.

[0042] 15 and 16 show the fibula 54 prepared to receive the bushing 82 and with the bushing attached. In FIG. 15, the medullary canal 64 has been reamed, if necessary, and the fibula 54 has been bicortically hollowed out to form a pair of coaxial cylindrical holes, a wider hole 160 through the near cortex 118 and an optional narrower hole 161 through the far cortex 120. In FIG. 16, the body 106 is seated within the wider hole 160 and medullary canal 64, and the post 108 is seated within the narrower hole 161 and protrudes from the fibula 54. The step 110 abuts the far cortex 120 and is optionally seated within a matching / complementary recess formed in the inner side of the far cortex adjacent the narrower hole 161. The length 140 of the entrance 130 is greater than the local width of the medullary canal 64.

[0043] III. Nails with Offset Tip This section describes an exemplary offset tip 162 for the nail 60 of the fastening system 50 and a procedure for utilizing the tip 162 to help correct misalignment and guide the nail into the bushing 82. See Figures 17-20. The offset tip may be interchangeably referred to as a kicked tip.

[0044] 17-20 show a series of exemplary positional relationships of the nail 60 and bushing 82 with respect to one another. These positional relationships may occur when the nail is engaged with the bushing by the surgeon after the bushing has been laterally installed in the bone. In other words, the bushing 82 is fixed and the nail 60 advances longitudinally along the medullary canal of the bone, as indicated by the movement arrows at 164, 166, and 168, thereby placing a section of the nail's tip region 68 inside the bushing's lateral opening 126. The nail 60 and bushing 82 are shown viewed parallel to the bushing's long axis 102, with the bushing 82 having a cross section as in FIG. 9, perpendicular to the long axis, and the nail's tip 162 is also visible as it enters and passes through the lateral opening 126.

[0045] In some embodiments, the surgeon may fluoroscopically monitor the positional relationship of the nail 60 and bushing 82 as the nail is mated with the bushing in the manner generally shown, with a visual axis parallel to the long axis 102. The entrance 130 of the lateral opening 126 may at least substantially span the medullary canal parallel to the long axis 102 by selecting an appropriately sized anchor / bushing from among a set, as described in section II above. Thus, the surgeon can often successfully perform the mating procedure illustrated in Figures 17-20 without fluoroscopically viewing the bushing and nail along a visual axis perpendicular to the long axis 102 (e.g., parallel to the lateral axis 170).

[0046] FIG. 17 shows only a distal portion of the tip region 68 of the nail 60. The tip region 68 has an elongated main portion 171 and a tip 162 disposed distally thereto. The tip may be elongated to define a tip axis 172 that is not collinear with a longitudinal axis 173 defined by the main portion 171. The axes 172, 173 may or may not be substantially parallel to one another. In the illustrated embodiment, the axes are spaced apart by a radial offset 174 caused by a bent region 176 (e.g., a double bend) within the nail. The nail may bend radially in opposite directions as it passes longitudinally through the bent region. Each bend may be in the plane in which the trailing end region 66 of the nail 60 curves. The tip is shown in FIG. The distal end may be tapered or cylindrical and may have a rounded or pointed distal end.

[0047] Misalignment of the nail 60 and bushing 82 relative to one another can prevent the distal end of the nail from entering the entrance 130 of the lateral opening 126 (see FIG. 17). For example, in the illustrated configuration, the distal end of the tip 162 is in contact with the lateral projection 122 and cannot advance, as indicated by the crossed out movement arrow at 178.

[0048] 18 shows the position of the nail 60 after it has been rotated 1 / 2 around its long axis by the surgeon, as indicated by the rotation arrow at 180. The tip axis 172 then intersects with the entrance 130 of the aperture 126, and the entrance bevel 132 provides a sloped surface that facilitates centering of the tip 162 laterally within the aperture 126 as the nail is advanced at 164. In other embodiments, the nail may be rotated a different amount, such as 90 degrees, among other things.

[0049] 19 illustrates the tip 162 having been advanced further into the side opening 126, as indicated by the motion arrow 166. The tip is further centered by contact between the tapered wall and the interior region of the side opening.

[0050] 20 illustrates further advancement of the tip, indicated by movement arrow 168, after the tip and curved region 176 have cleared bushing 82. The nail may be rotated about axis 80 a half turn in the opposite direction, if necessary, as indicated by rotation arrow 182, to return the nail to its original rotational orientation. In the illustrated embodiment, nail 60 has a preformed radial curvature 78 (see FIG. 1) that may preferably follow the curvature of the medullary canal. The radial curvature 78 and offset of tip 162 may be in the same plane.

[0051] IV. Apparatus This section describes the installation of bushings 82 and / or locking members 84 (see Sections I and II) as well as exemplary embodiments of non-implantable devices of fixation system 50 to facilitate procedures for using the devices. See Figures 21-38.

[0052] FIG. 21 illustrates an embodiment 190 of the instrument having a clamp portion 192 coupled to a guide portion 194. A pair of opposing jaws 196 of the clamp portion may engage the fibula 54, and the fibula may be clamped between the jaws, and / or one or more wire members 198 may be passed through one or more receiving channels 200 defined by the instrument to couple the instrument to the bone. By coupling the instrument to the bone with the jaws 196 and at least one wire member 198, the instrument may be better stabilized on the bone. The guide portion 194 defines a guide shaft 202. At least one drill 204 may be used to bore out the fibula 54 (or another bone) on the guide shaft to prepare the fibula to receive a bushing 82, and / or the bushing may be passed through the guide portion 194 along the guide shaft 202 and into the fibula. (Each drill may be interchangeably referred to as a drill bit.)

[0053] At least one drill may bicortically bore the fibula 54 (or another bone) to form a wider hole in the near cortex and a narrower hole in the far cortex, as described above in section II (see, e.g., FIG. 15 and FIG. 16). In some embodiments, each corresponding drill may be utilized to form holes of different sizes. Alternatively, a stepped drill 204 may be used to form both holes in a single pass. The stepped drill may have a shaft 206 with a proximal boring portion 208 to form the wider hole and a nose 210 protruding from the shaft to provide a distal boring portion 212 to form the narrower hole. In some embodiments, the proximal and distal boring portions of the drill may be configured to preferentially bore in opposing rotational directions of the drill, as described in U.S. Patent Application Serial No. 15 / 728,247, filed October 9, 2017, which is incorporated herein by reference. (The terms drill, bore, and form a hole are used interchangeably herein.) The shaft 206 may be sized to pass through a guide channel 214 defined by the guide portion 194 and centered on the guide axis 202.

[0054] The instrument 190 may include a coupling assembly 216 that couples the clamp portion 192 and the guide portion 194 together. The coupling assembly maintains centering of the guide portion and may include a holder 218 (interchangeably referred to as a housing) for the guide portion and a pair of linkage members 220, as described in more detail below.

[0055] 22 and 23 show an instrument 190 without a guide portion 194 and with jaws 196 in closed and open configurations, respectively. The instrument may have a pair of levers 222a, 222b pivotally connected to one another at a fulcrum 224 that defines a pivot axis 226 (see also FIG. 21). The jaws 196 may be formed by a portion of the lever located distal to the fulcrum 224, and a pair of handle members 228 may be formed by the lever proximal to the fulcrum.

[0056] The coupling assembly 216 maintains the holder 218 in a fixed position relative to a central plane 230 when the distance between the jaws 196 changes (i.e., the jaws are opened (moving away from each other) or closed (moving towards each other)) (compare FIGS. 22 and 23). The central plane may include the pivot axis 226 and may remain equidistant from the jaws (and optionally the handle member 228) as the separation distance changes. Thus, the guide portion 194, and in particular its guide shaft 202, may remain located within the central plane 230 as the jaws open and close. This positional relationship ensures that the guide shaft traverses the bone to approximate the long axis of the bone when the jaws are engaged with opposite sides of the bone. In some embodiments, the guide shaft may be adjustably offset from the central plane, if desired, as described below.

[0057] 24 and 25 show partial views of the instrument 190 in the configuration of FIGS. 22 and 23, respectively, illustrating how the coupling assembly 216 may operate. The holder 218 may be pivotally connected to the levers 222a, 222b on a pivot 226. The linkage members 220 may be pivotally connected to each other and to the holder 218 at one end of each linkage member to form a pivotable connection 232, and may be pivotally connected to the respective levers 222a or 222b at the other end of each linkage member, indicated at 234. The holder 218 may define a slot 236 that allows the pivotable connection 232 to slide along the slot when the jaw separation distance changes (compare FIGS. 24 and 25). As a result, the angular movement of the levers with respect to the holder 218 is coupled, and the holder 218 cannot pivot out of alignment with the central plane 230. In some embodiments, the positions of the fulcrum 224 and slot 236 can be switched. In other embodiments, the same type of centering action can be produced by replacing the slot 236 with a circular opening and providing a slot in each lever 222a, 222b so that each pivotable connection 234 can slide along the corresponding lever as the jaws are opened and closed.

[0058] 22 and 23 show additional exemplary aspects of the instrument 190. The instrument may have a locking mechanism 238 to prevent the jaws from opening (moving apart). The locking mechanism may or may not limit the jaws from closing (bringing together), as that role may be taken up by bones engaged by the jaws on the opposite side. In the illustrated embodiment, the instrument 190 has an externally threaded member 240 pivotally connected at one end to the lever 222b, which passes through a collar 242 of the other lever and threadably engages an internally threaded ring 244. The locking mechanism has an unlocked configuration of FIG. 22 when the ring 244 is spaced from the collar 242, and a locked configuration of FIG. 23 when the ring is in contact with the collar. In other embodiments, the locking mechanism may comprise interlocking teeth or the like.

[0059] The instrument 190 may have a gauge 246 for measuring the separation distance of the jaws from each other and therefore the local width of the bone where the jaws engage. The gauge may be located proximally or distally with respect to the fulcrum 224. In the illustrated embodiment, the gauge is associated with the handle members 228. In particular, the gauge has a scale 248 attached to one of the handle members 228 and a pointer 250 attached to the other handle member. The scale 248 may be arcuate or linear, among other things.

[0060] 22A shows further aspects of the scale 248. The scale may include indicia 252 indicating the current separation distance of the jaws from one another. The indicia may include, among other things, graduation lines (which may be uniformly spaced apart), alphanumeric characters (e.g., numbers), and color coding. For example, the numbers may report the distance between the jaws (e.g., in millimeters). The color coding may indicate whether the jaw separation distance (and therefore the local bone width) is sufficient to safely introduce an anchor. In the illustrated embodiment, sections 253a, 253b, and 253c of increasing distance from the lever 222a along the scale are colored red, yellow, and green, respectively, to indicate high, medium, and low risks for drilling and / or inserting the anchor.

[0061] 26 and 27 show an exemplary positional relationship between the wire member 198, the instrument 190, the fibula 54, and the medullary canal 64. The jaws 196 may define teeth 254 to engage opposing sides of the bone and improve purchase. The jaws may be angled inwardly and distally toward the central plane 230 when the jaws are fully closed and to the extent of the jaws' open position to prevent the locked instrument from dislodging from the bone. The jaws engage the bone in a clamping plane 256, which may be oriented to be at least generally perpendicular to the long axis 258 of the bone when the instrument is properly clamped to the bone (see FIG. 21). The clamping plane may be at least generally parallel to the guide axis 202, and optionally spaced therefrom, and perpendicular to the central plane 230. (At least generally perpendicular (or parallel) means within 10 degrees of strictly perpendicular (parallel). Each of the jaws may be oriented at an oblique angle with respect to a plane perpendicular to the pivot axis 226. Thus, the jaws may move along the surface of a cone centered on the pivot axis 226 as the jaws open and close.

[0062] The instrument channel 200 may define a trajectory for the wire member 198 to penetrate and / or pass through the bone transversely. The channel may be defined by the holder 218, one or more levers 222a, 222b, or both holders and one or both levers. The trajectory may be configured to pass through at least one region of the bone spaced along the bone from the clamping plane 256 and the guide shaft 202. For example, in the illustrated embodiment, the guide shaft 202 is positioned intermediate the clamping plane 256 and the region of the fibula that receives the wire member 198. In other embodiments, the clamping plane 256 may be positioned along the fibula between the region of the fibula that receives the wire member 198 and the guide shaft 202. In still other embodiments, a pair of trajectories may pass through the bone on opposite sides of the clamping planes.

[0063] The wire-receiving channel may be configured to define a trajectory through the cortical bone while avoiding at least a radially central portion of the medullary canal to allow the tip of the nail to advance along the medullary canal and past the wire member. In other words, the wire member avoids space being occupied by the nail. Each trajectory may pass through the central plane 230 before or after the trajectory passes through the bone. For example, in Figs. 26 and 27, both wire members pass through the central plane 230 before reaching the bone, while in Fig. 28, the wire member passes through the bone before reaching the central plane 230.

[0064] Each wire member may be provisionally positioned within the medullary canal, substantially within the space that the nail will occupy after being locked into the bushing, and then threaded into / through the bone. With the nail in this position, the wire members, when placed within the bone, do not prevent the nail from being re-advanced into the space after being retracted to allow for drilling along the guide shaft and bushing attachment.

[0065] 29 shows a pair of schematic fluoroscopic images illustrating the adjustment, indicated by the arrow at 260, of the position of the guide portion 194 of the instrument 190 while the instrument is clamped to the fibula 54 and further stabilized by a wire member (not shown). The guide portion and nail 60 (or reamer) are shown substantially coincident with the guide shaft 202, which may be radiopaque (at least in part) for easy fluoroscopic visualization. The tip of the nail is advanced along the medullary canal of the fibula 54 past the guide shaft 202 and rests on the guide portion 194.

[0066] The guide channel 214 of the guide portion 194 is not centered on the long axis of the nail 60 (or reamer) in the left image. Thus, if the alignment of the guide portion 194 with the nail 60 is not improved prior to boring the fibula over the guide shaft 202, it may be difficult for the surgeon to pass the nail through the bushing 82 that is installed in the boring out fibula. As explained in more detail below, the position of the guide portion 194 may be adjusted with the instrument clamped to the bone to improve the alignment of the guide portion with the nail as shown in the right image.

[0067] 30A-30C, 31, and 32 show an exemplary adjustment mechanism of the instrument 190 for changing the position of the guide portion 194 with respect to the holder 218 (and central plane 230). This adjustment moves the guide portion 194 while the holder 218 and jaws of the clamping portion remain fixed. This adjustment may offset the guide shaft 202 from the central plane 230, optionally by the same distance but in the opposite direction (see also FIGS. 22 and 23), to improve alignment of the guide shaft with the long axis of the nail. The guide portion may be locked in place by use of complementary mating structures provided by the guide portion and the holder 218, as described below. The complementary mating structures may be mated with each other in multiple alternative configurations to provide multiple predetermined individual adjustments to the offset of the guide shaft from the central plane 230. In other embodiments, the adjustment mechanism may allow adjustment of the spacing of the guide shaft from the central plane over a continuous range of positions.

[0068] The guide portion 194 may include a tube 262 defining a guide channel 214. A cap 264 (also referred to as a button) may be securely attached to a proximal end of the tube 262 (see FIGS. 30A and 32) with a number of set screws or the like. The guide channel 214 may be open only at both ends or may be open laterally along at least a portion of its length, thereby forming a groove 266. A locking sleeve 268 may surround a portion of the tube 262. The locking sleeve may form a knurled, tab 270 proximally. An axial tang 272 may be defined distally by the locking sleeve (see FIG. 32). A distal portion 274 of the tang may be received within an axial groove 276 defined on a radially outer side of the tube 262, thereby preventing rotation of the tube and locking member relative to one another about a coincident longitudinal axis 278 (see FIGS. 31 and 32). The proximal portion 280 of the tang may be received within and complementary to each of a plurality of pockets 282a, 282b, 282c defined by openings 284 through the holder 218. The tube 262 is held within the holder openings 284 by a retainer 286, which prevents axial movement of the tube while allowing the tube to rotate about its longitudinal axis when not locked by the locking sleeve 268. The locking sleeve may be biased distally parallel to the guide shaft 202 by a spring 288 to keep the guide portion locked.

[0069] 30A-30C illustrate an exemplary adjustment of the rotational position of guide portion 194. In FIG. 30A, proximal portion 280 of tang 272 is positioned within central pocket 282b, locking tube 262 in place. In FIG. 30B, the guide portion is unlocked by urging locking sleeve 268 proximally with respect to tube 262, parallel to longitudinal axis 278, as indicated by the movement arrow at 290. Upward pressure may be applied to knob 270 to compress spring 288 and remove proximal portion 280 of tang 272 from pocket 282b. In FIG. 30C, guide portion 194 is rotated, as indicated by the rotation arrow at 292, to align tang 272 with pocket 282a while spring 288 is in a compressed state. Tag 272 may then be allowed to move into pocket 282a by releasing the upward pressure on tab 270, thereby relocking the guide portion in the new rotational position.

[0070] Figure 31 shows a cross-sectional view of the guide portion in the locked position of Figure 30A. The location of the guide channel 214 in the alternative locked position of the guide tube is shown in phantom.

[0071] 33A-33C, 34, and 35 show only the guide portion 194 and holder 218 of another exemplary embodiment 190' of an attachment tool to the fastening system 50. The tool 190' may have any suitable combination of the elements and features described above for the tool 190, such as the clamp portion and its coupling assembly. Accordingly, functionally similar components of the tools 190 and 190' have been assigned the same reference numbers.

[0072] Guide portion 194 of instrument 190' has a tube 262 that defines a guide axis 202. The position of the guide axis can be changed by moving the tube relative to holder 218 to different alternative mating configurations of tang 272 with one of a plurality of pockets 282a-c defined by holder 218. However, in contrast to instrument 190, tube 262 of instrument 190' is axially and rotatably moveable relative to holder 218, as described further below.

[0073] The tube 262 has a tubular body portion 300 that defines the channel 214 and laterally extending projections, i.e., a tang 272 and a tab 302 (see FIGS. 33A-33C and 35). One or both of the tang 272 and the tab 302 may be integrally formed with the body portion 300. A threaded member 304 may be attached to the tab 302 at an internally threaded through hole 306 defined by the tab. More specifically, the threaded member may have a graspable head 308 forming a knob that is coaxial with and rigidly attached to a shaft 310 (see FIG. 35). The head may be knurled. The shaft may be externally threaded near the head for threaded engagement with the through hole 306. The shaft 310 defines a pair of circumferential recesses 312, 314 configured to receive lateral portions of a locking pin 316 to hold the tube 262 in a locked or unlocked configuration, respectively. The shaft may be received within an axial bore 318 defined by the holder 218.

[0074] The locking pin 316 may extend into a cross hole 320 defined by the holder 218 (see FIG. 34). The pin may have a shaft 322 defining a waist 324, and a button 326 may be formed on the proximal end of the shaft. A spring 328 may bias the position of the shaft 322 so that the waist 324 is out of alignment with the shaft 310 of the threaded member 304 until a user applies pressure to the button 326 to compress the spring 328.

[0075] 33A-33C show adjustment of the position of the tube 262 to change the spacing of the guide shaft 202 from the central plane 230 of the holder 218 (see also FIG. 34). In FIG. 33A, the guide shaft 202 is contained in the central plane 230 and the tube 262 is locked in a central position. More specifically, the tang 272 is disposed in the central pocket 282b of the holder 218. Axial movement of the tube 262 is prevented by a locking pin 316, which is partially disposed in an upper recess 312 of the shaft 310 of the threaded member 304 (see also FIG. 35).

[0076] In Figure 33B, the button 326 of the locking pin 316 has been depressed, as indicated by the motion arrow at 330. The locking pin moves inwardly, parallel to its axis, which moves the locking pin waist 324 into alignment with the shaft 310 of the threaded member 304 (see also Figure 34). The tube 262 is then unlocked and can be moved axially, as indicated by the motion arrow at 332, to remove the tang 272 from the central pocket 282b. The tube may be axially locked in the retracted position shown in Figure 33B, with the locking pin 316 partially disposed within the lower recess 314.

[0077] In Figure 33C, the unlocked tube 262 has been moved laterally and reoriented by pivoting the tube, as indicated by the rotational arrow at 334, about an axis 336 defined by the shaft 310 of the threaded member 304. The tang 272 is aligned with the lateral pocket 282c. The tube may then be moved axially to hold the tang within the lateral pocket until the locking pin 316 pops out into the locked position. The threaded member may be rotated via the head 308 to more firmly secure the tube in place.

[0078] 34 shows the opening 284 in the holder 218. The opening may be shaped to permit lateral movement of the tubular body of the tube 262, as indicated by the movement arrow at 338, as the tube 262 pivots about the shaft 310 of the threaded member 304.

[0079] 36-38 show only the guide portion 194 and holder 218 of another exemplary embodiment 190″ of an attachment tool for the fastening system 50. The tool 190″ may have any suitable combination of the elements and features described above for the tool 190, such as the clamp portion and its coupling assembly. Accordingly, functionally similar components of the tools 190 and 190″ have been assigned the same reference numbers.

[0080] The holder 218 of the instrument 190" is generally similar to the holder of the instrument 190. For example, the holder has a housing portion 350 defining an opening 284 for receiving the tube 262. The holder also has an arm portion 352 projecting from the housing portion and in fixed relationship therewith, defining a slot 236. However, in contrast to the instrument 190, the slot 236 of the arm portion 352 in the instrument 190" is located closer to the housing 350 than the hole 354, which is centered on the pivot 226.

[0081] The tube 262 has a mating portion 356 defining a pair of ridges 358 formed on opposite sides of the mating portion. The ridges are parallel to the guide axis 202 defined by the tube 262. The ridges 358 are configured to be alternatively received into each aligned pair of the plurality of pairs of grooves 360 defined by the housing portion 350 in the opening 284. Each aligned pair of grooves 360 defines a plane that is parallel to the central plane 230 of the instrument 190″ and perpendicular to the clamping plane 256. Thus, when the ridges 358 are engaged with any of the aligned pairs of grooves 360 by movement of the tube 262 and holder 218 relative to one another parallel to the guide axis 202, the guide axis is either contained within the central plane 230 or offset parallel thereto. In the illustrated embodiment, the tube 262 is generally indicated by the arrow at 362 in FIG. As shown in FIG. 1, the tube 262 may be held by the holder 218 at five different positions in a plane perpendicular to the guide axis. In other embodiments, more or fewer grooves may be provided, thereby providing more or fewer positions relative to the guide axis. To change the position of the tube 262, the tube may be removed from the housing portion 350 and then refitted at the desired position along the transverse axis 364. The tube may have an enlarged head 365, which may be knurled, to make it easier to grip the tube 262.

[0082] Guide portion 194 of instruments 190, 190', and 190" may include at least one tubular insert 366 configured to be removably received within tube 262. The insert may define an axial bore 368 axially therethrough. The insert 366, and particularly bore 368, may be sized to guide a drill or guidewire, or a narrower tool, such as locking member 84, into the bone. The outer diameter of the insert 366 may correspond to the inner diameter of tube 262 such that the insert fits snugly within the tube and remains parallel to the guide channel.

[0083] V. Driver This section describes an exemplary driver 380 for fastening system 50 that mounts to bushing 82. See Figures 39-42.

[0084] The driver 380 may have a distal shaft portion 382 attached to a proximal, graspable handle portion 384. The shaft portion may be formed at least in part by a sleeve 386 secured proximally to the handle portion. A pair of projections 388 may project from a distal end of the sleeve. The projections may be complementary to and mate with recesses 148 defined by the proximal end of the bushing 82. A rod member 390 having a knob 392 at a rear end passes through a channel 394 defined by the handle portion 384 and the sleeve 386 and may be rotatable about a longitudinal axis relative to the handle portion and the sleeve.

[0085] The distal section of the rod member may have male threads 396 that are complementary to the female threads 90 of the bushing 82 (see also FIG. 5). The rod member may be axially movable to extend and retract the distal end of the rod member from the sleeve. The bushing 82 may be locked to the driver 380 in a defined rotational position by mating the projections 388 with the recesses 148, while the rod member 390 is slightly retracted and then the rod member is advanced and rotated to create a threaded engagement between the male threads 396 and the female threads 90. Alternatively, the rod member may have a fixed axial position and may be rotated to threadably engage the bushing 82 and draw the bushing into a mating relationship with the projections 388.

[0086] The handle portion 384 may be shaped or marked to indicate to the surgeon the orientation of the through axis 134 of the bushing 82. For example, the handle portion 384 may be elongated in a transverse plane as shown in FIG. 42 in a direction perpendicular to a plane 398 collectively defined by the longitudinal axes 400 of the driver 380 and the projections 388.

[0087] VI. Method of fixing bones This section describes an exemplary method of fixing bone with the system of the present disclosure. The method steps described in this section may be performed in any suitable order and combination, may be implemented using any suitable combination of the system components of the present disclosure, and / or may be supplemented by any other method steps of the present disclosure.

[0088] A bone to be fixed may be selected. The bone may be a long bone or any other suitable bone. Exemplary bones that may be suitable include bones of the lower leg (e.g., femur, tibia, or fibula), arm (e.g., humerus, radius, or ulna), or similar bones. The bone may have any suitable discontinuity, such as at least one fracture, cut, nonunion, or the like. The discontinuity separates the bone into two or more pieces (interchangeably referred to as segments or fragments), which may be fixed relative to one another using this method.

[0089] A nail may be selected for fixation of a bone. The nail may have any suitable combination of properties and characteristics as disclosed herein. For example, the length, diameter, longitudinal shape, flexibility, and / or taper of the nail, among others, may be selected according to the selected bone and / or discrete location. The nail has a lockable section configured to be locked to an anchor. The lockable section may be elongated such that the anchor can be locked to the nail over a continuous range of locations along the lockable section, optionally within a tip region of the nail.

[0090] A bushing and corresponding locking member for the nail may be selected. The bushing and locking member may be selected from a set of bushings and locking members of different lengths. The size of the bushing and locking member may be selected based on a measured local width of the bone, such as the local width indicated by the gauge of the instrument engaging the bone (see below).

[0091] The bone may be prepared to receive the nail longitudinally into the medullary canal of the bone. The bone preparation may include forming an access opening from an end region of the bone to the medullary canal. The access opening may be created by any suitable technique, such as puncturing and / or drilling the bone. The medullary canal may then be reamed through the access opening using at least one reamer advanced longitudinally into the medullary canal. The reamer may remove cortical bone to ream the medullary canal, particularly in the diaphyseal region of the medullary canal. In some embodiments, the step of selecting the nail may be performed after reaming the hole in the medullary canal when the size of the medullary canal is determined by boring. In some embodiments, the step of reaming the hole may be omitted.

[0092] An incision may be made in the soft tissue to access a selected area of ​​bone. The location of the incision may be located where the nail will generally be attached to the bone with an anchor. This location may be selected so that the incision overlies the anticipated location of the lockable section of the nail inside the bone.

[0093] An instrument having a clamping portion may be engaged with the bone through the incision to attach the instrument to the bone. The instrument may have a guide portion coupled to the clamping portion and defining a self-centering guide axis, as described above in section IV. Jaws of the clamping portion may be engaged with opposing sides of the bone and held against the bone using a locking mechanism that prevents the jaws from moving away from each other. The jaws may engage the bone in a plane that may be transverse, such as substantially perpendicular, to the local long axis of the bone where the jaws contact the bone. The step of engaging the bone with the clamping portion may be performed with the nail already positioned in the medullary canal, which aids in fluoroscopic visualization of the anticipated attachment location of the lockable section of the nail and ensures that the guide axis defined by the instrument intersects the lockable section. In some embodiments, the location where the clamping portion is engaged with the bone may be selected by measuring the distance from the end of the bone where the access opening was made to estimate where the lockable section of the nail will be positioned after the nail is inserted into the bone.

[0094] The local width of the bone may be measured between the jaws by a gauge on the instrument. The gauge may indicate the local width as a numerical value and / or may indicate a level of risk associated with installing the bushing on the current guide shaft. The level of risk may be indicated by color coding on the gauge. If the risk is deemed unacceptable, the instrument may be moved to a different location on the bone where the gauge indicates the local width is sufficient and / or the level of risk is deemed acceptable.

[0095] The position, such as orientation, of the instrument may be stabilized using one or more wire members, such as K-wires. Each wire member may have a tip that passes through a channel defined by the instrument and enters and / or passes through the bone on a trajectory defined by the channel. The trajectory may avoid the medullary canal of the bone and may pass through the bone below or above the medullary canal. In some embodiments, the instrument may be stabilized using two wire members placed on non-parallel trajectories that are closest to each other before passing through the bone (e.g., inside the instrument), inside the bone, or after passing through the bone.

[0096] The position of the guide shaft defined by the instrument may be compared to the position of the nail or reamer extending along the medullary canal of the bone. The position of the guide shaft and nail may be determined by fluoroscopy using a viewing axis that is substantially coincident with the guide shaft. A radiopaque region of the guide portion, such as a tube, may be viewed to determine the position of the guide shaft (e.g., at the center of the radiolucent channel defined by the tube). The position of the guide shaft may be adjusted in a plane perpendicular to the guide shaft to bring the guide shaft closer to the long axis of the nail or reamer. The adjustment may be performed, among other things, by rotating the guide portion relative to the clamp portion of the instrument and / or by adjusting the translational position of the guide portion. The adjustment may improve the alignment of the tip of the nail with the guide shaft.

[0097] Holes may be formed in the bone on the guide shaft. The holes may include a wider hole formed in the near cortex and a narrower hole formed in and / or through the far cortex, which are coaxial with each other. The holes may be formed from the guide portion by at least one drill passing through the guide portion. The at least one drill may be a stepped drill that forms both holes. In some embodiments, the stepped drill has a shaft for forming the wider hole and a nose for forming the narrower hole, and the shaft and nose may preferentially drill in opposite rotational directions of each of the drills. In some embodiments, the at least one drill may be a pair of drills sized to separately form each hole. Each drill may be cannulated and advanced over a guide wire to be driven through the guide portion of the instrument on the guide shaft and into the bone. In some embodiments, the smaller drill of the pair of drills may be a K-wire.

[0098] The bushing may be attached to a driver (see Section V), threaded through a guide portion of the instrument, and placed into a hole formed in the bone. The bushing may be driven into the bone by the driver until a shoulder on the bushing bottoms out on the far cortex of the bone. The bushing may be driven into the bone by either pushing or tapping the bushing into the bone, or by utilizing the threads or thread-like features of the bushing and rotating and advancing the bushing into the bone until it is in place. In the in place configuration, the tip portion of the bushing may be disposed within and / or penetrate a narrower hole. The orientation of the bushing about its long axis may need to be adjusted so that the through axis of the lateral opening of the bushing is aligned with the long axis of the bone as dictated by the bushing and / or the driver (e.g., handle portion).

[0099] The nail may be advanced through a lateral opening in the bushing. Fluoroscopy may be used to assess whether the tip of the nail is properly aligned with the bushing as it is approached. In some embodiments, the nail may be rotated about its longitudinal axis to improve alignment before the tip of the nail is inserted through the lateral opening (see Section III).

[0100] A locking member may be inserted into the bushing to lock the nail to the bushing. The locking member may be advanced through a guide portion of the instrument and into the bushing while the instrument remains attached to the bone. The inner bottom wall of the bushing and the tip of the locking member may have features (protrusions) that engage the nail to increase the holding force of the interface.

[0101] The nail may be locked to one or more other anchors attached at spaced locations along the nail. The use of multiple anchors may in some cases be suitable for fixating more than two segments of a bone resulting from a fracture.

[0102] VII. System Component Configuration The nails, bushings, and locking members disclosed herein may have any suitable composition. Each may be formed from any suitable biocompatible and / or bioresorbable (bioabsorbable) material. Exemplary biocompatible materials that may be suitable include: (1) metals (e.g., titanium or titanium alloys, cobalt-chromium alloys, stainless steel, magnesium or magnesium alloys (e.g., alloys containing magnesium, calcium, and zinc), etc.); (2) polymers / plastics (e.g., ultra-high molecular weight polyethylene (UHMWPE), polymethylmethacrylate (PMMA), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), and / or PMMA / polyhydroxyethylmethacrylate (PHEMA)); (3) bioresorbable materials or polymers / plastics (e.g., alpha-hydroxycarboxylic acids (e.g., polylactic acid, polystyrene, polystyrene, polystyrene-based ... The biocompatible material may be selected from the group consisting of poly(hydroxyalkanoates) of the class PHB-PHV, poly(hydroxyalkanoates), poly(hydroxybutyrates ...

[0103] VIII. Working Examples The following examples describe selected aspects and embodiments of the present disclosure that relate to the bone fixation systems, assemblies, devices, and methods of the present disclosure. These examples are included for illustrative purposes and are not intended to limit or define the overall scope of the present disclosure. The devices, elements, features, aspects, and / or steps of the systems, assemblies, devices, and methods described in this section may be combined with each other and with any of the devices, elements, features, aspects, and / or steps of the systems, assemblies, devices, and methods described elsewhere in this disclosure in any suitable combination. EXAMPLES

[0104] Deformable anchor In this example, an exemplary anchor 62' is described that includes a bushing 82' that is deformable by a corresponding locking member 84'. This deformation provides the locking member 84' with increased resistance to rotation that would loosen the anchor's grip on the nail 60, resulting in a more secure and stable lock of the nail 60 to the anchor 62'. See Figures 43-50.

[0105] The bushing 82' and locking member 84' are similar to the bushing 82 and locking member 84 (see, e.g., FIGS. 1-20) and may have any suitable combination of features described in sections I and II above. For example, the bushing 82' may have a proximal body portion 106 that distally defines a step 110 and may have a post 108 that projects axially from the step 110. The body portion 106 may define a transverse opening 126, such as a slot in the illustrated embodiment. The body portion may also define an axial opening 128, such as an axial hole, that intersects with the transverse opening. A male thread feature 121, such as one or more male threads, may be defined by the exterior of the body portion 106 for attaching the bushing to bone via threaded engagement. A female thread 90 may be defined by an axial opening 128 on the interior of the body portion 106 for attaching the bushing 82' to the locking member 84' via threaded engagement with at least one male thread 92. Thus, locking member 84' may be described as a set screw. Various differences between anchor 62' of this example and anchor 62 of Section I are described below.

[0106] The male thread structure 121 of the bushing 82' may cover a larger area of ​​the radial circumference of the body portion 106 with respect to the bushing 82 (compare FIGS. 44 and 45 with FIGS. 6 and 7). More specifically, the male thread structure 121 may extend along the majority of the complete turns of the helix for each full turn of the thread. A lateral opening 126 and associated bevel 132 interrupt the thread structure 121. The thread structure may also be interrupted by a self-tapping feature 410, such as an axial notch, to form a complementary female thread in the bone when the bushing is driven into the bone (see FIG. 45). With this thread configuration, the bushing 82' may be driven into the bone exclusively by rotation and may attach to the bone more strongly than the bushing 82.

[0107] The step 110 of the bushing 82' has a rounded contour rather than flat (compare FIGS. 44 and 45 with FIGS. 6 and 7). The rounded step configuration may reduce the amount of cortical bone, if any, that needs to be removed from the inner wall of the far cortex of the bone relative to a flat step. Thus, the rounded step reduces the chance of weakening or otherwise damaging the far cortex when drilling the bone for the bushing. The radius of curvature of the step 110 may roughly match or be smaller than the average radius of curvature of the medullary canal in which the bushing is to be attached to the bone.

[0108] The locking member 84' may have features that provide a tighter threaded engagement with the bushing 82' as compared to the locking member 84 and bushing 82 (compare FIG. 46 with FIGS. 11 and 14). The male threads 92 of the locking member 84' may extend along a greater length of the locking member, such as more than ½ or ¾ of the length. Additionally, the outer diameter 412 of the male threads 92 may taper distally in a tip region of the locking member 84'. The outer diameter 412 may taper to match the diameter of a distally disposed unthreaded section 414 of the male threads 92. These features may reduce the risk of the female threads 90 of the bushing 82' scoring the threads of the male threads 92 and / or facilitate threading of the male threads 92 into the walls of the axial opening 128, as described further below.

[0109] The locking member 84' may have a distal projection 156 surrounding a recess 158. The distal projection of the locking member 84' may define a sharper annular rim than the locking member 84 (compare Figs. 46 and 47 with Fig. 13). The rim may deform the outer surface region 416 of the nail 60 when the distal end of the locking member 84' bears tightly against the nail (see Fig. 47). This deformation may be prompted by the difference in hardness between the locking member 84' and the nail 60. For example. The nail 60 and the locking member 84' may be constructed of, among other things, a titanium alloy and cobalt-chrome (an alloy of cobalt and chromium), respectively.

[0110] 48-50 illustrate how the locking member 84' may be installed within the bushing 82', as described above, by urging the nail 60 toward the distal end of the transverse opening 126 (compare FIG. 48 with FIG. 50), clamping the nail 60 tightly between the bushing 82' and the locking member 84', and optionally deforming the nail 60 by the locking member 84'. This installation may also deform the walls of the axial opening 128 to form a new internal thread feature 418 on the inside of the bushing. The internal thread feature 418 is a distal extension of the internal thread 90. The engagement of the new internal thread feature 418 with the external thread 92 is tight and adequately resists any tendency for the locking member 84' to gradually rotate about its long axis after installation and loosen its grip on the nail.

[0111] 48 shows nail 60 passing through bushing 82'. Locking member 84' is translationally mated with bushing 82' as indicated by the arrow at 420. Complementary threads 90, 92 are positioned for rotational mating but are not yet engaged with one another. Unthreaded section 414 fits snugly within axial opening 128 to ensure that bushing 82' and locking member 84' are coaxially aligned with one another, which avoids longitudinal thread scoring.

[0112] FIG. 49 shows the locking member 84' in threaded engagement with the bushing 82' via the threads 90, 92 at an intermediate assembly stage. The locking member 84' is rotated, as indicated by the arrow at 422, to create contact between the distal end of the locking member and the nail 60, which is forced toward the distal end of the transverse opening 126 as the locking member is further advanced by rotation. The bushing 82' and the locking member 84' have an interference fit with each other at this stage of installation because the outer diameter 412 of the locking member is greater than the diameter of the axial opening 128 distal to the female threads 90 (see also FIG. 46). As a result, the locking member 84' exerts a radially outward tension force on the opposing walls 424 of the axial opening 128, and the bushing 82' exerts a radially inward compression force on the locking member 84'. In response, the bushing 82' may bulge radially outward, as indicated by arrow 426, slightly increasing the width of the lateral opening 126. Alternatively, or in addition, the male threads 92 may deform the wall 424 to form, or at least begin to form, the female thread formation 418 (see also FIG. 50).

[0113] FIG. 50 shows the locking member 84' fully advanced into a seating position that locks the nail 60 into the bushing 82' by rotation. The nail 60 is forced into contact with the distal end of the transverse opening 126 and is clamped between the bushing and the locking member and is optionally deformed. The locking member 84' may exert an axial tension on the bushing 82' as the locking member is tightened against the nail 60. This tension may urge the wall 424 radially inward, as indicated by arrow 428, against the male threads 92 of the locking member 84' and deform the wall 424 to form the female thread feature 418. The bushing 82' may be formed from a softer material than the locking member 84', such that the bushing is preferentially deformed with respect to the locking member 84' as the female thread feature 418 is formed. For example, the bushing 82' may be made of a titanium alloy and the locking members may be made of cobalt-chromium, among other things. EXAMPLES

[0114] Instruments with eccentric guide shaft This example describes another exemplary embodiment 190''' of the fastening system 50 for facilitating installation of the bushing 82 (or 82') and / or the locking member 84 (or 84') (see Sections I, II, and IV, and Example 1). See Figures 51-54.

[0115] Instrument 190''' may have any suitable combination of features described elsewhere herein, including a self-centering guide shaft 202 with a rotationally adjustable offset. Instrument 190''' may be most similar to instrument 190 and may have a clamp portion 192 connected to a guide portion 194 (see FIG. 51).

[0116] The clamp portion 192 may have a pair of levers 222a, 222b pivotally connected to one another at a fulcrum 224. The levers form a pair of jaws 196 at one end for gripping bone and a pair of handle members 228 at the other end. A locking mechanism 238 configured as a ratchet allows the levers 222a, 222b to pivot the jaws 196 in a closing direction but not in an opening direction, i.e., the jaws can pivot toward one another but cannot move apart until the ratchet teeth and pawls disengage from one another. In some embodiments, the ratchet teeth and pawls may be positioned such that the ratchet cannot lock the jaws 196 against the bone unless the bone has at least a threshold diameter. The threshold diameter may be selected to ensure that the localized area is wide enough to permit drilling and bushing installation without significant risk of iatrogenic fracture.

[0117] The guide portion 194 may be connected to the clamp portion 192 by a holder 218 (see FIG. 52). The holder 218 may be maintained on a central plane of the clamp portion 192 when the jaws 196 are opened and closed. More specifically, the holder 218 may be pivotally connected to the clamp portion 192 on an axis of a fulcrum 224 and coupled to the levers 222a, 222b by a pair of pivotally connected linkage members 220. A pivotable connection 232 between the linkage members 220 may slide along a slot 236 defined by the holder 218 to maintain the holder (and guide portion 194) on a central plane of the clamp portion 192. The holder 218 may also define one or more channels 200 for receiving a wire member that couples the holder (and thus the instrument) to the bone. Each channel may extend from a proximal surface region to a distal end of the holder. The distal end of the holder 218 may be configured to contact bone and may be flush with the distal end of the guide portion 194. The holder 218 may surround at least an axial region of the guide portion. Further aspects of the guide shaft and the self-centering mechanism of the channel 200 are described above in section IV.

[0118] The guide portion 194 may be rotatably connected to the holder 218 (see FIGS. 52 and 53). The guide portion may include a tube 262 defining an eccentrically disposed guide channel 214 and a guide shaft 202 therethrough. The tube 262 may be at least partially disposed within an opening 284 defined by the holder 218 and may be connected to the holder by a complementary retaining feature that limits axial removal of the tube 262 from the holder 218. In the illustrated embodiment, the retaining feature includes a protrusion 430 of the holder 218 received within a groove 432 defined by the exterior of the tube 262. The groove 432 may extend circumferentially on the tube 262 and allow for rotation of the tube about its central longitudinal axis. The groove 432 may be axially open at a release portion 434 that allows for axial removal of the tube 262 from the holder 218 when the release portion 434 rotates into alignment with the protrusion 430.

[0119] The guide portion 194 and the holder 218 may collectively form a gauge 436 that measures and indicates the current offset of the guide shaft 202 from the central plane of the instrument 190''' as determined by the rotational orientation of the tube 262 (see Figs. 51-54). A scale 438 may be displayed by the guide portion 194 and an indicator 440 may be displayed by the holder 218, or vice versa (see Figs. 51 and 52). The scale may have reference marks and / or characters (e.g., letters, numbers, and / or symbols), among other things. For example, in the illustrated embodiment, the scale 438 has the numbers 2, 1, 0, 1, and 2 arranged in that order along a circumferential path on the tube 262. Each number represents the distance in millimeters of the guide shaft 202 from the central plane of the instrument 190'''. The numbers are not evenly spaced, and as the tube 262 is rotated through larger angles, the offset changes from 1 to 2 millimeters relative to 0 to 1 millimeter in either rotational direction.

[0120] The guide portion 194 may be movable in translation and / or rotation to a number of predefined offsets of the guide axis from the central plane 230. The predefined offsets may be formed by features of the guide portion 194 and the holder 218 that are complementary to one another. For example, the guide portion 194 may be held at a predefined rotational position by complementary features that correspond to the offsets measured by the gauge 436 (see FIGS. 53 and 54). A detent 442 resists rotation of the guide portion 194 at each predefined position, and the detent may be released by applying sufficient torque to the guide portion 194 by hand. In the illustrated embodiment, the detent 442 is a spring-loaded ball that is connected to the holder 218 by a screw 444. The exterior of the tube 262 defines a number of complementary recesses 446, each sized to receive a detent 442. (There are five recesses 446 in the illustrated embodiment.) Each recess 446 is located at the same radial orientation as one of the numbers on the scale 438.

[0121] The instrument 190''' may be formed entirely of radiolucent material and may include one or more radiopaque members that may be visualized under fluoroscopy. In the illustrated embodiment, the radiopaque members are an upper ring 448 and a lower ring 450, each centered on the guide shaft 202 (see FIG. 53). The rings 448, 450 may be coaxially aligned with one another under fluoroscopy to ensure that the viewing axis for fluoroscopy is parallel to the guide shaft 202, which may then be compared to the position of the nail (see also FIG. 29). In an exemplary embodiment, the rings 448, 450 are formed from metal and the rest of the instrument 190''' are formed from carbon fiber. In some embodiments, the radiopaque members are not centered on the guide shaft 202 and do not rotate with the guide portion 194. For example, the radiopaque members may be mounted on a holder 218. EXAMPLES

[0122] Drill pairs for near and far cortical hole preparation This example describes a near cortical drill 460 and a far cortical drill 462. This example also describes a two-drill procedure in which the drills 460, 462 are used sequentially to form respective holes 160, 161 of different diameters in the near cortex 118 and far cortex 120 of a bone (e.g., fibula 54) to receive correspondingly sized areas (provided by body portion 106 and post 108) of bushing 82 (or 82').

[0123] The two-drill procedure described herein may have advantages over a single-drill procedure using drill 204 (see FIG. 21). The single-drill procedure is described in more detail in U.S. Patent Application Serial No. 15 / 728,247, filed October 9, 2017, which is incorporated herein by reference. Advantages of the two-drill procedure may include more reliable formation of narrower holes 161 without excessively weakening or inadvertently over-drilling the far cortex 120. The two-drill procedure is enabled by the rounded shoulder 110 of the bushing 82', which reduces the amount of cortical bone, if any, that needs to be removed from the far cortex 120 to form a suitable space to receive the shoulder 110.

[0124] 55 and 57 respectively show a near cortical drill 460 separated (FIG. 55) and stopped from advancing further into the bone 54 (FIG. 57). The near cortical drill 460 has a shaft 464 equipped with a distal tip 466. The shaft 464 defines one or more flutes 468 that form at least one cutting edge 470 in a distal boring portion 472 and a proximal boring portion 474 of the drill. Collectively, the boring portions are configured to bore out the near cortex to drill a wider hole 160 to receive the body portion 106 of the bushing 82 (or 82'). More specifically, the distal boring portion 472 forms a narrower hole 118 in the near cortex 118 that is reamed out by the proximal boring portion 474 to drill the wider hole 160.

[0125] The stop member 476 may be disposed radially outward from the shaft 464 and may be formed integrally with or separately from the shaft. If formed separately, the stop member 476 may have an adjustable position along the shaft 464. The stop member is configured to establish a depth at which the near cortical drill 460 is prevented from advancing further into the bone 54. Advancement is prevented by contact between the proximal ends of the tubes 262 of the guide portions 194 of any of the clamp / guide instruments disclosed herein when drilling with the near cortical drill 460 is completed. The axial position of the stop member 476 along the shaft 464 ensures that the drill 460 is prevented from moving further distally after the proximal boring portion 474 has completely cored out the near cortex 118 to create a wider hole 160, but before the tip of the proximal boring portion 474 reaches the far cortex 120 (see FIG. 57 ). The axial location of the stop member may be selected prior to or after manufacture of the drill based on the range of bone sizes present in a population of potential subjects or based on measurements of at least one bone size specific to the particular subject receiving the bushing. The distal boring portion 472 may or may not bore out the far cortex to drill a blind hole 478, depending on whether the stop member 476 blocks travel of the drill before the distal boring portion reaches the distal cortex 120.

[0126] 56 and 58 respectively show the far cortical drill 462 separated (FIG. 56) and stopped from advancing further into the bone 54 (FIG. 58). The far cortical drill 462 has a shaft 480 (e.g., a faceted (trocar) tip) equipped with a distal tip 482. The tip 482 forms a proximal bore portion 484 that hollows out the far cortex 120 to drill a narrower hole 161 (FIG. 58). The shaft 480 defines one or more flutes 468 that form at least one cutting edge 488 in the proximal bore portion 490 of the drill. The proximal bore portion 490 is a side cut, which effectively widens the area of ​​the medullary canal 64 if necessary to better seat the rounded shoulder 110 of the bushing 82' against the wall of the medullary canal. However, the proximal bore is configured to avoid end truncation so that the proximal bore cannot axially bore through the far cortex 120 to drill a narrower hole 161. Thus, advancement of the far cortical drill 462 stops when it reaches the configuration of Fig. 58. The holes 160, 161 formed by the drills 460, 462 are shown in Fig. 59 after the drill 462 has been removed. EXAMPLES

[0127] Selected embodiment I This section describes selected embodiments of the present disclosure as a series of indexed paragraphs.

[0128] Paragraph A1. A system for bone fixation comprising: (i) an instrument having a pair of jaws configured to engage opposing sides of a bone, the jaws coupled to a guide portion defining a guide axis that remains in a central plane between and equidistant from such jaws as such jaws open and close, (ii) a bushing configured to be driven laterally into the bone on the guide axis, (iii) a nail configured for placement longitudinally in the medullary canal of the bone such that the nail passes through the bushing, and (iv) a locking member that locks the nail to the bushing.

[0129] Paragraph A2. The system of paragraph A1, further comprising at least one drill, wherein the guide portion is configured to guide drilling of at least one hole in the bone on the guide shaft using the at least one drill, the at least one hole comprising a hole having a diameter corresponding to a diameter of the bushing.

[0130] Paragraph A3. The system of paragraph A2, wherein the at least one drill is a stepped drill having a proximal boring portion configured to form a wider hole in the near cortex of the bone and a distal boring portion configured to form a narrower hole in the far cortex of the bone, and the bushing comprises a body portion having a diameter corresponding to the wider hole and a post having a diameter corresponding to the narrower hole.

[0131] Paragraph A4. The system of paragraph A2, wherein the at least one drill comprises a first drill configured to form a wider hole in the near cortex of the bone and a second drill configured to form a narrower hole in the far cortex of the bone, and the bushing comprises a body portion having a diameter corresponding to the wider hole and a post having a diameter corresponding to the narrower hole.

[0132] Paragraph A5. The system of any of paragraphs A1 to A4, wherein the bushing is configured to be advanced over the guide shaft, through the guide portion, and into the bone.

[0133] Paragraph A6. The system of any of paragraphs A1 to A5, wherein the guide portion has a tube that defines a guide axis and is configured to be movable relative to the jaws while the jaws remain engaged with the bone to offset the guide axis from the central plane.

[0134] Paragraph A7. The system of paragraph A6, wherein the tube is adjustable to offset the guide axis from the central plane in an opposite direction from the central plane.

[0135] Paragraph A8. The system of any of paragraphs A1 to A7, wherein the guide portion comprises a tube coupled to the jaws via a holder, the tube configured to be moved relative to the holder to offset the guide axis from the central plane.

[0136] Paragraph A9. The system of any of paragraphs A1 to A8, wherein the jaws are connected to one another at a pivot axis and the central plane includes the pivot axis.

[0137] Paragraph A10. The system of any of paragraphs A1 to A9, wherein the jaws define a plane that is parallel to and spaced from the guide axis.

[0138] Paragraph A11. The system of any of paragraphs A1 to A10, wherein the instrument defines a pair of channels configured to receive a pair of wire members and direct the wire members on non-parallel trajectories through the bone to stabilize the instrument on the bone.

[0139] Paragraph A12. The system of paragraph A11, wherein the channel is configured to direct the wire member on a trajectory through the bone and avoid the medullary canal.

[0140] Paragraph A13. The system of paragraphs A11 or A12, wherein the trajectories have closest approaches to each other before reaching the bone.

[0141] Paragraph A14. The system of any one of paragraphs A1 to A13, wherein the instrument has a gauge that measures a local width of the bone when engaged by the jaws.

[0142] Paragraph A15. The system of paragraph A14, wherein the gauge is configured to indicate whether a local width of the bone is sufficient for secure installation of the bushing.

[0143] Paragraph A16. The system of paragraph A15, wherein the gauge has color coding to indicate whether the local width of the bone is sufficient.

[0144] Paragraph A17. The system of any of paragraphs A1-A16, comprising a set of bushings having the same diameter and different lengths, each bushing in the set defining an aperture through which a nail is configured to pass, the apertures of each bushing having different sizes, measured parallel to a major axis of the bushing, corresponding to the different lengths of the bushings.

[0145] Paragraph A18. The system of any one of paragraphs A1 to A17, further including any other limitation of any other indexed paragraph of Section VIII.

[0146] Paragraph B1. A method of fixating a bone comprising: (i) engaging opposing sides of a bone with jaws of an instrument having a guide portion defining a guide axis, the jaws being coupled or configured to be coupled to the guide portion such that the guide axis remains in a central plane between and equidistant from the jaws as such jaws open and close; (ii) boring at least one hole transversely through the bone over the guide axis; (iii) placing a bushing into the bone at the at least one hole; (iv) advancing a nail longitudinally within the medullary canal of the bone such that the nail passes through the bushing; and (v) locking the nail into the bushing.

[0147] Paragraph B2. The method of paragraph B1, wherein the jaws define a clamping plane that is perpendicular to the central plane and parallel to and spaced from the guide axis.

[0148] Paragraph B3. The method of paragraph B2, wherein the engaging step includes orienting the clamping plane substantially perpendicular to a long axis of the bone.

[0149] Paragraph B4. The method of any one of paragraphs B1 to B3, wherein the jaws are pivotable relative to one another about a pivot axis defined by the instrument, the pivot axis being oblique to the guide axis, and the engaging step includes orienting the pivot axis obliquely to a longitudinal axis defined by the bone.

[0150] Paragraph B5. The method of any of paragraphs B1 to B4, further comprising offsetting the guide axis from the central plane before the hollowing step while the jaws remain engaged with the bone.

[0151] Paragraph B6. The method of paragraph B5, further comprising fluoroscopically viewing alignment between the nail or reamer and at least a portion of the guide portion, wherein offsetting the guide axis improves alignment.

[0152] Paragraph B7. The method of paragraphs B5 or B6, wherein the offsetting step includes moving at least a portion of the guide portion relative to the jaws such that the guide axis is parallel to and away from the central plane.

[0153] Paragraph B8. The method of paragraph B7, wherein the moving step includes rotating at least a portion of the guide portion relative to the jaws.

[0154] Paragraph B9. The method of paragraph B8, in which the rotating step includes rotating at least a portion of the guide portion about an axis of rotation that is parallel to and spaced apart from the guide axis.

[0155] Paragraph B10. The method of paragraph B8, in which the moving step includes producing a net translational displacement of at least a portion of the guide portion relative to the jaws.

[0156] Paragraph B11. The method of any of paragraphs B1 to B10, further comprising driving at least one wire member through the bone on a trajectory defined by the instrument to stabilize the instrument with respect to the bone.

[0157] Paragraph B12. The method of paragraph B11, in which the pushing step includes pushing a pair of wire members through the bone on non-parallel trajectories defined by the instrument.

[0158] Paragraph B13. The method of paragraph B12, in which the trajectories have closest approaches to each other before reaching the bone.

[0159] Paragraph B14. The method of any of paragraphs B11 to B13, wherein each trajectory is defined by a corresponding channel in the instrument, and each wire member passes through a corresponding channel after the pushing step.

[0160] Paragraph B15. The method of any of paragraphs B11 to B14, wherein each wire member is a K-wire.

[0161] Paragraph B16. The method of any one of paragraphs B1 to B15, further comprising using a gauge of the instrument to measure a local width of the bone between opposing sides engaged by the jaws.

[0162] Paragraph B17. The method of paragraph B16, wherein the gauge indicates the local width numerically and / or by color.

[0163] Paragraph B18. The method of any one of paragraphs B1 to B17, further comprising any other restriction of any other indexed paragraph of Section VIII.

[0164] Paragraph C1. A system for bone fixation comprising: (i) an instrument having a pair of jaws configured to engage opposing sides of a bone and a guide portion coupled to the jaws and defining a guide axis, the instrument configured to direct a pair of wire members through the bone on a pair of non-parallel trajectories to stabilize the instrument relative to the bone, (ii) a bushing configured to be driven laterally into the bone from the guide portion on the guide axis through at least one hole drilled in the bone, (iii) a nail configured for longitudinal placement in the medullary canal of the bone such that the nail passes through the bushing, and (iv) a locking member configured to lock the nail to the bushing.

[0165] Paragraph C2. The system of paragraph C1, wherein the instrument has a pair of channels that define a pair of non-parallel trajectories.

[0166] Paragraph C3. The system of paragraphs C1 or C2, wherein the pair of non-parallel trajectories are configured to have closest approaches relative to one another before reaching the bone.

[0167] Paragraph C4. The system of any of paragraphs C1 to C3, wherein the instrument comprises a pair of levers pivotally connected with respect to each other to form a jaw, the guide portion being connected to the levers via a holder, the holder defining each locus.

[0168] Paragraph C5. The system of paragraph C4, wherein the guide portion includes a tube defining a channel centered on the guide axis, and the holder surrounds the tube.

[0169] Paragraph C6. The system of any of paragraphs C1 to C5, wherein each trajectory is configured to avoid the medullary canal of the bone.

[0170] Paragraph C7. The system of any of paragraphs C1 to C6, further comprising a pair of wire members, each wire member being a K-wire.

[0171] Paragraph C8. The system of any one of paragraphs C1 to C7, further including any other limitation of any indexed paragraph of Section VIII.

[0172] Paragraph D1. A method of fixating a bone, the method including: (i) engaging opposing sides of a bone with jaws of an instrument having a guide portion coupled to the jaws and defining a guide axis; (ii) after the engaging step, forcing a pair of wire members into the bone, the wire members passing through the instrument and the bone on non-parallel trajectories defined by the instrument and stabilizing the instrument with respect to the bone; (iii) boring at least one hole laterally into the bone on the guide axis; (iv) inserting a bushing into the bone through the at least one hole; (v) advancing a nail longitudinally within the medullary canal of the bone such that the nail passes through the bushing; and (vi) locking the nail into the bushing.

[0173] Paragraph D2. The method of paragraph D1, wherein the pushing step includes guiding advancement of each wire member into the bone with a channel defined by the instrument.

[0174] Paragraph D3. The method of paragraph D2, wherein the instrument has a pair of levers forming a jaw, the pair of levers being coupled to the guide portion via a holder, and guiding the advancement of each wire member includes guiding the advancement of the wire member through a channel defined by the holder.

[0175] Paragraph D4. The method of any one of paragraphs D1 to D3, further including any other limitation of any other indexed paragraph of Section VIII.

[0176] Paragraph E1. A system for bone fixation comprising: (i) a nail configured to be placed longitudinally into the medullary canal of a bone, (ii) a bushing having a trailing portion and a distal portion, the trailing portion forming a step adjacent the distal portion and defining a transverse opening through which the nail is configured to pass, the distal portion being elongated and substantially cylindrical, and (iii) a locking member configured to lock the nail to the bushing.

[0177] Paragraph E2. The system of paragraph E1, wherein the rear end portion comprises a substantially cylindrical body portion.

[0178] Paragraph E3. The system of paragraphs E1 or E2, wherein the rear end portion is tapered or terminates abruptly to form a step.

[0179] Paragraph E4. The system of any of paragraphs E1-E3, wherein the trailing end portion includes one or more lateral projections configured to attach the bushing to a near cortex of a bone.

[0180] Paragraph E5. The system of paragraph E4, wherein at least one of the lateral projections forms at least a portion of an entrance to the lateral opening.

[0181] Paragraph E6. The system of paragraphs E4 or E5, wherein the one or more lateral protrusions are configured to form and / or function as male threads.

[0182] Paragraph E7. The system of any one of paragraphs E4 to E6, wherein the one or more protrusions comprise a plurality of teeth.

[0183] Paragraph E8. The system of paragraph E7, wherein the lateral projections form two or more sets of teeth circumferentially spaced from one another on the rear end portion, the teeth of the different sets being arranged on the same helical path as one another.

[0184] Paragraph E9. The system of paragraph E8, wherein the plurality of teeth comprises axial columns arranged parallel to a longitudinal axis of the bushing.

[0185] Paragraph E10. The system of any of paragraphs E4 to E9, wherein the one or more protrusions define a plurality of axial columns of teeth.

[0186] Paragraph E11. The system of any of paragraphs E1 to E10, wherein the shoulder is spherical or planar.

[0187] Paragraph E12. The system of any of paragraphs E1-E11, wherein the rear end of the bushing also defines an axial opening across the lateral opening and having female threads, and the locking member has male threads that are complementary to the female threads.

[0188] Paragraph E13. The system of any of paragraphs E1 to E12, wherein the distal end of the bushing is not cylindrical.

[0189] Paragraph E14. The system of any of paragraphs E1-E13, wherein the bushing defines a longitudinal axis, the transverse opening is elongated parallel to the longitudinal axis and has a tapered entrance.

[0190] Paragraph E15. The system of any of paragraphs E1 to E14, wherein the side opening has opposed ends spaced apart parallel to a through axis of the side opening, each opposed end being circumferentially chamfered to form an enlarged entrance.

[0191] Paragraph E16. The system of any of paragraphs E1 to E15, wherein the side opening has an inlet, the inlet having a length measured parallel to the major axis of the bushing that is at least 1 / 2 the length of the rear end portion measured parallel to the major axis.

[0192] Paragraph E17. The system of any of paragraphs E1 to E16, wherein the transverse opening has an entrance, the entrance having a maximum width measured parallel to a diagonal axis of the bushing perpendicular to the longitudinal axis of the bushing and perpendicular to the through axis of the opening, the maximum width being at least 1 / 2 the average diameter of the rear end portion.

[0193] Paragraph E18. The system of any of paragraphs E1 to E17, wherein the tip region of the nail has a main portion defining a long axis and a tip offset from the long axis.

[0194] Paragraph E19. The system of paragraph E18, wherein the tip is elongated substantially parallel to the major axis of the main portion.

[0195] Paragraph E20. The system of paragraph E18 or E19, wherein the main portion has a uniform diameter and the tip is tapered.

[0196] Paragraph E21. The system of any of paragraphs E18 to E20, wherein the trailing end region of the nail is curved in the plane and the tip is offset from the main portion in the plane.

[0197] Paragraph E22. The system of any of paragraphs E18 to E21, wherein the tip is less than 1 / 2 the length of the main portion.

[0198] Paragraph E23. The system of any of paragraphs E1-E22, wherein the nail has a head and a stem, the head defining a plurality of openings configured to receive fasteners to attach the head to bone, and the bushing and locking member configured to attach the stem to the bone.

[0199] Paragraph E24. The system of any one of paragraphs E1 to E23, further including any other limitation of any other indexed paragraph of Section VIII.

[0200] Paragraph F1. A method of fixating bone comprising: (i) axially boring a hole into bone to form a wider hole through the near cortex of the bone and a narrower hole in and / or through the far cortex of the bone; (ii) selecting a bushing having a trailing portion having a diameter corresponding to the wider hole and a leading portion having a diameter corresponding to the narrower hole, the trailing portion forming a step adjacent the leading portion; (iii) forcing the bushing as a unit into the axially boring bone until the step engages the far cortex and prevents further advancement of the bushing; (iv) advancing a nail longitudinally within the medullary canal such that the nail penetrates the bushing; and (v) locking the nail into the bushing.

[0201] Paragraph F2. The method of paragraph F1, wherein hollowing out the bone includes forming a wider hole that is cylindrical and a narrower hole that is at least partially cylindrical.

[0202] Paragraph F3. The method of paragraph F1 or F2, wherein the step of hollowing out the bone is performed with a first drill to form the wider hole and a second drill to form the narrower hole.

[0203] Paragraph F4. The method of paragraph F3, further comprising the step of mounting a guidewire over the shaft prior to the boring step, wherein the boring step is performed over the guidewire using a cannulated first drill and / or a cannulated second drill.

[0204] Paragraph F5. The method of paragraph F1 or F2, wherein the step of hollowing out the bone is performed with a stepped drill that forms wider and narrower holes.

[0205] Paragraph F6. The method of any of paragraphs F1-F5, wherein the hollowing out step includes forming a recessed area on an interior side of the far cortex adjacent the narrower hole, the recessed area being complementary to a rear end portion of the bushing at a step.

[0206] Paragraph F7. The method of any of paragraphs F1 through F6, wherein the trailing end portion is tapered or terminates abruptly to form a step.

[0207] Paragraph F8. The method of any of paragraphs F1-F7, wherein the compressing the bushing includes rotating the bushing multiple times about the longitudinal axis.

[0208] Paragraph F9. The method of any of paragraphs F1-F8, wherein the trailing end portion has one or more lateral projections, and wherein forcing the bushing includes engaging a near cortex of the bone with the one or more lateral projections.

[0209] Paragraph F10. The method of paragraph F9, wherein engaging the near cortex includes urging one or more lateral projections into the cortical bone at the wider bore.

[0210] Paragraph F11. The method of any of paragraphs F1-F10, wherein the forcing step includes pushing or tapping the bushing to urge the bushing into the bone.

[0211] Paragraph F12. The method of any of paragraphs F1-F11, wherein the nail has a trailing region and a leading region, and wherein locking the nail includes clamping a section of the leading region of the nail between a bushing and a locking member, and the method further includes attaching the trailing region of the nail to the bone using one or more fasteners that penetrate into openings defined by the trailing region.

[0212] Paragraph F13. The method of paragraph 12, wherein the trailing end region forms a wider head and the trailing end region forms a narrower stem.

[0213] Paragraph F14. The method of any one of paragraphs F1 to F13, further comprising any other restriction of any other indexed paragraph of Section VIII.

[0214] Paragraph G1. A system for bone fixation comprising: (i) an instrument having a clamping portion coupled to a guide portion defining a guide axis, the clamping portion including a pair of jaws configured to engage opposing sides of a bone, the instrument having a gauge to measure a local width of the bone between the jaws, (ii) a bushing configured to be driven laterally into the bone from the guide portion on the guide axis through at least one hole drilled into the bone, (iii) a nail configured for longitudinal placement in the medullary canal of the bone such that the nail passes through the bushing, and (iv) a locking member configured to lock the nail to the bushing.

[0215] Paragraph G2. The system of paragraph G1, wherein the gauge has color coding configured to indicate the local width as one of two or more different colors.

[0216] Paragraph G3. The system of paragraph G2, wherein each different color represents a width range, and the width ranges of two or more different colors do not overlap one another.

[0217] Paragraph G4. The system of paragraphs G2 or G3, wherein the gauge shows smaller widths as red and larger widths as green.

[0218] Paragraph G5. The system of paragraph G4, wherein the gauge indicates intermediate widths as yellow or orange.

[0219] Paragraph G6. Red corresponds to local widths where the installation of bushings is not advised for systems described in paragraphs G4 or G5.

[0220] Paragraph G7. The system of any one of paragraphs G1 to G6, wherein the gauge includes a graduated scale.

[0221] Paragraph G8. The system of paragraph G7, wherein the graduated scale includes one or more numbers indicating local widths according to standard units of measurement.

[0222] Paragraph G9. The system of any one of paragraphs G1 to G8, further including any other limitation of any other indexed paragraph of Section VIII.

[0223] Paragraph H1. A method of fixating a bone comprising: (i) engaging opposing sides of a bone with jaws of an instrument having a guide portion coupled to the jaws and defining a guide shaft; (ii) reading a gauge of the instrument, the gauge measuring a local width of the bone between the jaws; (iii) moving the jaws to a different location on the bone if the gauge indicates the local width is too small; (iv) boring the bone transversely over the guide shaft to drill at least one hole; (v) placing a bushing into the bone at the at least one hole; (vi) advancing a nail longitudinally within the medullary canal of the bone such that the nail passes through the bushing; and (vii) locking the nail into the bushing.

[0224] Paragraph H2. The method of paragraph H1, wherein reading the gauge includes reading a color from the gauge.

[0225] Paragraph H3. The method of paragraph H1 or H2, further including any other limitation of any other indexed paragraph of Section VIII.

[0226] Paragraph I1. A method of fixating a bone comprising: (i) engaging opposing sides of a bone with jaws of an instrument having a guide portion coupled to the jaws and defining a guide shaft; (ii) placing a nail or reamer along the medullary canal of the bone; (iii) determining by fluoroscopy a degree of alignment of the nail or reamer and the guide portion with respect to one another; (iv) if the degree of alignment is not sufficient, repositioning the guide shaft by moving at least a portion of the guide portion while such jaws remain engaged with the bone, relative to the jaws, to improve the degree of alignment; (v) retracting the nail or reamer; (vi) boring a hole in the bone from the guide portion on the guide shaft; (vii) placing a bushing into the boring hole in the bone; (viii) advancing the nail longitudinally within the medullary canal such that the nail passes through the bushing; and (ix) locking the nail into the bushing.

[0227] Paragraph I2. The method of paragraph I1, wherein the step of inserting the bushing includes threading the bushing onto the guide shaft and through the guide portion.

[0228] Paragraph I3. The method of paragraphs I1 through I2, further including any other limitation of any other indexed paragraph of Section VIII.

[0229] Paragraph J1. A system for bone fixation comprising: (i) a bushing configured to be bicortically positioned within a bone and span a medullary canal thereof, the bushing defining an axial opening across a lateral opening; (ii) a nail having a distal region and a posterior region, the nail configured to be placed along the medullary canal, the distal region of the nail passing through the bushing through the lateral opening and the posterior region defining one or more openings configured to receive a fastener that attaches the posterior region to the bone; and (iii) a locking member configured to be received within the axial opening and lock the distal region of the nail to the bushing, the distal region of the nail having a major portion and a tip portion, the tip portion being laterally offset from the major portion.

[0230] Paragraph J2. The system of paragraph J1, wherein the tip portion is substantially parallel to the main portion.

[0231] Paragraph J3. The system of paragraphs J1 or J2, wherein the main portion has a uniform diameter and the tip portion is tapered.

[0232] Paragraph J4. The system of any of paragraphs J1 to J3, wherein the trailing end region is curved in the plane and the leading portion is offset from the main portion in the plane.

[0233] Paragraph J5. The system of any of paragraphs J1 to J4, wherein the tip portion is less than 1 / 2 the length of the main portion.

[0234] Paragraph J6. The system of any one of paragraphs J1 to J5, further including any other limitation of any other indexed paragraph of Section VIII.

[0235] Paragraph K1. A method of fixating a bone comprising: (i) inserting a bushing into the bone such that the bushing spans the medullary canal, the bushing defining an axial opening across the lateral opening; (ii) selecting a nail having a leading region and a trailing region, the leading region having a main portion and a tip offset from a long axis of the main portion; (iii) advancing the tip along the medullary canal of the bone until the tip approaches the lateral opening; (iv) rotating the nail about its long axis, if necessary, to improve alignment of the tip and the lateral opening; (v) passing the tip through the lateral opening; (vi) locking the leading region of the nail to the nail using a locking member received within the axial opening of the bushing; and (vii) attaching the trailing region of the nail to the bone.

[0236] Paragraph L1. A system for bone fixation comprising: (i) an instrument having a clamp portion coupled to a guide portion, the guide portion defining a guide axis, the clamp portion including a pair of jaws configured to grip opposing sides of a bone, at least a portion of the guide portion configured to be repositioned relative to the clamp portion to offset the guide axis while the jaws are fixed; (ii) a bushing configured to be placed laterally into the bone (a) through the guide portion on the guide axis and / or (b) through at least one hole drilled into the bone from the guide portion on the guide axis, the bushing defining an opening; and (iii) a nail configured to be placed along the medullary canal of the bone such that the nail passes through the opening in the bushing.

[0237] Paragraph L2. The system of paragraph L1, wherein the guide portion defines a channel centered on the guide axis, the guide portion being radiopaque about the channel. EXAMPLES

[0238] SELECTED EMBODIMENTS II This section further describes selected embodiments of the present disclosure as a series of indexed paragraphs.

[0239] Paragraph 1. A system for bone fixation, comprising: (A) a bushing configured to be at least partially placed into at least one hole bored in a bone; (B) a nail configured to be placed along the medullary canal of the bone such that the nail passes through the bushing; and (C) a locking member configured to lock the nail to the bushing.

[0240] Paragraph 2. The system of Paragraph 1, further comprising an instrument including a guide portion defining a guide shaft, the guide shaft configured to be coupled to the bone such that the guide shaft traverses the bone, the bushing configured to be received within at least one bore bored through the bone along the guide shaft.

[0241] Paragraph 3. The system of paragraph 2, wherein the instrument comprises a pair of jaws, the jaws coupled to the guide portion and configured to engage a bone to couple the instrument to the bone, optionally the jaws are movable relative to one another about a pivot axis.

[0242] Paragraph 4. The system of paragraph 3, wherein the guide axis lies in a central plane that remains between and equidistant from the jaws as the jaws open and close, and optionally the jaws are movable relative to one another about a pivot axis that is also located in the central plane.

[0243] Paragraph 5. The system of paragraphs 3 or 4, wherein the instrument has a pair of levers pivotally connected to one another, the guide portion coupled to the pair of levers via a holder for the guide portion, the levers coupled to the holder by respective linkage members having pivotal connections to one another, the pivotable connections of the linkage members moving along slots defined by the holder as the jaws open and close, thereby ensuring that the guide portion remains an equal distance from the jaws regardless of how open the jaws are.

[0244] Paragraph 6. The system of any one of paragraphs 3 to 5, wherein the guide portion is configured to be movable from a first position to at least one second position with the jaws engaged with the bone, the guide portion being coupled to the jaws in each of the first and second positions, a guide axis of the guide portion in the first position lying in a central plane between the jaws, and a guide axis of the guide portion in each second position being parallel to but offset from the central plane and the guide axis of the guide portion in the first position.

[0245] Paragraph 7. The system of Paragraph 6, wherein the guide portion is configured to be movable from a first position to a respective second position while the guide portion remains coupled to the jaws.

[0246] Paragraph 8. The system of paragraphs 6 or 7, wherein the guide portion is movable to at least one third position, and the guide axis at each second position of the guide portion and the guide axis at each third position of the guide portion are parallel to each other but offset from the central plane in opposite directions.

[0247] Paragraph 9. The system of any one of paragraphs 6 to 8, wherein the guide portion is movable to form a plurality of offsets of the guide axis from a central plane, the guide portion being coupled to the jaws via a holder, and the plurality of offsets being predefined by features of the guide portion and the holder that are complementary to one another.

[0248] Paragraph 10. The system of Paragraph 9, wherein the plurality of offsets includes predefined offsets of 1 millimeter and 2 millimeters from the central plane.

[0249] Paragraph 11. The system of any one of Paragraphs 6 to 10, wherein the instrument has a gauge indicating a current offset of the guide axis from the central plane.

[0250] Paragraph 12. The system of any one of paragraphs 2 to 11, wherein the instrument has a guide portion configured to rotate with respect to the jaws about an axis parallel to but spaced from the guide axis, thereby moving the guide portion from a first position to a respective second position.

[0251] Paragraph 13. The system of any one of paragraphs 2 to 12, wherein the instrument is at least exclusively radiolucent.

[0252] Paragraph 14. The system of Paragraph 13, wherein the instrument has a guide portion defining a guide axis, the guide portion comprising a radiopaque member centered on the guide axis.

[0253] Paragraph 15. The system of Paragraph 14, wherein the radiopaque member is a radiopaque ring, and the guide portion comprises a pair of radiopaque rings each centered on the guide shaft and spaced apart from one another along the guide shaft.

[0254] Paragraph 16. The system of any one of paragraphs 2 to 15, wherein the instrument defines at least one wire-receiving channel configured to guide a wire member into the bone for coupling the instrument to the bone by the wire member, and optionally, the instrument defines a pair of wire members configured to guide the pair of wire members on non-parallel trajectories into the bone for coupling the instrument to the bone by each of the wire members.

[0255] Paragraph 17. The system of Paragraph 16, wherein each wire-receiving channel is configured to pass a trajectory of wire members into the bone to avoid space in the medullary canal occupied by a guide nail.

[0256] Paragraph 18. The system of paragraphs 16 or 17, wherein the instrument comprises a pair of levers pivotally connected to one another, each lever providing one of the jaws, and the guide portions are connected to the levers via holders for the guide portions, the holders defining respective wire-receiving channels.

[0257] Paragraph 19. The system of paragraph 18, wherein a distal end of the guide portion is flush with a distal end of the holder.

[0258] Paragraph 20. The system of Paragraph 19, wherein the holder has a proximal surface region facing away from the distal end of the holder, and each wire-receiving channel passes through the holder and enters the distal end of the holder from the proximal surface region.

[0259] Paragraph 21. The system according to any one of paragraphs 18 to 20, wherein the holder surrounds at least an axial region of the guide portion.

[0260] Paragraph 22. The system of any one of Paragraphs 16 to 21, wherein the pair of wire-receiving channels are configured such that the non-parallel trajectories have closest approaches to each other before reaching the bone from the instrument.

[0261] Paragraph 23. The system of Paragraph 22, wherein the pair of wire-receiving channels are configured such that the non-parallel trajectories have closest approaches to each other inside the instrument.

[0262] Paragraph 24. The system of any one of Paragraphs 16 to 23, further comprising wire members, each wire member being a K-wire.

[0263] Paragraph 25. The system of any one of Paragraphs 1 to 24, wherein the at least one hole comprises a wider hole and a narrower hole, and further comprising one or more drills configured to bore into the bone a wider hole along a guide axis in the near cortex of the bone and a narrower hole along a guide axis in the far cortex of the bone, and wherein the bushing comprises a trailing portion having a diameter corresponding to the wider hole and a leading portion having a diameter corresponding to the narrower hole.

[0264] Paragraph 26. The system of Paragraph 25, wherein the one or more drills comprise a first drill for drilling wider holes and a second drill for drilling narrower holes.

[0265] Paragraph 27. The system of Paragraph 26, wherein the first drill comprises a boring portion for drilling a wider hole and also comprises a stop member configured to contact the instrument to prevent axial advancement of the boring portion into the far cortex of the bone.

[0266] Paragraph 28. The system of paragraphs 26 or 27, wherein the second drill comprises a boring portion for drilling a narrower hole and a countersink portion for enlarging an area of ​​the medullary canal adjacent the narrower hole.

[0267] Paragraph 29. The system of any one of Paragraphs 1 to 28, wherein the bushing has an external thread formation for engaging bone at the at least one hole.

[0268] Paragraph 30. The system of any one of Paragraphs 1 to 29, wherein the bushing is configured to be advanced along the guide shaft, through the guide portion of the instrument, and into the bone.

[0269] Paragraph 31. The system of any one of Paragraphs 1 to 30, wherein the bushing comprises a body portion having a step and also comprises a post projecting distally from the step.

[0270] Paragraph 32. The system of Paragraph 31, wherein the step has a rounded contour formed by a proximal-distal reduction in diameter of the tip region of the body.

[0271] Paragraph 33. The system of paragraphs 31 or 32, wherein the support is cylindrical.

[0272] Paragraph 34. The system of any of Paragraphs 1 to 33, wherein the bushing defines a longitudinal axis and also defines a transverse opening configured for the nail to pass therethrough, the transverse opening being elongated parallel to the longitudinal axis of the bushing.

[0273] Paragraph 35. The system of paragraph 34, wherein the side opening has a chamfered entrance.

[0274] Paragraph 36. The system of any one of Paragraphs 1 to 35, wherein the locking member comprises a set screw having external threads that are complementary to the internal threads of the bushing.

[0275] Paragraph 37. The system of Paragraph 36, wherein the bushing defines a transverse opening and an axial opening that intersect with one another, the nail is configured to pass through the transverse opening, and the set screw is configured to advance into the bushing along the axial opening.

[0276] Paragraph 38. The system of Paragraphs 36 or 37, wherein the set screw is disposed in threaded engagement with the bushing and configured to advance against the nail until the nail is clamped in combination by the bushing and the set screw.

[0277] Paragraph 39. The system of Paragraph 38, wherein at least one of the bushing and the set screw has a protrusion configured to contact and deform a surface area of ​​the nail when the set screw is tightened against the nail.

[0278] Paragraph 40. The system of Paragraph 39, wherein at least one of the bushing and the set screw having the protrusion is constructed from a material that is harder than the nail.

[0279] Paragraph 41. The system of paragraphs 39 or 40, wherein the set screw has a protrusion configured to contact and deform a surface area of ​​the nail, the set screw protrusion protruding distally from a shaft of the set screw and forming a distal edge of the set screw.

[0280] Paragraph 42. The system of paragraph 41, wherein the distal edge is annular.

[0281] Paragraph 43. The system of any of Paragraphs 39 to 42, wherein the bushing has a protrusion configured to contact and deform a surface area of ​​the nail, the protrusion of the bushing being disposed within a lateral opening of the bushing.

[0282] Paragraph 44. The system of any of Paragraphs 36 to 43, wherein the external threads of the set screw are configured to deform the bushing to form a distal extension of the internal threads within the bushing.

[0283] Paragraph 45. The system of paragraph 44, wherein the set screw is made from a harder material than the bushing.

[0284] Paragraph 46. The system of paragraph 45, wherein each of the bushing and the set screw are fabricated from a metal alloy, the metal alloy of the set screw being harder than the metal alloy of the bushing.

[0285] Paragraph 47. The system of paragraph 46, wherein the set screw is made from a cobalt-chromium alloy and the bushing is made from a titanium alloy.

[0286] Paragraph 48. The system of any one of Paragraphs 44 to 47, wherein the male threads of the set screw have a longer axial length than the female threads of the bushing before the distal extension of the female threads is formed.

[0287] Paragraph 49. The system of any of Paragraphs 1 to 48, wherein the tip region of the nail is configured to pass through a lateral opening in the bushing, the tip region of the nail having an elongated main portion and a distal tip, the distal tip being radially offset from the main portion.

[0288] Paragraph 50. The system of Paragraph 49, wherein the central axis of the distal tip is substantially parallel to and offset from the longitudinal axis of the main portion.

[0289] Paragraph 51. The system of paragraphs 49 or 50, wherein the main portion has a uniform diameter and the tip is tapered.

[0290] Paragraph 52. The system of any one of Paragraphs 49 to 51, wherein the trailing end region of the nail is curved in the nail plane and the tip is offset from the main portion in the nail plane.

[0291] Paragraph 53. The system of any one of Paragraphs 49 to 52, wherein the tip is less than ½ the length of the main portion.

[0292] Paragraph 54. The system of any one of Paragraphs 1 to 53, wherein the guide shaft is movable relative to the bone to vary a lateral position of the guide shaft relative to the bone while the instrument remains coupled to the bone, and optionally the guide shaft is movable while the bone remains clamped by the instrument and / or coupled to the bone with one or more wire members, and optionally the guide shaft is movable from a first position to at least one second position where the guide shaft is parallel to its orientation in the first position, and optionally the guide shaft is defined by a guide portion that is rotatable to move the guide shaft.

[0293] Paragraph 55. The system of any one of Paragraphs 1 to 54, further comprising any limitation or combination of limitations of Examples 4 and 6. EXAMPLES

[0294] SELECTED EMBODIMENT III This section further describes selected embodiments of the present disclosure as a series of indexed paragraphs.

[0295] Paragraph 1. A method of fixating a bone, the method including: (A) selecting an instrument having a pair of jaws and a guide portion defining a guide shaft, the guide portion being disposed in a central plane such that the guide shaft remains between and equidistant from the jaws as the jaws open and close; (B) engaging a long bone with the jaws such that the guide shaft traverses the bone; (C) boring a hole in the bone along the guide shaft; (D) placing a bushing at least partially into the hole in the bone; (E) advancing a nail along the medullary canal of the bone such that the nail passes through the bushing; and (F) locking the nail into the bushing.

[0296] Paragraph 2. The method of paragraph 1, wherein the drilling step includes hollowing out the bone to drill a wider hole along a guide axis in the near cortex of the bone and a cylindrical narrower hole along the guide axis in the far cortex of the bone, and the placing step includes placing a trailing portion of a bushing into the wider hole and a leading portion of the bushing into the narrower hole.

[0297] Paragraph 3. The method of paragraph 1 or paragraph 2, wherein the step of placing the bushing includes threading the bushing into engagement with the bone at the hole.

[0298] Paragraph 4. The method of any one of paragraphs 1 to 3, wherein the locking step includes gripping the nail in cooperation with a bushing and a set screw.

[0299] Paragraph 5. The method of any of paragraphs 1 through 4, wherein the bushing defines a transverse opening and an axial opening that intersect each other, and wherein advancing the nail includes passing a tip of the nail through the transverse opening, and wherein locking includes advancing a set screw into the bushing along the axial opening.

[0300] Paragraph 6. The method of any one of paragraphs 1 to 5, wherein the placing step includes threading the bushing along a guide shaft through a guide portion of the instrument.

[0301] Paragraph 7. The method of any one of paragraphs 1 to 6, wherein the bushing comprises a body portion forming a step and also comprises a post projecting distally from the step, and the step of inserting comprises advancing the bushing into the bone until contact between the step of the bushing and the far cortex of the bone prevents further advancement.

[0302] Paragraph 8. The method of any one of paragraphs 1 to 7, further comprising moving the guide portion relative to the jaws while the jaws remain engaged with the bone to offset the guide axis from the central plane.

[0303] Paragraph 9. The method of paragraph 8, wherein the drilling step is performed along a guide axis, the guide axis being offset from the central plane.

[0304] Paragraph 10. The method of paragraph 8 or paragraph 9, wherein the step of moving the guide portion includes rotating the guide portion relative to the jaws about an axis that is parallel to but offset from the guide axis.

[0305] Paragraph 11. The method of any one of Paragraphs 1 to 10, further comprising the step of: driving a pair of wire members from the instrument into the bone on non-parallel trajectories defined by the instrument, each wire member coupling the instrument to the bone.

[0306] Paragraph 12. The method of paragraph 11, wherein the step of forcing the pair of wire members includes threading a distal end of each wire member through a respective wire-receiving channel defined by the instrument and through the bone.

[0307] Paragraph 13. A method of fixating a bone, the method including: (A) engaging opposing sides of a long bone with jaws of an instrument having a guide portion coupled to the jaws and defining a guide axis across the bone; (B) coupling the instrument to the bone with a pair of wire members that are driven into the bone on non-parallel trajectories defined by the instrument; (C) boring a hole in the bone along the guide axis; (D) placing a bushing at least partially into the hole in the bone; (E) advancing a nail along the medullary canal of the bone such that the nail passes through the bushing; and (F) locking the nail into the bushing.

[0308] Paragraph 14. The method of paragraph 13, wherein the step of coupling the instruments includes threading a distal end of each wire member through a wire-receiving channel of the instruments, the wire-receiving channels defining one of the non-parallel trajectories.

[0309] Paragraph 15. The method of paragraph 14, wherein the step of coupling the device includes threading a distal end of the wire member through the bone.

[0310] Paragraph 16. The method of paragraphs 14 or 15, wherein the instrument comprises a pair of levers pivotally connected to one another and forming a jaw, the guide portions being connected to the levers via holders, the holders defining respective wire-receiving channels.

[0311] Paragraph 17. The method of paragraph 16, wherein the holder contacts the bone when the bonding step is completed.

[0312] Paragraph 18. The method of any one of Paragraphs 13 to 17, wherein the step of coupling the instruments comprises positioning each wire member to pass through a respective wire-receiving channel of the instrument and through the bone.

[0313] Paragraph 19. The method of any one of Paragraphs 13 to 18, wherein the bonding step comprises arranging the wire members on non-parallel trajectories having closest approaches to each other before reaching the bone from the instrument.

[0314] Paragraph 20. The method of any one of Paragraphs 13 to 19, wherein each trajectory avoids the medullary canal of the bone.

[0315] Paragraph 21. The method of any one of Paragraphs 13 to 20, wherein each wire member is a K-wire.

[0316] Paragraph 22. A system for bone fixation comprising: (i) a bushing configured to be placed across the medullary canal of a long bone, the bushing having a body and a post, the body having an externally threaded configuration and defining a side opening, the post projecting from a shoulder formed by a distal region of the body; (B) a nail configured to be placed along the medullary canal of the bone such that the nail passes through the side opening of the bushing; and (C) a setscrew configured to be advanced into the bushing and engage the nail, the setscrew and the bushing cooperatively gripping the nail.

[0317] Paragraph 23. The system of Paragraph 22, wherein at least one of the bushing and the set screw has a protrusion configured to contact and deform a surface area of ​​the nail as the set screw is advanced into the bushing and strikes the nail.

[0318] Paragraph 24. The system of Paragraph 23, wherein at least one of the bushing and the set screw having the protrusion is constructed from a material that is harder than the nail.

[0319] Paragraph 25. The set screw is in contact with the surface area of ​​the nail 25. The system of paragraph 23 or 24, wherein the set screw has a protrusion configured to deform, the protrusion protruding distally from the shaft of the set screw and forming a distal edge of the set screw.

[0320] Paragraph 26. The system of paragraph 25, wherein the distal edge is annular.

[0321] Paragraph 27. The system of any one of Paragraphs 23 to 26, wherein the bushing has a protrusion configured to contact and deform a surface area of ​​the nail, the protrusion of the bushing being formed by a wall of the lateral opening.

[0322] Paragraph 28. The system of any of Paragraphs 22 to 27, wherein the set screw is made of a harder material than the bushing, the set screw has external threads that are complementary to the internal threads of the bushing, and the external threads of the set screw are configured to form a distal extension of the internal threads of the bushing when the set screw is advanced into the bushing and engages the nail.

[0323] Paragraph 29. The system of paragraph 28, wherein the set screw is made from a harder metal alloy and the bushing is made from a softer metal alloy.

[0324] Paragraph 30. The system of paragraph 29, wherein the harder metal alloy is a cobalt-chromium alloy and the softer metal alloy is a titanium alloy.

[0325] Paragraph 31. The system of any one of Paragraphs 22 to 30, wherein the support pillar is cylindrical.

[0326] Paragraph 32. The system of any one of Paragraphs 22 to 31, wherein the step has a rounded contour formed by a proximal-distal reduction in diameter of the tip region of the body.

[0327] Paragraph 33. The system of any of Paragraphs 22 to 32, wherein the bushing defines a longitudinal axis, the transverse opening is elongated parallel to the longitudinal axis and has a chamfered entrance.

[0328] Paragraph 34. A method of fixating bone comprising: (A) drilling a wider hole through the near cortex of a long bone and a narrower hole in the far cortex of the bone; (B) selecting a bushing having a body portion having a diameter corresponding to the wider hole and a post having a diameter corresponding to the narrower hole, the post protruding from a step formed by a tip region of the body portion; (C) forcing the bushing into the wider and narrower holes until contact between the step and the far cortex of the bone prevents further advancement of the bushing; (D) advancing a nail along the medullary canal such that the nail penetrates the bushing; and (E) locking the nail into the bushing.

[0329] Paragraph 35. The method of paragraph 34, wherein each of the wider and narrower holes is cylindrical.

[0330] Paragraph 36. The method of paragraph 34 or paragraph 35, wherein the drilling step is performed with a first drill for forming the wider holes and a second drill for forming the narrower holes.

[0331] Paragraph 37. The method of any one of Paragraphs 34 to 36, wherein the drilling step includes forming a recessed area in the far cortex of the bone, the recessed area being complementary to the shoulder of the bushing.

[0332] Paragraph 38. The method of any one of Paragraphs 34 to 37, wherein the pushing step includes disposing a bushing in threaded engagement with the bone.

[0333] Paragraph 39. The method of any one of Paragraphs 34 to 38, wherein the step of locking the nail includes clamping an axial region of the nail between a bushing and a set screw.

[0334] Paragraph 40. The method of Paragraph 39, wherein the bushing has internal threads that are complementary to the external threads of the bushing, further comprising the step of using the external threads of the set screw to form a distal extension of the internal threads of the bushing.

[0335] Paragraph 41. The method of paragraph 40, wherein the set screw is formed from a harder material than the bushing.

[0336] Paragraph 42. The method of paragraph 41, wherein the set screw is formed from a cobalt-chromium alloy and the bushing is formed from a titanium alloy.

[0337] Paragraph 43. A method of fixating a bone comprising: (A) engaging a bone with jaws of an instrument having a guide portion coupled to the jaws and defining a guide axis across the bone; (B) placing a nail or reamer along the medullary canal of the bone; (C) determining by fluoroscopy a degree of alignment of the nail or reamer and the guide portion with respect to one another; (D) if the degree of alignment is not sufficient, repositioning the guide axis with respect to the jaws by moving the guide portion while the jaws remain engaged with the bone; (E) retracting the nail or reamer; (F) boring a hole through the bone from the guide portion along the guide axis; (G) placing a bushing at least partially into the hole in the bone; (H) advancing the nail along the medullary canal such that the nail passes through the bushing; and (I) locking the nail into the bushing.

[0338] Paragraph 44. The method of Paragraph 43, wherein the step of inserting the bushing includes threading the bushing along the guide shaft and through the guide portion.

[0339] Paragraph 45. A system for bone fixation comprising: (A) a bushing configured to be bicortically positioned within a bone lateral to a medullary canal of the bone, the bushing defining an axial opening across the lateral opening; (B) a nail having a distal region and a trailing region, the nail configured to be placed along the medullary canal such that the distal region of the nail passes through the lateral opening, the trailing region defining one or more openings configured to receive a fastener that attaches the trailing region to the bone; and (C) a locking member configured to thread into the axial opening of the bushing and advance against the nail to lock the distal region of the nail to the bushing, the distal region of the nail having an elongated main portion and a distal tip, the tip being radially offset from the main portion.

[0340] Paragraph 46. The system of Paragraph 45, wherein the central axis of the tip is substantially parallel to and offset from the longitudinal axis of the main portion.

[0341] Paragraph 47. The system of paragraph 45 or paragraph 46, wherein the main portion has a uniform diameter and the tip is tapered.

[0342] Paragraph 48. The system of any of Paragraphs 45 to 47, wherein the trailing end region is curved in the plane and the leading end is offset in the plane from the main portion.

[0343] Paragraph 49. The system of any one of Paragraphs 45 to 48, wherein the tip is less than ½ the length of the main portion.

[0344] Paragraph 50. A method of fixating a bone, the method comprising: (A) placing a bushing at least partially into the bone such that the bushing spans laterally the medullary canal of the bone, the bushing defining an axial opening across the lateral opening; (B) selecting a nail having a leading region and a trailing region, the leading region having a main portion and a tip, the tip being radially offset from a longitudinal axis of the main portion; (C) advancing the tip along the medullary canal of the bone until the tip approaches the lateral opening; (D) rotating the nail about its long axis, if necessary, to improve alignment of the tip with the lateral opening; (E) passing the tip through the lateral opening; (F) locking the leading region of the nail to the nail using a locking member received within the axial opening of the bushing; and (G) attaching the trailing region of the nail to the bone.

[0345] Paragraph 51. A system for bone fixation comprising: (A) a nail configured to be placed along the medullary canal of a bone; (B) a bushing having externally threaded configuration for engaging the bone, the bushing defining a lateral opening through which the nail is configured to pass and also defining an axial opening having internal threads; and (C) a setscrew having external threads disposed in threaded engagement with the internal threads of the bushing and configured for threaded advancement until the nail is grasped by the bushing and the setscrew in combination, the setscrew fitting with an interference fit within the bushing such that advancement of the setscrew forms a distal extension of the internal threads in the axial opening of the bushing.

[0346] Paragraph 52. The system of Paragraph 51, wherein the set screw is made from a harder material than the bushing.

[0347] Paragraph 53. The system of Paragraph 52, wherein the set screw is made from a cobalt-chromium alloy and the bushing is made from a titanium alloy.

[0348] Paragraph 54. The system of any one of Paragraphs 51 to 53, wherein the male threads of the set screw have a longer axial length than the female threads of the bushing.

[0349] The disclosure set forth above may encompass multiple different inventions having independent utility. While each of these inventions is disclosed in a preferred form, the specific embodiments thereof as disclosed and illustrated herein should not be considered limiting since many variations are possible. The subject matter of the inventions includes all novel and non-obvious combinations and subcombinations of the various elements, features, functions, and / or properties disclosed herein. The following claims point out certain combinations and subcombinations that are considered novel and non-obvious. Inventions embodied in other combinations and subcombinations of features, functions, elements, and / or properties may be claimed in this application, or in applications claiming priority from a related application. Such claims are also considered to be within the subject matter of the inventions disclosed herein, whether directed to different or the same inventions, and whether the original claims are broader, narrower, the same, or different in scope. Additionally, ordinal numbers such as first, second, or third to identified elements are used to distinguish between elements and do not indicate a particular location or order of such elements, unless otherwise specified. Finally, this disclosure incorporates material by reference. In the event that such incorporation by reference results in an ambiguity or discrepancy in the meaning of a term, the literal content of the application shall govern the interpretation of the term. [Explanation of symbols]

[0350] 50 Fastening System 52 Fixing Assembly 54 Left fibula 56 Fracture 58 Diaphyseal region 60 Intramedullary nail 62 Anchor 64 Medulla canal 66 Posterior end area 68 Tip area 70, 72 bone fragments 74 Side opening 76 Edge area 82 Bushing 84 Locking member 86 void 88 Lockable Section 90 Female thread 92 Male thread 94 Tip 96 Inner wall area 98 Rear end part 100 Tip part 106 Main body 108 Pillar 110 Multilayered section 121 Male thread structure 122 Radial protrusion 124 teeth 126 Side Opening 128 Axial opening 130 Entrance 144 Column 150 Cylindrical shaft 192 Clamp part 194 Guide part 196 Opposing Jaws 198 Wire material 200 Acceptance Channel 202 Guide shaft 204 Drill 206 Shaft 218 Holder

Claims

1. 1. A system for bone fixation comprising: an instrument defining a guide shaft and configured to be coupled to a bone such that the guide shaft extends across the bone; a bushing configured to be at least partially received within at least one hole bored through the bone along the guide axis, the bushing defining a lateral opening through which a nail is configured to extend; a nail configured to be placed along the medullary canal of the bone such that the nail passes through the lateral opening of the bushing; a locking member configured to lock the nail to the bushing; the instrument comprises a guide portion and a pair of openable and closable jaws, the guide portion defining the guide axis, the pair of jaws coupled to the guide portion and configured to engage the bone to couple the instrument to the bone; The bushing may pass through the guide portion along the guide axis and into the bone; A system for bone fixation, wherein the instrument is used to attach the bushing and / or the locking member.

2. The system of claim 1 , wherein the guide shaft remains positioned in a central plane that is between and equidistant from the jaws as the jaws open and close.

3. The system of claim 2 , wherein the jaws are pivotable about a pivot axis that lies within the central plane.

4. 3. The system of claim 2, wherein the instrument has a pair of levers pivotally connected to one another, the guide portion coupled to the pair of levers via a holder for the guide portion, the levers coupled to the holder by respective linkage members having a pivotable connection to one another, the pivotable connections of the linkage members moving along slots defined by the holder when the jaws open and close, thereby ensuring that the guide portion remains in a central plane equidistant from the jaws regardless of how open the jaws are.

5. 2. The system of claim 1, wherein the guide portion is configured to be movable from a first position to at least one second position while the jaws are engaged with the bone, the guide portion is coupled to the jaws in each of the first and second positions, the guide axis of the guide portion at the first position lies in a central plane located between and equidistant from the jaws, and the guide axis of the guide portion at each second position is parallel to but offset from the central plane and the guide axis of the guide portion at the first position.

6. The system of claim 5 , wherein the guide portion is configured to be movable from the first position to each of the second positions while the guide portion remains coupled to the jaws.

7. 6. The system of claim 5, wherein the guide portion is movable to at least one third position, and the guide axis at each second position of the guide portion and the guide axis at each third position of the guide portion are parallel to each other but offset from the central plane in opposite directions.

8. 6. The system of claim 5, wherein the guide portion is movable to provide a plurality of offsets of the guide axis from the central plane, the guide portion is coupled to the jaws via a holder, the guide portion has a mating structure, the holder has a plurality of complementary mating structures configured to mate with the mating structures, and the plurality of offsets are provided by varying the complementary mating structures with which the mating structures mate.

9. The system of claim 8 , wherein the plurality of offsets includes predetermined offsets of 1 millimeter and 2 millimeters from the central plane.

10. The system of claim 5 , wherein the instrument has a gauge indicating a current offset of the guide axis from the central plane.

11. 6. The system of claim 5, wherein the guide portion is configured to rotate relative to the jaws about an axis that is parallel to but spaced from the guide axis, thereby moving the guide portion from the first position to each of the second positions.

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