Fibular nail for treating fibular bone fractures

Abstract

An apparatus and methods for a fibular nail are provided for repairing fibular bone fractures. The fibular nail includes an elongated body having fins at a proximal end for anchoring within an intramedullary space of the fibula and a distal end for actuating the fins. The fibular nail is positioned to extend the distal end across the fracture. An actuator is used to deploy the fins to anchor the fibular nail within the intramedullary space. The distal end includes fixation holes for fastening the nail to surrounding bones. The fixation holes are strategically disposed along the distal end at angles and intervals that facilitate receiving bone screws and K-wires to stabilize the surrounding bones. Bone screws are inserted through the fixation holes into holes drilled in the surrounding bones to fasten the fibular nail across the fracture to fixate the portions of the fibula.

Description

Docket No. 102015.0112PCT -1-FIBULAR NAIL FOR TREATING FIBULAR BONE FRACTURESPRIORITY

[0001] This application claims the benefit of, and priority to, U.S. Provisional Application, entitled “Fibular Nail For Treating Fibular Bone Fractures,” filed on October 11, 2024, and having application serial number 63 / 706,563, the entirety of said application being incorporated herein by reference.FIELD

[0002] Embodiments of the present disclosure generally relate to treating bone fractures. More specifically, embodiments of the disclosure relate to an apparatus and methods for a fibular nail for treating and repairing fibular bone fractures.BACKGROUND

[0003] A fusion bone implant may be utilized in conjunction with one or more fasteners to generate compression and stability at a bone interface. An implant coupled with fasteners generally serves to stabilize bones, or bone parts, relative to one another so as to promote bone fusion. In many applications, fusion bone implants and fasteners are used to fuse bones, or bone parts, of the human body, such as bones in the foot, the ankle, the hand, the wrist, as well as various other portions of the body. During the course of certain medical procedures, a surgeon may immobilize one or more bones or the bone fragments by stabilizing the bones together in a configuration which approximates the natural anatomy. To this end, the surgeon may use fasteners to attach the bones to a fusion bone implant that holds the bones in alignment with one another while they fuse together.SUMMARY

[0004] An apparatus and methods for a fibular nail are provided for repairing fibular bone fractures. The fibular nail includes an elongated body having fins at a proximal end for anchoring within an intramedullary space of the fibula and a distal end for actuating the fins. The fibular nail is positioned to extend the distal end across the fracture. An actuator is used to deploy the fins to anchor the fibular nail within the intramedullary space. The distal end includes fixation holes for fastening the nail to surrounding bones. The fixation holes are strategically disposed along the distal end at angles and intervals that facilitate receiving bone screws and K-wires to stabilize the surrounding bones. Bone screws are22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -2- inserted through the fixation holes into holes drilled in the surrounding bones to fasten the fibular nail across the fracture to fixate the portions of the fibula.

[0005] In an exemplary embodiment, an apparatus for repairing a fibular bone fracture comprises: an elongated body disposed between a proximal end and a distal end; one or more fins at the proximal end for engaging within an intramedullary space of the fibula bone; and a plurality of holes disposed along the distal end for stabilizing the fibular bone.

[0006] In another exemplary embodiment, the distal end is configured to be positioned across the fracture. In another exemplary embodiment, the distal end is configured to be coupled with an actuator for deploying the one or more fins to anchor the elongated body within the intramedullary space. In another exemplary embodiment, the elongated body is configured to receive a pushing insert for changing the one or more fins between a neutral configuration and a deployed configuration. In another exemplary embodiment, the one or more fins are configured to increase the diameter of the proximal end between about 34% and about 130% in the deployed configuration. In another exemplary embodiment, a distal end of the pushing insert is configured to receive a drive shaft that can be rotated to move the one or more fins between the neutral configuration and the deployed configuration.

[0007] In another exemplary embodiment, the plurality of holes includes one or more fixation holes for fastening the distal end to fibular bone portions. In another exemplary embodiment, the fixation holes are disposed along the distal end at angles and intervals that facilitate receiving bone screws to stabilize the surrounding bones. In another exemplary embodiment, fixation holes are configured to allow the bone screws to be inserted through the fixation holes into holes drilled in the surrounding bones to fasten the distal end across the fracture. In another exemplary embodiment, the plurality of holes includes one or more holes for receiving K-wires. In another exemplary embodiment, at least one of the plurality of holes is aligned with an anterior-posterior direction.

[0008] In another exemplary embodiment, the plurality of holes comprises a first hole, a second hole, a third hole, a fourth hole, a fifth hole, a sixth hole, and a seventh hole. In another exemplary embodiment, the first hole is projected at an angle of about 90-degrees with respect to a Sagittal plane, the second hole is projected at an angle of about 25.51- degrees with respect to the Sagittal plane, the third hole is projected at an angle of about 90-degrees with respect to the Sagittal plane, the fourth hole is projected at an angle of about 25.51 -degrees with respect to the Sagittal plane, the fifth hole is projected at an angle22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -3- of about 75.65-degrees with respect to the Sagittal plane, the sixth hole is projected at an angle of about.74-degress with respect to the Sagittal plane, and the seventh hole is projected at an angle of substantially 0-degrees with respect to the Sagittal plane.

[0009] In another exemplary embodiment, the first hole is projected at an angle of substantially 0-degrees with respect to a Coronal plane, the second hole is projected at an angle of about 69.72-degrees with respect to the Coronal plane, the third hole is projected at an angle of substantially 0-degrees with respect to the Coronal plane, the fourth hole is projected at an angle of about 69.72-degrees with respect to the Coronal plane, the fifth hole is projected at an angle of about 84.68-degrees with respect to the Coronal plane, the sixth hole is projected at an angle of about 84.92-degress with respect to the Coronal plane, and the seventh hole is projected at an angle of about 80-degrees with respect to the Coronal plane. In another exemplary embodiment, the first hole and the second hole are both directed along a Transverse plane, the third hole is projected at an angle of about 80-degrees with respect to the Transverse plane, the fourth hole and the fifth hole are both projected at an angle of about 100-degrees with respect to the Transverse plane, the sixth hole is projected at an angle of about 110-degrees with respect to the Transverse plane, and the seventh hole is projected at an angle of about 90-degrees with respect to the Transverse plane.

[0010] In another exemplary embodiment, the midpoint of first hole is offset by about 3.50 ± 3mm from the end of the distal end, the midpoint of the second hole is offset from the midpoint of the first hole by about 6.63 ± 3mm, the midpoint of third hole is offset from the midpoint of the second hole by about 4.87 ± 2mm, the midpoint of the fourth hole is offset from the midpoint of the third hole by about 5.50 ± 2mm, the midpoint of the fifth hole is offset from the midpoint of the fourth hole by about 7.00 ± 3mm, the midpoint of the sixth hole is offset from the midpoint of the fifth hole by about 6.50 ± 3mm, and the midpoint of the seventh hole is offset from the midpoint of the sixth hole by about 8.00 ± 4mm. In another exemplary embodiment, the first hole is configured to receive a K-wire in an anterior-posterior direction. In another exemplary embodiment, the second hole and the fourth hole are configured to receive bone screws in a lateral to medial direction. In another exemplary embodiment, the third hole is configured to receive a bone screw in an anterior-posterior direction. In another exemplary embodiment, the fifth hole, the sixth hole, and the seventh hole are configured to receive bone screws or sutures in a lateral to medial direction.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -4-

[0011] These and other features of the concepts provided herein may be better understood with reference to the drawings, description, and appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The drawings refer to embodiments of the present disclosure in which:

[0013] Figure 1 is a diagram that illustrates various dividing planes and directed views relative to a human patient, according to the present disclosure;

[0014] Figure 1A is a perspective view of an exemplary embodiment of a fibular nail disposed in a right leg of the human patient shown in Fig. 1;

[0015] Figure 2 illustrates an isometric view of an exemplary embodiment of a fibular nail in accordance with the present disclosure;

[0016] Figure 3 illustrates a close-up view of an exemplary embodiment of fins comprising the fibular nail of Fig. 2 in a neutral configuration, according to the present disclosure;

[0017] Figure 4 illustrates a close-up view of an exemplary embodiment of fins comprising the fibular nail of Fig. 2 in an engaged configuration, in accordance with the present disclosure;

[0018] Figure 5 illustrates a table that includes dimensions of the fins in the neutral and engaged configurations shown respectively in Fig. 3 and Fig. 4, according to the present disclosure;

[0019] Figure 6 illustrates a perspective view of an exemplary embodiment of a fibular nail being implanted by way of an inserter, in accordance with the present disclosure;

[0020] Figure 7 illustrates fins of the fibular nail shown in Fig. 6 being deployed by way of a drive shaft, according to the present disclosure;

[0021] Figure 8 illustrates an exemplary-use environment wherein an extraction shaft is coupled with an exemplary embodiment of a fibular nail for ablating the fibular nail, in accordance with the present disclosure;

[0022] Figure 9 illustrates the exemplary -use environment of Fig. 8 wherein a drive shaft is inserted into the extraction shaft and the fibular nail, according to the present disclosure;

[0023] Figure 10 illustrates the exemplary-use environment of Fig. 9 wherein the drive shaft is rotated to collapse deployed fins for ablating the fibular nail, in accordance with the present disclosure;22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -5-

[0024] Figure 11 illustrates a lateral view and a front view of a first exemplary embodiment of a distal end of a fibular nail, showing a layout of holes disposed in the distal end, according to the present disclosure;

[0025] Figure 12 illustrates a lateral view and a front view of a second exemplary embodiment of a distal end of a fibular nail, showing a layout of holes disposed in the distal end, in accordance with the present disclosure;

[0026] Figure 13 illustrates a close-up lateral view and a close-up front view of the second exemplary embodiment of the distal end shown in Fig. 12, showing fastening angle projections of holes disposed in the distal end, according to the present disclosure;

[0027] Figure 14 illustrates a close-up dorsal view of the second exemplary embodiment of the distal end shown in Fig. 12, showing fastening angle projections of holes disposed in the distal end, in accordance with the present disclosure;

[0028] Figure 15 illustrates a close-up front view of the second exemplary embodiment of the distal end shown in Fig. 12, showing offset intervals between the holes disposed in the distal end, according to the present disclosure;

[0029] Figure 16 illustrates lateral and front views of several exemplary embodiments of the distal end shown in Fig. 11, in accordance with the present disclosure; Figure 19

[0030] Figure 17 illustrates lateral and front views of several exemplary embodiments of the distal end shown in Fig. 12, according to the present disclosure;

[0031] Figure 18 illustrates an isometric view of an exemplary embodiment of a fibular nail, in accordance with the present disclosure;

[0032] Figure 19 illustrates a ghost view of the exemplary embodiment of the fibular nail shown in Fig. 18, in accordance with the present disclosure;

[0033] Figure 20 illustrates a cross-sectional view of an exemplary embodiment of a fibular nail with fins of the fibular nail in a deployed configuration, according to the present disclosure;

[0034] Figure 21 illustrates a cross-sectional view of an exemplary embodiment of a fibular nail with fins of the fibular nail in a neutral configuration, in accordance with the present disclosure;22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -6-

[0035] Figure 22 illustrates a perspective view of an exemplary embodiment of a fibular nail being implanted by way of an inserter, according to the present disclosure;

[0036] Figure 23 illustrates fins of the fibular nail shown in Fig. 22 being deployed by way of a drive shaft, in accordance with the present disclosure;

[0037] Figure 24 illustrates an exemplary-use environment wherein an extraction shaft is coupled with an exemplary embodiment of a fibular nail for ablating the fibular nail, according to the present disclosure;

[0038] Figure 25 illustrates the exemplary -use environment of Fig. 24 wherein a drive shaft is inserted into the extraction shaft and the fibular nail, in accordance with the present disclosure;

[0039] Figure 26 illustrates the exemplary -use environment of Fig. 25 wherein the drive shaft is rotated to collapse deployed fins for ablating the fibular nail, according to the present disclosure;

[0040] Figure 27 illustrates a perspective view of an exemplary embodiment of an inserter configured for implanting the fibular nail into a fibula, in accordance with the present disclosure; and

[0041] Figure 28 illustrates an exemplary embodiment of a layout of guide holes disposed in jig comprising the inserter of Fig. 27, according to the present disclosure.

[0042] While the present disclosure is subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. The present disclosure should be understood to not be limited to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.DETAILED DESCRIPTION

[0043] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one of ordinary skill in the art that the fibular nail and methods disclosed herein may be practiced without these specific details. In other instances, specific numeric references such as “first bone screw,” may be made. However, the specific numeric reference should not be interpreted as a literal sequential order but rather interpreted that the “first bone22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -7- screw” is different than a “second bone screw.” Thus, the specific details set forth are merely exemplary. The specific details may be varied from and still be contemplated to be within the spirit and scope of the present disclosure. The term “coupled” is defined as meaning connected either directly to the component or indirectly to the component through another component. Further, as used herein, the terms “about,” “approximately,” or “substantially” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0044] In general, the present disclosure describes an apparatus and methods for a fibular nail for repairing fibular bone fractures. The fibular nail includes an elongated body having fins at a proximal end for anchoring within an intramedullary space of the fibula and a distal end for actuating the fins. The fibular nail is positioned to extend the distal end across the fracture. An actuator is used to deploy the fins to anchor the fibular nail within the intramedullary space. The distal end includes fixation holes for fastening the nail to surrounding bones. The fixation holes are strategically disposed along the distal end at angles and intervals that facilitate receiving bone screws and K-wires to stabilize the surrounding bones. Bone screws are inserted through the fixation holes into holes drilled in the surrounding bones to fasten the fibular nail across the fracture to fixate the portions of the fibula.

[0045] Figure 1 is a diagram that illustrates various dividing planes and directed views relative to a human patient 104, according to the present disclosure. As shown, the primary planes of concern include a Sagittal plane, a Coronal plane, and a Transverse plane. Lateral views are perpendicular to the Sagittal plane while front views are perpendicular to the Coronal plane. Further, dorsal views are directed downward and perpendicular to the Transverse plane.

[0046] Figure 1A is a perspective view of an exemplary embodiment of a fibular nail 100 disposed in a right leg of the human patient 104 shown in Fig. 1. The fibular nail 100 is inserted into the intramedullary space of a fibula bone 108. As described herein, a distal end 124 (see Fig. 2) of the fibular nail 100 extends across a fracture in the fibula, such that the bone portions of the fibula can be fixated by bone screws inserted through holes in the distal end 124.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -8-

[0047] Figure 2 illustrates an isometric view of an exemplary embodiment of a fibular nail 100 in accordance with the present disclosure. The fibular nail 100 includes an elongated body 112 having fins 116 at a proximal end 120 for anchoring within an intramedullary space of the fibula 108 and a distal end 124 for actuating the fins 116. The elongated body 112 is configured to receive a pushing insert 128 for changing the fins 116 between a neutral configuration 132 and a deployed configuration 136. As further shown in Fig. 2, the pushing insert 128 includes threads 140 that are configured to ensure that the pushing insert 128 does not migrate between the neutral and deployed configurations 132, 136.

[0048] Figure 3 illustrates a close-up view of an exemplary embodiment of fins 116 comprising the fibular nail 100 of Fig. 2 in the neutral configuration 132, according to the present disclosure. Figure 4 illustrates a close-up view of an exemplary embodiment of fins 116 comprising the fibular nail 100 of Fig. 2 in the engaged configuration 136, in accordance with the present disclosure. Figure 5 illustrates a table 144 that includes dimensions of the fins 116 in the neutral and engaged configurations 132, 136 shown respectively in Fig. 3 and Fig. 4, according to the present disclosure. In some embodiments, deploying the fins 116 increases the diameter of the proximal end 120 between about 34% to 36%, without limitation. Furthermore, in some embodiments, as shown in Fig. 5, deploying the fins 116 can increase the diameter of the proximal end 120 between about 108% and about 130%, without limitation.

[0049] Figure 6 illustrates a perspective view of an exemplary embodiment of a fibular nail 100 being implanted into a fibula 108 by way of an inserter 148, in accordance with the present disclosure. Once the fibular nail 100 is suitably implanted, a drive shaft 152 can be inserted through the inserter 148 to a distal end 142 (see Fig. 2) of the pushing insert 128 of the fibular nail 100. As shown in Fig. 7, the drive shaft 152 can be rotated in direction 156 to deploy the fins 116 within the intramedullary space of the fibula 108.

[0050] Figures 8 through 10 illustrate ablation of the fibular nail 100. As shown in Fig. 8, after extraction of all bone screws, an extraction shaft 160 can be coupled with the fibular nail 100 by rotating the extraction shaft 160 along direction 164. Next, as shown in Fig. 9, the drive shaft 152 can be inserted through the extraction shaft 160 and engaged with the distal end 142 (see Fig. 2) of the pushing insert 128. Rotating the drive shaft 152 in direction 168 collapses the fins 116 from the deployed configuration 132 (see Fig. 4) to the neutral configuration 136 (see Fig. 3). Once the fins 116 are in the neutral configuration 132, the fibular nail 100 can be removed from the fibula 108.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -9-

[0051] Figure 11 illustrates lateral and front views of a first exemplary embodiment of the distal end 124 of the fibular nail 100, showing a layout of holes disposed in the distal end 124, according to the present disclosure. As shown in Fig. 11, the holes are labeled A', A, B, C, D and E. In the illustrated embodiment, hole A' comprises a K-wire hole that is configured to receive a K-wire. Hole A' is oriented along an anterior-posterior direction. Holes A through E are fixation holes that are configured to receive fasteners such as bone screws.

[0052] Figure 12 illustrates lateral and front views of a secondary exemplary embodiment of the distal end 124 of the fibular nail 100, showing a layout of holes disposed in the distal end 124, according to the present disclosure. As shown in Fig. 12, the holes are labeled A', A, B, C, D, E, and F. In the illustrated embodiment, hole A' comprises a K-wire hole that is oriented along an anterior-posterior direction. Holes A through F are fixation holes that are configured to receive fasteners such as bone screws.

[0053] Figure 13 illustrates close-up lateral and front views of the second exemplary embodiment of the distal end 124 shown in Fig. 12, showing fastening angle projections of holes disposed in the distal end, according to the present disclosure. As shown in the lateral view, hole A' is projected at an angle of about 90-degrees in the Sagittal plane, and thus hole A' is oriented along an anterior-posterior direction, as mentioned above. Further, with respect to the Sagittal plane, hole A is projected at an angle of about 25.51 -degrees, hole B is projected at an angle of about 90-degrees, hole C is projected at an angle of about 25.51- degrees, hole D is projected at an angle of about 75.65-degrees, hole E is projected at an angle of about 116.74-degress, and hole F is projected at an angle of substantially 0- degrees.

[0054] With continuing reference to Fig. 13, taken with respect to the Coronal plane, hole A' is projected at an angle of substantially 0-degrees due to its alignment with the anterior- posterior direction. Hole A is projected at an angle of about 69.72-degrees, hole B is projected at an angle of substantially 0-degrees, hole C is projected at an angle of about 69.72-degrees, hole D is projected at an angle of about 84.68-degrees, hole E is projected at an angle of about 84.92-degress, and hole F is projected at an angle of about 80-degrees.

[0055] Figure 14 illustrates a close-up dorsal view of the second exemplary embodiment of the distal end 124 shown in Fig. 12, showing fastening angle projections of holes disposed in the distal end 124, in accordance with the present disclosure. In Fig. 14, the22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -10- angle projections of the holes are oriented with respect to the Transverse plane (i.e., the anterior-posterior direction). As shown in Fig. 14, hole A' and hole B are both directed along the anterior-posterior direction. Continuing, hole A is projected at an angle of about 80-degrees, both hole C and hole E are projected at an angle of about 100-degrees, hole D is projected at an angle of about 110-degrees, and hole F is projected at an angle of about 90-degrees.

[0056] Figure 15 illustrates a close-up front view of the distal end 124 of Fig. 12, showing offset intervals between the holes disposed in the distal end 124, according to the present disclosure. As shown in Fig. 15, the midpoint of hole A' is offset by about 3.50 ± 3mm from the end of the distal end 124. The midpoint of hole A is offset from the midpoint of hole A' by about 6.63 ± 3mm, while the midpoint of hole B is offset from the midpoint of hole A by about 4.87 ± 2mm. The midpoint of hole C is offset from the midpoint of hole B by about 5.50 ± 2mm, while the midpoint of hole D is offset from the midpoint of hole C by about 7.00 ± 3mm. Continuing, the midpoint of hole E is offset from the midpoint of hole D by about 6.50 ± 3mm, and the midpoint of hole F is offset from the midpoint of hole E by about 8.00 ± 4mm. As further shown in Fig. 15, table 172 exemplary specifications pertaining to holes A' through F, including, but not limited to, Fastening Method, Fastening Orientation, Other Specifications, and Alternative Solutions, without limitation.

[0057] Figure 16 illustrates lateral and front views of several exemplary embodiments of the distal end 124 shown in Fig. 11, in accordance with the present disclosure. In embodiment 176, holes A' and B are both aligned in the anterior-posterior direction. Embodiment 180 is similar to embodiment 176, with the exception that in embodiment 180, hole A is aligned with hole A' and hole B in the anterior-posterior direction. Embodiment 184 includes an additional hole A" that is disposed between hole A' and hole B. In embodiment 184, holes A", A', and B are all aligned in the anterior-posterior direction. Further, embodiment 188 is similar to embodiment 184, with the exception that in embodiment 188, hole A is aligned with holes A", A', and B, and all are aligned in the anterior-posterior direction.

[0058] Figure 17 illustrates lateral and front views of several exemplary embodiments of the distal end 124 shown in Fig. 12, according to the present disclosure. In embodiment 192, holes A' and B are both aligned in the anterior-posterior direction. Embodiment 196 is similar to embodiment 192, with the exception that in embodiment 196, hole A is aligned with hole A' and hole B in the anterior-posterior direction. Embodiment 200 includes an22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -11- additional hole A" that is disposed between hole A' and hole B. In embodiment 200, holes A", A', and B are all aligned in the anterior-posterior direction. Continuing, embodiment 204 is similar to embodiment 200, with the exception that in embodiment 204, hole A is aligned with holes A", A', and B, and all are aligned in the anterior-posterior direction.

[0059] Figure 18 illustrates an isometric view of an exemplary embodiment of a fibular nail 208, in accordance with the present disclosure. Figure 19 illustrates a ghost view of the fibular nail 208 shown in Fig. 18. The fibular nail 208 includes an elongated body 212 having fins 216 at a proximal end 220 for anchoring within the intramedullary space of the fibula 108 and a distal end 224 for actuating the fins 216. The elongated body 212 is configured to receive a pushing insert 228 for changing the fins 216 between a neutral configuration 232 (see Fig. 21) and a deployed configuration 236 (see Fig. 20). As will be appreciated, the fibular nail 208 of Figs. 18-19 is substantially similar to the fibular nail 100 shown in Fig. 2, with the exception that the fibular nail 208 comprises fins 216 and that include exterior teeth 222. The exterior teeth 222 are configured to grip the bone tissue comprising the fibula 108 and thus fixate the fibular nail 208 within the intramedullary space of the fibula 108. As further shown in Fig. 19, the pushing insert 228 includes threads 240 that are configured to ensure that the pushing insert 228 does not migrate between the neutral and deployed configurations 232, 236 unless the pushing insert 228 is rotated with respect to the fibular nail 208.

[0060] Figures 20-21 illustrate cross-sectional views of the fibular nail 208 with the fins 216 of the fibular nail 208 respectively in the deployed configuration 236 and the neutral configuration 232. The pushing insert 228 is configured to move the fins 216 between the neutral and deployed configurations 232, 236. The pushing insert 228 comprises an elongated member 244 that includes the threads 240 disposed at a proximal end 248 and a shaped opening 252 disposed at a distal end 256. The shaped opening 252 is configured to receive a drive shaft 260 (see Figs. 25-26) configured to enable rotating the pushing inert 228 with respect to the fibular nail 208. The threads 240 are configured to engage with similar threads inside the fibular nail 208 and cause the pushing insert 228 to move longitudinally with respect to the fibular nail 208. As shown in Fig. 20, the fins 216 expand into the deployed configuration 236 when the pushing insert 228 is moved to a proximal position relative to the fibular nail 208. As shown in Fig. 21, the fins 216 collapse into the neutral configuration 232 when the pushing insert 228 is moved to a distal position relative to the fibular nail 208. As mentioned above, the threads 240 ensure that the pushing insert22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -12-228 does not migrate between the neutral and deployed configurations 232, 236 unless the pushing insert 228 is rotated.

[0061] As mentioned herein, deploying the fins 216 increases the diameter of the proximal end 220 of the fibular nail 208. In some embodiments, deploying the fins 216 increases the diameter of the proximal end 220 between about 34% to about 36%, without limitation. However, in some embodiments, deploying the fins 216 can increase the diameter of the proximal end 220 between about 108% to about 130%, without limitation. As mentioned hereinabove, Fig. 5 illustrates a table that includes dimensions of the fins 216 in the engaged and neutral configurations 236, 232, shown respectively in Figs. 20-21.

[0062] As further shown in Figs. 20-21, threads 264 are disposed inside the distal end 224 of the fibular nail 208. The threads 264 are configured to engage with similar threads 268 comprising an extraction shaft 272 (see Figs. 24-26) for ablating the fibular nail 208 from the fibula 108. As shown in Fig. 24, the extraction shaft 272 can be coupled with the fibular nail 208 by threadably engaging and rotating the extraction shaft 272 in direction 296. As shown in Fig. 25, the drive shaft 260 can be inserted into the extraction shaft 272 and moved along direction 276 such that the extraction shaft 272 guides the drive shaft 260 to the distal end 256 of the pushing insert 228. Once the drive shaft 260 is engaged with the shaped opening 252 of the pushing insert 228, the drive shaft 260 can be rotated in direction 280 (see Fig. 26) to collapse the fins 216 from the deployed configuration 236 (see Fig. 20) to the neutral configuration 232 (see Fig. 21). Once the fins 216 are in the neutral configuration 232, the fibular nail 208 can be removed from the fibula 108.

[0063] Figure 22 illustrates a perspective view of an exemplary embodiment of a fibular nail 208 being implanted into a fibula 108 by way of an inserter 284, in accordance with the present disclosure. As best shown in Fig. 27, the inserter 284 includes protrusions 288 that are configured to engage with notches 292 (see Figs. 18-21) disposed at the distal end 224 of the fibular nail 208. Engaging the protrusions 288 and the notches 292 enables controlling the orientation of the fibular nail 208 within the fibula 108 by manipulating the inserter 284. Once the fibular nail 208 is suitably implanted, the drive shaft 260 can be inserted through the inserter 284 to the distal end 256 of the pushing insert 228 (see Figs. 20-21). As shown in Fig. 23, with the drive shaft 260 engaged with the shaped opening 252 of the pushing insert 228, as described herein, the drive shaft 260 can be rotated in direction 296 to deploy the fins 216 within the intramedullary space of the fibula 108.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -13-

[0064] Figures 27-28 illustrate an exemplary embodiment of an inserter 284 configured for implanting a fibular nail 208 into a fibula 108, as shown and described with respect to Figs. 22-23. The inserter 284 comprises a cylindrical portion 300 that is coupled with a guide portion 304 by way of an arc portion 308. As will be appreciated, the arc portion 308 is a generally rigid member that serves to fixate the cylindrical and guide portions 300, 304 with respect to each other.

[0065] The cylindrical portion 300 is generally configured to slide within an interior of a positioning jig 312 shown in Figs. 22-23. As shown in Figs. 27-28, the cylindrical portion 300 includes a central opening 316 that extends from a proximal end 320 to a distal end 324 of the cylindrical portion 300. The central opening 316 is configured to guide an insertion shaft 328 (see Figs. 22-23) to the distal end 224 of the fibular nail 208. The insertion shaft 328 is substantially similar to the extraction shaft 272 described in connection with Figs. 24-26. Like the extraction shaft 272, the insertion shaft 328 is configured to threadably engage with the threads 264 of the fibular nail 208 and to guide the drive shaft 260 to the shaped opening 252 of the pushing insert 228.

[0066] Moreover, the insertion shaft 328 serves to maintain engagement between protrusions 288 disposed at the proximal end 320 with notches 292 (see Figs. 18-21) disposed at the distal end 224 of the fibular nail 208. Engaging the protrusions 288 and the notches 292 enables controlling the orientation of the fibular nail 208 by manipulating the inserter 284 during implantation into the fibula 108. Once the fibular nail 208 is suitably implanted, the drive shaft 260 can be inserted through the insertion shaft 328 to the distal end 256 of the pushing insert 228 (see Figs. 20-21). As shown in Fig. 23, with the drive shaft 260 engaged with the shaped opening 252 of the pushing insert 228, as described herein, the drive shaft 260 can be rotated in direction 296 to deploy the fins 216 within the intramedullary space of the fibula 108.

[0067] As further shown in Figs. 27-28, the cylindrical portion 300 includes threads 332 disposed at the distal end 324. The threads 332 are configured to engage with similar internal threads comprising a knob 336, shown in Figs. 22-23. The threads 332 and the knob 336 enable adjusting the relative positions of the inserter 284 and the positioning jig 312 with respect to one another. As such, the positioning jig 312 can be moved with respect to the inserter 284 by turning the knob 336.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -14-

[0068] As best shown in Fig. 28, the guide portion 304 of the inserter 284 includes a variety of guide holes and a multiplicity of fastener sizing indicators 352. In the illustrated embodiment, the guide holes include holes 340 that are configured for 3.0 mm screws, holes 344 that are configured for 3.5 mm screws, and holes 348 that are configured for K- wire sleeves. It is contemplated that the holes 340 can include any number of holes configured to accommodate different types and sizes of fasteners, nails, K-wires, and the like, without limitation. In the illustrated embodiment, fastener types and sizes are identified with respect to the holes 340, 344, 348 by the fastener sizing indicators 352. In some embodiments, the fastener sizing indicators 352 can be images, symbols, and / or textual labels that are embossed or debossed into the guide portion 304, without limitation. In some embodiments, the fastener sizing indicators 352 can include different colors to differentiate the holes 340, 344, 348, without limitation.

[0069] While the fibular nail and methods have been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the fibular nail is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the fibular nail. Additionally, certain of the steps may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. To the extent there are variations of the fibular nail, which are within the spirit of the disclosure or equivalent to the fibular nail found in the claims, it is the intent that this patent will cover those variations as well. Therefore, the present disclosure is to be understood as not limited by the specific embodiments described herein, but only by scope of the appended claims.22882569.1 al0 / 08 / 25

Claims

Docket No. 102015.0112PCT -15-CLAIMSWhat is claimed is:

1. An apparatus for repairing a fibular bone fracture, comprising: an elongated body disposed between a proximal end and a distal end; one or more fins at the proximal end for engaging within an intramedullary space of the fibula bone; and a plurality of holes disposed along the distal end for stabilizing the fibular bone.

2. The apparatus of claim 1, the distal end is configured to be positioned across the fracture.

3. The apparatus of claim 1, the distal end is configured to be coupled with an actuator for deploying the one or more fins to anchor the elongated body within the intramedullary space.

4. The apparatus of claim 2, the elongated body is configured to receive a pushing insert for changing the one or more fins between a neutral configuration and a deployed configuration.

5. The apparatus of claim 3, the one or more fins are configured to increase the diameter of the proximal end between about 34% and about 130% in the deployed configuration.

6. The apparatus of claim 4, a distal end of the pushing insert is configured to receive a drive shaft that can be rotated to move the one or more fins between the neutral configuration and the deployed configuration.

7. The apparatus of claim 1, the plurality of holes includes one or more fixation holes for fastening the distal end to fibular bone portions.

8. The apparatus of claim 7, the fixation holes are disposed along the distal end at angles and intervals that facilitate receiving bone screws to stabilize the surrounding bones.22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -16-9. The apparatus of claim 8, fixation holes are configured to allow the bone screws to be inserted through the fixation holes into holes drilled in the surrounding bones to fasten the distal end across the fracture.

10. The apparatus of claim 7, the plurality of holes includes one or more holes for receiving K-wires.

11. The apparatus of claim 10, at least one of the plurality of holes is aligned with an anterior-posterior direction.

12. The apparatus of claim 7, the plurality of holes comprises a first hole, a second hole, a third hole, a fourth hole, a fifth hole, a sixth hole, and a seventh hole.

13. The apparatus of claim 12, the first hole is projected at an angle of about 90-degrees with respect to a Sagittal plane, the second hole is projected at an angle of about 25.51 -degrees with respect to the Sagittal plane, the third hole is projected at an angle of about 90-degrees with respect to the Sagittal plane, the fourth hole is projected at an angle of about 25.51 -degrees with respect to the Sagittal plane, the fifth hole is projected at an angle of about 75.65-degrees with respect to the Sagittal plane, the sixth hole is projected at an angle of about.74-degress with respect to the Sagittal plane, and the seventh hole is projected at an angle of substantially 0- degrees with respect to the Sagittal plane.

14. The apparatus of claim 12, the first hole is projected at an angle of substantially 0- degrees with respect to a Coronal plane, the second hole is projected at an angle of about 69.72-degrees with respect to the Coronal plane, the third hole is projected at an angle of substantially 0-degrees with respect to the Coronal plane, the fourth hole is projected at an angle of about 69.72-degrees with respect to the Coronal plane, the fifth hole is projected at an angle of about 84.68-degrees with respect to the Coronal plane, the sixth hole is projected at an angle of about 84.92-degress with respect to the Coronal plane, and the seventh hole is projected at an angle of about 80-degrees with respect to the Coronal plane.

15. The apparatus of claim 12, the first hole and the second hole are both directed along a Transverse plane, the third hole is projected at an angle of about 80-degrees with respect to the Transverse plane, the fourth hole and the fifth hole are both projected22882569.1 al0 / 08 / 25Docket No. 102015.0112PCT -17- at an angle of about 100-degrees with respect to the Transverse plane, the sixth hole is projected at an angle of about 110-degrees with respect to the Transverse plane, and the seventh hole is projected at an angle of about 90-degrees with respect to the Transverse plane.

16. The apparatus of claim 12, the midpoint of first hole is offset by about 3.50 ± 3mm from the end of the distal end, the midpoint of the second hole is offset from the midpoint of the first hole by about 6.63 ± 3mm, the midpoint of third hole is offset from the midpoint of the second hole by about 4.87 ± 2mm, the midpoint of the fourth hole is offset from the midpoint of the third hole by about 5.50 ± 2mm, the midpoint of the fifth hole is offset from the midpoint of the fourth hole by about 7.00 ± 3mm, the midpoint of the sixth hole is offset from the midpoint of the fifth hole by about 6.50 ± 3mm, and the midpoint of the seventh hole is offset from the midpoint of the sixth hole by about 8.00 ± 4mm.

17. The apparatus of claim 16, the first hole is configured to receive a K-wire in an anterior-posterior direction.

18. The apparatus of claim 16, the second hole and the fourth hole are configured to receive bone screws in a lateral to medial direction.

19. The apparatus of claim 16, the third hole is configured to receive a bone screw in an anterior-posterior direction.

20. The apparatus of claim 16, the fifth hole, the sixth hole, and the seventh hole are configured to receive bone screws or sutures in a lateral to medial direction.22882569.1 al0 / 08 / 25

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