Femoral nail with multiple Anti-rotation screw capabilities

Abstract

A femoral nail system comprises a femoral nail comprising an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween, a lag screw hole located in the proximal end section for receiving a lag screw and a first anti-rotation screw hole located in the proximal end section for receiving a first anti-rotation screw, and a lag screw configured to be inserted into the lag screw hole, the lag screw comprising a second anti-rotation screw hole for receiving a second anti-rotation screw, wherein the elongate body is configured to be inserted into an intramedullary canal of a femoral bone to stabilize a femoral fracture, and wherein the lag screw is configured to be inserted into the lag screw hole to intersect a femoral head of the femoral bone to stabilize a femoral head fracture.

Description

FEMORAL NAIL WITH MULTIPLE ANTI-ROTATION SCREW CAPABILITIESCLAIM OF PRIORITY

[0001] This patent application claims the benefit of U.S. Provisional Patent Application No. 63 / 645,660, filed May 10, 2024, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure is generally directed to, but not by way of limitation, systems, devices and methods for performing medical procedures, such as long bone fracture fixation procedures. More specifically, but not by way of limitation, the present disclosure is directed to intramedullary nails and associated fixation screws used to provide internal fixation of a long bone, such as a femur bone.BACKGROUND

[0003] Sometimes long bones of the human body, such as the femur, tibia and humerus, can become fractured due to trauma. It can be desirable to repair the long bone by setting, e.g., immobilizing, the fractured pieces of the bone to permit healing. One area of the body that presents challenges is the femur due to, for example, the presence of the femoral head being connected to the shaft by a narrower neck at an angle. Various known procedures for repairing a femoral fracture include open reduction and internal fixation. Such procedures can involve implanting various devices including prostheses, plates and nails to facilitate healing. In some instances, however, some fractures of the femur can be difficult to repair due to, for example, undesirable movement of the fragments relative to the main portion of the bone.

[0004] One manner of repairing proximal femoral fractures can include the use of an intramedullary nail. Intramedullary nails can be used to align and stabilize fractures of a femur by inserting the nail into the intramedullary canal of the femur to extend across one or more fracture lines of the femur. Fasteners, such as screws or other fixation devices, can be inserted into exterior cortical bone surfaces of the femur and through bores within the intramedullary nail to immobilize the intramedullary nail. Additionally, the same fasteners orother fasteners can be used to attach bone fragments to the intact portion of the bone. Thus, fasteners can be positioned to extend across opposite sides of the fracture to secure the opposing portions of the fractured femur together. In some configurations, the fasteners can be arranged to apply compression to the bone fragments to facilitate healing. However, it can be difficult to achieve satisfactory immobilization of the bone fragments with the fasteners that results in a desired healing process.

[0005] Examples of intramedullary nails are described in Pat. No. US 9,474,557 B2 to Schwammberger et al., titled “Intramedullary Nail”; Pat. No. US 9,072,552 B2 to Simon et al., titled “Intramedullary Nail and Implant System Comprising the Nail”; Pat. No. US 12,207,849 B2 to Harder et al., titled “Set Screw for Femoral Nail”; Pat. No. US 11,583,328 B2 to Daly et al., titled “Femoral Nail and Instrumentation System”; Pub. No. CN 113952013 A, titled “Proximal Femoral Intramedullary nail with Proximal Cross Nail”; Pat. No. US 9,662,156 B2 to Overes, titled “Femoral Neck Fracture Implant”; Pub. No. CN 209826929 U, titled “Proximal Femoral Compression Intramedullary Nail”; and Pat. No. US 10,463,416 B2 to Rossney et al., titled “Systems and Methods for Intramedullary Nail Implantation.”OVERVIEW

[0006] The present inventors have recognized, among other things, that problems to be solved in femoral intramedullary nails is the placement of fixation fasteners through the femoral nail to correct a fractured femoral head. For example, sometimes the femoral head can become fractured along the neck close to the greater and lesser trochanters, separating the head and neck from the shaft. A nail can be placed in the intramedullary canal and a fastener can be inserted through the nail to engage the head across the fracture line. However, sometimes the separated femoral head can rotate about the axis of the fastener during movement of the joint by the patient. The rotation of the femoral head can potentially inhibit or prevent proper healing.

[0007] The present subject matter can provide solutions to these and other problems, such as by providing a femoral intramedullary nail that includes multiple options for receiving fasteners to secure a fractured femoral head and neck to the trochanter portion of the bone. A lag screw can be inserted into the nail to engage with a central or middle portion of the fractured femoral head. Additionally, one or more anti-rotation screws can be inserted into the bone to prevent the fractured femoral head from rotating on the lag screw. For example, an anti-rotation screw can be placed through the lag screw at an angle to intersect a differentportion of the fractured femoral head. Additionally, or alternatively, an anti-rotation screw can be placed through the nail without intersecting the lag screw to intersect another portion of the fractured femoral head and neck. In examples, either one of these anti-rotation screws can be used separately or they can be used together. Thus, a surgeon can utilize judgement to select which, if any, anti-rotation screws to use based on the anatomy and the shape and location of the fracture of the femoral head. Furthermore, placement of the lag screw and anti-rotation screws can be adjusted superiorly or inferiorly relative to the femoral head via the adjusting the implantation depth of the femoral nail in the intramedullary canal. In additional examples, anti-rotation screws can be provided in different lengths to allow a surgeon to select how far the anti-rotation screw advances into the femoral head.

[0008] In an example, a femoral nail system can comprise a femoral nail comprising an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween, a lag screw hole located in the proximal end section for receiving a lag screw and a first anti-rotation screw hole located in the proximal end section for receiving a first anti-rotation screw, and a lag screw configured to be inserted into the lag screw hole, the lag screw comprising a second anti-rotation screw hole for receiving a second anti-rotation screw, wherein the elongate body is configured to be inserted into an intramedullary canal of a femoral bone to stabilize a femoral fracture, and wherein the lag screw is configured to be inserted into the lag screw hole to intersect a femoral head of the femoral bone to stabilize a femoral head fracture.

[0009] In an additional example, a femoral nail system can comprise a femoral nail comprising an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween, and a lag screw hole located in the proximal end section for receiving a lag screw, a lag screw configured to be inserted into the lag screw hole, the lag screw comprising an anti-rotation screw hole for receiving a second anti-rotation screw, an anti-rotation screw configured to be inserted into the anti-rotation screw hole in the lag screw, and an alignment guide configured to attach a lag screw driver and an anti-rotation screw insertion sheath such that the lag screw can be guided into the lag screw hole and the anti-rotation screw can be guided into the anti-rotation screw hole.

[0010] In another example, a method for assembling a lag screw and an anti-rotation screw with a femoral nail can comprise inserting a femoral nail into an intramedullary canal of a femur, the femoral nail comprising a lag screw bore configured to receive a lag screwhaving an anti -rotation screw bore, attaching an alignment jig to the femoral nail, inserting a lag screw guide sheath through an alignment bore in the alignment jig to provide a trajectory along an axis of the lag screw bore, connecting an alignment guide to a lag screw driver inserted in the lag screw guide sheath, attaching an anti-rotation screw guide sheath to the alignment guide to provide a trajectory along an axis of the anti -rotation screw bore.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1 is schematic view of an intramedullary nail with a lag screw inserted into a femoral bone having a fractured femoral neck.

[0012] FIG. 2 is a front schematic view of a proximal end of a femur having a femoral nail system of the present disclosure comprising a femoral nail, a lag screw, a diverging antirotation screw and a parallel anti-rotation screw.

[0013] FIG. 3 is a front view of the femoral nail system of the present disclosure configured to have the femoral nail with the lag screw inserted therein.

[0014] FIG. 4 is a front view of the femoral nail system of FIG. 3 with the femoral nail having the lag screw and the parallel anti-rotation screw inserted therein.

[0015] FIG. 5 is a front view of the femoral nail system of FIG. 3 with the femoral nail having the lag screw and the diverging anti-rotation screw inserted therein.

[0016] FIG. 6 is a front view of the femoral nail system of FIG. 3 with the femoral nail having the lag screw, the parallel anti-rotation screw and the diverging anti-rotation screw inserted therein.

[0017] FIG. 7A is a side view of a femoral nail of the present disclosure comprising a head section, a neck section and a shaft section.

[0018] FIG. 7B is a side view of the femoral nail of FIG. 7A showing proximal screw holes and distal screw holes.

[0019] FIG. 7C is a top view of the femoral nail of FIG. 7A and FIG. 7B showing a socket and slots for receiving a set screw.

[0020] FIG. 8 is a cross-sectional view of the femoral nail of FIG. 7B showing the proximal screw holes include a lag screw hole, a parallel anti-rotation screw hole and a set screw hole.

[0021] FIG. 9 is a front view of a lag screw of the present disclosure showing an exit for an anti -rotation screw hole.

[0022] FIG. 10 is a side view of the lag screw of FIG. 9 showing an entrance for the antirotation screw hole and a first slot.

[0023] FIG. 11 is a rear view of the lag screw of FIG. 9 showing the first slot and a second slot positioned on opposite sides of the entrance for the anti-rotation screw hole.

[0024] FIG. 12 is a cross-sectional view through the lag screw of FIG. 9 showing the entrance and the exit for the anti-rotation screw hole.

[0025] FIG. 13 is a side view of an anti -rotation screw of the present disclosure.

[0026] FIG. 14 is a cross-sectional view of the anti-rotation screw of FIG. 13.

[0027] FIG. 15 is a side view of a set screw of the present disclosure that can be attached to a femoral nail to immobilize a lag screw.

[0028] FIG. 16 is a top view a femoral nail of the present disclosure having the set screw of FIG. 15 assembled therewith.

[0029] FIG. 17 is a schematic diagram of the set screw of FIG. 15 positioned within a femoral nail to secure a lag screw with a parallel anti-rotation screw inserted through the set screw.

[0030] FIG. 18 is a cross-sectional view of the assembly of FIG. 17 showing the set screw engaging the lag screw.

[0031] FIG. 19A is a schematic diagram showing a lag screw located in a first position within a femoral nail of the present disclosure.

[0032] FIG. 19B is a schematic diagram showing the lag screw of FIG. 19B located in a second position within the femoral nail.

[0033] FIG. 20 is a schematic view of a targeting jig that can be attached to a femoral nail of the present disclosure to insert a lag screw and a diverging anti-rotation screw into the femoral nail using an anti-rotation screw targeting wedge placed proximate the femoral bone.

[0034] FIG. 21 is a schematic view of an anti -rotation screw targeting arm of the present disclosure that can be used to place a diverging anti-rotation screw through a lag screw assembled with a femoral nail.

[0035] FIG. 22 is a schematic view of the anti -rotation screw targeting arm of FIG. 21 being used in conjunction with a targeting jig.DETAILED DESCRIPTION

[0036] FIG. 1 is a schematic side view of femur 100 comprising shaft 102, neck 104, and head 106. As shown, neck 104 of femur 100 can have fracture 108 wherein head 106 is separated from neck 104. Intramedullary nail 110 can be inserted into femur 100 to treat fracture 108. Intramedullary nail 110 can extend into shaft 102 of femur 100. Intramedullary nail 110 can include transverse bore 112 extending along axis Al. Transverse bore 112 can be configured to receive lag screw 114. Lag screw 114 can extend through intramedullary nail 110 and into head 106. Thus, lag screw 114 can extend across fracture 108. Lag screw 114 has an outer diameter that is slightly smaller than the diameter of transverse bore 112. This allows lag screw 114 to pass through transverse bore 112 and reduce fracture 108.

[0037] In some scenarios, it is possible for head 106 to undesirably rotate about axis AL For example, lag screw 114 can be freely rotatable within transverse bore 112. Flexing of the hip joint including femur 100 by the patient, e.g., by walking, can place rotational forces on head 106, which can cause rotation of lag screw 114 in transverse bore 112. Thus, head 106 can rotate along fracture 108 relative to greater trochanter region 120 and lesser trochanter region 122. Movement of head 106 along fracture 108 can prevent the formation of bone cells across fracture 108 that heal the fracture. With the present disclosure, a femoral nail system can include a femoral nail, a lag screw and a set screw to fix the rotational position of the lag screw relative to the femoral nail, while still optionally allowing the lag screw to be positioned along axis AL Furthermore, the present disclosure provides for a femoral nail system that includes multiple anti-rotation screw options that can be placed through either or both the intramedullary nail and the lag screw to prevent rotation of head 106 by providing on or more additional anchor points spaced radially from axis AL Thus, a surgeon can choose the most appropriate configuration of the femoral nail system based on the specific location and shape of fracture 108.

[0038] FIG. 2 is a front schematic view of a proximal end of femur 200 having femoral nail 202 implanted therein along with lag screw 204 and two anti-rotation (AR) screws, e.g., diverging AR screw 206 and parallel AR screw 208. Femoral nail 202, lag screw 204, diverging AR screw 206 and parallel AR screw 208 can comprise femoral nail system 201.

[0039] Femoral nail 202 can comprise head section 210, neck section 211, stem section 212 and cap section 214. Head section 210, neck section 211 and stem section 212 can comprise a proximal end section, an intermediate section, and a distal end section,respectively. Lag screw 204 can comprise shaft 216, head 218, neck 220 and end portion 222. Diverging AR screw 206 can comprise shaft 224, head 226, neck 228 and end portion 230. Parallel AR screw 208 can comprise shaft 232, head 234, neck 236 and end portion 238.

[0040] Femoral nail 202 can be inserted into femur 200 and one or more of lag screw 204, diverging AR screw 206 and parallel AR screw 208 can be attached to femoral nail 202 to fixate one or more fragments of head 240 relative to shaft 241. For example, head 240 can be broken along fracture 242 so that head 240 is separated from shaft 241. As such, a surgeon can select which of lag screw 204, diverging AR screw 206 and parallel AR screw 208 to implant into femur 200 to treat the fragmentation thereof. For example, based on the location of fracture 242 to the greater and lesser trochanters and the angle of fracture 242 relative to shaft 241, a surgeon can decide that neither of (FIG. 3), one of (FIG. 4 and FIG. 5) or both of (FIG. 6) diverging AR screw 206 and parallel AR screw 208 would be beneficial in healing of fracture 242.

[0041] FIG. 3 is a front view of femoral nail system 201 of the present disclosure comprising femoral nail 202 with lag screw 204 inserted therein. FIG. 3 illustrates a configuration of femoral nail system 201 suitable for use when a surgeon determines that rotation of head 240 can be prevented by the use of set screw 350 (FIG. 15) without the use of a separate anti-rotation screw. For example, a surgeon can determine that fracture 242 is positioned or shaped such that it is not likely that flexure of the hip joint will apply forces to head 240 that cause rotation of head 240 greater than what can be overcome by lag screw 204 and the set screw. However, the configuration of FIG. 3 can be used in other situations.

[0042] FIG. 4 is a front view of femoral nail system 201 of FIG. 3 with femoral nail 202 having lag screw 204 and parallel AR screw 208 inserted therein. FIG. 4 illustrates a configuration of femoral nail system 201 suitable for use when a surgeon determines that rotation of head 240 can be prevented by the use of set screw 350 (FIG. 15) with the use of an additional anti-rotation screw. For example, a surgeon can determine that fracture 242 is positioned or shaped such that it is not likely that flexure of the hip joint will apply forces to head 240 that cause rotation of head 240 greater than what can be overcome by lag screw 204, the set screw and parallel AR screw 208. A surgeon can determine that, based on the position and shape of fracture 242, head 240 has available bone matter on the superior side of head 240 such that parallel AR screw 208 can be used. However, the configuration of FIG. 4 can be used in other situations.

[0043] FIG. 5 is a front view of femoral nail system 201 of FIG. 3 with femoral nail 202 having lag screw 204 and diverging AR screw 206 inserted therein. FIG. 5 illustrates a configuration of femoral nail system 201 suitable for use when a surgeon determines that rotation of head 240 can be prevented by the use of set screw 350 (FIG. 15) with the use of an additional anti-rotation screw. For example, a surgeon can determine that fracture 242 is positioned or shaped such that it is not likely that flexure of the hip joint will apply forces to head 240 that cause rotation of head 240 greater than what can be overcome by lag screw 204, the set screw and diverging AR screw 206. A surgeon can determine that, based on the position and shape of fracture 242, head 240 has available bone matter on the inferior side of head 240 such that diverging AR screw 206 can be used. However, the configuration of FIG. 5 can be used in other situations.

[0044] FIG. 6 is a front view of femoral nail system 201 of FIG. 3 with femoral nail 202 having lag screw 204, parallel AR screw 208 and diverging AR screw 206 inserted therein. FIG. 6 illustrates a configuration of femoral nail system 201 suitable for use when a surgeon determines that rotation of head 240 can be prevented by the use of set screw 350 (FIG. 15) with the use of two additional anti -rotation screws. For example, a surgeon can determine that fracture 242 is positioned or shaped such that it is not likely that flexure of the hip joint will apply forces to head 240 that cause rotation of head 240 greater than what can be overcome by lag screw 204, the set screw, diverging AR screw 206 and parallel AR screw 208. A surgeon can determine that, based on the position and shape of fracture 242, head 240 has available bone matter on the superior side and the inferior side of head 240 such that parallel AR screw 208 and diverging AR screw 206 can be used. However, the configuration of FIG. 6 can be used in other situations.

[0045] FIG. 7A is a side view of femoral nail 202 of the present disclosure comprising head section 210, neck section 211, stem section 212 and cap section 214. FIG. 7B is a side view of femoral nail 202 of FIG. 7A showing proximal screw holes 250 and distal screw holes 252. FIG. 7C is a top view of femoral nail 202 of FIG. 7A and FIG. 7B showing socket 260, first slot 272A and second slot 272B for receiving set screw 350 (FIG. 15). FIG. 8 is a cross-sectional view of femoral nail 202 of FIG. 7B showing proximal screw holes 250 including lag screw hole 254 and parallel anti-rotation hole 256. FIG. 7A, FIG. 7B, FIG. 7C and FIG. 8 are discussed concurrently.

[0046] Proximal screw holes 250 can comprise lag screw hole 254 and parallel antirotation hole 256. Distal screw holes 252 can comprise first screw hole 258A, second screwhole 258B and third screw hole 258C. Cap section 214 can comprise socket 260, notch 262 and threading 264. Head section 210 can extend along axis AA. Neck section 211 can comprise a tapered section extending from head section 210 along axis AA. Stem section 212 can extend from neck section 211 at an angle relative to axis A A along axis AB. In examples, axis AB can be angled relative to axis AA at angle al in the range of approximately two degrees to approximately six degrees. In an example, angle al can be approximately 4 degrees. However, other angles can be used. A distal end portion of stem section 212 can include distal screw holes 252. Distal screw holes 252 can be configured to receive fixation features, e.g., threaded fasteners, that can extend through stem section 212 and affix to bone matter. As shown in FIG. 7A, femoral nail 202 can have length LL. Lenth LL can extend from the proximal -most end of head section 210 to the distal -most end of stem section 212. In examples, length LL can be configured so that femoral nail 202 has short lengths, intermediate lengths and long lengths. In examples, short intramedullary nails can be used so that distal screw holes are located proximate the diaphysis region of the femur and long intramedullary nails can be used so that distal screw holes 252 are placed proximate the metaphysis region of the femur. Long intramedullary nails can include curvature to conform with curvature of a natural femur bone. As mentioned, distal screw holes 252 can be used to receive fasteners to affix femoral nail 202 to bone. Second screw hole 258B can extend in the anterior-posterior (A-P) direction. In examples, second screw hole 258B can be useful on short intramedullary nails so that femoral nail 202 can receive a fastener without interfering with other hardware that might be implanted on the femoral bone. For example, a laterally placed plate, e.g., a plate attached to exterior surfaces of the femoral bone on the lateral side, can be installed without interference from a fastener extending through second screw hole 258B.

[0047] Femoral nail 202 can comprise an internal lumen, e.g., passage 270 (FIG. 8), that extends from socket 260 to distal opening 266. Socket 260 can comprise one or more of notch 262 and threading 264 to facilitate coupling to an alignment guide or aiming device, a jig or the like. Furthermore, threading 264 can be used to receive a fastener, e.g., set screw 350 of FIG. 15, to secure lag screw 204 (FIG. 2) to femoral nail 202.

[0048] Lag screw hole 254 can comprise a hole or bore extending through head section 210 from one side to the other along axis BB of FIG. 8. In examples, lag screw hole 254 can be circular to receive lag screw 204. Lag screw hole 254 can include cut-back 255 at an entrance to accommodate diverging AR screw 206 and head 218. Lag screw hole 254 canform exit 257 in femoral nail 202. In examples, lag screw hole 254 can have a diameter in the range of approximately ten millimeters to approximately twelve millimeters. In examples, lag screw hole 254 can have a diameter of approximately eleven millimeters. However, other diameters can be used. Lag screw hole 254 can include cut-back 254A and cut-back 254B to provide clearance for diverging AR screw 206.

[0049] Parallel anti-rotation hole 256 can comprise a hole or bore extending through head section 210 from one side to the other along axis CC of FIG. 8. In examples, parallel antirotation hole 256 can be circular to accommodate parallel AR screw 208. In examples, parallel anti-rotation hole 256 can be cylindrical along its entire length. In examples, parallel anti-rotation hole 256 can have a diameter in the range of approximately four millimeters to approximately six millimeters. In examples, parallel anti-rotation hole 256 can have a diameter of approximately five millimeters. However, other diameters can be used.

[0050] Lag screw hole 254 can be positioned distance DI from the proximal -most surface of head section 210. That is, axis BB can be positioned distance DI from the exposed end of head section 210. In examples, distance DI can be in the range of approximately 34.5 millimeters to approximately 42.5 millimeters. In examples, distance DI can be approximately forty millimeters. However, other distances can be used.

[0051] Parallel anti-rotation hole 256 can be positioned superiorly of lag screw hole 254. Parallel anti-rotation hole 256 can be positioned distance D2 from the proximal-most surface of head section 210. That is, axis CC can be positioned distance D2 from the exposed end of head section 210. In examples, distance D2 can be in the range of approximately 24.25 millimeters to approximately 30.25 millimeters. In examples, distance D2 can be approximately 27.25 millimeters. However, other distances can be used.

[0052] Head section 210 can extend along axis AA. Socket 260 can extend into the distal-most or exposed end of head section 210. Socket 260 can connect to passage 270 within head section 210. Passage 270 can include first slot 272A and second slot 272B. Lag screw hole 254 can extend along axis BB. Parallel anti-rotation hole 256 can extend along axis CC. In examples, axis BB and axis CC can be parallel. In examples, axis BB and axis CC can be within approximately five degrees of parallel. Lag screw hole 254 and parallel anti-rotation hole 256 can be angled relative to axis AA. In examples, the angles a2 of axis BB and axis CC can be in the range of approximately one-hundred-ten degrees to approximately one-hundred-thirty degrees. In examples, angle a2 can be approximately one- hundred-twenty-one degrees. However, other angles can be used.

[0053] FIG. 9 is a front view of lag screw 204 of the present disclosure showing antirotation screw hole 280 having exit 282. FIG. 10 is a side view of lag screw 204 of FIG. 9 showing first slot 284A and entrance 286 for anti-rotation screw hole 280. FIG. 11 is a rear view of lag screw 204 of FIG. 9 showing first slot 284 A and second slot 284B positioned on opposite sides of entrance 286 for anti-rotation screw hole 280. FIG. 12 is a cross-sectional view through lag screw 204 of FIG. 11 showing entrance 286 and exit 282 for anti -rotation screw hole 280.

[0054] As discussed, lag screw 204 can comprise shaft 216, head 218, neck 220 and end portion 222. Lag screw 204 can additionally include central passage 288 (FIG. 12), which can be connected to socket 290 and can extend through end portion 222. End portion 222 can comprise threading configured to engage with bone matter. Additionally, central passage 288 can include threading 292 and anti-rotation screw hole 280 can include threading 294.Central passage 288 can extend along axis DD. Anti-rotation screw hole 280 can extend along axis EE (FIG. 12). Axis DD of central passage 288 can extend along the center of lag screw 204. Axis EE of anti-rotation screw hole 280 can be angled relative to axis DD. In examples, angle a3 of axis EE can be in the range of approximately eleven degrees to approximately seventeen degrees. In examples, angle a3 can be approximately 14.25 degrees. However, other angles can be used.

[0055] Central passage 288 can be configured to receive a guide wire or pin to facilitate advancement of lag screw 204 into anatomy. Socket 290 and threading 292 can be configured to receive a tool or instrumentation for implantation of lag screw 204 into bone matter. For example, a manual or powered rotational drive instrument can be attached to socket 290 and threading 292. Lag screw 204 can have length LI. In examples length LI can be in the range of approximately sixty-five millimeters to approximately one-hundred- thirty -five millimeters. In examples, length LI can be approximately ninety -five millimeters. However, other lengths can be used.

[0056] Anti-rotation screw hole 280 can be configured to receive diverging AR screw 206 (FIG. 2). Threading 294 can be configured to engage with threading of diverging AR screw 206, as shown in FIG. 17. Beyond threading 294, anti -rotation screw hole 280 can comprise a cylindrical passage.

[0057] First slot 284A and second slot 284B (FIG 11) can extend along the exterior of shaft 216. In examples, first slot 284A and second slot 284B can extend parallel to axis DD. First slot 284A and second slot 284B can be positioned on opposite sides of entrance 286 andexit 282. First slot 284A and second slot 284B can have first ends disposed proximate to entrance 286 and second ends disposed proximate to exit 282. As discussed with reference to FIG. 15 through FIG. 18, first slot 284A and second slot 284B can be configured to engage with first end 368A and second end 368B of set screw 350.

[0058] FIG. 13 is a side view of anti-rotation screw 300 of the present disclosure. FIG. 14 is a cross-sectional view of anti-rotation screw 300 of FIG. 13. FIG. 13 and FIG. 14 are discussed concurrently. Anti-rotation screw 300 can comprise shaft 302, head 304, neck 306 and end portion 308. Anti -rotation screw 300 can be configured for use as diverging AR screw 206 and / or parallel AR screw 208 of the present disclosure. Thus, shaft 302 can comprise shaft 224 and shaft 232, head 304 can comprise head 226 and head 234, neck 306 can comprise neck 228 and neck 236, and end portion 308 can comprise end portion 230 and end portion 238.

[0059] Head 304 can comprise socket 310 including internal threading 312. Head 304 can additionally include external threading 314. External threading 314 can be configured for engaging with threading of lag screw 204 or with bone matter.

[0060] Shaft 302 can be configured for insertion into anti -rotation screw hole 280 and parallel anti-rotation hole 256. For example, end portion 308 can be inserted into and through anti-rotation screw hole 280 so that shaft 302 engages with anti-rotation screw hole 280. External threading 314 can be configured to mate with threading 294 (FIG. 12). End portion 308 can include threading configured to engage with bone matter. In examples, the threading of end portion 308 can extend onto shaft 302 all the way up to head 304 or to an intermediate location between head 304 and end portion 308.

[0061] Shaft 302 can be of solid construction. For example, shaft 302 can be configured to not have an internal lumen. Anti-rotation screw 300 can have length L2. In examples length L2 can be in the range of approximately twenty -five millimeters to approximately one- hundred-fifteen millimeters. In examples, length L2 can be approximately sixty millimeters. However, other lengths can be used.

[0062] A set of anti -rotation screws can be provided with femoral nail system 201 having instances anti -rotation screw 300 of different lengths. In examples, anti -rotation screws can be provided in five-millimeter increments. As such, a surgeon can determine and select a particular length of anti -rotation screw 300 for use in one or both of anti -rotation screw hole 280 and parallel anti-rotation hole 256 based on the particular anatomy, e.g., fracture pattern, of a patient.

[0063] FIG. 15 is a side view of set screw 350 for securing lag screw 204 of FIG. 9 to femoral nail 202 of FIG. 7A and FIG. 7B. Set screw 350 can comprise fastener 352 and bushing 354. Fastener 352 can comprise threaded portion 356, neck 358 and rim 360. Bushing 354 can comprise body 362, first rail 364A, second rail 364B and screw passage 366. First rail 364A can include first end 368A and second rail 364B can include second end 368B. Body 362 can comprise socket 370, which can comprise base 372 and overhang 374.

[0064] Body 362 can be generally cylindrical in shape and configured to fit within socket 260 (FIG. 7C) of femoral nail 202. First rail 364A and second rail 364B can extend from the perimeter of body 362 and can comprise protrusions configured to slide within first slot 272A and second slot 272B (FIG. 7C) of femoral nail 202. First end 368A and second end 368B can protrude beyond the bottom or distal end of body 362. Screw passage 366 can comprise an oblong slot that is sized to receive an anti-rotation screw. Screw passage 366 can be elongated in the direction of axis GG to allow for an anti-rotation screw inserted therein to be uncoupled from downward force of set screw 350 onto lag screw 204.

[0065] Fastener 352 can be rotatably assembled with bushing 354 along axis GG so that relative rotation can be imparted therebetween. For example, rim 360 can be slid radially into base 372 between first rail 364 A and second rail 364B. Neck 358 can be positioned adjacent to overhang 374. Thus, when assembled, fastener 352 cannot be axially displaced from bushing 354, but rim 360 is permitted to rotate alongside overhang 374.

[0066] FIG. 16 is a top view femoral nail 202 of the present disclosure having set screw 350 of FIG. 15 assembled therewith. Bushing 354 can be inserted into socket 260 of femoral nail 202. Bushing 354 can be aligned so that first rail 364A aligns with first slot 372A and second rail 364B aligns with second slot 372B. Bushing 354 can be advanced axially into socket 260 so that threaded portion 356 of fastener 352 engages with threading 264 of femoral nail 202 (FIG. 8). When set screw 350 is assembled with femoral nail 202 inside socket 260, fastener 352 cannot be radially displaced from bushing 354 out of base 372. However, rotation of fastener 352 can be achieved without bushing 354 rotating. Thus, fastener 352 can be rotated to advance bushing 354 into socket 260 to engage lag screw 204.

[0067] FIG. 17 is a schematic diagram of set screw 350 of FIG. 15 positioned within femoral nail 202 to secure lag screw 204 with parallel AR screw 208 inserted through set screw 350. FIG. 18 is a cross-sectional view of the assembly of FIG. 17 showing set screw 350 engaging lag screw 204. FIG. 17 and FIG. 18 are discussed concurrently.

[0068] To assemble femoral nail system 201, set screw 350 can be positioned in socket 260. Bushing 354 can be inserted into socket 260 and threaded portion 356 of fastener 352 can be engaged with threading 264 of socket 260. Fastener 352 can be rotated for positioning of bushing 354 spaced from, e.g., above, lag screw 204.

[0069] Lag screw 204 can be inserted into lag screw hole 254 of femoral nail 202. As discussed, an instrument or tool can be attached to socket 290 and threading 292 to facilitate rotation of lag screw 204 and driving of threading of end portion 222 through bone matter. Lag screw 204 can be advanced so that first slot 284A and second slot 284B are aligned with socket 260 (FIG. 7C). Lag screw 204 can be rotated to position first slot 284A and second slot 284B upward to face toward set screw 350.

[0070] Diverging AR screw 206, e.g., an instance of anti-rotation screw 300, can be inserted into anti-rotation screw hole 280 within lag screw 204. End portion 308 can be inserted into entrance 286 and pushed out of exit 282 so that shaft 302 is positioned within anti-rotation screw hole 280. External threading 314 (FIG. 14) of anti-rotation screw 300 can be engaged with threading 294 (FIG. 11) of lag screw 204.

[0071] Set screw 350 can be advanced within socket 260 to push bushing 354 into engagement with lag screw 204. Fastener 352 can be rotated to push bushing 354 downward. Bushing 354 can be advanced so that first end 368 A of first rail 364 A engages first slot 284 A and second end 368B of second rail 364B engages second slot 284B. in examples, first end 368 A and second end 368B can be advanced to not bottom out on first slot 284 A and second slot 284B. Thus, set screw 350 can prevent rotation of lag screw 204 on axis BB (FIG. 8), but lag screw 204 can slide axially along axis BB. Some surgeons can choose to leave lag screw 204 axially unbound. However, some surgeons can choose to advance set screw 350 so that first end 368A and second end 368B bottom out, e.g., engage with forceful contact, in first slot 284A and second slot 284B to axially bind lag screw 204 and prevent axially movement thereof.

[0072] Parallel AR screw 208, e.g., an instance of anti-rotation screw 300, can be inserted into parallel anti-rotation hole 256 to extend into and through screw passage 366 of set screw 350. As mentioned, screw passage 366 can be oblong in the direction of axis AA (FIG. 7A) so that set screw 350 can be moved into different positions relative to parallel AR screw 208 without screw passage 366 making downward contact on parallel AR screw 208. Thus, parallel AR screw 208 can be allowed to interact with bone matter without influence from set screw 350.

[0073] FIG. 19A is a schematic diagram showing lag screw 204 located in a first position within femoral nail 202 of the present disclosure. FIG. 19B is a schematic diagram showing lag screw 204 of FIG. 19B located in a second position within femoral nail 202. FIG. 19A and FIG. 19B are discussed concurrently.

[0074] Lag screw 204 can be inserted into femoral nail 202 at lag screw hole 254 and can penetrate therefrom at exit 257. Diverging AR screw 206 can be inserted into lag screw 204 at anti-rotation screw hole 280 and can penetrate therefrom at exit 282.

[0075] In the configuration of FIG. 19 A, lag screw 204 can be positioned within femoral nail 202 such that exit 257 and exit 282 are aligned such that a distance therebetween is approximately zero. FIG. 19A shows lag screw 204 in a laterally advanced position where lag screw 204 and diverging AR screw 206 make less penetration into bone matter.

[0076] In the configuration of FIG. 19B, lag screw 204 can be positioned within femoral nail 202 such that exit 282 is displaced further away from exit 257 such that distance D3 is approximately ten millimeters. FIG. 19B shows lag screw 204 in a medially advanced position where lag screw 204 and diverging AR screw 206 make more penetration into bone matter. Head 218 of lag screw 204 and head 226 of diverging AR screw 206 can be received in cut-back 255, which can allow for full medial advancement thereof. In either position, and positions therebetween, the intersection of the axis of diverging AR screw 206 and the axis of lag screw 204 can be positioned within the outer perimeter of head section 210 of lag screw 204. Thus, diverging AR screw 206 can diverge away from lag screw 204.

[0077] A surgeon can determine the medial -lateral position of lag screw 204 and diverging AR screw 206 so that such fasteners cross a fragment of a femoral head. Likewise, the lengths of lag screw 204 and diverging AR screw 206 can be selected so that the relative lateral position between end portion 222 and end portion 230 can be adjusted.

[0078] FIG. 20 is a schematic view of targeting jig 400 that can be attached to femoral nail 202 of the present disclosure to insert lag screw 204 and diverging anti-rotation screw 206 into femoral nail 202 using anti-rotation screw targeting wedge 402 placed proximate femur 200 to target diverging anti-rotation screw 206 position and orientation based on the position and orientation of lag screw 204. Targeting jig 400 can comprise body 404, coupler 406, lag screw bore 408 and AR screw bore 410. Targeting jig 400 can be used with lag screw sheath 412, lag screw driver 414, lag screw coupler 415 AR screw sheath 416 and AR screw driver 418. Lag screw driver 414 can have shaft 420. Anti-rotation screw targeting wedge 402 can comprise body 422 having first portion 424 for coupling with lag screwsheath 412 and second portion 426 for coupling with AR screw sheath 416. Lag screw coupler 415 can be used to attach and detach lag screw 204 to lag screw driver 414.

[0079] Targeting jig 400 can be attached to cap section 214 of femoral nail 202 using coupler 406. Coupler 406 can be inserted into socket 260. A force fit can be used to maintain axial connection between targeting jig 400 and femoral nail 202. Protrusions can be inserted into notches 262 to allow rotational force to be transferred therebetween. However, additional or other coupling mechanisms can be used. Additionally, the protrusions and notches 262 can be used to clock the position of body 404 relative to the holes in femoral nail 202 to position screw bore 408 to generally align with lag screw hole 254 and screw bore 410 to generally align with anti-rotation screw hole 280.

[0080] Screw bore 408 can comprise a hole that is approximately as wide and tall as lag screw sheath 412. Screw bore 408 can be configured to orient lag screw sheath 412 along axis BB (FIG. 8). Thus, when shaft 420 of lag screw driver 414 is inserted into lag screw sheath 412, screw bore 408 can guide lag screw driver 414 along axis BB to intersect lag screw hole 254, particularly in an anterior-posterior alignment.

[0081] Screw bore 410 can comprise an oblong slot that is approximately as wide as AR screw sheath 416 but that is taller than AR screw sheath 416. Screw bore 410 can be configured to orient AR screw sheath 416 along axis EE (FIG. 8). Thus, when the shaft of AR screw driver 418 is inserted into AR screw sheath 416, screw bore 4410 can guide AR screw driver 418 along axis EE to intersect anti -rotation screw hole 280, particularly in an anterior-posterior alignment.

[0082] Because screw bore 410 is taller than AR screw sheath 416 and the present invention herein allows variable positioning of diverging AR screw 206 based on axial positioning of lag screw 204 along axis BB, a surgeon can adjust the superior-inferior position of diverging AR screw 206 for desired fit within the femoral head and neck. As such, anti-rotation screw targeting wedge 402 can be used to ensure lag screw 204 and diverging AR screw 206 are aligned, particularly in the superior-inferior direction. Antirotation screw targeting wedge 402 can be attached to lag screw driver 414 and AR screw sheath 416 to attach said components at the proper angle therebetween. In particular, antirotation screw targeting wedge 402 can align AR screw sheath 416 along axis EE based on position of lag screw driver 414 along axis BB to ensure diverging AR screw 206 and lag screw 204 intersect within femoral nail 202 as shown in FIG. 8. First portion 424 and second portion 426 can comprise fastening means to attach lag screw driver 414 and AR screwsheath 416 to body 422. In examples, first portion 424 and second portion 426 can comprise clamps or brackets.

[0083] FIG. 21 is a schematic view of anti -rotation screw targeting arm 450 of the present disclosure that can be used to place diverging anti-rotation screw 206 through lag screw 204 assembled with femoral nail 202. FIG. 22 is a schematic view of anti-rotation screw targeting arm 450 of FIG. 21 being used in conjunction with targeting jig 400. Anti-rotation screw targeting arm 450 can comprise body 452, AR sleeve guide 454 having bore 456, coupler 458 with slot 460, and fastener 462. Shaft 420 of lag screw driver 414 can comprise flat 464 and bore 466. Anti-rotation screw targeting arm 450 can be configured to align lag screw driver 414 and AR screw sheath 416 similarly to anti -rotation screw targeting wedge 402. However anti-rotation screw targeting arm 450 can be placed outside of targeting jig 400 rather than between femoral nail 202 and targeting jig 400. Coupler 458 can comprise slot 460 configured to receive flat 464 of shaft 420. Slot 460 and flat 464 can have planar surfaces configured to mate flush so that anti-rotation screw targeting arm 450 and lag screw driver 414 can be coupled in only one relative orientation thereby ensuring that lag screw driver 414 and AR screw sheath 416 align along axis BB and axis EE as described herein. A shaft of fastener 462 can be inserted into bore 466 in a threaded engagement to allow fastener 462 to immobilize anti-rotation screw targeting arm 450 relative to lag screw driver 414.

[0084] The present disclosure describes femoral intramedullary nail systems designed to treat femoral fractures, particularly those involving a fractured femoral neck. The femoral intramedullary nail system of the present disclosure can comprise a femoral nail with multiple screw holes, including a main lag screw hole for securing the femoral head and one or more anti-rotation screw holes. In examples, an anti-rotation screw hole can be positioned superiorly of the lag screw hole, though inferior placement can also be used. In examples, an anti-rotation screw hole can be aligned parallel to the lag screw hole, though non-parallel alignments can also be used. In examples, an anti-rotation screw hole can be diverging relative to the lag screw hole. That is, the diverging anti-rotation screw hole can intersect the lag screw, e.g., such that the head of the anti-rotation screw is within the lag screw, and can extend away from the lag screw at an angle. In examples, one or both of a parallel and diverging anti-rotation screw can be used. A set screw mechanism can be included with the femoral intramedullary nail to allow the lag screw to be locked rotationally and / or axially. For example, the set screw can engage slots of the lag screw to prevent the lag screw from rotating about its axis. The set screw can be further clamped down on the lag screw at theslots to prevent axial movement. The ability to accommodate multiple anti-rotation screws allows a surgeon to select from different screw options to prevent rotation of the femoral head.

[0085] The present disclosure provides multiple benefits in performing femoral fracture repair procedures.

[0086] Intramedullary nail systems of the present disclosure provide surgical flexibility and customized treatment. Surgeons are able to choose locations and length of anti-rotation screws, if any, to use based on specific fracture patterns and anatomy. The multiple configuration options allow for customized treatment approaches. Various fracture patterns, e.g., fractures of a femoral neck, can be treated using the intramedullary nail systems.

[0087] Intramedullary nail systems of the present disclosure provide enhanced stability. The stabilized lag screw and anti-rotation screws prevent undesirable rotation of the femoral head about the lag screw axis. As such, multiple anchor points can provide better fixation of the fractured head.

[0088] Intramedullary nail systems of the present disclosure provide adjustable positioning. The systems allow for superior / inferior adjustment of screw placement by controlling the nail implantation depth. The lag screw can vary axially by approximately ten millimeters to achieve optimal positioning. The lengths of the anti-rotation screws can be selected to improve engagement with bone matter.

[0089] Intramedullary nail systems of the present disclosure provide improved fracture management. The nail systems can address and prevent femoral head rotation during healing, which can arise when a patient flexes the hip joint. The nail systems provide multiple options for securing fractured fragments while maintaining stability of the bone.

[0090] The intramedullary nail systems of the present disclosure provide advancement in femoral fracture treatment by offering multiple options for securing the femoral head while preventing rotation, allowing surgeons to select the most appropriate configuration based on individual patient needs and fracture patterns.Examples

[0091] Example l is a femoral nail system comprising: a femoral nail comprising: an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween; a lag screw hole located in the proximal end section for receiving a lag screw; and a first anti-rotation screw hole located inthe proximal end section for receiving a first anti-rotation screw; and a lag screw configured to be inserted into the lag screw hole, the lag screw comprising: a second anti-rotation screw hole for receiving a second anti-rotation screw; wherein the elongate body is configured to be inserted into an intramedullary canal of a femoral bone to stabilize a femoral fracture; and wherein the lag screw is configured to be inserted into the lag screw hole to intersect a femoral head of the femoral bone to stabilize a femoral head fracture.

[0092] In Example 2, the subject matter of Example 1 optionally includes at least one distal fixation hole located in the distal end section for receiving a distal fixation element.

[0093] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the lag screw hole is angled relative to the central axis at an angle in a range of approximately one-hundred-five degrees to approximately one-hundred-thirty -five degrees.

[0094] In Example 4, the subject matter of any one or more of Examples 1-3 optionally include wherein the second anti-rotation screw hole is angled relative to the lag screw at an angle in a range of approximately ten degrees to approximately seventeen degrees.

[0095] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the first anti-rotation screw hole is located proximal of the lag screw hole.

[0096] In Example 6, the subject matter of Example 5 optionally includes wherein the first anti-rotation screw hole is parallel to the lag screw hole.

[0097] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include a set screw hole extending into the proximal end section of the femoral nail to intersect the lag screw hole; and the lag screw comprises: a set screw bore configured to receive a set screw when the lag screw is inserted into the lag screw hole of the femoral nail; and a first channel and a second channel disposed on opposite sides of the set screw bore.

[0098] In Example 8, the subject matter of Example 7 optionally includes the set screw, the set screw comprising: a head configured to be threaded into the set screw hole; a first flange configured to be positioned in the first channel; and a second flange configured to be in the second channel.

[0099] In Example 9, the subject matter of Example 8 optionally includes wherein the set screw comprises: a fastener portion including threading for engaging the set screw hole; and a bushing portion including the first flange and the second flange; wherein the fastener portion is rotatable relative to the bushing portion along a central axis to allow the bushing portion to translate axially into the set screw bore without rotation while the fastener portion rotates.

[0100] In Example 10, the subject matter of Example 9 optionally includes wherein the set screw further comprises a bore to receive an anti-rotation screw extending through the second anti-rotation screw hole when the set screw is inserted in the set screw hole.

[0101] In Example 11, the subject matter of any one or more of Examples 9-10 optionally include wherein: the bushing portion includes a first rail and a second rail protruding therefrom; and the set screw bore includes a first channel and a second channel to receive the first rail and the second rail, respectively.

[0102] In Example 12, the subject matter of any one or more of Examples 8-11 optionally include wherein the second anti-rotation screw hole is configured to allow the lag screw to vary axially in a range of approximately eight millimeters to approximately fifteen millimeters within the lag screw hole when an anti-rotation screw is inserted in the second anti-rotation screw hole and the lag screw is inserted in the lag screw hole.

[0103] In Example 13, the subject matter of Example 12 optionally includes wherein the second anti-rotation screw intersects the lag screw within the lag screw hole of the femoral nail.

[0104] In Example 14, the subject matter of Example 13 optionally includes wherein the lag screw hole includes a cutback to allow the lag screw to allow the second anti-rotation screw hole to be accessible.

[0105] In Example 15, the subject matter of any one or more of Examples 13-14 optionally include wherein a center of the lag screw hole is located approximately 40 millimeters from an end of the proximal end section; and a center of a first anti-rotation screw hole is located approximately 27.24 millimeters from an end of the proximal end section.

[0106] In Example 16, the subject matter of any one or more of Examples 1-15 optionally include a first anti-rotation screw; and a second anti-rotation screw.

[0107] In Example 17, the subject matter of Example 16 optionally includes wherein the first anti -rotation screw and the second anti -rotation screw are identical.

[0108] In Example 18, the subject matter of any one or more of Examples 1-17 optionally include an anti-rotation screw configured for use in the first anti-rotation screw hole or the second anti -rotation screw hole.

[0109] In Example 19, the subject matter of any one or more of Examples 13-18 optionally include wherein the anti-rotation screw comprises: a shaft; a threaded distal portion located at a distal end of the shaft; and a head located at a proximal end of the shaft, the head comprising: a threaded outer diameter portion; and a socket at a proximal end-face.

[0110] In Example 20, the subject matter of Example 19 optionally includes wherein the second anti-rotation screw hole in the lag screw comprises a threaded socket to receive the threaded outer diameter portion of the anti-rotation screw.

[0111] Example 21 is a femoral nail system comprising: a femoral nail comprising: an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween; and a lag screw hole located in the proximal end section for receiving a lag screw; a lag screw configured to be inserted into the lag screw hole, the lag screw comprising: an anti-rotation screw hole for receiving a second anti-rotation screw; an anti-rotation screw configured to be inserted into the antirotation screw hole in the lag screw; and an alignment guide configured to attach a lag screw driver and an anti-rotation screw insertion sheath such that the lag screw can be guided into the lag screw hole and the anti-rotation screw can be guided into the anti-rotation screw hole.

[0112] In Example 22, the subject matter of Example 21 optionally includes an alignment jig configured to attach to the femoral nail to align the lag screw driver and the anti -rotation screw insertion sheath in a coronal plane.

[0113] In Example 23, the subject matter of Example 22 optionally includes wherein the alignment guide comprises: a wedge body configured to couple to the lag screw driver inserted into a lag screw sheath and the anti-rotation screw insertion sheath between the femoral nail and the alignment jig.

[0114] In Example 24, the subject matter of Example 23 optionally includes wherein the wedge body comprises: a first coupler for attaching to the lag screw driver; and a second coupler for attaching to the anti-rotation screw insertion sheath; wherein the first coupler and the second coupler are angled relative to each other at an angle equal to an angle between the lag screw and the anti -rotation screw hole.

[0115] In Example 25, the subject matter of any one or more of Examples 22-24 optionally include wherein the alignment guide comprises: a targeting arm configured to couple to the lag screw driver and the anti-rotation screw insertion sheath outside of the alignment jig.

[0116] In Example 26, the subject matter of Example 25 optionally includes wherein the targeting arm comprises: an arm body; a coupler configured to attach to the lag screw driver; and a sleeve guide configured to receive the anti-rotation screw insertion sheath; wherein the coupler and the sleeve guide are angled relative to each other at an angle equal to an angle between the lag screw and the anti -rotation screw hole.

[0117] Example 27 is a method for assembling a lag screw and an anti -rotation screw with a femoral nail, the method comprising: inserting a femoral nail into an intramedullary canal of a femur, the femoral nail comprising a lag screw bore configured to receive a lag screw having an anti-rotation screw bore; attaching an alignment jig to the femoral nail; inserting a lag screw guide sheath through an alignment bore in the alignment jig to provide a trajectory along an axis of the lag screw bore; connecting an alignment guide to a lag screw driver inserted in the lag screw guide sheath; attaching an anti-rotation screw guide sheath to the alignment guide to provide a trajectory along an axis of the anti -rotation screw bore.

[0118] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.Various Notes

[0119] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0120] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0121] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope ofthat claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0122] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” or “approximately” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” or “approximately” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” or “approximately” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, “about 50%” or “approximately 50%” means in the range of 45% - 55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1 - 1.5, 1.5 - 2, 2 - 2.75, 2.75 - 3, 3 - 3.90, 3.90 - 4, 4 - 4.24, 4.24 - 5, 2 - 5, 3 - 5, 1 - 4, and 2 - 4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about” or “approximately.”

[0123] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMSTHE CLAIMED INVENTION IS:

1. A femoral nail system comprising: a femoral nail comprising: an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween; a lag screw hole located in the proximal end section for receiving a lag screw; and a first anti-rotation screw hole located in the proximal end section for receiving a first anti-rotation screw; and a lag screw configured to be inserted into the lag screw hole, the lag screw comprising: a second anti-rotation screw hole for receiving a second anti-rotation screw; wherein the elongate body is configured to be inserted into an intramedullary canal of a femoral bone to stabilize a femoral fracture; and wherein the lag screw is configured to be inserted into the lag screw hole to intersect a femoral head of the femoral bone to stabilize a femoral head fracture.

2. The femoral nail system of claim 1, further comprising at least one distal fixation hole located in the distal end section for receiving a distal fixation element.

3. The femoral nail system of claim 1, wherein the lag screw hole is angled relative to the central axis at an angle in a range of approximately one-hundred-five degrees to approximately one-hundred-thirty-five degrees.

4. The femoral nail system of claim 1, wherein the second anti-rotation screw hole is angled relative to the lag screw at an angle in a range of approximately ten degrees to approximately seventeen degrees.

5. The femoral nail system of claim 1, wherein the first anti-rotation screw hole is located proximal of the lag screw hole.

6. The femoral nail system of claim 5, wherein the first anti-rotation screw hole is parallel to the lag screw hole.

7. The femoral nail system of claim 1, further comprising: a set screw hole extending into the proximal end section of the femoral nail to intersect the lag screw hole; and the lag screw comprises: a set screw bore configured to receive a set screw when the lag screw is inserted into the lag screw hole of the femoral nail; and a first channel and a second channel disposed on opposite sides of the set screw bore.

8. The femoral nail system of claim 7, further comprising the set screw, the set screw comprising: a head configured to be threaded into the set screw hole; a first flange configured to be positioned in the first channel; and a second flange configured to be in the second channel.

9. The femoral nail system of claim 8, wherein the set screw comprises: a fastener portion including threading for engaging the set screw hole; and a bushing portion including the first flange and the second flange; wherein the fastener portion is rotatable relative to the bushing portion along a central axis to allow the bushing portion to translate axially into the set screw bore without rotation while the fastener portion rotates.

10. The femoral nail system of claim 9, wherein the set screw further comprises a bore to receive an anti-rotation screw extending through the second anti-rotation screw hole when the set screw is inserted in the set screw hole.

11. The femoral nail system of claim 9, wherein: the bushing portion includes a first rail and a second rail protruding therefrom; and the set screw bore includes a first channel and a second channel to receive the first rail and the second rail, respectively.

12. The femoral nail system of claim 8, wherein the second anti-rotation screw hole is configured to allow the lag screw to vary axially in a range of approximately eight millimeters to approximately fifteen millimeters within the lag screw hole when an antirotation screw is inserted in the second anti-rotation screw hole and the lag screw is inserted in the lag screw hole.

13. The femoral nail system of claim 12, wherein the second anti -rotation screw intersects the lag screw within the lag screw hole of the femoral nail.

14. The femoral nail system of claim 13, wherein the lag screw hole includes a cutback to allow the lag screw to allow the second anti-rotation screw hole to be accessible.

15. The femoral nail system of claim 13, wherein: a center of the lag screw hole is located approximately 40 millimeters from an end of the proximal end section; and a center of a first anti-rotation screw hole is located approximately 27.24 millimeters from an end of the proximal end section.

16. The femoral nail system of claim 1, further comprising: a first anti-rotation screw; and a second anti-rotation screw.

17. The femoral nail system of claim 16, wherein the first anti -rotation screw and the second anti -rotation screw are identical.

18. The femoral nail system of claim 1, further comprising an anti -rotation screw configured for use in the first anti-rotation screw hole or the second anti-rotation screw hole.

19. The femoral nail system of claim 13, wherein the anti -rotation screw comprises: a shaft; a threaded distal portion located at a distal end of the shaft; and a head located at a proximal end of the shaft, the head comprising:a threaded outer diameter portion; and a socket at a proximal end-face.

20. The femoral nail system of claim 19, wherein the second anti -rotation screw hole in the lag screw comprises a threaded socket to receive the threaded outer diameter portion of the anti-rotation screw.

21. A femoral nail system comprising: a femoral nail comprising: an elongate body having a proximal end section extending along a central axis, a distal end section and an intermediate section extending therebetween; and a lag screw hole located in the proximal end section for receiving a lag screw; a lag screw configured to be inserted into the lag screw hole, the lag screw comprising: an anti-rotation screw hole for receiving a second anti-rotation screw; an anti-rotation screw configured to be inserted into the anti-rotation screw hole in the lag screw; and an alignment guide configured to attach a lag screw driver and an anti-rotation screw insertion sheath such that the lag screw can be guided into the lag screw hole and the anti-rotation screw can be guided into the anti-rotation screw hole.

22. The femoral nail system of claim 21, further comprising an alignment jig configured to attach to the femoral nail to align the lag screw driver and the anti-rotation screw insertion sheath in a coronal plane.

23. The femoral nail system of claim 22, wherein the alignment guide comprises: a wedge body configured to couple to the lag screw driver inserted into a lag screw sheath and the anti-rotation screw insertion sheath between the femoral nail and the alignment jig.

24. the femoral nail system of claim 23, wherein the wedge body comprises: a first coupler for attaching to the lag screw driver; anda second coupler for attaching to the anti-rotation screw insertion sheath; wherein the first coupler and the second coupler are angled relative to each other at an angle equal to an angle between the lag screw and the anti -rotation screw hole.

25. The femoral nail system of claim 22, wherein the alignment guide comprises: a targeting arm configured to couple to the lag screw driver and the anti-rotation screw insertion sheath outside of the alignment jig.

26. The femoral nail system of claim 25, wherein the targeting arm comprises: an arm body; a coupler configured to attach to the lag screw driver; and a sleeve guide configured to receive the anti-rotation screw insertion sheath; wherein the coupler and the sleeve guide are angled relative to each other at an angle equal to an angle between the lag screw and the anti -rotation screw hole.

27. A method for assembling a lag screw and an anti-rotation screw with a femoral nail, the method comprising: inserting a femoral nail into an intramedullary canal of a femur, the femoral nail comprising a lag screw bore configured to receive a lag screw having an antirotation screw bore; attaching an alignment jig to the femoral nail; inserting a lag screw guide sheath through an alignment bore in the alignment jig to provide a trajectory along an axis of the lag screw bore; connecting an alignment guide to a lag screw driver inserted in the lag screw guide sheath; attaching an anti-rotation screw guide sheath to the alignment guide to provide a trajectory along an axis of the anti -rotation screw bore.

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