Intramedullary nail aiming systems and methods

Abstract

To provide intramedullary aiming systems, instruments, and methods of treating bone fractures.SOLUTION: Aiming systems may include one or more instruments configured to ensure optimal alignment and placement of one or more components of an intramedullary nailing system, such as anteversion alignment, anti-rotation, lag screw aiming, distal aiming, and other instruments suitable to enhance and optimize the surgical procedure.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to surgical devices, and more particularly to intramedullary nail implants for the treatment of bone fractures, e.g., for trauma applications. [Background technology]

[0002] Fractures of long bones, such as the femur, tibia, and humerus, may be treated by fixing the bone to stabilize and align the fractured bone to facilitate the healing process. In some cases, an intramedullary nail may be introduced through the medullary cavity of the bone to stabilize the fractured fragments and stabilize the long bone when fractured. In the case of the femur, a trochanteric nail may be inserted through the greater trochanter into the canal of the femur to stabilize various proximal femoral fractures. The trochanteric nail may be secured using one or more locking screws, for example, for proximal and / or distal fixation. Femoral neck fixation may include inserting locking screws into the femoral neck / head at an angle to the intramedullary nail. One or more aiming or targeting instruments may be used to facilitate the insertion of the intramedullary nail and the respective locking screws. However, there remains a need for improved intramedullary systems and instruments to stabilize the bone and align the components to improve patient outcomes. Summary of the Invention

[0003] Intramedullary nail targeting systems, instruments, and methods of treatment are provided. The intramedullary nail may be suitable for implantation into the medullary canal of a fractured long bone, such as a femur, and thereafter providing proximal and / or distal fixation, for example, using one or more anchors, fasteners, fixation screws, etc. The targeting systems and instruments may be configured to ensure optimal alignment and positioning of one or more components of the intramedullary nail system.

[0004] According to one embodiment, a targeting system for inserting a lag screw into an intramedullary nail is provided. The proximal targeting system includes an intramedullary nail and a nail insertion handle. The intramedullary nail has a proximal end with a proximal through opening and a distal end. The nail insertion handle includes a coupling portion for releasably coupling to the proximal end of the intramedullary nail, a handle portion, and an aiming guide having an opening that aligns with the proximal through opening of the intramedullary nail. The handle portion includes an anteversion alignment system configured for optimally inserting the lag screw into the proximal through opening of the intramedullary nail, an anti-rotation system configured to stabilize the bone as the lag screw is inserted, and a lag screw aiming assembly configured to positively insert into the bone, thereby defining a trajectory into the proximal opening of the intramedullary nail.

[0005] The proximal targeting system may include one or more of the following features: The handle portion may define an anteversion guidewire hole aligned with a central plane of the nail insertion handle and a pair of radiopaque goal posts positioned on either side of the guidewire hole. The radiopaque goal posts may include two parallel rows of pins held in the handle portion, where an optimal anteversion position for lag screw insertion is found when the goal posts are centered parallel and a guidewire positioned through the anteversion guidewire hole is centered with the neck and head of the bone. The anti-rotation system may include a plurality of anti-rotation holes, an anti-rotation sleeve positionable through the holes, and an anti-rotation guidewire positionable through the sleeve. The anti-rotation holes may each include a retaining pin configured to secure the anti-rotation sleeve within the anti-rotation hole. The anti-rotation holes may include an upper pair of holes converging distally at a first angle and a lower pair of holes converging distally at a second angle such that the second angle is greater than the first angle. The lag screw aiming assembly may include a driver sleeve positionable through an opening in the aiming guide, a wire sleeve having a distal cutting flute positionable through the driver sleeve, and a trocar positionable through the wire sleeve.

[0006] According to one embodiment, the targeting system may include an intramedullary nail, a nail insertion handle, a driver sleeve, a wire sleeve, and a guidewire. The intramedullary nail has a proximal end and a distal end. The nail insertion handle includes a coupling portion for releasably coupling to the proximal end of the intramedullary nail, a handle portion, and an aiming guide having an opening that aligns with an opening in the intramedullary nail. The driver sleeve is positionable through the opening in the aiming guide. The wire sleeve is positionable through the driver sleeve, the wire sleeve having a plurality of graduated markings. The guidewire is positionable through the wire sleeve. When the wire sleeve is flush with the guidewire, a reading on the driver sleeve next to the graduated markings indicates an optimal lag screw length.

[0007] The targeting system may include one or more of the following features: The driver sleeve may include a tubular body having a plurality of teeth configured to engage a ratchet in the aiming arm. The distal tip of the wire sleeve may include a cutting flute. The wire sleeve may include an enlarged head portion defining a spring cut that allows the wire sleeve to be snapped into the driver sleeve. The targeting system may also include a trocar positionable through the wire sleeve. The trocar may include a shaft having a sharpened distal tip configured to facilitate insertion through soft tissue. The trocar may include a head portion having a male mating member receivable within a corresponding female mating member in the wire sleeve such that the trocar and wire sleeve pivot together to aid in passing through the soft tissue. The trocar may have a bent shaft to facilitate retention within the wire sleeve.

[0008] According to one embodiment, a method of inserting an intramedullary nail into a patient's bone may include, in any suitable order, one or more of: (1) inserting a coring reamer instrument into an axial end of a long bone to access the medullary canal, the coring reamer having a hollow coring tip with circumferential teeth configured to cut and harvest bone; (2) securing the intramedullary nail to a nail insertion handle with a keyed interface and a connecting bolt, the nail insertion handle including an implant holder including a connecting portion and a handle portion, the connecting portion including a keyed tab configured to mate with a corresponding recess in a proximal end of the intramedullary nail, the connecting bolt passing through internal threads in the implant holder and threading into the intramedullary nail; and (3) inserting the intramedullary nail into the medullary canal with the nail insertion handle. In one embodiment, the nail insertion handle includes an anteversion guidewire hole located along a central plane of the handle and a pair of radiopaque goal posts positioned on either side of the guidewire hole. The method may further include (4) positioning a guidewire through the guidewire hole and adjusting the nail insertion handle until the goal post is parallel and centered with the intramedullary nail and the guidewire is centered through the neck and head of the bone, thereby ensuring an optimal anteversion position for lag screw insertion. The method may include (5) attaching an aiming arm to a handle portion of the nail insertion handle with a pair of alignment pins and a mounting knob. In one embodiment, the aiming arm includes a plurality of anti-rotation sleeve holes. The method may include (6) positioning an anti-rotation sleeve through the sleeve holes and positioning an anti-rotation guidewire through the anti-rotation sleeve, each anti-rotation sleeve hole including a retaining pin configured to secure the anti-rotation sleeve within the anti-rotation hole. The method may include (7) inserting a driver sleeve through the opening in the aiming arm, inserting a wire sleeve through the driver sleeve, and inserting a trocar through the wire sleeve, and / or (8) attaching a driver to the lag screw and inserting the lag screw through the driver sleeve and into the opening in the intramedullary nail.

[0009] According to one embodiment, a targeting system for inserting a distal fastener into an intramedullary nail includes an intramedullary nail, a nail insertion handle, a distal aiming arm, a deflection assembly, and a targeting module. The intramedullary nail has a proximal end and a distal end having a distal through opening. The nail insertion handle includes a coupling portion for removably connecting to the proximal end of the intramedullary nail and a handle portion. The distal aiming arm is attachable to the handle portion of the nail insertion handle, the distal aiming arm including a plurality of dovetail recesses. The deflection assembly includes a dovetail assembly for mounting to the dovetail recesses and an adjustment assembly for adjusting a vertical position of the deflection assembly relative to the distal aiming arm. The targeting module is attachable to the deflection assembly and defines an opening through the targeting module. A sleeve is positionable through the opening of the targeting module. The deflection assembly is adjustable to account for deflection of the intramedullary nail, thereby defining a trajectory to the distal through opening in the intramedullary nail.

[0010] The distal targeting system may include one or more of the following features: The distal aiming arm may include a mounting head having two mirrored connecting surfaces. The two mirrored connecting surfaces may have two angles acting in different planes. The distal aiming arm may include a plate having an arcuate bend, and dovetail recesses may be defined on an inner and outer surface of the plate to accommodate incremental placement of the deflection assembly. Each dovetail recess may define a ball detent divot configured to receive a corresponding ball detent on the deflection assembly. The adjustment assembly may include a fine adjustment knob for vertically adjusting the deflection assembly and a coarse adjustment button. The targeting module may include a plurality of overlapping holes. The targeting module may be attached to the deflection assembly with a tenon configured to fit into a corresponding groove in a bottom surface of the deflection assembly. The sleeve may have a D-shaped shaft including a flat that interacts with a retaining pin in the targeting module.

[0011] According to one embodiment, the targeting system includes a distal aiming arm including a plurality of dovetail recesses, a deflection assembly including a dovetail assembly for mounting to the dovetail recesses and an adjustment assembly for adjusting a vertical position of the deflection assembly relative to the distal aiming arm, and a targeting module attachable to the deflection assembly, the targeting module having an opening therethrough and an alignment display having markings for determining an optimal targeting position.

[0012] The distal targeting system may include one or more of the following features: The markings on the alignment display may include radiopaque measurement markings visible on an x-ray. The dovetail assembly may include a movable block and a cam lock attached to a foot having a ball detent. The foot may include a male dovetail protrusion having a planar outer surface and an arched bottom surface configured to be received in one of the dovetail recesses of the distal aiming arm. The cam lock may include a cam lever connected to the foot and an internal compression spring that maintains a preload on the foot. The deflection assembly may include an outer casing having a handle portion for holding the dovetail assembly, a base for securing the targeting module, and a neck for holding the adjustment assembly. The adjustment assembly may include a fine adjustment knob having a rotatable knob attached to a threaded shaft threadedly engaged with the outer casing. The adjustment assembly may include a coarse adjustment button having a threaded through opening held within the neck of the casing. The threaded shaft extends through the coarse adjustment button, and in one position the threaded shaft is engaged with the coarse adjustment button and in another position the threaded shaft is disengaged from the coarse adjustment button.

[0013] According to one embodiment, a method of aligning a fastener with an intramedullary nail may include, in any suitable order, one or more of: (1) inserting an intramedullary nail having a distal through opening into a patient's medullary canal with a nail insertion handle; (2) attaching a distal aiming arm to the nail insertion handle, the distal aiming arm having a plurality of dovetail recesses; (3) attaching a deflection assembly to the dovetail recesses; (4) attaching a targeting module to the deflection assembly, the targeting module defining an opening therethrough; (5) positioning a sleeve through the opening of the targeting module; and (6) adjusting a vertical position of the deflection assembly relative to the distal aiming arm to account for deflection of the intramedullary nail and define a trajectory to the distal through opening of the intramedullary nail. The method may also include (7) viewing an alignment display on the targeting module to adjust a vertical position of the targeting module, and / or (8) attaching a driver to the locking screw and inserting the locking screw through a sleeve and into the distal through opening of the intramedullary nail.

[0014] Also provided are kits that include various shapes and sizes of intramedullary nails, bone anchors, fasteners, insertion tools, proximal aiming systems, distal aiming systems, K-wires, and other tools and devices that may be suitable to assist in the surgical procedure. [Brief description of the drawings]

[0015] A more complete understanding of the present invention, together with its attendant advantages and features, will be more readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Figure 1] 1 shows a proximal femur with an anteversion alignment system coupled to a trochanteric nail and a lag screw optimally inserted into the femoral neck and head via the anteversion alignment system, according to one embodiment. [Diagram 2] 1 shows an anteversion alignment system attached to a trochanteric nail configured to align the trochanteric nail to an optimal anteversion angle prior to insertion of a lag screw. [Diagram 3]FIG. 13 is a side close-up view of an anteversion alignment system including a radiopaque goal post and an anteversion K-wire, according to one embodiment. [Figure 4A] 1 illustrates a workflow including misalignment and alignment configurations for an anteversion alignment system, according to one embodiment. [Figure 4B] 1 illustrates a workflow including misalignment and alignment configurations for an anteversion alignment system, according to one embodiment. [Figure 4C] 1 illustrates a workflow including misalignment and alignment configurations for an anteversion alignment system, according to one embodiment. [Diagram 5] Shown is an anteversion alignment system with the lag screw positioned in the optimal anteversion position. [Figure 6] 1 illustrates an anti-rotation system integrated into a trochanteric nail aiming arm, according to one embodiment, configured to stabilize the femoral neck and head when a lag screw is inserted. [Figure 7] 1 illustrates an anterior-posterior view of an anti-rotation system having converging paths for the anti-rotation guidewire, according to one embodiment. [Figure 8A] 13 illustrates an embodiment of an anti-rotation hole having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 8B] 13 illustrates an embodiment of an anti-rotation hole having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 8C] 13 illustrates an embodiment of an anti-rotation hole having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 8D] 13 illustrates an embodiment of an anti-rotation hole having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 9] 1 illustrates a lag screw targeting assembly according to one embodiment configured to securely insert a sleeve assembly into bone during a trochanteric nailing procedure. [Figure 10A]1 is an embodiment of a lag screw sleeve assembly including a lag screw driver sleeve, a lag screw wire sleeve, and a lag screw trocar. [Figure 10B] 1 is another embodiment of a lag screw sleeve assembly including a lag screw driver sleeve, a lag screw wire sleeve, and a lag screw trocar. [Figure 11A] 13 illustrates a ratchet mechanism configured to lock the lag screwdriver sleeve to the aiming arm, according to one embodiment. [Figure 11B] 13 illustrates a ratchet mechanism configured to lock the lag screwdriver sleeve to the aiming arm, according to one embodiment. [Figure 11C] 13 illustrates a ratchet mechanism configured to lock the lag screwdriver sleeve to the aiming arm, according to one embodiment. [Figure 12A] 13 shows the lag screw assembly components, including the connection between the lag screw wire sleeve and the lag screw driver sleeve, and the interface between the trocar and the lag screw wire sleeve. [Figure 12B] 13 shows the lag screw assembly components, including the connection between the lag screw wire sleeve and the lag screw driver sleeve, and the interface between the trocar and the lag screw wire sleeve. [Figure 12C] 13 shows the lag screw assembly components, including the connection between the lag screw wire sleeve and the lag screw driver sleeve, and the interface between the trocar and the lag screw wire sleeve. [Figure 12D] 13 shows the lag screw assembly components, including the connection between the lag screw wire sleeve and the lag screw driver sleeve, and the interface between the trocar and the lag screw wire sleeve. [Figure 13] 1 illustrates a lag screw aiming assembly with a quick connect handle, according to one embodiment. [Figure 14A]1 illustrates a quick connect handle coupled to a trocar, according to one embodiment. [Figure 14B] 1 illustrates a quick connect handle coupled to a trocar, according to one embodiment. [Figure 15] 13 illustrates the insertion of a lag screw guidewire through the lag screw sleeve assembly according to one embodiment. [Figure 16] 13 illustrates an embodiment for measuring the length of a lag screw guidewire having a lag screw wire sleeve. [Figure 17A] 1A-1D are isometric views of a push connect handle assembly having different handle types. [Figure 17B] 1A-1D are isometric views of a push connect handle assembly having different handle types. [Figure 18A] FIG. 1 illustrates a cross-sectional view of a push connect handle assembly, according to one embodiment. [Figure 18B] FIG. 1 illustrates a cross-sectional view of a push connect handle assembly, according to one embodiment. [Figure 19A] FIG. 2 is a cross-sectional view of the female push connect assembly and the male and female connections when assembled. [Figure 19B] FIG. 2 is a cross-sectional view of the female push connect assembly and the male and female connections when assembled. [Figure 20] 1 illustrates an embodiment of a trochanteric nail proximal aiming system, according to one embodiment. [Figure 21A] 1 illustrates an insertion handle assembly and nail connection geometry according to one embodiment. [Figure 21B] 1 illustrates an insertion handle assembly and nail connection geometry according to one embodiment. [Figure 21C] 1 illustrates an insertion handle assembly and nail connection geometry according to one embodiment. [Figure 21D] 1 illustrates an insertion handle assembly and nail connection geometry according to one embodiment. [Figure 22A] 1 shows examples of nail connection geometries for different nail types. [Figure 22B] 1 shows examples of nail connection geometries for different nail types. [Figure 23A] 13 illustrates a connection bolt for securing the insertion handle to the trochanteric nail according to one embodiment. [Figure 23B] 13 illustrates a connection bolt for securing the insertion handle to the trochanteric nail according to one embodiment. [Figure 23C] 13 illustrates a connection bolt for securing the insertion handle to the trochanteric nail according to one embodiment. [Figure 24A] 1 illustrates an insertion handle and aiming arm assembly according to one embodiment. [Figure 24B] 1 illustrates an insertion handle and aiming arm assembly according to one embodiment. [Figure 25A] 1 illustrates an assembly of sub-components of an aiming arm according to one embodiment. [Figure 25B] 1 illustrates an assembly of sub-components of an aiming arm according to one embodiment. [Figure 25C] 1 illustrates an assembly of sub-components of an aiming arm according to one embodiment. [Figure 26A] 1 illustrates a proximal aiming system having an anti-rotation wire sleeve, according to one embodiment. [Figure 26B] 1 illustrates a proximal aiming system having an anti-rotation wire sleeve, according to one embodiment. [Figure 27A] 1 illustrates a lag screwdriver sleeve with ratchet teeth according to one embodiment. [Figure 27B] 1 illustrates a lag screwdriver sleeve with ratchet teeth according to one embodiment. [Figure 27C] 1 illustrates a lag screwdriver sleeve with ratchet teeth according to one embodiment. [Figure 28A] 13 illustrates a lag screw wire sleeve with lag screw length calibration scales according to one embodiment. [Figure 28B] 13 illustrates a lag screw wire sleeve with lag screw length calibration scales according to one embodiment. [Figure 29]1 is a lag screw trocar having a bent shaft, according to one embodiment. [Figure 30A] 13 illustrates the assembly of the lag screw sleeve with the aiming arm according to one embodiment. [Figure 30B] 13 illustrates the assembly of the lag screw sleeve with the aiming arm according to one embodiment. [Figure 31A] 1 illustrates a lag screw driver and a lag screw retaining rod according to one embodiment. [Figure 31B] 1 illustrates a lag screw driver and a lag screw retaining rod according to one embodiment. [Figure 31C] 1 illustrates a lag screw driver and a lag screw retaining rod according to one embodiment. [Figure 32A] 13A-13C show a proximal aiming system having a lag screw driver and a retaining rod used for targeted lag screw insertion, according to one embodiment. [Figure 32B] 13A-13C show a proximal aiming system having a lag screw driver and a retaining rod used for targeted lag screw insertion, according to one embodiment. [Figure 33A] 13 illustrates an impaction mallet used to insert and remove the implant, according to one embodiment. [Figure 33B] 13 illustrates an impaction mallet used to insert and remove the implant, according to one embodiment. [Figure 33C] 13 illustrates an impaction mallet used to insert and remove the implant, according to one embodiment. [Figure 33D] 13 illustrates an impaction mallet used to insert and remove the implant, according to one embodiment. [Diagram 34] 1 illustrates an impact mallet with a slap removal shaft according to one embodiment. [Figure 35A]1A and 1B show oblique and side views, respectively, of a coring reamer having a coring tip, a core ejector, and a reamer shaft according to one embodiment, configured to create a hole in the axial end of a long bone to access the medullary canal. [Figure 35B] 1A and 1B show oblique and side views, respectively, of a coring reamer having a coring tip, a core ejector, and a reamer shaft according to one embodiment, configured to create a hole in the axial end of a long bone to access the medullary canal. [Figure 36A] 1 illustrates a cross-sectional view of the engagement between a core ejector and a reamer shaft according to one embodiment. [Figure 36B] 1 illustrates a cross-sectional view of the engagement between a core ejector and a reamer shaft according to one embodiment. [Figure 37] 13 is one embodiment of a guidewire pusher for keeping the ball-tip guidewire in place as the reamer and reamer shaft are removed from the medullary canal. [Figure 38A] 13 illustrates an embodiment of engagement between a ball-tip wire and a guidewire pusher. [Figure 38B] 13 illustrates an embodiment of engagement between a ball-tip wire and a guidewire pusher. [Figure 39A] 13 illustrates an additional embodiment of engagement between a ball-tip wire and a guidewire pusher. [Figure 39B] 13 illustrates an additional embodiment of engagement between a ball-tip wire and a guidewire pusher. [Diagram 40] FIG. 1 illustrates an exploded view of a nail assembly including an insertion handle, a nail connection bolt, and a trochanteric nail according to one embodiment. [Figure 41A] 13 illustrates a mating interface on the nail connection bolt and guidewire pusher according to one embodiment. [Figure 41B] 13 illustrates a mating interface on the nail connection bolt and guidewire pusher according to one embodiment. [Diagram 42] 13 illustrates an assembly for using a guidewire pusher through a trochanteric nail, according to one embodiment. [Diagram 43]FIG. 13 shows a close-up view of the nail insertion handle and a guidewire pusher inserted through the trochanteric nail, according to one embodiment. [Figure 44A] 13A-13C show a distal aiming arm that can be attached to different nail insertion handles coupled to different types of intramedullary nails, according to one embodiment. [Figure 44B] 13A-13C show a distal aiming arm that can be attached to different nail insertion handles coupled to different types of intramedullary nails, according to one embodiment. [Figure 45A] 1 illustrates a distal aiming assembly including a distal aiming arm attached to the nail insertion handle, a deflection assembly having a targeting module, and a sleeve for targeting a distal hole of the intramedullary nail, according to one embodiment. [Figure 45B] 1 illustrates a distal aiming assembly including a distal aiming arm attached to the nail insertion handle, a deflection assembly having a targeting module, and a sleeve for targeting a distal hole of the intramedullary nail, according to one embodiment. [Figure 46A] 13 illustrates a distal aiming arm including a mounting head and a mounting dovetail along a plate according to one embodiment. [Figure 46B] 13 illustrates a distal aiming arm including a mounting head and a mounting dovetail along a plate according to one embodiment. [Figure 46C] 13 illustrates a distal aiming arm including a mounting head and a mounting dovetail along a plate according to one embodiment. [Figure 46D] 13 illustrates a distal aiming arm including a mounting head and a mounting dovetail along a plate according to one embodiment. [Figure 46E] 13 illustrates a distal aiming arm including a mounting head and a mounting dovetail along a plate according to one embodiment. [Figure 47A] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 47B] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 47C]1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 47D] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 47E] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Fig.47F] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 47G] 1 illustrates a deflection assembly attached to a distal aiming arm, according to one embodiment. [Figure 48A] 13 illustrates an embodiment of a targeting module that can be attached to a deflection assembly. [Figure 48B] 13 illustrates an embodiment of a targeting module that can be attached to a deflection assembly. [Figure 48C] 13 illustrates an embodiment of a targeting module that can be attached to a deflection assembly. [Figure 49] 1 illustrates a targeting assembly having a targeting module attached to a deflection assembly, according to one embodiment. [Figure 50A] 13 illustrates an embodiment of an anti-rotation hole in a targeting module having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 50B] 13 illustrates an embodiment of an anti-rotation hole in a targeting module having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 50C] 13 illustrates an embodiment of an anti-rotation hole in a targeting module having a retaining pin configured to lock an anti-rotation sleeve within the anti-rotation hole. [Figure 51] 1 shows an alignment display having markings to indicate optimal distal targeting, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Intramedullary nail targeting systems, instruments, and methods of treatment are provided. The intramedullary nail may be suitable for implantation within the medullary canal of a fractured long bone with proximal and / or distal fixation, e.g., one or more anchors, fasteners, fixation screws, etc. In one embodiment, the trochanteric nail is inserted through the greater trochanter into the canal of the femur to stabilize various proximal femoral fractures. Although generally described with reference to femoral hip fractures, it will be understood that the intramedullary nail system may be similarly adapted for use for fixation of other areas or other long bones, such as the tibia, humerus, clavicle, fibula, ulna, radius, bones of the foot, bones of the hand, or other suitable bones.

[0017] The targeting or aiming system may include one or more instruments or systems configured to ensure optimal alignment and placement of one or more components of the intramedullary nail system. In one embodiment, the intramedullary nail aiming system may include an anteversion alignment system configured to align the trochanteric nail in an optimal anteversion position prior to insertion of the lag screw. In another embodiment, the aiming system may include an anti-rotation system configured to stabilize the fracture to prevent rotation when the lag screw is inserted. In another embodiment, the aiming system may include a lag screw aiming assembly configured to allow the surgeon to reliably insert the lag screw sleeve into the bone during the trochanteric nailing procedure. In yet another embodiment, the system may include a proximal aiming system and / or a distal aiming system used to aim and insert the proximal and distal bone anchors or fasteners into the nail. The instruments may further include a reaming instrument, a wire pusher, a quick connect handle, an impaction mallet, and other tools and instruments that may be suitable to enhance or optimize the surgical procedure.

[0018] Referring now to the drawings, where like reference numbers refer to like elements, FIG. 1 illustrates an anteroposterior (A / P) view of a femur 2 having an intramedullary nail system 10 according to one embodiment. The intramedullary nail system 10 may include an intramedullary nail 12 and one or more bone anchors 14, fasteners, locking screws, etc. configured to provide proximal and / or distal fixation. In the case of the femur 2, the intramedullary nail 12 may be a trochanteric nail configured to be inserted through the greater trochanter and into the canal of the femur 2, and the proximal anchor 14 may be a lag screw inserted through the femoral neck and femoral head of the femur 2.

[0019] The intramedullary nail 12, such as a trochanteric nail, may be a long rod or stem extending from a first or proximal end 20 to a second or distal end 22. The nail 12 is configured to extend longitudinally within the medullary canal of the femur 2. The nail 12 may be configured as a cylindrical shaft or tubular rod, or the shaft may be configured with any geometric cross-sectional shape (e.g., rectangular, oval, elliptical, oval, polygonal, etc.) that fits into the medullary canal. The nail 12 may be substantially straight or curved to mimic the natural anatomical curvature of a long bone. In this embodiment, the intramedullary nail 12 may be configured to be positioned in the proximal end of the femur through the greater trochanter for subtrochanteric fracture fixation. However, it is envisioned that the intramedullary nail 12 may be configured to be positioned through other approaches and locations (e.g., distal end) depending on the bone (e.g., femur, tibia) and type of fracture.

[0020] The proximal end 20 of the nail 12 may include one or more proximal openings 24 configured to receive one or more bone anchors 14, fasteners, or proximal fixation devices, such as threaded lag screws. The lag screws 14 may be configured to extend laterally through the intramedullary nail 12 to secure the proximal end 20 of the intramedullary nail 12 within the medullary canal. The lag screws 14 may be femoral talar screws or other suitable anchors configured to be aimed at the neck and head of the proximal femur. The proximal end 20 of the nail 12 may optionally include additional openings 24 for, for example, one or more cross-locking devices.

[0021] The distal end 22 of the nail 12 may include one or more distal openings 26 configured to receive one or more bone anchors 14, fasteners, or distal fixation devices (not shown). The distal fixation devices may be configured to extend laterally through the distal end 22 of the intramedullary nail 12 for anchoring the distal end 22 of the intramedullary nail 12 within the canal. Any of the openings 24, 26 may be threaded or textured (e.g., to receive a locking fastener), may not be threaded / textured (e.g., to receive a compression fastener), or may be otherwise configured to receive a bone anchor 14.

[0022] The intramedullary nails 12 and bone anchors 14 may be available in a variety of lengths, widths, and styles based on the patient's anatomy. The nails 12 may be configured in mirrored configurations in both left and right designs to accommodate both the left and right sided anatomy of the patient. The system may be adapted to secure small or large bone fragments, single or multiple bone fragments, or otherwise secure one or more fractures. Specifically, the system may include a series of intramedullary nails 12 and anchors 14 designed for fixation of fractures and fragments in diaphyseal and metaphyseal bones. The nails 12 may be provided in a variety of shapes, sizes, and designs tailored to specific bones, locations, and fracture types. Examples of suitable intramedullary nails and systems are described in more detail in U.S. Pat. No. 11,045,242, which is incorporated herein by reference in its entirety for all purposes.

[0023] The intramedullary nail 12 may be made of titanium, stainless steel, cobalt chrome, carbon composite, plastics or polymers such as polyetheretherketone (PEEK), polyethylene, ultra-high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), combinations or alloys of such materials, or any other suitable material that is strong enough to be secured to and retain bone and is also biocompatible enough to be implanted in the body. Similarly, the lag screw 14 or other bone fastener may be made of titanium, cobalt chrome, cobalt-chromium-molybdenum, stainless steel, tungsten carbide, combinations or alloys of such materials, or other suitable biocompatible materials. While the above list of materials includes many typical materials from which intramedullary nails and bone fasteners are made, it should be understood that intramedullary nails and fasteners made of any suitable material are contemplated.

[0024] The nail insertion tool 30 may be used to install the nail 12 and align one or more of the bone anchors 14 with their respective openings 24, 26 in the nail 12. In some embodiments, the nail insertion tool 30 may have an implant holder 31 having an implant holder tip or connecting portion 32, a handle grip or handle portion 34, and an aiming arm 36. The implant holder 31, handle portion 34, and aiming arm 36 may be separate parts or may be formed from an integrally formed single component. The implant holder 31 with the connecting portion 32 releasably engages or couples with the proximal portion 20 of the nail 12. For example, the free end of the connecting portion 32 may have a snap-fit ​​design or other suitable mechanism to temporarily hold the intramedullary nail 12 for installation.

[0025] Depending on the instrument, the nail insertion instrument 30 may have a generally arcuate or J-shaped body. The handle portion 34 may include a hand grip and a lower aiming arm 36 having one or more openings 38 configured to guide the bone anchor 14 into position. Each opening 38 may have a bore axis that is substantially aligned with a corresponding bore axis of a respective nail opening 24, 26. The openings 38 may be configured to receive a sheath or sleeve (further described in FIGS. 9 and 20) configured to protect soft tissue and to be aligned with the openings 24, 26 of the intramedullary nail 12 to allow insertion of a drill, driver, K-wire, fastener, or the like configured to be inserted through the openings 24, 26 and into the bone. The nail insertion instrument 30 may include attachment locations for one or more modules (e.g., a recon module, an oblique module) for guiding additional fasteners 14 into the nail 12. Additional details of a suitable nail insertion tool and assembly are described in more detail in US Pat. No. 11,045,242, which is incorporated herein by reference in its entirety for all purposes.

[0026] Trochanteric Nail Anteversion Alignment System The trochanteric nail 12 may be inserted through the greater trochanter into the canal of the femur 2 to stabilize a variety of proximal femoral fractures. Femoral neck anteversion is the angle that represents the twist that exists in the femur 2 between the hip and knee. During insertion of the trochanteric nail 12, the surgeon matches the patient's natural anteversion angle to ensure that the lag screw 14 is centered through the femoral neck and femoral head. Due to the minimally invasive nature of the trochanteric nailing procedure, this anteversion alignment may be performed under x-ray guidance.

[0027] 1-5, an anteversion alignment system 40 is shown according to one embodiment. The anteversion alignment system 40 is configured to align the trochanteric nail 12 to an optimal anteversion angle prior to insertion of the lag screw 14. The anteversion alignment system 40 is integrated into the aiming arm 36 and / or the nail insertion handle 34. The anteversion alignment system 40 includes an anteversion guidewire or K-wire lumen 42 and a radiopaque goal post 44.

[0028] As best seen in FIG. 2, the anteversion guidewire or K-wire lumen 42 is located on the top surface of the insertion handle 30 along the central plane of the instrument. The anteversion guidewire or K-wire lumen 42 may be located on a protuberance or ridge on the top surface of the instrument 30. The anteversion guidewire or K-wire lumen 42 may be a channel or passageway extending from a first or proximal end 46 to a second or distal end 48. The lumen 42 is sized and dimensioned to receive a guidewire or K-wire 50 therethrough. The guidewire or K-wire 50, also known as a Kirschner wire, is a thin wire or pin having a distal tip 52 configured to temporarily engage bone. However, in this case, the anteversion K-wire 50 is utilized to indicate the anteversion angle during imaging without being inserted into the patient. The wire 50 allows visualization of the anteversion angle of the trochanteric nail 12. By being able to see this, the position of the instrument 30 may be adjusted as necessary prior to inserting the lag screw 14. As can best be seen in FIG. 4C, the optimal anteversion angle can be achieved when the wire 50 is centered through the femoral neck and head of the femur 2 on a lateral x-ray.

[0029] As best seen in FIG. 3, the goal posts 44 may include radiopaque goal posts 44 located on either side of the K-wire 50. In one embodiment, the radiopaque goal posts 44 include two parallel rows of pins made of a radiopaque material, such as stainless steel, titanium, tungsten, or other material that is visible upon imaging. The goal posts 44 may be aligned as two parallel rows of pins held in the handle 34, e.g., a pair of pins on each side. The goal posts 44 are aligned parallel to the center plane of the insertion handle 30 and are spaced apart to generally correspond, for example, to the outer diameter of the intramedullary nail 12. Under x-ray, the radiopaque carbon fiber handle 34 appears translucent, while the goal posts 44 appear opaque and are clearly present on the x-ray image. The goal posts 44 function as an alignment aid when aligning the C-arm to the insertion handle 30 on a lateral x-ray. The objective is to align the C-arm to be parallel to the center plane of the handle 30. As can be best seen in FIG. 5, optimum alignment is achieved when the peg 12 is centered between the goal posts 44.

[0030] 4A-4C detail one workflow for aligning the anteversion system 40. FIG. 4A shows a view of the nail 12 inserted into the femur 2 with the anteversion system 40, with the C-arm misaligned with the insertion handle 30. In this view, the anteversion system 40 and attached nail 12 appear tilted, the K-wire 50 is not centered on the nail 12, and the goalposts 44 are not parallel to each other or aligned with the nail 12. When the C-arm is adjusted to the optimal trajectory, the goalposts 44 are centered parallel around the nail 12, as shown in FIG. 4B. However, FIG. 4B still shows misalignment of the nail anteversion due to the K-wire being misaligned with the femoral neck and head. As shown in FIG. 4C, rotational adjustment of the nail 12 to optimal anteversion is achieved when the K-wire 50 is centered through the femoral neck and head. In this view, the implant holder 31 and attached nail 12 appear straight and vertically aligned, the K-wire 50 is centered through the femoral neck and head, and the goal posts 44 are aligned parallel to one another. Once the optimal anteversion is found, the lag screw 14 can be positioned within the nail 12 via the handle 34 and aligned within the body of the nail 12. Through this workflow, the anteversion alignment system 40 allows for placement of the lag screw 14 at the optimal anteversion angle as shown in FIG.

[0031] FIG. 5 shows a side view of the femur 2, intramedullary nail 12, handle implant holder 31 with the K-wire 50 removed, and lag screw 14. As shown, the lag screw 14 is inserted into the intramedullary nail 12 with optimal anteversion angle and placement at the femoral neck and femoral head. The anteversion alignment system 40 requires the use of minimal instruments and settings. The alignment system 40 utilizes a goal post 44 built into the nail insertion handle 34 and a single K-wire 50 that is readily available during the entire trochanteric nailing procedure. In addition, the anteversion alignment system 40 is non-invasive to the patient since the anteversion K-wire 50 is positioned to show the anteversion angle on an x-ray without being inserted into the patient.

[0032] Trochanteric nail anti-rotation system The trochanteric nail 12 may be positioned in the femoral canal through the greater trochanter to ensure stability for many types of fractures located at the proximal end of the femur 2. In some fractures, particularly base neck fractures occurring at the junction of the femoral neck and trochanteric region, the rotational stability of the hip fracture is low. In such fractures, the torque required to insert the lag screw 14 through the femoral neck and head may cause the femoral head to spin. Therefore, the surgeon may need to stabilize the fracture to prevent this rotation while inserting the lag screw.

[0033] 6-8D, an anti-rotation system 60 is shown according to one embodiment. The anti-rotation system 60 is configured to stabilize and prevent rotation of the femoral head as the lag screw 14 is inserted and rotated through the nail 12 into the neck and head of the femur 2. The anti-rotation system 60 is integrated into the aiming arm 36 and / or the nail insertion handle 34. The anti-rotation system 60 may include an anti-rotation sleeve bore 62 integrated into the carbon fiber aiming arm 36, an anti-rotation sleeve 64 positionable through the sleeve bore 62, and an anti-rotation guidewire 66 positionable through the anti-rotation sleeve 64.

[0034] As best seen in FIG. 6, the anti-rotation system 60 may include a plurality of anti-rotation sleeve holes 62 through the nail insertion handle 34. The holes 62 are sized and dimensioned to receive respective anti-rotation sleeves 64. The anti-rotation holes 62 may be formed directly in the carbon fiber aiming arm 36. Thus, no additional instrumentation or assembly is required. The sleeves 64 may be tissue protection sleeves configured to provide a guide path for inserting an anti-rotation guidewire 66 into the bone while minimizing damage to the surrounding soft tissue. The sleeves 64 extend from a first or proximal end 70 outside the handle 30 to a second or distal end 72 adjacent the bone. The sleeves 64 may be hollow tubes defining a channel sized and dimensioned to receive the guidewires 66 therethrough. The guidewires 66 may be Kirschner wires (K-wires) or other thin wires or pins having a distal tip 74 configured to temporarily engage the bone. The distal tip 74 may be threaded to provide additional stability and fixation within the bone.

[0035] 7, the anti-rotation system 60 may include up to six anti-rotation options with three paths on the left side of the aiming arm 36 and three paths on the right side of the aiming arm 36. The anti-rotation system 60 may include an upper pair of holes 62A, one on the left side and one on the right side, and a lower set of holes 62B, two on the left side and two on the right side. The upper pair of holes 62A may be located above the set of lower holes 62B through the body of the aiming arm 36. The upper pair of holes 62A may converge distally at an angle x1, and the lower set of holes 62B may converge at an angle x2 that is greater than angle x1. In one embodiment, angle x1 is an angle of 0.8° and the trajectories are offset 15° from the axis of the lag screw 14 in the A / P view. The lower set of holes 62B may be located 10 mm above and below the lag screw axis and have an axis that is aligned parallel to the lag screw 14 in the A / P view. The lower set of holes 62B may converge where angle x2 is an angle of 3°. Although specific locations and angles are shown, it is contemplated that other suitable paths may be used. The surgeon may use any or all of the six anti-rotation options to help stabilize the bone fragments in the proximal femur. The converging trajectory allows the anti-rotation guidewire 66 to consistently slip out of the intramedullary nail 12 and remain within the bone through the femoral neck and head. The converging anti-rotation sleeve trajectory may provide additional benefits. For example, with a converging trajectory, the anti-rotation wire 50 is more likely to remain within the bone as it is advanced through the femoral neck and head. Additionally, the converging angle may help prevent skiving and deflection of the wire 50 away from the bone during initial insertion.

[0036] 8A-8D, the anti-rotation system 60 may include a retaining pin 76 configured to secure the anti-rotation sleeve 64 within the anti-rotation bores 62. Retention of the sleeve 64 prevents the sleeve 64 from moving or falling off during use. As shown in FIG. 8A, the retaining pin 76 may include a PEEK retaining pin positioned to interfere with the anti-rotation bores 62. For example, one retaining pin 76 may be positioned along one side of each anti-rotation bore 62. As shown in FIG. 8B, the anti-rotation sleeve 64 may have a D-shaped shaft that interacts with the PEEK retaining pin 76. The D-shaped shaft of the sleeve 64 has a cross-sectional shape resembling a D-shape with a portion of the shaft defining a flat side 78. When the sleeve 64 is inserted into the unlocked position shown in FIG. 8C, the flat portion 78 of the D-shaped shaft clears the PEEK pin 76. When the sleeve 64 is rotated to the locked position shown in FIG. 8D, the shaft interferes with and deflects the PEEK pin 76 which engages the friction fit retention of the sleeve 64. The friction fit engagement eliminates all toggles and clearance between the bore 62 and the sleeve 64. This reduces the risk of sleeve deflection and improves wire placement accuracy. The retention pin 76 thus prevents the anti-rotation sleeve 64 from moving or falling off and minimizes skiving / deflection of the anti-rotation guidewire 50 during insertion.

[0037] Trochanteric Nail Lag Screw Sleeve Assembly The trochanteric nail 12 may be placed into the femoral canal via the greater trochanter to fixate multiple types of fractures in the upper portion of the femur 2. The trochanteric nail 12 may utilize a lag screw 14 that is inserted through the proximal diameter of the nail 12 into the femoral head. Prior to drilling and insertion of the lag screw, the lag screw sleeve and trocar are preferably inserted down to the bone. Once inserted, these sleeves act as a baseline for guidewire insertion, lag screw length measurement, lag screw drilling, and lag screw insertion. It is important that the lag screw sleeves are inserted all the way into the bone to establish a reliable and accurate measurement baseline. Advancing these large sleeves through soft tissue can cause resistance and difficulty to the user during insertion.

[0038] 9-16, a lag screw aiming assembly 80 is shown according to one embodiment. The lag screw aiming assembly 80 includes a lag screw sleeve assembly 82 configured to allow a surgeon to securely insert the sleeve into bone during a trochanteric nailing procedure. The lag screw sleeve assembly 82 fits into the aiming arm 36 of the nail insertion instrument 30. The lag screw sleeve assembly 82 extends from a proximal end 84 configured to interface with a handle (e.g., shown in FIG. 14A ) to a distal end 86 configured to contact bone. As shown in FIG. 9 , after the trochanteric nail 12 is inserted into the femur 2 to a desired depth and the aiming arm 36 is attached to the handle 34, the lag screw sleeve assembly 82 is inserted through the aiming arm 36.

[0039] As best seen in FIGS. 10A and 10B, the lag screw sleeve assembly 82 includes a lag screw driver sleeve 88, a lag screw wire sleeve 90, and a lag screw trocar 92. The lag screw driver sleeve 88 functions as an outer sleeve for the assembly as well as a cannula for the lag screw step drill, lag screw tap, and lag screw driver. The lag screw driver sleeve 88 defines a tubular body having a hollow central through channel 94 and an outer surface defining a plurality of notches or teeth 96 configured to engage a ratchet 104 or catch mechanism in the aiming arm 36. The ratchet mechanism acts as a retaining feature for the driver sleeve 88. The proximal end includes an enlarged head portion 98 that may act as a stop for the lag screw wire sleeve 90. The lag screw driver sleeve 88 advances through the aiming arm 36 and is retained therein.

[0040] FIG. 10B provides a lag screw driver sleeve with an extended distal end with a chamfered tip. This chamfered tip provides a more streamlined profile to facilitate insertion through soft tissue. Additionally, this chamfered tip allows clear visualization of the proximal end of the lag screw during insertion into the femoral head. This allows the surgeon to optimize the insertion depth of the lag screw under x-ray guidance. The lag screw driver sleeve also provides a measurement baseline at the distal end of the driver sleeve for lag screw length measurement. The sleeve assembly is inserted such that the measurement baseline feature on the lag screw driver sleeve contacts the bone. The lag screw wire is then inserted under x-ray to the optimal depth within the femoral head as determined by the surgeon. The wire must then be measured to determine the optimal lag screw length.

[0041] With further emphasis on FIGS. 11A-11C, advancement and retention of the lag screwdriver sleeve 88 may be facilitated by a ratchet assembly 102 within the aiming arm 36. The ratchet assembly 102 may include a ratchet 104 configured to interact with notches or teeth 96 on the driver sleeve 88 and a ratchet slide lock 106 configured to lock / unlock the ratchet 104. The ratchet assembly 102 allows a user to quickly engage and disengage the ratchet 104 for easy insertion and removal of the driver sleeve. The ratchet 104 may allow linear motion in one direction when engaged to provide controlled one-way motion and prevent rearward motion. The ratchet 104 may include a pawl 108 that interacts with the teeth 96 of the sleeve 88. As the pawl 108 advances past the teeth 96, the sleeve 88 moves in the permitted direction and prevents the sleeve 88 from moving rearward. The ratchet 104 may be a pivoting component to allow the pawl 108 to be engaged and disengaged from the teeth 96. The ratchet 104 may pivot about a fixed pivot pin 112 when a user depresses a thumb lever or paddle 110. The ratchet 104 may be spring loaded such that the ratchet 104 returns to an engaged position (e.g., the position shown in FIG. 11A) when the paddle 110 is released.

[0042] As shown in FIG. 11A, when the ratchet 104 is engaged, the sleeve 88 is free to advance through the aiming arm 36 and through the soft tissue, but is locked from moving in the reverse direction away from the patient. This mechanism allows the surgeon to reliably advance through the soft tissue without backing out the driver sleeve 88 as a result of soft tissue forces. As shown in FIG. 11C, the user may disengage the ratchet 104 from the ratchet teeth 96 on the driver sleeve 88 to adjust the sleeve position using the ratchet paddle 110. As shown in FIG. 11B, when the driver sleeve 88 is fully inserted, the ratchet slide 106 can be advanced forward to lock the driver sleeve 88 in place in both directions. In this configuration, the arm 114 of the slide 106 abuts the base of the ratchet 104, thereby preventing the ratchet 104 from pivoting out of engagement. This locked position sets a rigid baseline position for the remainder of the lag screw insertion process. When the lag screw 14 is inserted into the nail 12 and bone, the ratchet slide lock 106 can be pulled back to an unlocked position to disengage the ratchet 104 and facilitate easy removal of the sleeve.

[0043] 12A-12D, the lag screw wire sleeve 90 is inserted into and retained by the lag screw driver sleeve 88 and acts as a guide sleeve for the lag screw guidewire and trocar 92. The lag screw wire sleeve 90 defines a tubular body having a hollow central through channel 120 sized and dimensioned to receive a guidewire 134. The distal end of the wire sleeve 90 may include a distal tip having cutting flutes 122 that facilitate easy insertion as the wire sleeve 90 is pushed and twisted through the soft tissue. The proximal end of the wire sleeve 90 may include an enlarged head portion 124 that abuts the head 98 of the driver sleeve 88 when fully inserted and acts as a stop for the lag screw trocar 92.

[0044] The wire sleeve 90 may be retained within the driver sleeve 88 by, for example, a spring tab 126. The wire sleeve 90 defines a spring cut 128 that allows it to be snapped into the driver sleeve 88. For example, the spring cut 128 may extend along the shaft of the wire sleeve 90 and through the head portion 90. As the wire sleeve 90 is inserted through the driver sleeve 88, the spring tab 126 is deflected, allowing the wire sleeve 90 to pass. When the spring tab 126 reaches an undercut 130 in the driver sleeve 88, the tab 126 snaps into place, locking the wire sleeve 90 from backing out but allowing the wire sleeve 90 to spin freely. Retention of the wire sleeve 90 within the driver sleeve 88 maintains a rigid assembly between these components, but allows the wire sleeve 90 to rotate as needed.

[0045] The lag screw trocar 92 is retained within the wire sleeve 90. The trocar 92 may include a shaft 134 having a sharpened distal tip 136 configured to facilitate insertion of the assembly through soft tissue. As best seen in FIG. 12D, the trocar 90 may define a slight bend in its shaft 134. The bent trocar shaft 134 facilitates retention within the wire sleeve 90. For example, the bent shaft 134 may provide a friction fit retention within the wire sleeve 90 as the trocar 92 is inserted to prevent it from falling out of the assembly 82. A proximal portion of the trocar 90 may include an enlarged head portion 138, which may abut the head 124 of the wire sleeve 90 when fully inserted. A base of the head portion 138 may include an engagement member 140 configured to interact with a corresponding member 142 of the wire sleeve 90. For example, the mating members 140, 142 may include male extensions or protrusions with corresponding female recesses. In one embodiment, the mating members 140, 142 include a male hexagon on the trocar 92 and a female hexagon on the wire sleeve 90. When the trocar 92 is fully inserted into the wire sleeve 90 and the mating members 140, 142 are seated together, the instruments 90, 92 can pivot together to aid in passing the assembly through soft tissue. The proximal end of the trocar 90 may include a handle interface 144 configured to secure a handle 150, such as a quick connect handle.

[0046] 13-14B show the lag screw aiming assembly 80 with a handle 150 attached to the trocar 90. The handle 150 can be a quick connect handle with a collar 152 and a grip 154. The quick connect handle 150 provides the surgeon with additional leverage to advance through soft tissue. The collar 152 can include a quick attachment mechanism such as a push and click, twist and lock, or other fastening system. The handle grip 154 ​​can include a T-shape with a horizontal grip attached to a vertical axis or other suitable ergonomic design. Once attached, the handle 150 provides the surgeon with more leverage to push and twist the assembly through the soft tissue until it reaches the cortex of the femur. The cutting flutes 122 and sharp trocar tip 136 at the distal tip of the wire sleeve 90 allow the surgeon to push and twist the sleeve assembly 82 to advance through the soft tissue.

[0047] With emphasis on FIG. 15, after the trocar 92 is removed, the lag screw guide wire 158 may be passed through the lag screw wire sleeve 90. The lag screw sleeve assembly 82 facilitates the insertion and measurement of the lag screw guide wire 158. After the sleeve assembly 82 is inserted into the bone, the lag screw wire 158 may be inserted under x-ray or other imaging to an optimal depth within the femoral head as determined by the surgeon. The wire 158 may then be measured to determine the optimal lag screw length.

[0048] FIG. 16 shows a calibrated wire sleeve 90 configured to measure a lag screw guidewire 158. The calibrated wire sleeve 90 may include multiple markings 160, such as graduated markings. The markings 160 may be etched or printed on the outer surface of the wire sleeve 90, for example, with dots, lines, numbers, or other visual symbols to represent the depth or length of the wire 158. The calibrated wire sleeve 90 may be used to quickly take measurements without the need for additional measuring instruments. To take a measurement, the wire sleeve 90 may be disengaged from the driver sleeve retention and pulled back so that it is flush with the proximal tip of the guidewire 158. At this point, the calibrated value may be read from the proximal surface of the wire sleeve 90 where the end of the driver sleeve 88 aligns with a given marking 160. For example, the measurement shown in FIG. 16 is 115 mm. In this manner, measurements using the sleeve assembly 82 allow for quick and efficient measurements without additional instruments. Because the trochanteric nail procedure can be performed very quickly, the time saved is of significant value to the surgeon.

[0049] 17A-19B show a push connect handle assembly 170 according to one embodiment. The medical instrument uses and supports a variety of axial quick connect male and female interfaces that allow modularity and interoperability between the instrument and the handle and / or power system. In some cases, the female connection requires that the collar be pulled back to both rotate and axially lock the male and female connections together before the male connection can be inserted and the collar released.

[0050] In this embodiment, the push connect handle 170 eliminates the need for two-handed quick connect operation during assembly. Similar to the handle assembly 150, the push connect handle assembly 170 may include a collar 172 configured for quick and secure connection of different instrument tips or attachments, and a grip 174 configured to be held and operated by a user. The collar 172 may have a circular or cylindrical body defining a central through opening 176 and a female connection 178 defined at the bottom of the collar 172. The female connection 178 may be configured for quick push connect assembly to different instrument tips or attachments. As shown in FIG. 7A, the handle grip 174 may include a T-shape with a horizontal grip attached to a vertical shaft. In FIG. 7B, the handle grip 174 may include a vertical grip aligned with the central axis of the tool. It will be appreciated that any suitable ergonomic grip 174 suitable for securely holding an instrument may be used.

[0051] The collar 172 retains a threaded cap 180 having a pair of opposing arms 182 configured to retain a male portion 184 of an instrument tip. The male connection 184 may be a shaft having a free end that is receivable into the female connection 178 of the collar 172. In this embodiment, the male and female sides 178, 184 may be pressed together and locked without pulling back on the collar 172. As can be best seen in FIGS. 19A and 19B, the top of the cap 180 may be partially or completely surrounded by a spring-loaded ring 186. The ring 186 may have a circular body sized and dimensioned to fit within the through opening 176 of the collar 172. The ring 186 is biased downwardly via a spring 188 positioned at the top of the opening 176.

[0052] The pair of angled tracks or gaps 190 are configured to retain the pair of locking pins 192 therein. The angled tracks or gaps 190 may be defined between a distal tip 194 of the shaft 196 of the handle 174 and an upper surface of the threaded cap 180. The angled gaps 190 may be inclined or angled to point distally toward one another. The locking pins 192 may be configured to move along the tracks 190 to retain the male end 184 of the connection. In particular, the male side 180 of the connection pushes back against the locking pins 192, which rest on the angled gaps 190, and the spring-loaded ring 186, which allows only insertion but does not allow removal of the locking pins 192 after they have been spring-loaded into place. The quick connect locks both the male and female connections 178, 184 against rotation as well as axially. Removal may be accomplished by pulling back on the collar 172 on the female connection 176. The ability to push connect some handle types improves usability and reduces connection changeover time and frustration.

[0053] Trochanteric Nail Proximal Aiming System Trochanteric nails may be used to stabilize fractures of the proximal femur. The Trochanteric Nail Proximal Aiming System may be used by an orthopedic surgeon to insert the trochanteric nail into the patient, insert the lag screw through the proximal end, and insert the distal locking screw for short nails. The nail is first connected to the insertion handle and inserted into the femur after reaming is completed. The insertion handle allows the surgeon to advance, retract, and / or rotate the nail. The insertion handle is also used as a connection point for the aiming guide.

[0054] 20A-34, an aiming system 100 is shown according to one embodiment. The proximal aiming system 100 is similar to the lag screw assembly 80, with reference numbers referring to like elements. As can be best seen in FIG. 20, the aiming system 100 includes an implant holder 31 having a connecting portion 32 that is attachable to a proximal end of the nail 12, a handle portion 34 secured to the implant holder 31, an aiming arm 36 attached to the handle portion 34, and a driver sleeve 88 extending through the aiming arm 36 for targeting the lag screw hole 24 in the nail 12.

[0055] The aiming arm 36 may be constructed from a composite carbon fiber material and may be used to target the placement of the proximal lag screw 14 and distal locking screw without fluoroscopy and associated radiation. The lag screw targeting hole 38 may include a ratchet mechanism and a ratchet lock intended to control the insertion depth of the lag screw driver sleeve 88. A lag screw wire sleeve 90 and a trocar 92 may each be positioned through the lag screw driver sleeve 88. The lag screw wire sleeve 90 may be retained by the lag screw driver sleeve 88 to allow for the placement of a K-wire through the lag screw hole 24 of the nail 12. The lag screw trocar 92 may be inserted through the lag screw wire sleeve 90 to aid in removing soft tissue when targeting the lag screw hole 24 of the nail 12.

[0056] The lag screw driver 116 may be used to insert the lag screw 14 through the lag screw driver sleeve 88, and the lag screw retaining rod 118 may be used to hold the lag screw 14 on the driver 116 while inserting or removing the lag screw 14. The lag screw driver 116 and retaining rod 118 are used to hold and insert the lag screw 14 through the lag screw driver sleeve 88. The locking screw targeting holes are intended to target the placement of the locking screw driver sleeve, wire sleeve, and trocar. The aiming system 100 also allows the surgeon to rotationally fix the femoral neck and head using an anti-rotation wire sleeve that targets the placement of a K-wire around the trochanteric nail 12.

[0057] 21A-21D, the insertion handle assembly connects to and holds the nail 12 during insertion of the nail. The insertion handle assembly may include a carbon fiber composite for the handle grip 34 mated to the implant holder 31. The implant holder 31 may, for example, be press-fitted into one end of the handle 34 and secured using a pin 33. The opposite end of the insertion handle 34 may have alignment holes 35 (e.g., a pair of locating pin holes) and a threaded insert 37 used to orient and connect the aiming arm 36. The alignment holes 35 and threaded insert 37 may be used to attach various trochanteric nail aiming arms 36. The threaded insert 37 may be retained within the handle 34 via a pin 39 or in another suitable manner. The insertion handle 34 may include one or more radiographic marker pins 43 visible under x-ray or other imaging. The radiological marker pin 43 may help guide the placement of the nail 12 under x-ray, thereby allowing the surgeon to position the implant 12 more precisely.

[0058] The implant holder tip or connecting portion 32 may be a stainless steel shaft that protrudes from the handle grip 34 and acts as a connection point for the nail 12. The shaft of the connecting portion 32 defines an internal thread for holding a connection bolt 270 used to connect the nail 12 to the insertion handle 34. In one embodiment, the implant holder tip or connecting portion 32 may be a keyed implant holder tip configured to mate with both a 125° nail and a 130° nail in a single orientation. As best seen in FIGS. 21C-21D, the implant holder tip 32 may include keyed interfaces 21, 41 that ensure that the nail 12 is connected in the correct orientation to the insertion handle 34. The stainless steel shaft of the connecting portion 32 may have orientation tabs 41 configured to mate with corresponding recesses 21 in the proximal end 20 of the nail 12. For example, three equally spaced orientation tabs 41 may engage with respective recesses 21 to properly position the nail 12 relative to the insertion handle 34. 22A and 22B, the 125° and 130° nail implants 12 may have three keyed slots 21. The spacing of the keyways 21 may differ between these two nail types. The implant holder tip 32 may be configured to only fit both of these nail tips in a single orientation to ensure proper nail placement. Thus, a single insertion handle 34 may be used for both nail types, ensuring that the nail 12 can only be connected to the insertion handle 34 in the correct orientation for insertion and targeting.

[0059] 23A-23C, the nail connection bolt 270 is configured to secure the trochanteric nail 12 to the insertion handle 34. The cannulated nail connection bolt 270 may include a top or head 272, a cylindrical shank 274, and a lower threaded portion 276 configured to engage the corresponding threads 23 of the nail 12. The male threads 276 on the nail connection bolt 270 pass through the female threads 45 of the implant holder 31 to hold these parts together. The implant holder 31 is designed with the female threads 45 to hold the nail connection bolt 270, for example, to prevent the connection bolt 270 from falling onto the floor or becoming dislodged during use. These same male threads 276 on the nail connection bolt 270 are then used to connect with the nail 12.

[0060] As shown in FIGS. 24A-B and 25A-C, an alignment pin 47 and a mounting knob 49 can be used to assemble the aiming arm 36 to the insertion handle 34. The system 100 can include two or more different aiming arms 36 intended to target the nail 12 at 125° and 130°. The aiming arm 36 can define one or more holes 38A, 38B having trajectories that target the placement of the lag screw, locking screw, and anti-rotation wire sleeve. For example, the hole 38A can target the proximal lag screw opening 24 of the nail 12, and the hole 38B can target the distal locking screw opening 26 of the nail 12. One or more retaining pins 51, such as PEEK retaining pins, can be used to facilitate retention of the driver sleeve and anti-rotation wire during use. A ratchet mechanism 104 and a ratchet lock 106 control the insertion depth of the lag screw driver sleeve 88.

[0061] 26A and 26B show anti-rotation wire sleeves 68 according to one embodiment. In this embodiment, the aiming arm 36 defines four holes 62 that target the placement of the anti-rotation wire sleeves 68. Guide wires or K-wires 66 can then be inserted through these sleeves 68 to prevent rotation of the femoral head during placement of the lag screws. These K-wires 66 can also be used to guide the insertion of cannulated screws into the femoral head on either side of the nail 12.

[0062] 27A-27C, the lag screw driver sleeve 88 is configured to be inserted through the aiming arm lag screw hole 38. Ratchet teeth 96 on the shaft interact with the aiming arm 36 to facilitate control of the insertion depth of the sleeve 88. In one embodiment, the flat side 95 of the shaft is configured to mate with the D-shaped hole 38 in the aiming arm 36 to ensure that the sleeve 88 is inserted in the correct orientation. In this embodiment, the female threads 97 of the sleeve 88 are configured to mate with corresponding male retaining threads 91 on the wire sleeve 90 to retain the lag screw wire sleeve 90.

[0063] 28A and 28B show a lag screw wire sleeve 90 with lag screw length calibration graduations according to one embodiment. The lag screw wire sleeve 90 is sized and dimensioned to be inserted into and retained by the lag screw driver sleeve 88. The wire sleeve 90 guides the insertion of both the K-wire and the lag screw trocar 92. One or more markings 160, such as calibration markings, can be used to determine the lag screw length required. To make this measurement, the wire sleeve 90 can be seated flush with the lag screw driver sleeve 88. The K-wire 158 is then inserted to the desired depth. The wire sleeve 90 is then pulled back so that the proximal surface of the sleeve 90 is aligned with the proximal tip of the K-wire 158. In this position, the proximal surface of the lag screw driver sleeve 88 indicates the required lag screw length. The lag screw wire sleeve 90 allows the user to use the calibration markings 160 on the shaft to determine the lag screw length without the use of a separate depth gauge. This reduces the number of instruments required and simplifies the workflow.

[0064] FIGURE 29 illustrates a lag screw trocar 92 according to one embodiment. The lag screw trocar 92 is used to remove soft tissue as the lag screw driver sleeve 88 and wire sleeve 90 are inserted. In one embodiment, the trocar 92 may have a bent shaft 134 that facilitates retention of the trocar 92 within the lag screw wire sleeve 90. FIGURES 30A and 30B illustrate the lag screw driver sleeve 88 inserted through the aiming arm 36, the lag screw wire sleeve 90 positioned through the driver sleeve 88, and the lag screw trocar 92 positioned through the wire sleeve 90.

[0065] 31A-31C and 32A-32B, a lag screw driver 116 and a lag screw retaining rod 118 are shown according to one embodiment. The lag screw driver 116 is used to insert the lag screw 14 through the lag screw driver sleeve 88. The lag screw retaining rod 118 is inserted into and retained by the lag screw driver 88 to secure the lag screw 14 to the driver 116 during insertion or removal. The lag screw driver 116 includes a hollow shaft 117 and a handle 119, such as a T-handle. The shaft 117 may provide depth indicator markings 131 to indicate when the driver 116 has reached a desired depth relative to the sleeve 88. The shaft 117 terminates in a distal tip 121 that interacts with a corresponding recess in the lag screw 14. The proximal end of the shaft 117 defines female retaining threads 123 that interact with corresponding male threads 125 on the retaining rod 118. The retention rod 118 includes a shaft 127 that is sized and dimensioned to fit over the driver shaft 117. The distal end of the shaft 127 includes connecting threads 129 configured to interface with the lag screw 14. The lag screw retention rod 118 is inserted into the lag screw driver 116 using the retention threads 123, 125 on each portion and is retained by the lag screw driver 116. The retention rod 118 threads past and is retained by the internal threads 123 on the driver 116. The distal connecting threads 129 on the retention rod 118 retain the lag screw 14 to the driver 116 while the lag screw 14 is being inserted or removed.

[0066] 33A-33D and 34, an impaction mallet 440 may be used to insert and remove the nail 12. The mallet 440 includes a mallet head 442, a mallet handle 444, and a mallet shaft 446 connecting the head and handle 442, 444. The mallet head 442 may have a generally rectangular shape with a slot 448 defined therein. The mallet head 442 may have a top surface 450, an opposing bottom surface 452 through which the shaft 446 extends, and an opposing striking surface 454 for applying an impact force. The slot 448 may be defined through the top surface 450 and may define a first portion along a central axis z1 extending along a central plane through the instrument 440, and a second portion along a diagonal axis z2 extending along a transverse plane. The bottom region of the slot 448 may be inclined or angled. The depth of the slot 448 along axis z1 may be deeper than the depth of the slot 448 along axis z2. During insertion, the mallet 440 impacts an impaction rod attached to the insertion handle 34 to drive the implant 12 into the femur. During removal, the slap removal shaft 460 may be used as shown in FIG. 34. In FIG. 33C, the slap removal rod 460 is inserted into the slot 448 along axis z2. The mallet 440 is rotated 45° to the position shown in FIG. 33D, where the rod 460 is seated in the deeper area of ​​the slot 448 along axis z1. The slot 448 surrounds the removal shaft 460 and slides along the shaft 460 to push the implant 12 out of the patient. The geometry of the slot is configured to hold the mallet 440 on the shaft 460 during slap removal. A retention slot 460 on the mallet 440 prevents the mallet 440 from slipping off the slap removal rod 460 during impaction.

[0067] Intramedullary Nail Coring Reamer Instrument Intramedullary nails, such as trochanteric nails, are inserted into the canal of a long bone via its axial end (e.g., the piriform or greater trochanter for antegrade and trochanteric nails, respectively, and the intercondylar notch for retrograde nails) to stabilize various long bone fractures. Prior to inserting the nail, access to the canal of the long bone may be freed at one of these axial ends, for example, by reaming the dense cortical wall over the entry wire used to establish the starting point or hole. Open reaming may be performed using a tapered rigid reamer, which works with sharp side cutting edges to scrape away bone and flutes to push the cut material out. However, if a fracture line is present at the preferred entry point, the tapered rigid reamer has a tendency to push adjacent bone fragments apart instead of cutting a hole of the desired size. This may affect the location, rotation, and alignment (e.g., reduction) of the bone fragments.

[0068] 20A-21B, a coring reamer instrument 200 is shown according to one embodiment. The coring reamer 200 is configured to create a hole or opening in the axial end of a long bone to access the medullary canal while minimizing the possibility of breaking a bone or detaching bone fragments. The coring reamer 200 is configured to cut and collect material within the body of the reamer 200, which can later be removed and used as a bone graft if desired. The coring reamer 200 extends from a proximal end 202 configured to interface with a handle (e.g., a quick connect handle) to a distal end 204 configured to cut bone along a central longitudinal tool axis. The coring reamer 200 includes a coring tip 206 configured to cut and collect bone, a core ejector 208 configured to eject the collected bone, and a reamer shaft 210 configured to support and move the core ejector 208.

[0069] The coring tip 206 includes a hollow cylindrical body or tubular shaft 212 with a through opening 214 configured to receive the cut bone. The coring tip 206 includes leading cutting teeth 216 on the diameter of the rotating shaft 212 with a hollow core, which avoids potential splitting of the reduced fracture by not pushing material outward, but instead packing the removed material inside the device. The teeth 216 may be spaced and aligned around the circumference of the distal end of the coring tip 206. The tooth profile may be straight, angled, or other geometric shapes configured to enhance cutting efficiency and direct the cut material toward the inside of the coring tip 206.

[0070] The hollow opening 214 may be cylindrical such that as the cut bone is filled into the opening 214, it forms a cylindrical block or core of filled bone. One or more windows on the side of the coring tip 206 may be in fluid communication with the opening 214 to visualize the amount of bone collected and / or to facilitate removal of the bone. As the instrument 200 advances, it cuts through the cylindrical block of material that will be filled into the hollow core of the reamer 200, which may be removed as a single piece.

[0071] This filled bone material can be pushed out of the core using a sliding ejector component 208 and used as autogenous bone graft if desired. The core ejector 208 can be a hollow tube having a proximal portion 218 that is gripped by a user and a distal portion 220 that is receivable inside the coring tip 206. The exterior surface of the proximal portion 218 of the ejector 208 can be patterned with a series of ridges or grooves or other texture to enhance grip so that the user can slide the ejector 208 along the longitudinal tool axis. The distal portion 220 of the ejector 208 can have a cylindrical body sized and dimensioned to be received inside the hollow opening 214 through the coring tip 206. The ejector 208 pushes the bone core out of the coring tip 206 when advanced proximally.

[0072] The reamer shaft 210 supports the core ejector 208 and is configured to attach to a user handle. The reamer shaft 210 may have a cylindrical body having a proximal member 222 and a distal member 224. The distal member 224 may have a cylindrical body sized and dimensioned to be received through the core ejector 208. The proximal end 202 of the reamer shaft 210 may include a connector interface 226, such as a male quick connect for attachment to a quick connect handle. The male connector 226 may be configured to connect to a power tool (e.g., a power drill) to rotate the assembly for cutting with the coring tip 206.

[0073] 36A-36B, the location or relative position of the reamer shaft 210 with respect to the core ejector 208 can be locked. The distal member 224 of the reamer shaft 210 extends through the core ejector 208, and the inner surface of the core ejector 208 can engage the outer surface of the reamer shaft 210 at a discrete location. In one embodiment, the distal member 224 of the reamer shaft 210 includes a locking groove 228 configured to receive and guide a spring wire 232 attached to the core ejector 208, and a wire track 230. FIG. 36A shows the core ejector 208 with the proximal gripper 218 retracted on the reamer shaft 210 such that the wire 232 is received within the locking groove 228. As the core ejector 208 moves distally to eject the bone core, the spring wire 232 on the ejector 208 interacts with the wire track 230. 36B, the wire 232 is received at its distal most point within a second locking groove 228 on the reamer shaft 224. As the core ejector 208 slides along the reamer shaft 210, the wire 232 engages onto the ejector 208 to provide a tactile and locked location along the shaft of the reamer 210. Although a wire / groove engagement interface is illustrated, it should be understood that other suitable locking mechanisms may also be used.

[0074] The coring reamer 200 may be used to cut a precise diameter hole in the axial end of a long bone to access the medullary canal for an intramedullary nail. The coring reamer 200 may cut the bone and collect the cut bone within the body of the reamer 200. The cut bone may be packed into a core which may be easily removed using the core ejector 208. The coring reamer 200 may help minimize the chance of separating bone fragments or aggravating a fracture during cutting.

[0075] Trochanteric Nail Guide Wire Pusher Trochanteric nails can be positioned in the femoral canal through the greater trochanter to fixate multiple types of fractures in the upper part of the femur. In preparation for the insertion of the nail, the medullary canal can be reamed. To begin the reaming, the surgeon can first insert a ball-tip guidewire through the entire length of the medullary canal. A cannulated reamer head can be connected to a cannulated reamer shaft, which can be connected to a cannulated power drill for reaming. A cannulated reaming instrument can be threaded over the ball-tip wire to guide the reamer through the length of the canal. When the reaming is completed, the reaming instrument is removed, but the ball-tip guidewire can remain in the canal to guide the insertion of the nail. A common problem during this procedure step is that the ball-tip wire can come out with the reaming instrument when it is removed. This problem can be mitigated by the use of a guidewire pusher.

[0076] 37-43, a guidewire implant 240 is shown according to one embodiment. The guidewire pusher 240 may be used to hold the ball-tip guidewire in place as the reamer and reamer shaft are removed from the medullary canal. As shown in FIG. 37, the guidewire pusher 240 may include a proximal knob 242, a neck 244, and a long shaft 246 having a distal tip 248 for pushing the ball-tip guidewire 250. The knob 242 may have a rounded profile, such as a cylinder with flattened or contoured sides, that is easily held by a user. The guidewire pusher 240 may include one or more ball-tip wire-engaging surfaces for interacting with the ball-tip guidewire 250.

[0077] 38A and 38B show examples of ball-tip wire engagement with guidewire pusher 240. As the name implies, ball-tip wire 250 is a wire with an end having a spherical shape that minimizes sharp edges and points. In FIG. 38A, distal tip 248 of shaft 246 defines a concave recess 252 sized and dimensioned to receive the ball tip of wire 250. In this embodiment, shaft 246 of guidewire pusher 240 may have a diameter equal to ball-tip wire 250, which may be used to push wire 250 partially flush with the cannula. In FIG. 38B, guidewire pusher 240 defines an enlarged recess 254 defined on one side of proximal knob 242. Recess 254 may have a circular shape with a larger diameter than wire 250. Recess 254 may include a flat or concave bottom surface for contacting the end of wire 250. In this embodiment, the larger wire-engaging recess 254 may be used to hold the wire 250 in place when the reaming instrument is removed.

[0078] 39A and 39B show three separate fine engagement surfaces that may be used to engage the ball-tip wire 250. In FIG. 39A, the proximal knob 242 has a protruding mouth 256 with a cup-like or recessed recess 258 for holding the end of the ball-tip wire 250. The mouth 256 may be positioned across the knob 242 opposite the enlarged recess 254. In FIG. 39B, recesses 260 may be positioned above and below the mouth 256. The recesses 260 may be angled or sloped with a flat or rounded bottom surface configured to contact the end of the wire 250, thereby providing a tight engagement with the ball-tip wire 250. The guidewire pusher 240 includes several options for engaging the ball-tip guidewire 250 when working through a cannulated instrument. The various alternatives may be combined to create an instrument that is adaptable to a variety of applications and surgeon preferences.

[0079] 40-43, in addition to the guidewire engagement function, the guidewire pusher 240 may be used to provisionally assemble the trochanteric nail 12 to a nail insertion instrument, such as the nail implant holder 31. In this embodiment, the trochanteric nail 12 may be secured to the nail implant holder 31 using a connecting portion 32 and a cannulated nail connection bolt 270. As shown in FIG. 41A, the cannulated nail connection bolt 270 may include a top or head 272, a cylindrical shank 274, and a threaded portion 276 configured to engage corresponding threads in the nail 12.

[0080] The head 272 of the connection bolt 270 may have an outer surface with protrusions or teeth extending around the circumference of the head 272. The top surface of the head 272 may define a drive recess 278 configured to receive a driver to assemble and tighten the implant 12 to the insertion handle 30. The drive recess 278 is also configured to mate with a corresponding key 280 at the base of the neck 244 on the guidewire pusher 240. In one embodiment, the nail connection bolt 270 defines a hex drive recess 278 configured to be engaged by a hex driver instrument (not shown) and a hex key 288 of the guidewire pusher 240. While a hex shaped mating engagement is illustrated, it will be understood that other suitable shapes of recess and key or other engagement are contemplated.

[0081] The mating drive interface 280 of the guidewire pusher 240 can help aid in the assembly of the structure. As shown in FIG. 42, the distal tip 248 of the guidewire pusher 240 can be inserted through the nail connection bolt 250, the nail implant holder 31, and through the intramedullary nail 12. As shown in FIG. 43, the long shaft 246 of the guidewire pusher 240 can be used to axially orient the three components. The key 280 of the guidewire pusher 240 can be used to engage and advance the connection bolt 270 through the nail implant holder 31 and into the nail 12. In this manner, the guidewire pusher 240 can be used to aid in the assembly of the trochanteric nail 12 to the insertion handle 30 and the connection bolt 270. It can often be difficult for one person to assemble the three instruments at once using a standard hex driver. The guidewire pusher's ability to capture and orient all of the components transforms a tedious task into an efficient two-handed operation.

[0082] Intramedullary Nail Distal Targeting System Intramedullary nails may be positioned within the medullary canal of a long bone to treat a fracture. Trochanteric nails may be inserted into the canal of the femur through the greater trochanter. Antegrade nails may involve entry through either the piriformis fossa (PF) or the greater trochanteric (GT) tip of the femur. In addition to proximal fixation (e.g., lag screws), bone anchors or fasteners may also be inserted through the distal end of the nail to provide distal locking. Targeting systems may be useful in aiding in the accurate and reliable insertion of distal fasteners into the intramedullary nail.

[0083] 44A-51, a distal targeting system 300 is shown according to one embodiment. The distal targeting system 300 is configured to target screw placement into the distal slots and holes 26 of several types of intramedullary nails 12, including long trochanteric nails, antegrade greater trochanteric nails, and antegrade piriformis nails. For example, FIG. 44A illustrates one embodiment of a long trochanteric nail 12 having a trochanteric insertion handle 30, and FIG. 44B illustrates one embodiment of an antegrade nail 12 having an antegrade insertion handle 30.

[0084] Regardless of the type of nail and insertion handle, the distal targeting system 300 provides the surgeon with a method to accurately and reliably aim and insert fasteners and screws through the distal hole 26 of the intramedullary nail 12. The distal targeting system 300 allows the surgeon to target both left and right nails 12 that vary in length in suitable increments, for example. The compatibility of interchangeable nails provides the surgeon with a wide range of capabilities using a single instrument set. The distal targeting system 300 also allows the deflection adjustment to account for any deflection of the nail 12 that may occur upon entry into the medullary canal.

[0085] 45A, the distal targeting system 300 includes a distal aiming arm 302 attachable to a nail insertion handle 30 coupled to the intramedullary nail 12, a deflection assembly 304 attachable to the distal aiming arm 302, a targeting module 306 attachable to the deflection assembly 304, and a sleeve 306 positionable through the targeting module 306 to set the trajectory of a distal fastener to interact with the distal opening 26 of the nail 12. The distal aiming arm 302 has a body extending from a proximal end 310 attached to the nail insertion handle 30 to a free distal end 312. An inner surface 314 faces toward the intramedullary nail 12 and an opposite outer surface 316 faces outward.

[0086] 46A and 46B, the distal aiming arm 302 includes a mounting head 320 connected to the insertion handle 30 and a plate 322 for supporting the deflection assembly 304. The mounting head 302 is designed to connect with any nail insertion handle 30, such as a trochanteric nail insertion handle or an antegrade insertion handle. The mounting head 320 may be an angled block having one or more through holes 324 configured to align with mating holes in the insertion handle 30. For example, the two outer holes 324 may be configured to receive alignment pins 326 and the central hole 324 may be configured to receive a connecting screw 328. To assemble the distal aiming arm 302 to the insertion handle 30, the two alignment pins 326 on the mounting head 320 are assembled into mating holes in the insertion handle 30, and then the connecting screw 328 is used to tighten the assembly to facilitate firm targeting.

[0087] With further emphasis on FIGS. 46C and 46D, the mounting head 320 may include two mirrored connecting surfaces 330 to facilitate targeting of the left and right nail 12. The connecting surface 330 may have two angles y1, y2 acting in different planes. The first angle y1 of the connecting surface 330 may exist to account for the anteversion of the nail 12 (e.g., an angle of 12° accounts for 12° of the anteversion of the nail). In one embodiment, the distal locking hole 24 may be rotated about the longitudinal axis of the nail 12 by 12° relative to the proximal hole 22 to account for the anatomy of the femur. The second angle y2 of the connecting surface 330 may exist to account for the lateral bending of the nail 12 (e.g., an angle of 2.5° for a 5° lateral bending of the nail). For example, the trochanteric long nail and the antegrade greater trochanteric nail may have a 5° lateral bending, while the antegrade piriform fossa nail may lack a lateral bending.

[0088] The plate 322 of the distal aiming arm 302 may extend distally from the mounting head 320. The plate 322 may be substantially flat between the inner surface 314 and the outer surface 316. The plate 322 may have an arcuate bend or curve from the mounting head 320 and a generally straight portion toward the distal end 312. The inner surface 314 and the outer surface 316 of the plate 322 may define a number of mounting recesses or dovetails 332 configured to secure the deflection assembly 304. As can be best seen in FIG. 45B, the mounting dovetails 332 are designed to accommodate incremental placement of the deflection assembly 304. The dovetails 332 may be present on both sides 314, 316 of the aiming arm 302 to allow reversibility between left and right nails 12. The dovetails 332 may include a series of recesses or female recessed areas along one side of each face 314, 316 configured to receive the feet 366 of the deflection assembly 304. In one embodiment, the dovetails 332 may be equally spaced at defined increments (e.g., 20 mm increments). The dovetails 332 may be positioned to target nail lengths ranging from 240 mm to 480 mm in 20 mm increments, for example. Each female dovetail 332 may define an arched surface at the bottom of the dovetail 322 configured to receive a corresponding arched surface on the foot 366 of the deflection assembly 304.

[0089] Each dovetail 332 may include a ball detent divot 334 configured to receive a ball detent 368 of the deflection assembly 304. The ball detent divot 334 is a partially spherical recess sized and dimensioned to receive a portion of the ball detent 368. The ball detent divot 334 may be located in any suitable location within each dovetail 322 to align with the deflection assembly 304. After the deflection assembly 304 is connected to the aiming arm 302 via the dovetail 332, the ball detent 368 on the deflection assembly 304 fits within the ball detent divot 334. This holds the deflection assembly 304 in place and provides tactile feedback to the user that the portion is fully seated.

[0090] 47A-G illustrate a deflection assembly 304 according to one embodiment. The deflection assembly 304 allows for vertical adjustment of the targeting trajectory to allow for anterior or posterior deflection as the intramedullary nail 12 is inserted into the medullary canal. The deflection assembly 304 can include an outer casing 340, a dovetail assembly 342 for attachment to the distal aiming arm 302, and an adjustment assembly 344 for adjusting the vertical position of the deflection assembly 304 relative to the distal aiming arm 302.

[0091] The outer casing 340 may include a handle portion 346 for holding the deflection assembly 304, a base 348 for securing the targeting module 306, and a neck 350 for holding the vertical adjustment assembly 344. The handle portion 346 may have a grip for holding the deflection assembly 304 by a user. The base 348 may have an enlarged width and a bottom surface 352 configured to mate with the targeting module 306. For example, the bottom surface 352 of the casing 340 may define a dovetail 354 configured to receive a corresponding tenon 410 on the targeting module 306. A blind hole 356 may extend vertically through the neck 350 and handle portion 346 of the casing 340. Opposing vertical windows 358 are provided through the handle portion 346 of the casing 340 and are in fluid communication with the blind hole 356 to provide for vertical movement of the dovetail assembly 342. A cross window 360 is provided through the casing neck 350 and is in fluid communication with the blind bore 356 for receiving the coarse adjustment screw release.

[0092] The deflection assembly 304 is attached to the distal aiming arm 302 using a dovetail assembly 342. The dovetail assembly 342 includes a moveable block 362 and a cam lock 364 attached to a male dovetail or foot 366 having a ball detent 370. As best seen in FIG. 47B, the foot 366 includes a male dovetail protrusion having a planar outer surface and an arcuate bottom surface configured to be received within a corresponding female dovetail recess 332 in the plate 322. After the deflection assembly 304 is attached to the distal aiming arm 302, the cam lock 364 is used to secure the attachment. The cam lock 364 functions using a cam lever 370 connected to the male dovetail or foot 366 in the aiming arm 302. The foot 366 is positioned on one side of the block 362 extending through the window 358, and the cam lever 370 is positioned on the opposite side of the block 362 extending through the opposite window 358. An internal compression spring 372 maintains a preload against the male dovetail 366 to ensure easy assembly to the aiming arm 302. FIG. 47E shows the cam lock 364 in a locked position with the cam lever 370 pivoted upward to lock the dovetail assembly 342. FIG. 47F shows the cam lock 364 in an unlocked position with the cam lever 370 pivoted outward.

[0093] The adjustment assembly 344 provides vertical adjustment of the deflection assembly 304 relative to the distal aiming arm 302. The vertical adjustment of the deflection assembly 304 can be operated in two different ways: fine adjustment and course adjustment. The fine deflection adjustment allows the user to finely adjust the vertical position of the deflection assembly 304. The coarse deflection adjustment allows the user to more quickly adjust the targeting system to account for the deflection of the nail. The adjustment assembly 344 includes a fine adjustment knob 380 and a coarse adjustment button 382. The fine adjustment knob 380 includes an upper knob 384 attached to a threaded shaft 386 that translates the rotational movement of the knob 384 into vertical movement of the block 362. The coarse adjustment button 382 is held within the neck 350 of the casing 340 through a window 360, with a portion of the button 382 protruding through the window 360. The threaded shaft 386 of the fine adjustment knob 380 extends through the neck 350 , through the coarse adjustment button 382 , and through a blind hole 356 in the body of the casing 340 .

[0094] As best seen in FIG. 47G, the coarse adjustment button 382 defines a threaded through opening that engages / disengages the threads of the threaded shaft 386. A pin 388 slides along the slot, preventing disassembly from the neck 350. In the initial position, the threaded shaft 386 may be engaged by the coarse adjustment mechanism. The distal end of the shaft 386 is secured to the top of the block 362. The threaded knob 380 allows the surgeon to make fine deflection adjustments. The screw release button 382 allows the surgeon to make larger adjustments quickly, allowing course adjustment of the vertical position. When the screw release button 382 is pressed, the threads are disengaged from the shaft 386, allowing free up and down movement. Ball detents may be placed in, for example, 5 mm increments along the full adjustment range to provide tactile feedback to the surgeon as the instrument is adjusted. The user may also use the threaded knob 380 for fine manipulation of the vertical adjustment. One turn of knob 380 can provide, for example, 1 mm of vertical movement, allowing the user to make small adjustments to the instrument position.

[0095] As best seen in FIG. 47E, the casing 340 of the deflection assembly 304 may include one or more markings 390, such as graduated markings, along the edge of the window 358. The markings 390 may be etched or printed on the exterior surface of the handle 346, for example, with dots, lines, numbers, or other visual symbols, to indicate the vertical height or position of the deflection assembly 304. An indicator 392 may also be etched or printed on the face of the block 362. The indicator 392 on the block 362 indicates the vertical measurement to the user as the block 362 travels vertically along the window 358. The markings 390 may be used to quickly locate the desired positioning.

[0096] 48A-48C, examples of targeting modules 306 are shown. Different targeting modules 306 may be used to precisely target a particular type of nail 12 (e.g., trochanteric nail, antegrade greater trochanter, antegrade piriform fossa). FIGS. 48A-48C show three different types of targeting modules 306: antegrade greater trochanter (GT) in FIG. 48A, trochanteric nail in FIG. 48B, and antegrade piriform fossa (PF) in FIG. 48C. The targeting modules 306 are configured to target left and right nails 12. It should be understood that any suitable configuration may be used to target a particular intramedullary nail 12.

[0097] Each targeting module 306 may include a targeting block having an inner surface 404 facing the intramedullary nail 12 and an opposing outer surface 406 facing outward. It will be appreciated that the side may be reversible depending on the handedness of the nail 12. One or more openings or holes 408 extend between the inner surface 404 and the outer surface 406, the openings or holes 408 being positioned to precisely target the distal holes 26 of the nail 12, including the dynamic and static slot locations in each nail type. The holes 408 may be different or overlapping. The trajectories of these holes 408 may be positioned at an angle of +2.5° relative to the trochanteric and GT modules. This angle is added to the 2.5° angle on the aiming arm mounting head 320 to align with the 5° lateral bending characterized on the trochanteric and GT nails. The PF module may include a -2.5° angle to offset the 2.5° angle on the aiming arm mounting head 320 to align with a PF nail that does not include a lateral bend.

[0098] As shown in FIG. 49, the targeting module 306 is attached to the deflection assembly 304. In one embodiment, the targeting module 306 includes a tenon 410 configured to fit into a corresponding groove 354 in the bottom surface 352 of the casing 340 of the deflection assembly 304. The tenon 410 may protrude from each of the top and bottom surfaces of the block 402 so that the block 402 can be reoriented and flipped depending on the nail. The joint between the targeting module 306 and the deflection assembly 304 may be a sliding dovetail joint between the tenon 410 and the dovetail 354. In one embodiment, the targeting module 306 is attached to the deflection assembly using a snap-fit ​​design that allows for quick attachment. The attachment may be further secured with an optional side bracket 412 that extends along one side of the block 402. The side bracket 412 may be integral with the block 402 or a separate component. The side bracket 412 may include one or more openings 414 configured to receive a fastener, such as a threaded screw, to further secure the side bracket 412 to the base 348 of the deflection assembly 304. This threaded interface may facilitate a more robust connection of the module 306 to the deflection assembly 304 for precise targeting.

[0099] As shown in FIGS. 50A-50C, the targeting holes 408 of the targeting module 306 may include one or more retaining pins 420 configured to retain the sleeve 308 therein. Similar to the retaining pins 76, the retaining pins 420 are configured to secure the D-shaped sleeve (shown in FIG. 50C). The module holes 306 may include PEEK retaining pins 420 for self-retention of the driver sleeve 308. The PEEK retaining pins 420 may be positioned to interfere with the targeting holes 408. For example, one retaining pin 420 may be positioned along one side of each targeting hole 408 such that the pins 420 intersect the module holes 408. The sleeve 308 may have a D-shaped shaft that interacts with the PEEK retaining pins 420. The D-shaped shaft of the sleeve 308 has a transverse shape resembling a D shape with a portion of the shaft defining a flat side 422. To engage this self-retaining feature, the sleeve 308 is inserted with the flats 422 of the shaft oriented parallel to the longitudinal axis of the PEEK pin 420 and then rotated 180 degrees so that the shaft interferes with the retaining pin 420. The resulting friction fit retains the sleeve 308 within the targeted hole 408.

[0100] FIG. 51 shows the sleeve 308 positioned through one opening 408 of the targeting module 306 to align with the distal opening 26 of the intramedullary nail 12. The system 300 may also include an alignment display 430 to provide the surgeon with quantitative information to determine exactly how much deflection has occurred. This allows the surgeon to more quickly and reliably adjust the targeting system to the optimal position. The alignment display 430 may be a radiolucent instrument with radiopaque measurement markings that are attachable to or integral with the targeting module 306. The measurement markings, such as graduated markings, may include dots, lines, numbers, or other visual symbols to indicate the vertical position of the targeting module 306. The alignment display 430 may include a radiopaque marker that is visible under x-ray or other imaging, which informs the user of the exact measurement of the nail's deflection. The alignment display 430 allows the surgeon to quantify the amount of adjustment required and clearly identify when the system has reached the optimal targeting position at the center of the nail hole 26. This allows the user to more quickly and accurately reach the optimal trajectory for screw placement during surgery.

[0101] As best seen in FIG. 45A, after the complete targeting system 300 is assembled, sleeves 308 (e.g., 5 mm locking screw sleeves) are inserted into modular holes 408 that correspond to the holes 26 or slots that the user intends to target in the nail 12. The distal targeting system 300 provides targeting holes 408 into which one or more sleeves 308, such as screw sleeves, drill sleeves, and / or driver sleeves, can be inserted. Course and fine adjustments 380, 382 can be used to adjust the sleeves 308 to an optimal trajectory, for example, under x-ray guidance or other imaging. The system 300 holds these sleeves 308 firmly in the desired trajectory during drilling and screw insertion. The targeting system 300 provides the surgeon with a method to accurately and reliably insert locking screws through the distal end of an intramedullary nail.

[0102] It should further be understood that various changes in the details, materials, and arrangements of parts described and illustrated to explain the nature of the invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the claims. Those skilled in the art will appreciate that the above-described embodiments are non-limiting. It will also be understood that one or more features of one embodiment may be partially or fully incorporated in one or more other embodiments described herein.

Claims

1. 1. A targeting system for inserting a lag screw into an intramedullary nail, the system comprising: an intramedullary nail having a proximal end with a proximal through opening and a distal end; a nail insertion handle including a connection portion for releasably connecting to the proximal end of the intramedullary nail, a handle portion, and an aiming guide having an opening that aligns with the proximal through opening of the intramedullary nail; A targeting system, wherein the handle portion includes an anteversion alignment system configured for optimal insertion of a lag screw into the proximal through opening of the intramedullary nail, an anti-rotation system configured to stabilize the bone as the lag screw is inserted, and a lag screw aiming assembly configured to be securely inserted into the bone, thereby defining a trajectory of the intramedullary nail into the proximal through opening.

2. 10. The targeting system of claim 1, wherein the handle portion defines an anteversion guidewire lumen aligned along a central plane of the nail insertion handle and a pair of radiopaque goal posts positioned on either side of the guidewire lumen.

3. 3. The targeting system of claim 2, wherein the radiopaque goal posts comprise two parallel rows of pins carried in the handle portion, and an optimal anteversion position for lag screw insertion is found when the goal posts are centered parallel and a guidewire positioned through the anteversion guidewire hole is centered with the neck and head of the bone.

4. 2. The targeting system of claim 1, wherein the anti-rotation system comprises a plurality of anti-rotation holes, an anti-rotation sleeve positionable through the holes, and an anti-rotation guidewire positionable through the sleeve and into the bone.

5. The targeting system of claim 4 , wherein the anti-rotation holes each include a retaining pin configured to secure the anti-rotation sleeve within the anti-rotation hole.

6. 5. The targeting system of claim 4, wherein the anti-rotation holes include an upper pair of holes that converge distally at a first angle and a lower pair of holes that converge distally at a second angle, the second angle being greater than the first angle.

7. 2. The targeting system of claim 1, wherein the lag screw aiming assembly includes a driver sleeve positionable through the opening in the aiming guide, a wire sleeve having a distal cutting flute positionable through the driver sleeve, and a trocar positionable through the wire sleeve.

8. 1. A targeting system comprising: an intramedullary nail having a proximal end and a distal end; a nail insertion handle including a connection portion for releasably connecting to the proximal end of the intramedullary nail, a handle portion, and an aiming guide having an opening that aligns with an opening in the intramedullary nail; a driver sleeve positionable through the opening in the aiming guide; a wire sleeve positionable through said driver sleeve, said wire sleeve having a plurality of graduated markings; and a guidewire positionable through the wire sleeve, wherein a reading of the driver sleeve adjacent to the graduated markings indicates an optimal lag screw length when the wire sleeve is flush with the guidewire.

9. The targeting system of claim 1 , wherein the driver sleeve includes a tubular body having a plurality of teeth configured to engage a ratchet in an aiming arm.

10. The targeting system of claim 1 , wherein the distal tip of the wire sleeve includes cutting flutes.

11. The targeting system of claim 1 , wherein the wire sleeve includes an enlarged head portion defining a spring cut that allows the wire sleeve to be snapped into the driver sleeve.

12. 10. The targeting system of claim 1, further comprising a trocar positionable through the wire sleeve, the trocar including a shaft having a sharpened distal tip configured to facilitate insertion through soft tissue.

13. 13. The targeting system of claim 12, wherein the trocar includes a head portion having a male fitting receivable into a corresponding female fitting in the wire sleeve such that the trocar and wire sleeve pivot together to assist in passing through soft tissue.

14. The targeting system of claim 12 , wherein the trocar has a bent shaft to facilitate retention within the wire sleeve.

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