Intramedullary tibial nail with variable-angle screw opening

Abstract

An orthopedic intramedullary (IM) nail for internal fixation of a patient's bone is disclosed. In some embodiments, the IM nail is arranged and configured as a tibial IM nail arranged and configured for implantation into a patient's tibia. An orthopedic tibial intramedullary (IM) nail for internal fixation of a patient's tibia is arranged and configured to be side-specific such that anatomically specific tibial IM nails can be used, for example, to target specific bone anatomical structures such as the anatomy of a patient's consequences, ligamentous attachments, etc. Further, the tibial IM nail can include a variable angle screw aperture at its distal end portion to target specific bone anatomical structures such as the anatomy of a patient's consequences while avoiding anatomical structures such as nerves, blood vessels, tendons, etc. Additionally and / or alternatively, the tibial IM nail can include a variable angle screw aperture at its proximal end portion to enhance screw positioning.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is a non - provisional application of the pending U.S. Provisional Patent Application No. 63 / 344,451, entitled "Intramedullary Tibial Nail with Variable Angle Screw Openings", filed on May 20, 2022, and claims the benefit thereof, and the entire disclosure of that application is incorporated herein by reference.

[0002] The present disclosure relates to an orthopedic intramedullary (IM) nail for stabilizing the bone, bone portion, bone fragment, etc. of one or more patients, and more specifically, targets an IM nail such as a tibial IM nail including, for example, one or more variable - angle screw openings. For example, a tibial IM nail may include variable - angle screw openings at the distal end portion to enable a surgeon to target a specific bone anatomy, such as the anatomy of a patient's tibia, while avoiding anatomical structures such as nerves, blood vessels, tendons, etc. Additionally and / or alternatively, a tibial IM nail may include variable - angle screw openings at the proximal end portion to enable a surgeon to enhance screw positioning.

Background Art

[0003] Orthopedic fixation devices (implants) can be used, for example, to stabilize injuries, support fracture sites, fuse joints, and / or correct deformities. Orthopedic implants can be permanently or temporarily attached, implanted within a bone canal or other cavity, implanted beneath soft tissue, attached to the outer surface of a bone, or placed externally, and can be attached to the bone at various locations, including being attached by fasteners such as screws, pins, and / or wires. Some orthopedic fixation devices allow two or more bone fragments, or the positions and / or orientations of two or more bones, to be adjustable relative to each other. Orthopedic fixation devices are generally machined or formed from isotropic materials such as metals including, for example, titanium, titanium alloys, stainless steel, cobalt - chromium alloys, and tantalum.

[0004] Intramedullary (IM) nails are a type of orthopedic fixation device. The main function of an IM nail is to stabilize fracture fragments, thereby enabling load transfer across the fracture site while maintaining the anatomical alignment of the bone. Currently, a number of different commercially available IM nails are available.

[0005] One known type of IM nail is the tibial IM nail. The tibial IM nail is arranged and configured to be inserted into the medullary canal of a patient's tibia. In use, the proximal end portion of the tibial IM nail needs to enable proper fragment fixation near the tibial plateau without penetrating the tibial plateau. Further, in use, fixing the distal end portion of the tibial IM nail should avoid anatomical structures such as nerves, blood vessels, tendons, etc.

[0006] One drawback of current tibial IM nails is that they are designed and configured to be side-independent. That is, current tibial IM nails are identical to each other (e.g., current tibial IM nails are the same regardless of whether they are implanted in a patient's right or left tibia). That is, to date, there are no mirror-image tibial nails, and two nails cannot be perfectly overlapped with each other in a perfect fit. As a result, it is almost impossible to target specific bone landmarks within or adjacent to a patient's tibia. For example, if a current tibial IM nail is used to target a specific landmark on a patient's left tibia, the same tibial IM nail implanted in the patient's right tibia will not be able to target the landmark.

[0007] Therefore, for example, current tibial IM nails cannot target a patient's aftermath. Generally, aftermath fractures are spiral fractures and may not be detected by X-ray examination, resulting in inadequate treatment. Further, aftermath fractures are difficult to treat even if detected. Current tibial IM nails cannot target aftermath fractures. As a result, aftermath fractures are usually treated using bone plates and / or screws, which are designated as separate procedures. It would be beneficial if the distal end portion of the tibial IM nail could enable fixation of aftermath fractures.

[0008] Also, the proximal end of the tibial IM nail is beneficial for the surgeon to determine the protrusion of the screw head and / or to allow for increased flexibility to balance the ability to provide increased fixation. The surgeon can choose, select, and / or balance between providing an increase in fixation force and minimizing the protrusion of the screw head to minimize patient irritation.

[0009] Accordingly, there remains a need for an improved orthopedic tibial IM nail for internal fixation of bone. The present disclosure meets these needs and provides other benefits and advantages in novel and non-obvious ways. SUMMARY OF THE INVENTION

[0010] The summary of the present invention is provided to introduce a series of concepts in a simplified form that are further described in the detailed description of the following invention. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be an aid in determining the scope of the claimed subject matter.

[0011] In some embodiments, an intramedullary (IM) nail is disclosed. The IM nail includes a body having a proximal end portion, a distal end portion, and a plurality of screw holes arranged and configured to receive fasteners for fixing the IM nail to a patient's bone, wherein at least one of the plurality of screw holes is arranged and configured as a variable angle screw opening to allow adjustment of a screw track positioned within the variable angle screw opening. The variable angle screw opening includes an inlet opening on a first side of the body and an outlet opening on a second side of the body, the inlet opening including a first ridge extending from its inner surface, the first ridge being arranged and configured to engage a first portion of a fastener inserted therein, and the outlet opening including a second ridge extending from its inner surface, the second ridge being arranged and configured to engage a second portion of a fastener inserted therein.

[0012] In any preceding or subsequent embodiment of the IM nail, the inlet opening includes a circular shape.

[0013] In any preceding or subsequent embodiment of the IM nail, the outlet opening includes an elongated opening. In some embodiments, in use, the elongated opening is arranged and configured to increase variability in a first direction while restricting variability in a second direction (e.g., enabling a variable trajectory of a screw in only a plane).

[0014] In any preceding or subsequent embodiment of the IM nail, the first ridge extends from a first direction toward a second direction, and the second ridge extends from the second direction toward the first direction.

[0015] In some embodiments, in use, the first ridge extends from the lower surface of the inlet opening toward the upper surface of the inlet opening, and the second ridge extends from the upper surface of the outlet opening toward the lower surface of the outlet opening.

[0016] In some embodiments, in use, the first ridge extends from the upper surface of the inlet opening toward the lower surface of the inlet opening, and the second ridge extends from the lower surface of the outlet opening toward the upper surface of the outlet opening.

[0017] In any preceding or subsequent embodiment of the IM nail, the distal end portion includes a plurality of screw holes including the most distal first screw hole, and the most distal first screw hole is arranged and configured as a variable angle screw opening.

[0018] In any preceding or subsequent embodiment of the IM nail, the proximal end portion includes a plurality of screw holes including the most proximal first screw hole, and the most proximal first screw hole is arranged and configured as a variable angle screw opening.

[0019] In any preceding or subsequent example of the IM nail, the IM nail is arranged and configured as a tibial IM nail for implantation into a patient's tibia.

[0020] In any or subsequent example of the IM nail, the IM nail is arranged and configured as an anatomical, side-specific IM nail.

[0021] In some embodiments, an anatomically laterally specific tibial IM nail is disclosed. In some embodiments, the tibial IM nail includes a body, a proximal end portion, a distal end portion, and a plurality of screw holes arranged and configured to receive fasteners for securing the tibial IM nail to a patient's bone. In some embodiments, one or more of the plurality of screw holes are arranged and configured as variable angle screw openings that allow a surgeon to adjust the screw trajectory to engage one or more bone fragments.

[0022] The distal end portion of the tibial IM nail includes a plurality of screw holes arranged and configured to receive fasteners. The plurality of screw holes includes a most distal first screw hole. The most distal first screw hole includes a variable angle screw opening such that a surgeon can select a desired screw trajectory to engage one or more bone fragments, such as targeting the patient's posterior malleolus.

[0023] In some embodiments, the proximal end portion of the tibial IM nail includes a plurality of screw holes arranged and configured to receive fasteners. The plurality of screw holes includes a most proximal first screw hole. The most proximal first screw hole includes a variable angle screw opening such that a surgeon can adjust the angle or trajectory of fastener insertion to balance increased fixation to the patient's posterior medial plateau and minimize the protrusion of the screw head on the patient's tibial tubercle.

[0024] In some embodiments, the variable angle screw opening includes an inlet opening on a first side of the body of the tibial IM nail and an outlet opening on a second side of the tibial IM nail. The inlet opening includes a plurality of fins arranged and configured to engage the head portion of a fastener inserted therein. In some embodiments, the inlet opening may have a circular shape.

[0025] In some embodiments, the variable angle screw aperture includes an inlet aperture on a first side of the tibial IM nail body and an outlet aperture on a second side of the tibial IM nail body. The inlet aperture includes a circumferential ridge arranged and configured to engage a portion of a fastener inserted therein. In some embodiments, the inlet aperture may have a circular shape.

[0026] In some embodiments, the outlet aperture is configured as an elongated aperture. In some embodiments, in use, the elongated aperture is arranged and configured to provide an increase in variability in a first direction while minimizing or restricting variability in a second direction (e.g., allowing a variable trajectory of the screw in only a plane).

[0027] In some embodiments, the outlet aperture of the variable angle screw aperture includes a distal cortical locking ridge or protrusion extending from the inner surface of the outlet aperture. The distal cortical locking ridge is arranged and configured to interact with the threads of the fastener, thereby providing locking strength of the fastener to the IM nail.

[0028] In some embodiments, the variable angle screw aperture includes an inlet aperture on a first side of the tibial IM nail body and an outlet aperture on a second side of the tibial IM nail body. The inlet aperture includes a first ridge arranged and configured to engage a portion of a fastener inserted therein. The outlet aperture includes a second ridge arranged and configured to engage a portion of a fastener inserted therein.

[0029] In some embodiments, the first ridge may extend from the lower surface of the variable angle screw aperture, and the second ridge may extend from the upper surface of the variable angle screw aperture.

[0030] In some embodiments, the remaining plurality of screw holes formed in the proximal end portion and the distal end portion include internal threads for engaging the threads formed on the fastener. Accordingly, the remaining screw holes are configured as locking screw apertures.

[0031] A kit or set of tibial IM nails is also disclosed. In some embodiments, the kit or set includes a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail, the right tibial IM nail and the left tibial IM nail being mirror images of each other. That is, the kit or set of tibial IM nails includes a mutual set of laterally specific anatomical tibial IM nails, one tibial IM nail being arranged and configured for implantation into a patient's left tibia and one of the tibial IM nails being arranged and configured for implantation into a patient's right tibia.

[0032] A method of treating a patient's comminuted fracture is also disclosed. In some embodiments, the method includes selecting a laterally specific tibial IM nail from a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail, implanting the selected tibial IM nail into the intramedullary canal of the patient, and targeting the patient's comminuted fracture via a fastener inserted through a threaded hole formed in a distal end portion of the selected tibial IM nail.

[0033] Embodiments of the present disclosure provide a number of advantages. For example, by designing and providing a tibial IM nail with an anatomically specific configuration and / or by incorporating a variable angle screw opening in the distal end portion of the tibial IM nail, the tibial IM nail can be arranged and configured to target specific bone anatomical structures such as, for example, the posterior malleolus of the patient, which has heretofore been impossible with tibial IM nails. Additionally, by incorporating a variable angle screw opening in the proximal end portion of the tibial IM nail, the tibial IM nail is configured to provide the surgeon with the ability to select the angle or trajectory of fastener insertion in order to balance or select between increased fixation and screw head prominence according to the anatomical structure of an individual patient.

[0034] At least some further features and advantages of embodiments of the present disclosure, as well as the structure and operation of various embodiments of the present disclosure, are described in detail below with reference to the accompanying drawings.

[0035] By way of example, specific embodiments of the disclosed apparatus are described herein with reference to the following accompanying drawings.

Brief Description of the Drawings

[0036]

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[0037] It will be understood that the drawings are not necessarily to scale and that the examples disclosed are sometimes illustrated in schematic and partial views. In certain instances, details that are not necessary for an understanding of the methods and devices disclosed, as well as details that obscure other details, may be omitted. It will also be understood that the present disclosure is not limited to the specific examples illustrated herein. In the drawings, like reference numerals refer to like elements throughout, unless otherwise noted.

[0038] Here, various features of the IM nail or the like will be more fully described below with reference to the accompanying drawings, which show and explain one or more features of the IM nail. It should be understood that the various features or the like can be used independently of one another or in combination. It will be understood that the IM nails disclosed herein can be embodied in many different forms and should not be construed as limited to the embodiments shown herein. Rather, these embodiments are provided so that the present disclosure conveys specific features of the IM nail to those skilled in the art.

[0039] Disclosed herein are various IM nails that include one or more features configured and arranged to be implanted within the medullary canal of a patient's bone. As will be described in more detail herein, in various embodiments, an IM nail, such as a tibial IM nail, is arranged and configured to be anatomically specific (e.g., a tibial IM nail includes one or more features arranged and configured to be disposed in either the patient's left tibia or the patient's right tibia, but not both). This is in contrast to currently commercially available IM nails, which are arranged and configured to be implanted in both the left and right bones (e.g., tibias). Thus, by designing a side-specific tibial IM nail, the distal end of the tibial IM nail can be arranged and configured to target one or more specific bone landmarks, such as, for example, patient outcomes.

[0040] In addition and / or alternatively, in accordance with one or more features of the present disclosure, an IM nail, such as a tibial IM nail, includes one or more variable angle screw apertures. For example, as will be described in more detail below, a tibial IM nail may include a variable angle screw aperture in its distal end portion. In some embodiments, the most distal screw hole may be configured as a variable angle screw aperture. Thus, the positioned tibial IM nail provides improved flexibility that allows a surgeon to select a desired screw trajectory and engage one or more bone fragments, such as, for example, to target patient outcomes. That is, by configuring the most distal screw hole as a variable angle screw aperture, for example, the distal end portion of the tibial IM nail provides variable angle nailing to the surgeon such that the surgeon can target specific bone fragments. In this way, the surgeon can capture a greater variety of bone fragments. For example, in use, the tibial IM nail may allow the surgeon to target and capture outcomes while avoiding soft tissue interference caused by positioning the screw within the anterior tibial muscle and / or may allow the surgeon to target patient outcomes while avoiding the patient's ligamentous attachments, which can negatively affect the movement of the ligamentous joints, as well as other nerves, blood vessels, tendons, etc. Thus, by providing a tibial IM nail having a variable angle screw aperture, a more available screw trajectory is provided during distal tibial nailing.

[0041] Additionally, and / or alternatively, the tibial IM nail may include a variable angle screw aperture at its proximal end portion. In some embodiments, the most proximal screw hole may be configured as a variable angle screw aperture. Thus, the positioned tibial IM nail allows the surgeon to adjust the angle or trajectory of fastener insertion to balance increased fixation to the medial plateau of the patient (e.g., enabling targeting of the posterior medial corner or portion of the patient's tibia), and to improve flexibility in minimizing the protrusion of screw heads on the patient's tibial tubercle. That is, in use, incorporating a variable angle screw aperture in the most proximal screw hole allows the screw trajectory to be directed more anteriorly or posteriorly, which either increases fixation of the posterior medial corner of the posterior medial plateau or decreases the protrusion of screw heads on the tibial tubercle when directed more anteriorly.

[0042] As shown and described herein, in some embodiments, the IM nail can be arranged and configured as an anatomical, side-specific IM nail and / or a tibial IM nail arranged and configured for implantation into a patient's tibia. However, one or more features of the present disclosure can be used in other applications, such as, for example, in relation to a tibial IM nail that is not anatomical, side-specific, and / or arranged and configured for implantation into other parts of the body, such as, for example, a femoral, humeral, or hindfoot IM nail. Thus, the present disclosure should not be limited to a particular type of IM nail unless specifically claimed.

[0043] Referring to FIGS. 1A, 1B, and 1C, an embodiment of a laterally specific tibial IM nail 100 according to one or more features of the present disclosure is shown. As shown, the left tibial IM nail 100 is shown implanted within the intramedullary canal of the patient's left tibia B. The right tibial IM nail would be a mirror image of the left tibial IM nail shown. In use, as described above, the tibial IM nail 100 is arranged and configured to be implanted into the medullary canal of the patient's tibia. As shown, the laterally specific tibial IM nail 100 includes a body 102, such as, for example, a cannula-shaped body. The body 102 includes a proximal end portion or region 110 and a distal end portion or region 130 (the terms portion or region are used interchangeably without intent to limit or distinguish). Additional information regarding laterally specific tibial IM nails can be found in International PCT Application PCT / US2022 / 049780, filed Nov. 14, 2022, entitled "Anatomic Specific Orthopedic Intramedullary Tibial Nails", the entire contents of which are incorporated herein by reference.

[0044] Generally as shown, the distal end portion 130 may include a curve or bend. In some embodiments, the curve or bend may start at about 60 mm from the distal tip of the tibial IM nail 100, come from posterior to anterior, and be about 2 degrees in the anteroposterior direction, but this is only one configuration and other configurations are envisioned.

[0045] Furthermore, generally as shown, in some embodiments, the proximal end portion 110 may include a curve or bend. In some embodiments, the curve or bend may come from posterior to anterior, be located at about 27 mm from the proximal end of the tibial IM nail 100, and extend proximally through an angle of about 10 degrees in the anteroposterior direction, but this is only one configuration and other configurations are envisioned.

[0046] According to one or more features of the present disclosure, by providing a laterally specific IM nail, the proximal end portion 110 and the distal end portion 130 may also include a curvature or bend in the medial-lateral plane (e.g., the proximal end portion 110 and the distal end portion 130 may include a curvature or bend in the medial-lateral plane in addition to, or as an alternative to, the curvature or bend in the anterior-posterior plane). By providing the curvature or bend in the medial-lateral plane, the IM nail can better handle the natural rotation of the tibia of the distal portion relative to the proximal portion.

[0047] In some embodiments, the proximal end portion 110 may be arranged and configured to couple or receive a nail cap. In some embodiments, the nail caps may be provided as a set in 5 mm increments starting at 0 mm to 20 mm, although this is only one configuration and other configurations are envisioned. In other embodiments, the nail cap may include an extension or a navi that locks the most proximal screw to its variable angle screw. Thus, the nail cap may be arranged and configured to provide a secondary locking already provided by the variable angle feature.

[0048] With further reference to FIGS. 2A, 2B, and 2C, the distal end portion 130 includes a plurality of screw openings, holes, etc. 132 (terms used interchangeably herein without intent to limit or distinguish) arranged and configured to receive fasteners, screws, etc. (terms used interchangeably herein without intent to limit or distinguish) in situ. In some embodiments, the plurality of screw holes 132 may be threaded. Alternatively, the screw holes may be unthreaded, or some combination of threaded and unthreaded holes, or may have any other configuration known currently or developed in the future. As shown in the illustrated embodiment, the distal end portion 130 includes first, second, third, and fourth screw holes 132A, 132B, 132C, and 132D, although more or fewer screw holes may be incorporated.

[0049] According to one or more features of the present disclosure, the lateral-specific tibial IM nail 100 includes a most distal first screw hole 132A disposed and configured as a variable angle screw opening 134. In connection with the illustrated embodiment, the most distal first screw hole 132A is shown and described as a variable angle screw opening and may include a distal corner cortical locking ridge or protrusion (described in more detail below). Of course, any or all of the screw holes formed within the distal end portion 130 of the IM nail 100, and any or all of the screw holes formed within the proximal end portion 110 of the IM nail 100, one or more or all of the other screw holes formed within the IM nail 100 may be formed as variable angle screw openings and may include distal corner cortical locking ridges or protrusions.

[0050] That is, the threaded hole may be in the form of a locking screw (or fastener) opening. For example, as shown in the illustrated embodiment, the threaded holes 132B, 132C, 132D may be arranged as locking screw openings that include a plurality of threads formed on their inner surfaces to engage with the threads formed on the outer surface of the head portion of the bone fastener. Therefore, it can be said that the arranged bone fastener is locked to the tibia IM nail 100 via the locking screw openings 132B, 132C, 132D. That is, as will be understood by those skilled in the art, the bone fastener can be passed through one of the locking screw openings 132B, 132C, 132D formed in the tibia IM nail 100 into the patient's bone. The bone fastener is fixed to the tibia IM nail 100 via the threads formed on the head portion of the bone fastener that cooperate with the threaded locking screw openings 132B, 132C, 132D formed within the tibia IM nail 100. Thereby, the tibia IM nail 100 is fixed to the patient's bone, and a firm fixation is provided between the tibia IM nail 100 and the bone fastener. That is, since the head portion of the bone fastener mutually engages with the threads formed in the locking screw openings 132B, 132C, 132D of the tibia IM nail 100, the tibia IM nail 100 and the fastener form a stable system or structure, and the fracture stability may depend on or be assisted by the rigidity of the structure. By locking the bone fastener within the tibia IM nail 100, angular and axial stability can be achieved, the possibility of the bone fastener switching, sliding, or coming off is eliminated, and the risk of postoperative reduction loss is reduced.

[0051] As shown, in accordance with one or more features of the present disclosure, the tibial IM nail 100 includes a variable angle opening or a variable angle fastener (or screw) opening 134 (terms used interchangeably herein without intent to limit or distinguish). Thus, the incorporation of the variable angle screw opening 134 enables variable angle targeting through one or more openings formed in the tibial IM nail 100. That is, in the illustrated example, the most distal first screw hole 132A is arranged and configured as a variable angle screw opening 134 for receiving a non-locking or variable angle bone fastener. In use, the variable angle screw opening 134 is arranged and configured such that a bone fastener inserted therein can achieve a wider range of insertion angles compared to, for example, a conventional locking screw that is screwed into the tibial IM nail 100. For example, the angular position of the bone fastener can be rotated through a range of angles (e.g., approximately ±7.5 degrees for a total angle of 15 degrees, although the allowable range of rotation can vary to include angles greater than and less than 15 degrees). This is in contrast to a locking screw opening that does not provide or limit the angle to a relatively fixed trajectory of the bone fastener.

[0052] In use, the angled variable screw aperture 134 can be provided in any suitable manner, configuration, etc., known currently or developed in the future to enable multi-axial positioning or angling of the bone fastener relative to the tibial IM nail 100. For example, as shown, the variable angle screw aperture 134 can include fins or protrusions 136 that extend radially inward from the inner surface of the variable angle screw aperture 134 into the internal region of the variable angle screw aperture 134 and are configured to engage or cooperate with the head portion of the bone fastener. In use, the fins 136 engage and / or deform with the head portion of the bone fastener to secure the bone fastener at a desired position and in a desired angular orientation within the variable angle screw aperture 134. Additional information regarding the operation and configuration of the fins 136 can be found in U.S. Patent Application No. 15 / 706,877, entitled "Systems and Methods for Using Polyaxial Plates", with an earliest filing date of Jul. 25, 2005, current U.S. Patent No. 10,092,337, U.S. Patent Application No. 13 / 524,506, entitled "Variable Angle Locking Implant", filed Jun. 15, 2012, and U.S. Patent Application No. 17 / 616,785, entitled "Orthopedic Implant with Improved Variable Angle Locking Mechanism", filed Dec. 6, 2021, the entire contents of which are incorporated herein by reference. In use, the fins 136 may be arranged and configured in a single row or layer of fins, multiple rows or layers of fins, multiple rows or layers of fins, and the fins are offset relative to each other.

[0053] Additionally, and / or alternatively, the variable angle screw aperture 134 can have any other suitable configuration known currently or developed in the future, including, for example, a plurality of nibs (e.g., protrusions, studs, etc.) for gripping the threads. In some embodiments, referring to FIG. 3, the variable angle screw aperture 134 can be configured as a single circumferential or continuous locking ridge or fin 138 that extends circumferentially from the inner surface of the aperture towards the center of the screw aperture. This is in contrast to providing a plurality of fins or protrusions 136 along the inlet side of the variable angle screw aperture 134. Alternatively, as will be described in more detail below in connection with FIGS. 6A, 6B, and 6C, the variable angle screw aperture 134 can be configured to have intermittent locking ridges that extend partially from the inner surface of the aperture towards the center of the screw aperture.

[0054] By incorporating the variable angle screw aperture 134, the tibial IM nail 100 is arranged and configured to provide variable angle screw fixation, whereby a surgeon can target specific bone fragments so as to be able to capture a greater variety of bone fragments using the tibial IM nail 100. For example, as illustrated, by configuring the most distal first screw hole 132A as a variable angle screw aperture 134, the surgeon can angle the fastener in the anteroposterior direction with respect to the central longitudinal axis of the distal end portion 130. When arranged in this way, in use, the screw can be inserted into the most distal first screw hole 132A and into the patient's posterior condyle or within the anatomical structure of other bones. For example, by making the most distal first screw hole 132A a variable angle screw aperture 134, the surgeon can angle the fastener between 55 degrees and 70 degrees with respect to the central longitudinal axis of the distal end portion 130. Thus, referring further to FIGS. 4A and 4B, the screw 150 can be inserted directly through the first screw hole 132A formed in the distal end portion 130 of the IM nail 100 into the patient's posterior condyle. By incorporating the variable angle screw aperture 134, the surgeon can target the patient's posterior condyle and provide an increase in fixation to the patient's posterior condyle or an increase in clearance under the patient's anterior tibial tendon. Again, this is in contrast to current tibial IM nails, which cannot target patient-specific bone anatomical structures such as, for example, the patient's posterior condyle (e.g., the distal first screw hole of current tibial IM nails cannot be angled to target the patient's posterior condyle). When arranged in this way, in use, the IM nail 100 can be used to treat the patient's posterior condyle fracture. In use, the surgeon can select a corresponding side-specific tibial IM nail from a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail according to the fracture site (e.g., either the patient's right tibia or left tibia). Thereafter, the surgeon can transplant or insert the selected tibial IM nail into the intramedullary canal of the patient and target the patient's posterior condyle fracture by inserting a fastener or screw 150 through the first screw hole 132A formed in the distal end portion 130 of the IM nail 100.

[0055] As best shown in FIG. 2C, according to one or more features of the present disclosure, the exit opening of the variable angle screw opening 134 (e.g., the side opposite the entrance hole where the fastener is first inserted) can be configured as an elongated opening (e.g., the exit opening can be arranged and configured as an elongated or slotted opening having, for example, a trapezoidal or oval shape). Thus, in the illustrated embodiment, the variable angle screw opening 134 can include an elongated slot on the exit side and a circular opening with fins or continuous or intermittent locking ridges on the entrance side.

[0056] In the illustrated example, the elongated exit opening is arranged and configured to be elongated in an axial plane (e.g., front-to-back direction) during use. Thus, the variable angle screw opening 134 is arranged and configured to provide an increase in variation in a first direction (such as front-to-back), while minimizing or restricting variation in a second direction (such as up and down). In this way, the variable angle screw opening 134 is arranged and configured to provide increased variation in the first direction while minimizing the amount of material removed from the IM nail (e.g., by minimizing the size of the opening in the second direction, less material is removed from the body 102 of the IM nail 100 when forming the variable angle screw opening, thereby increasing the strength and structural integrity of the nail).

[0057] In addition, in the illustrated embodiments, the exit opening of the variable angle screw opening 134 can include a distal cortical locking ridge or protrusion 140 (FIG. 2C) extending from the inner surface of the exit opening. As illustrated, in some embodiments, the distal cortical locking ridge 140 can extend intermittently. For example, the distal cortical locking ridge 140 can extend from the upper side or surface of the elongated exit opening. Alternatively, in some embodiments, the distal cortical locking ridge 140 may be arranged and configured to extend continuously around the exit opening of the variable angle screw opening 134. In use, the distal cortical locking ridge 140 is arranged and configured to interact with the threads of the fastener, thereby providing the locking strength of the fastener to the body 102 of the IM nail 100 (e.g., the distal cortical locking ridge 140 engages the threads on the shaft of the fastener on the exit side of the variable angle screw opening 134, thereby increasing the restraint of the fastener and increasing the rotational stability of the tibial IM nail 100 (e.g., reducing switching of the IM nail). The distal cortical locking ridge 140 is shown and described in relation to the variable angle screw opening, but it is contemplated that the distal cortical locking ridge can also be used in combination with the locking screw hole to provide an increase in fixation.

[0058] Referring to FIGS. 1A, 1B, 1C, 5A, and 5B, separate from or in combination with the distal end portion 130 of the tibial IM nail 100 described above in relation to FIGS. 1A, 1B, 1C, 2A, 2B, 2C, 3, 4A, and 4B, the proximal end portion 110 of the tibial IM nail 100 includes a plurality of screw openings, holes, slots, etc. 112 and is arranged and configured to receive a plurality of screws. As illustrated in the illustrated embodiment, in some embodiments, the proximal end portion 110 of the tibial IM nail 100 can include first, second, third, fourth, and fifth holes 112A, 112B, 112C, 112D, 112E, although other configurations are contemplated.

[0059] In the illustrated embodiment, in some embodiments, one or more of the screw holes 112 formed in the proximal end portion 110 of the tibial IM nail 100 may be formed as slots. For example, as shown, the third screw opening 112C from the proximal end portion 110 may be in the form of a slot. By utilizing the slot, dynamization or micromotion of the tibial IM nail 100 in its original position becomes possible. In some embodiments, the third screw opening (e.g., slot) 112C may extend in the original position substantially in the medial-lateral direction. In some embodiments, the slot 112C may have a length of approximately 7 mm.

[0060] Referring to FIGS. 5A and 5B, the most proximal first screw hole 112A according to one or more features of the present disclosure may be arranged and configured as a variable angle screw opening 114.

[0061] In use, the most proximal first screw hole 112A formed in the proximal end portion 110 of the tibial IM nail 100 can be configured similarly to the most distal one. As described above, the variable angle screw opening 134 formed in the distal end portion 130 of the tibial IM nail 100, for example, the most proximal first screw hole 112A formed in the proximal end portion 110 of the tibial IM nail 100, may include a plurality of fins or a single circumferential ridge formed in an entrance hole or an intermittent locking ridge, and a distal cortical locking ridge formed in an elongated opening and / or an exit opening. By incorporating the variable angle screw opening 114 into the most proximal first screw hole 112A formed in the proximal end portion 110 of the tibial IM nail 100, the tibial IM nail 100 enables the surgeon to enhance the fixation to the posterior medial plateau of the patient and increase the flexibility to select between the elevation of the screw head on the patient's tibial tubercle. That is, in use, the surgeon often needs to balance the increase in fixation to the posterior medial plateau of the patient and the extension of the screw head. When choosing an increase in fixation to the posterior medial plateau of the patient, an increase in the protrusion of the screw head is likely to occur, which may lead to an increase in inflammation. Depending on the surgical procedure performed, one surgeon may choose one over the other (for example, when one surgeon performs one surgical procedure, they may desire an increase in fixation, while when another surgeon performs another procedure, they may desire a decrease in the protrusion of the screw head). By utilizing the variable angle screw opening 114 of the most proximal first screw hole 112A formed in the proximal end portion 110 of the tibial IM nail 100, the tibial IM nail 100 enables the surgeon to select an increase in fixation or minimization of the protrusion of the screw head. That is, in use, by incorporating the variable angle screw opening 114 into the most proximal first screw hole 112A formed in the proximal end portion 110 of the tibial IM nail 100, the tibial IM nail 100 enables the surgeon to increase the angle or trajectory of the fastener to provide an increase in fixation to the posterior medial plateau of the patient or decrease the angle or trajectory of the fastener to minimize the elevation of the screw head. Therefore, the surgeon can select the angle or trajectory of fastener insertion to balance or select between an increase in fixation and the protrusion of the screw head according to the anatomical structure of the individual patient.This is in contrast to conventional IM nails that have only a fixed track for fastener insertion.

[0062] As shown in FIGS. 6A, 6B, and 6C, in accordance with one or more features of the present disclosure, for example, variable angle screw openings 114, 134 such as the most proximal first screw hole 112A formed within the proximal end portion 110 and / or the most distal first screw hole 132A formed within the distal end portion 130 may include first and second ridges or straight threads 140 to create mechanical integration between the IM nail 100 and the fastener. That is, as shown, the variable angle screw openings 114, 134 may include a first ridge 140A extending from the lower surface of the variable angle screw openings 114, 134 and a second ridge 140B extending from the upper surface of the variable angle screw openings 114, 134, or vice versa. In the illustrated embodiment, the first ridge 140A may be positioned adjacent to the entrance side or surface of the variable angle screw openings 114, 134, while the second ridge 140B may be positioned adjacent to the exit side or surface of the variable angle screw openings 114, 134.

[0063] As shown in FIG. 6A, the entrance side of the variable angle screw openings 114, 134 of the IM nail 100 may include an elongated hole arranged and configured to provide an increase in clearance for angling the fastener. For example, when formed in the proximal end portion 110 of the IM nail 100, the elongated hole may be arranged and configured to provide an angle of ±4 degrees (as generally shown in FIG. 7A). Alternatively, when formed in the distal end portion 130 of the IM nail 100, the elongated hole may be arranged and configured to provide an angle of ±7.5 degrees (as generally shown in FIG. 7B), although these are one configuration and more or fewer angles may be provided.

[0064] In use, the resistance to axial translation along the axes of the variable angle screw openings 114, 134 is created by a first locking ridge 140A that is linear and positioned downward on the inlet side of the opening. In use, the opening may use the same taper as in the previous embodiment, and the outlet side of the opening may be the same as described above (e.g., a linear locking ridge provided along the upper portion of the opening). Incorporation of a single linear locking ridge 140A along the inlet side of the opening in use provides a simplified mechanism compared to multiple fins, while also minimizing the amount of material required for removal from the IM nail.

[0065] According to one or more features of the present disclosure, a plurality of tibial IM nails may be provided in a kit. For example, the kit may include a set of mutually side-specific anatomical tibial IM nails where one tibial IM nail is arranged and configured for implantation into a patient's left tibia and one of the tibial IM nails is arranged and configured for implantation into a patient's right tibia. In use, the tibial IM nails may be mirror images of each other.

[0066] The above description has wide application. Thus, consideration of any example is for illustrative purposes only and is not intended to suggest that the scope of the present disclosure, including the claims, is limited to these exemplary examples. In other words, although the exemplary examples of the present disclosure have been described in detail herein, it is to be understood that the inventive concept may be embodied and employed in various other manners, except when limited by the prior art, and it is intended that the appended claims be construed to include such variations.

[0067] Terms such as "substantially" and "approximately" are intended to cover minor deviations such as dimensional errors of plus or minus 10%.

[0068] As used herein, the terms "a" or "an" preceding an element refer to one or more of that element. Thus, the terms "a" (or "an"), "one or more", and "at least one" may be used interchangeably herein. The use of "comprising", "including", or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof, as well as additional items. Thus, the terms "comprising", "including", or "having" and variations thereof are non-limiting expressions and may be used interchangeably herein. The phrases "at least one", "one or more", and "and / or" as used herein are non-limiting expressions that are both conjunctive and disjunctive in operation.

[0069] All directional reference terms (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are used only for purposes of identification to assist the reader's understanding of the present disclosure, particularly with respect to the position, orientation, or use of the present disclosure, and do not result in a limitation. Connective reference terms (e.g., attached, coupled, connected, and joined) should be construed broadly and may include intermediate members between assemblies of elements and relative movement between elements, unless otherwise indicated. Thus, a connective reference term does not necessarily mean that two elements are directly connected and in a fixed relationship to each other. Identifying reference terms (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to indicate importance or priority and are used to distinguish one feature from another. Drawings are for illustrative purposes only, and the relative dimensions, positions, sequences, and sizes reflected in the drawings attached hereto may be changed.

Claims

**Claim 1** An intramedullary (IM) nail, comprising a body including a proximal end portion, a distal end portion, and a plurality of screw holes arranged and configured to receive fasteners for fixing the IM nail to a patient's bone; at least one of the plurality of screw holes is arranged and configured as a variable-angle screw opening to enable adjustment of a screw track positioned within the variable-angle screw opening; the variable-angle screw opening includes an inlet opening on a first side surface of the body and an outlet opening on a second side surface of the body, the inlet opening includes a first ridge extending from its inner surface, the first ridge is arranged and configured to engage a first portion of the fastener inserted therein, the outlet opening includes a second ridge extending from its inner surface, and the second ridge is arranged and configured to engage a second portion of the fastener inserted therein. The IM nail. **Claim 2** The IM nail according to claim 1, wherein the outlet opening includes an elongated opening. **Claim 3** The IM nail according to claim 1 or 2, wherein the inlet opening includes a circular shape. **Claim 4** The IM nail according to any one of claims 1 to 3, wherein the first ridge extends from a first direction to a second direction, and the second ridge extends from the second direction to the first direction. **Claim 5** In use, the first ridge extends from the lower surface of the inlet opening to the upper surface of the inlet opening, and the second ridge extends from the upper surface of the outlet opening to the lower surface of the outlet opening. The IM nail according to any one of claims 1 to 4. **Claim 6** In use, the first ridge extends from the upper surface of the inlet opening to the lower surface of the inlet opening, and the second ridge extends from the lower surface of the outlet opening to the upper surface of the outlet opening. The IM nail according to any one of claims 1 to 4. **Claim 7** The distal end portion includes a plurality of screw holes including a most distal first screw hole, and the most distal first screw hole is arranged and configured as the variable-angle screw opening. The IM nail according to any one of claims 1 to 6. **Claim 8** The proximal end portion includes a plurality of screw holes including a most proximal first screw hole, and the most proximal first screw hole is arranged and configured as a variable-angle screw opening. The IM nail according to any one of claims 1 to 7. **Claim 9** The IM nail according to any one of claims 1 to 8, wherein the IM nail is arranged and configured as a tibial IM nail for implantation into a patient's tibia.

10. The IM nail according to any one of claims 1 to 9, wherein the IM nail is arranged and configured as an anatomical, side-specific IM nail.

11. An anatomically side-specific tibial IM nail, comprising a body including a proximal end portion, a distal end portion, and a plurality of screw holes arranged and configured to receive fasteners for fixing the tibial IM nail to a patient's bone; a tibial IM nail, wherein at least one of the plurality of screw holes is arranged and configured as a variable-angle screw opening to enable adjustment of a screw track positioned within the variable-angle screw opening.

12. The tibial IM nail according to claim 11, wherein the distal end portion includes a plurality of screw holes including a most distal first screw hole, and the most distal first screw hole is arranged and configured as a variable-angle screw opening.

13. The tibial IM nail according to any one of claims 11 and 12, wherein the proximal end portion includes a plurality of screw holes including a most proximal first screw hole, and the most proximal first screw hole is arranged and configured as a variable-angle screw opening.

14. The tibial IM nail according to any one of claims 11 to 13, wherein the variable-angle screw opening includes an inlet opening on a first side of the body and an outlet opening on a second side of the body, and the inlet opening includes a plurality of fins arranged and configured to engage a head portion of the fastener inserted therein.

15. The tibial IM nail according to any one of claims 11 to 13, wherein the variable-angle screw opening includes an inlet opening on a first side of the body and an outlet opening on a second side of the body, and the inlet opening includes a circumferential ridge arranged and configured to engage a portion of the fastener inserted therein.

16. The tibial IM nail according to any one of claims 14 and 15, wherein the inlet opening has a circular shape.

17. The tibial IM nail according to any one of claims 14 to 16, wherein the outlet opening has an elongated opening.

18. The tibial IM nail according to claim 17, wherein the outlet opening includes a distal cortex locking ridge extending from an inner surface thereof, and the distal cortex locking ridge is arranged and configured to interact with a thread of the fastener inserted therein.

19. The variable-angle screw opening includes an inlet opening on a first side surface of the main body and an outlet opening on a second side surface of the main body. The inlet opening includes a first ridge extending from its inner surface. The first ridge is arranged and configured to engage a first portion of the fastener inserted therein. The outlet opening includes a second ridge extending from its inner surface. The second ridge is arranged and configured to engage a second portion of the fastener inserted therein. The tibial IM nail according to any one of claims 11 to 13.

20. The tibial IM nail according to claim 19, wherein the first ridge extends from a first direction to a second direction, and the second ridge extends from the second direction to the first direction.

21. During use, the first ridge extends from the lower surface of the inlet opening to the upper surface of the inlet opening, and the second ridge extends from the upper surface of the outlet opening to the lower surface of the outlet opening. The tibial IM nail according to claim 19.

22. During use, the first ridge extends from the upper surface of the inlet opening to the lower surface of the inlet opening, and the second ridge extends from the lower surface of the outlet opening to the upper surface of the outlet opening. The tibial IM nail according to claim 19.

23. The tibial IM nail according to any one of claims 19 to 22, wherein the inlet opening includes a circular shape.

24. The tibial IM nail according to any one of claims 19 to 23, wherein the outlet opening comprises an elongated opening.

25. A kit of tibial IM nails, A plurality of tibial IM nails according to any one of claims 11 to 24, wherein the plurality of tibial IM nails includes at least one right tibial IM nail and at least one left tibial IM nail. The at least one right tibial IM nail is arranged and configured to be implanted into the intramedullary canal of a patient's right tibia. The at least one left tibial IM nail is arranged and configured to be implanted into the intramedullary canal of a patient's left tibia. The at least one right tibial IM nail and the at least one left tibial IM nail are mirror images of each other. A kit of tibial IM nails.

26. A method for treating a comminuted fracture of a patient, Selecting a side-specific tibial IM nail from a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail, Inserting the selected tibial IM nail into the intramedullary canal of the patient; Targeting the metaphyseal fracture of the patient through a fastener inserted through a screw hole formed in a distal end portion of the selected tibial IM nail. A method comprising the steps.

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