EP4432943A1

EP4432943A1 - Anatomic specific orthopedic intramedullary tibial nails

Info

Publication number: EP4432943A1
Application number: EP22826748.0A
Authority: EP
Inventors: Adam ZYSK; Kohsuke Watanabe; Henry B. Faber; William M. Ricci; III Paul TORNETTA; Roy W. Sanders; James Krieg; Daniel S. CHAN; Joseph R. HSU; Benjamin OLLIVERE
Original assignee: Smith and Nephew Orthopaedics AG; Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Current assignee: Smith and Nephew Orthopaedics AG; Smith and Nephew Asia Pacific Pte Ltd; Smith and Nephew Inc
Priority date: 2021-11-16
Filing date: 2022-11-14
Publication date: 2024-09-25
Also published as: WO2023091366A1; JP2024543394A

Abstract

An orthopedic tibial intramedullary ("IM") nail for internal fixation of a patient's tibial bone arranged and configured to be side-specific so that the anatomic specific tibial IM nails can be used to, for example, target specific bony anatomy such as, for example, the patient's posterior malleolar, the syndesmotic joint, etc.

Description

ANATOMIC SPECIFIC ORTHOPEDIC INTRAMEDULLARY TIBIAL NAILS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a non-provisional of, and claims the benefit of the filing date of, pending U.S. provisional patent application number 63/279,906, filed November 16,

2021, entitled “Anatomic Specific Orthopedic Intramedullary Tibial Nails” the entirety of which application is incorporated by reference herein.

FIELD OF THE DISCLOSURE

[0002] The present disclosure is directed to orthopedic intramedullary (“IM”) nails for stabilizing one or more patient’s bones, bone portions, bone fragments, etc., and more specifically to anatomic specific tibial IM nails arranged and configured to be implanted within a patient’s tibia to target specific bony anatomy such as, for example, the patient’s posterior malleolar, while avoiding anatomic structures such as nerves, vessels, tendons, etc. In addition, the anatomic specific tibial IM nails are arranged and configured to enhance screw positioning.

BACKGROUND

[0003] Orthopedic fixation devices (implants) may be used, for example, to stabilize an injury, to support a bone fracture, to fuse a joint, and/or to correct a deformity.

Orthopedic fixation devices may be attached permanently or temporarily, and may be attached to the bone at various locations, including implanted within a canal or other cavity of the bone, implanted beneath soft tissue and attached to an exterior surface of the bone, or disposed externally and attached by fasteners such as screws, pins, and/or wires. Some orthopedic fixation devices allow the position and/or orientation of two or more bone pieces, or two or more bones, to be adjusted relative to one another. Orthopedic fixation devices are generally machined or molded from isotropic materials, such as metals including, for example, titanium, titanium alloys, stainless steel, cobalt-chromium alloys, and tantalum.

[0004] An intramedullary (“IM”) nail is one type of orthopedic fixation device. The primary function of the IM nail is to stabilize the fracture fragments, and thereby enable load transfer across the fracture site while maintaining anatomical alignment of the bone. Currently, there are a large number of different commercially available IM nails in the marketplace.

[0005] One known type of an IM nail is a tibial IM nail. A 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 a tibial IM nail needs to allow for adequate fragment fixation near the tibia plateau without penetrating through the tibia plateau. In addition, in use, fixation of the distal end portion of the tibial IM nail should avoid anatomic structures such as nerves, vessels, tendons, etc.

[0006] One disadvantage of current tibial IM nails is that they are designed and configured to be side agnostic. That is, current tibial IM nails are identical to each other (e.g., current tibial IM nails are identical regardless if being implanted within the patient’s right tibia or left tibia). That is, to date, there are no mirror-image tibial nails, where the two nails cannot be overlaid on each other with a perfect fit. As a result, targeting specific bony landmarks in or adjacent to the patient’s tibia is nearly impossible. For example, if a current tibial IM nail was used to target a specific landmark in the patient’s left tibial, the same tibial IM nail implanted into the patient’s right tibia would be incapable of targeting the landmark.

[0007] Thus, for example, current tibial IM nails are incapable of targeting the patient’s posterior malleolar. Generally speaking, posterior malleolar fractures are poorly treated as they may go undetected on X rays because they are spiral type fractures. In addition, even when detected, posterior malleolar fractures are difficult to treat. Current tibial IM nails are incapable of targeting posterior malleolar fractures. As a result, posterior malleolar fractures are typically treated using bone plates and/or screws, which are designated as a separate procedure. It would be beneficial for the distal end portion of the tibial IM nail to enable fixation of posterior malleolar fractures.

[0008] It would also be beneficial for the distal end portion of the tibial IM nail to enable fixation of across the syndesm otic joint. Once again, current tibial IM nails do not adequately accommodate fixation across the syndesm otic joint into the patient’s fibula. Once again, by being side agnostic, current tibial IM nails have inadequate screw trajectories to accommodate side specific points of fixation. As a result, current tibial IM nails do not enable fixation across the syndesmosis in both limbs (e.g., if current tibial IM nails included a screw trajectory that enable fixation across the syndesmosis in one limb such as, for example, the patient’s left tibia, the tibial IM nail wouldn’t enable fixation across the syndesmosis in the contralateral limb such as, for example, the patient’s right tibia - current tibial IM nails do not enable targeting in both limbs). [0009] Finally, it would be beneficial for any tibial IM nail to be arranged and configured so that the driving end of screws used for fixation can be inserted such that they are not too proud of the bone, as this can cause irritation to the patient.

[0010] Thus, there remains a need to provide improved orthopedic tibial IM nails for internal fixation of a bone. The present disclosure satisfies this need and provides other benefits and advantages in a novel and unobvious manner.

BRIEF SUMMARY

[0011] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0012] An anatomic, side-specific tibial IM nail is disclosed. In some examples, the tibial IM nail includes a body, a proximal end portion, and a distal end portion. The distal end portion includes a plurality of screw holes arranged and configured to receive a fastener. The plurality of screw holes including a distal most, first screw hole. The distal most, first screw hole being angled or inclined in a superior-inferior direction relative to a central longitudinal axis of the distal end portion. In some examples, the distal most, first screw hole may be angled or inclined by an angle a with angle a being approximately ten-degrees so that a first screw positioned within the distal most, first screw hole can target a patient’s posterior malleolus or other bony anatomy. [0013] In any preceding or subsequent example, the plurality of screw holes formed in the distal end portion further include second, third, and fourth screw holes positioned from a distal end of the body.

[0014] In any preceding or subsequent example, the second screw hole and the fourth screw hole extend substantially parallel to each other. In some examples, the second screw hole and the fourth screw hole extend substantially parallel to an anterior-posterior plane in situ.

[0015] In any preceding or subsequent example, the distal most, first screw hole may be angled by an angle co in a medial-lateral direction. In some examples, the angle co is about ±70 degrees from the anterior-posterior plane (or relative to second and fourth screw holes). In some examples, the angle co is about ±62.5 degrees from the anterior- posterior plane (or relative to second and fourth screw holes).

[0016] In any preceding or subsequent example, the third screw hole may be angled by an angle Q in the medial-lateral direction. In any preceding or subsequent example, the angle Q is about ±30 degrees from the anterior-posterior plane (or relative to the second and fourth screw holes).

[0017] An anatomic, side-specific tibial IM nail is disclosed. In some examples, the tibial IM nail includes a body, a proximal end portion, and a distal end portion. The proximal end portion includes a plurality of screw holes arranged and configured to receive a fastener. The plurality of screw holes including a proximal most, first screw hole. The proximal most, first screw hole includes a downward angle or inclination of angle p in a superior-inferior direction. In some examples, angle p is approximately 10 degrees.

[0018] In any preceding or subsequent example, the proximal end portion further includes a second screw hole positioned from a proximal end of the body. In some examples, the first and second screw holes are arranged and configured to project, cross, exit, or the like from an outer surface of the patient’s tibia at substantially the same level or plane. In some examples, the second screw hole is substantially perpendicular to a central longitudinal axis of the proximal end portion.

[0019] In any preceding or subsequent example, the proximal end portion further includes third and fourth screw holes positioned from the proximal end of the body.

[0020] In any preceding or subsequent example, one or more of the plurality of screw holes is arranged and configured as a slotted hole.

[0021] In any preceding or subsequent example, the third screw opening is arranged and configured as a slotted hole.

[0022] In any preceding or subsequent example, the third screw hole extends substantially in a medial-lateral direction in situ.

[0023] In any preceding or subsequent example, the proximal most, first screw hole and the second screw hole are angled in the medial-lateral plane by an angle §i, §2, respectively, and thus relative to the third screw hole. In some examples, angles §1, §2 are identical. In some examples, angles §1, §2 are about ±47.5 degrees. In some examples, angle §1 is different from angle §2. In some examples, angle §1 is about ±44 degrees while angle §2 is about ±47.5 degrees.

[0024] In any preceding or subsequent example, the fourth screw hole is angled or inclined in the superior-inferior direction by an angle £. In some examples, angle £ is about ±5 degrees.

[0025] In any preceding or subsequent example, the fourth screw hole is angled in the medial-lateral plane and thus relative to the third screw hole by an angle X- In some examples, angle X is about ±25 degrees. Alternatively, in some examples, angle X is about ±35 degrees. Alternatively, in some examples, angle X is about ±40 degrees.

[0026] In any preceding or subsequent example, the proximal end region includes a fifth screw hole.

[0027] In any preceding or subsequent example, the fifth screw hole extends in the medial-lateral plane, and thus parallel to the third screw hole. In some examples, the third screw hole and the fifth screw hole are separated from each other by the fourth screw hole positioned between the third and fifth screw holes.

[0028] In some examples, an anatomic, side-specific tibial IM nail is disclosed. The anatomic, side-specific tibial IM nail being arranged and configured to be implanted within one of a patient’s right tibial and a patient’s left tibial, but not the other one of the patient’s right and left tibial. [0029] In some examples, a kit or set of tibial IM nails is disclosed. In some examples, the kit or set includes a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail, wherein the right and left tibial IM nails are mirror-images of each other. That is, the kit or set of tibial IM nails includes mutual sets of side-specific anatomic tibial IM nails wherein one tibial IM nail is arranged and configured for implantation into the patient’s left tibia and one of the tibial IM nails is arranged and configured for implantation into the patient’s right tibia.

[0030] In some examples, a method for treating a patient’s posterior malleolar fracture is disclosed. In some examples, the method includes 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 patient’s intramedullary canal, and targeting the patient’s posterior malleolar fracture via a fastener inserted through a screw hole formed in a distal end portion of the selected tibial IM nail. For example, in some examples, the method for treating a patient’s posterior malleolar fracture includes selecting 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 depending on a location of the fracture, implanting the selected side-specific tibial IM nail into the patient’s intramedullary canal, and inserting a fastener through a screw hole formed in a distal end portion of the side-specific tibial IM nail, the fastener targeting the patient’s posterior malleolar fracture.

[0031] In some examples, a method for treating a patient’s syndesmotic joint is disclosed. In some examples, the method includes 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 patient’s intramedullary canal, and targeting the patient’s syndesmotic joint via a fastener inserted through a screw hole formed in a distal end portion of the selected tibial IM nail. For example, the method for treating a patient’s syndesmotic joint fracture includes selecting 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 depending on a location of the fracture, implanting the selected side-specific tibial IM nail into the patient’s intramedullary canal, and inserting a fastener through a screw hole formed in a distal end portion of the side-specific tibial IM nail, the fastener targeting the patient’s syndesmotic joint fracture.

[0032] Exemplary embodiments of the present disclosure provide numerous advantages. For example, by designing and providing tibial IM nails in anatomically specific configurations, the tibial IM nails can be arranged and configured to target specific bony anatomy such as, for example, the patient’s posterior malleolar fracture, syndesmotic joint, etc., which heretofore have not been possible with tibial IM nails.

[0033] Further features and advantages of at least some of the exemplary embodiments of the present disclosure, as well as the structure and operation of various exemplary embodiments of the present disclosure, are described in detail below with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] By way of example, specific examples of the disclosed device will now be described, with reference to the accompanying drawings, in which:

[0035] FIG. 1A is a perspective view of an example of a tibial intramedullary (“IM”) nail in accordance with one or more features of the present disclosure, the tibial IM nail shown implanted within a patient’s left tibia;

[0036] FIG. IB is an alternate perspective view of the tibial IM nail shown in FIG.

1A;

[0037] FIG. 2 is a detailed, perspective view of a distal end portion or region of the tibial IM nail shown in FIG. 1A;

[0038] FIG. 3 is a top-down view of the distal end portion or region of the tibial IM nail shown in FIG. 1A;

[0039] FIG. 4 is a detailed, perspective view of a proximal end portion or region of the tibial IM nail shown in FIG. 1A;

[0040] FIG. 5 is a top-down view of the proximal end portion or region of the tibial IM nail shown in FIG. 1A;

[0041] FIGS. 6A-6D illustrate various views of an alternate example of a proximal end portion or region of a tibial IM nail in accordance with one or more features of the present disclosure; [0042] FIGS. 7A-7D illustrate various views of an alternate example of a proximal end portion or region of a tibial IM nail in accordance with one or more features of the present disclosure;

[0043] FIGS. 8A-8D illustrate various views of an alternate example of a proximal end portion or region of a tibial IM nail in accordance with one or more features of the present disclosure;

[0044] FIG. 9 illustrates an alternate example of a tibial IM nail in accordance with one or more features of the present disclosure;

[0045] FIGS. 10A and 10B illustrate various views of a screw inserted through a first screw hole formed in the distal end portion or region of the tibial IM nail shown in FIG.

1A, the screw being used to target a patient’s posterior malleolus in accordance with one or more features of the present disclosure; and

[0046] FIGS. 11A and 11B illustrate various views of a screw inserted through an alternate or third screw hole formed in the distal end portion or region of the tibial IM nail shown in FIG. 1A, the screw being used to target a patient’s syndesmotic joint in accordance with one or more features of the present disclosure.

[0047] It should be understood that the drawings are not necessarily to scale and that the disclosed examples are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and devices or which render other details difficult to perceive may have been omitted. It should be further understood that this disclosure is not limited to the particular examples illustrated herein. In the drawings, like numbers refer to like elements throughout unless otherwise noted.

DETAILED DESCRIPTION

[0048] Various features or the like of IM nails will now be described more fully hereinafter with reference to the accompanying drawings, in which one or more features of the IM nails will be shown and described. It should be appreciated that the various features or the like may be used independently of, or in combination, with each other. It will be appreciated that an IM nail as disclosed herein may be embodied in many different forms and should not be construed as being limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will convey certain features of the IM nails to those skilled in the art.

[0049] Disclosed herein are various IM nails including one or more features arranged and configured to be implanted within the medullary canal of a patient’s tibia. As will be described in greater detail herein, in various examples, the tibial IM nails are arranged and configured to be anatomically specific (e.g., the tibial IM nails include one or more features that are arranged and configured to be positioned in either the patient’s left tibia or the patient’s right tibia, but not both). This is in contrast to current tibial IM nails on the marketplace, which are arranged and configured to be implanted into both the right and left tibias. Thus arranged, by designing side-specific tibial IM nails, the distal end of the tibial IM nails may be arranged and configured to target one or more specific bony landmarks such as, for example, the patient’s posterior malleolus, the syndesm otic joint, etc. while the proximal end of the tibial IM nails may be arranged and configured to target the posterior medial and posterior lateral comers or portions of the patient’s tibia.

[0050] Referring to FIGS. 1A and IB, an example of a side-specific tibial IM nail 100 in accordance with one or more features of the present disclosure is illustrated. As illustrated, a left-sided tibial IM nail 100 is illustrated implanted within an intramedullary canal of a patient’s left tibia B. A right-sided tibial IM nail would be a mirror-image of the left-sided tibial IM nail shown. In use, as previously mentioned, a tibial IM nail 100 is arranged and configured to be implanted into the medullary canal of a patient’s tibia. As illustrated, the side-specific tibial IM nail 100 includes a body 102 such as, for example, a cannulated body. The body 102 includes a proximal end portion or region 110 and a distal end portion or region 130 (terms portion or region used interchangeably herein without the intent to limit or distinguish).

[0051] As generally illustrated, the distal end portion 130 may include a bow or a bend. In some examples, the bow or bend may be approximately 2 degrees in the anterior-posterior direction, coming from posterior to anterior, starting approximately 60mm from the distal tip of the tibial IM nail 100, although this is but one configuration and other configurations are envisioned.

[0052] With additional reference to FIG. 9, in some examples, the proximal end portion 110 may include a bow or a bend. In some examples, the bow or bend may extend proximally via an angle of approximately 10 degrees in the anterior-posterior direction, coming anterior from posterior, and located approximately 27mm from the proximal end of the tibial IM nail 100, although this is but one configuration and other configurations are envisioned.

[0053] In accordance with one or more features of the present disclosure, by providing side-specific IM nails, the proximal and distal end portions 110, 130 may also include a bow or a bend in the medial-lateral plane (e.g., the proximal and distal end portions 110, 130 may include a bow or a bend in or out of the medial-lateral plane in addition to, or alternatively from, the bow or bend in the anterior-posterior plane). By providing a bow or bend in the medial-lateral plane, the IM nail is better able to address inherent rotation in the tibia bone of the distal part relative to the proximal part.

[0054] In some examples, the proximal end portion 110 may be arranged and configured to couple or receive a nail cap. In some examples, the nail caps may be provided as a set in 5mm increments starting with 0mm to 20mm, although this is but one configuration and other configurations are envisioned.

[0055] With additional reference to FIG. 2, the distal end portion 130 includes a plurality of screw openings, holes, etc. 132 (terms used interchangeably herein without the intent to limit) arranged and configured to receive a fastener, screw, etc. (terms used interchangeably herein without the intent to limit) in situ. In some examples, the plurality of screw holes 132 can be threaded. Alternatively, the screw holes can be non-threaded, or some combination of threaded holes and non-threaded holes, or have any other configuration now known or hereafter developed. As illustrated, in some examples, the distal end portion 130 includes first, second, third, and fourth screw holes 132A-132D, although more or less screw holes may be incorporated. [0056] In accordance with one or more features of the present disclosure, the sidespecific tibial IM nail 100 includes a distal most, first screw hole 132A that is angled or inclined in the superior-inferior direction relative to a central longitudinal axis of the distal end portion 130. Thus arranged, in use, a screw may be inserted into the distal most, first screw hole 132A and into the patient’s posterior malleolus or other bony anatomy. For example, the distal most, first screw hole 132A may have an angle a. In some examples, angle a may be between 8 degrees and 15 degrees, preferably approximately 10 degrees relative to the central longitudinal axis of the distal end portion 130. As such, with additional reference to FIGS. 10A and 10B, a screw 150 may be inserted through the first screw hole 132 A formed in the distal end portion 130 of the IM nail 100 and directly into the patient’s posterior malleolus. Once again, this is in contrast to current tibial IM nails, which cannot enable targeting of patient specific bony anatomy such as, for example, the patient’s posterior malleolus (e.g., the distal most, first screw hole in current tibial IM nails cannot be angled at an approximately 10-degree angle since current tibial IM nails are designed to be implanted into both the patient’s left and right tibias). Thus arranged, in use, the IM nail 100 may be used to treat a patient’s posterior malleolar fracture. In some examples, in use, a surgeon may select a corresponding sidespecific tibial IM nail from a plurality of tibial IM nails including a right tibial IM nail and a left tibial IM nail depending on the location of the fracture (e.g., either the patient’s right tibia or left tibia). Thereafter, the surgeon may implant or insert the selected tibial IM nail into the patient’s intramedullary canal and target the patient’s posterior malleolar fracture via inserting a fastener or screw 150 through the first screw hole 132A formed in the distal end portion 130 of the IM nail 100. [0057] With additional reference to FIG. 3, which illustrates a top-down view of the tibial IM nail 100 implanted within a patient’s tibia (e.g., looking proximal to distally), in some examples, the second screw hole 132B and fourth screw hole 132D (e.g., the screw hole positioned second from the distal end and the most proximal screw hole from the distal end of the tibial IM nail 100) may extend substantially parallel to the anterior- posterior plane in situ. Thus arranged, the second screw hole 132B and fourth screw hole 132D may be parallel to each other and to the anterior-posterior plane. In use, by arranging the second and fourth screw holes 132B, 132D parallel to each other and parallel to the anterior-posterior plane, the second and fourth screw holes 132B, 132D are oriented to provide easier targeting such as, for example, freehand targeting of the screw holes 132B, 132D using fluoroscopy, which enables faster surgical times especially for simple shaft fractures. Alternatively, it is envisioned that the second screw hole 132B and fourth screw hole 132D may be provided at an angle P relative to the anterior- posterior plane. In some examples, the angle P may be between 0 degrees and 15 degrees to account for specific amounts of tibial torsion. However, as previously mentioned, in some examples, angle P is preferably zero degrees.

[0058] Moreover, in some examples, the distal most, first screw hole 132A may be angled in the medial-lateral direction. For example, the distal most, first screw hole 132A may be angled by an angle co. In some examples, angle co may be approximately ±60 degrees to about ±80 degrees, preferably about ±70 degrees and more preferably about ±62.5 degrees, from the anterior-posterior plane (or relative to the second and fourth screw holes 132B, 132D), although other angles may be used. Once again, facilitating targeting of the patient’s posterior malleolar and avoiding the patient’s syndesmosis joint.

[0059] In addition, as illustrated, in some examples, the third screw hole 132C (e.g., the screw hole positioned third from the distal end of the tibial IM nail 100) may be angled in the medial-lateral direction. For example, the third screw hole 132C may be angled by an angle Q. In some examples, angle Q may be approximately ±30 degrees to about ±40 degrees, preferably about ±30 degrees, from the anterior-posterior plane (or relative to the second and fourth screw holes 132B, 132D), although other angles may be used. Thus arranged, the third screw hole 132C facilitates screw positioning and/or fixation in a low distal one-third of the fracture that often comes across transverse. In addition, it can facilitate fibular fixation, which could be beneficial in elderly or severely osteoporotic patients.

[0060] In addition, with additional reference to FIGS. 11A and 11B, a screw 152 may be inserted through the third screw hole 132C formed in the distal end portion 130 of the IM nail 100 into the patient’s syndesm otic joint. Once again, this is in contrast to current tibial IM nails, which cannot enable targeting of patient specific bony anatomy such as, for example, the patient’s syndesmotic joint (e.g., screw holes in current tibial IM nails cannot be angled at an approximately 30-degree angle since current tibial IM nails are designed to be implanted into both the patient’s left and right tibias). Thus arranged, in accordance with one or more features of the present disclosure, the IM nail 100 may be used to treat a patient’s syndesmotic joint. In some examples, in use, a surgeon may 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 depending on the location of the fracture (e.g., either the patient’s right tibia or left tibia). Thereafter, the surgeon may implant or insert the selected tibial IM nail into the patient’s intramedullary canal and target the patient’s syndesmotic joint via inserting a fastener or screw 152 through the third screw hole 132C formed in the distal end portion 130 of the IM nail 100.

[0061] In some examples, in order to account for tibial torsion within the distal end portion 130 of the tibial IM nail 100, an offset may be provided between the third screw hole 132C and the distal most, first screw hole 132A as the distal tibia naturally experiences degrees of torsion that may require surgeons to rotate the tibial IM nail 100 in order to achieve the desired distal fixation, which may result in suboptimal screw placement. By providing side-specific tibial IM nails 100, this can be accommodated by offsetting the third screw hole 132C and the distal most, first screw hole 132A. In some examples, the offset may range from 1-89 degrees to account for the naturally occurring tibial torsion. Alternatively, in an alternate example, in order to account for tibial torsion within the distal end portion 130 of the tibial IM nail 100, an offset may be provided using the second screw hole 132B and the fourth screw hole 132D.

[0062] Referring to FIGS. 1A, IB, 4, and 5, in accordance with one or more features of the present disclosure that may be used separately from or in combination with the distal end portion 130 of the tibial IM nail 100 discussed above in connection with FIGS. 1A-3, the proximal end portion 110 of the tibial IM nail 100 includes a plurality of screw openings, holes, etc. 112 arranged and configured to receive a plurality of screws. As illustrated, in some examples, the proximal end portion 110 of the tibial IM nail 100 includes first, second, third, and fourth holes 112A, 112B, 112C, 112D, although other configurations are envisioned.

[0063] As illustrated, in some examples, 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 a slot. For example, as illustrated, the third screw hole 112C from the proximal end portion 110 may be in the form of a slot. By utilizing a slot, dynamization or micro-motion of the tibial IM nail 100 in situ is enabled. In some examples, the third screw hole (e.g., slot) 112C may extend in substantially the medial-lateral direction in situ. In some examples, the slot 112C may have a length of approximately 7mm.

[0064] With reference to FIG. 4, the proximal most, first screw hole 112A and the second screw hole 112B are arranged and configured to maximize support of the posterior aspects of the patient’s tibia while protecting the knee joint. That is, in accordance with one or more features of the present disclosure, the first and second screw holes 112 A, 112B formed in the proximal end portion 110 of the tibial IM nail 100 are arranged and configured to exit the patient’s tibia at the same level. For example, as illustrated, the proximal most, first screw hole 112A includes a downward angle or inclination in a superior-inferior direction relative to a central longitudinal axis of the proximal end portion 110. Thus arranged, in use, a screw may be inserted into the proximal most, first screw hole 112A. In situ, the longitudinal axis of the screw positioned within the proximal most, first screw hole 112A crosses the outer surface of the patient’s tibia at substantially the same level as a screw positioned within the second screw hole 112B (e.g., plane at which a first screw inserted into the proximal most, first screw hole 112A exits the bone is the same as a second screw inserted into the second screw hole 112B). For example, the proximal most, first screw hole 112A may have an angle or incline of angle p. In some examples, angle p may be between 5 degrees and 15 degrees, preferably approximately 10 degrees relative to the central longitudinal axis of the proximal end portion 110 (e.g., a downward ten-degree inclination away from the patient’s knee). Meanwhile, the second screw hole 112B may be substantially perpendicular to the central longitudinal axis of the proximal end portion 110. Thus arranged, first and second screws positioned with the first and second screw holes 112 A, 112B are arranged and configured to come together, and thus their trajectories can cross or exit the outer surface of the patient’s tibia at the same level in situ.

[0065] With additional reference to FIG. 5, which illustrates a top-down view of the tibial IM nail 100 implanted within a patient’s tibia (e.g., looking proximal to distally), in some examples, the proximal most, first screw hole 112A and the second screw hole 112 are arranged and configured to may be angled in the medial-lateral plane. That is, in some examples, the first and second screw holes 112 A, 112B may be angled relative to the medial -lateral plane by an angle §i, §2, respectively, and thus relative to the third screw hole (e.g., slot) 112C, which may be arranged and configured to extend in the medial-lateral direction. In some examples, angles §1, §2, may be the same.

Alternatively, angles §1, §2, may be different. In some examples, angle §1 may be approximately ±40 degrees to about ±50 degrees, preferably about ±44 degrees. Angle §2 may be approximately ±45 degrees to about ±50 degrees, preferably about ±47.5 degrees. Thus arranged, first and second screws inserted into the first and second screw holes 112 A, 112B are better able to target the posterior-medial and posterior-lateral comers or portions of the patient’s tibia. In addition, the first and second screws inserted into the first and second screw holes 112 A, 112B are better able to avoid the proximal tibial tubercle.

[0066] In addition, in some examples, as illustrated in FIG. 4, the fourth screw hole 112D may be angled or inclined in the superior-inferior direction relative to the proximal end portion 110. For example, the fourth screw hole 112D may have an angle £. In some examples, angle £ may be approximately 0 degrees to about ±10 degrees, preferably about ±5 degrees relative to the proximal end portion 110. As such, in some examples, the fourth screw hole 112D may be inclined or declined. Thus arranged, additional opportunities to increase fixation in the event of a more proximal transverse fracture can be achieved.

[0067] With additional reference to FIG. 5, in some examples, the fourth screw hole 112D is arranged and configured to may be angled in the medial-lateral plane. That is, in some examples, the fourth screw hole 112D may be angled relative to the medial -lateral plane, and thus relative to the third screw hole (e.g., slot) 112C, which may be arranged and configured to extend in the medial-lateral direction, by an angle X- In some examples, angle X may be approximately ±25 degrees to about ±35 degrees, preferably about ±25 degrees. Thus arranged, a screw inserted into the fourth screw hole 112D is angled to reduce screwhead prominence on the tibial tubercle.

[0068] Referring to FIGS. 6A-6D, which illustrates a top-down (e.g., looking proximal to distally), anterior, lateral, and posterior views of an alternate example of a tibial IM nail 100 implanted within a patient’s tibia, in some examples, angle §i of the proximal most, first screw hole 112A may be ±30 degrees relative to the medial -lateral plane, and thus relative to the third screw hole (e.g., slot) 112C. Thus arranged, the first screw inserted into the first screw hole 112A is arranged and configured to reduce the potential for tissue irritation at the level of the first screw due to the proximal most screw being positioned off the tibial tubercle. In this example, angle §2 of the second screw hole 112B may be approximately ±47.5 degrees and angle X of the fourth screw hole 112D relative to the medial-lateral plane, and thus relative to the third screw hole (e.g., slot) 112C, may be approximately ±25 degrees.

[0069] Referring to FIGS. 7A-7D, which illustrates a top-down (e.g., looking proximal to distally), anterior, lateral, and posterior views of an alternate example of a tibial IM nail 100 implanted within a patient’s tibia, in some examples, angle X of the fourth screw hole 112D may be angled ±35 degrees to ±40 degrees, preferably, ±40 degrees, relative to the medial-lateral plane, and thus relative to the third screw hole (e.g., slot) 112C. Thus arranged, the fourth screw inserted into the fourth screw hole 112D is arranged and configured to reduce the potential for tissue irritation at the level of the fourth screw due to the fourth screw being rotated off the tibial tubercle, and to increase separation between the third screw positioned within the third screw hole 112C and the fourth screw positioned within the fourth screw hole 112D thereby providing improved fixation when using both a screw positioned within the third screw hole 112C and a screw positioned within the fourth screw hole 112D. That is, in this example, with angle X of the fourth screw hole 112D being angled between ±35 degrees to ±40 degrees, preferably, ±40 degrees, relative to the medial-lateral plane, the fourth screw is directed to the postero-lateral aspect of the patient’s tibia and changes how the screw head sits as well as its possible interference with other anatomic structures nearby. In contrast, in connection with alternate examples, when angle X is angled at ±25 degrees or ±35 degrees, the fourth screw is directed to the postero-medial aspect of the patient’s tibia and tends to favor a smaller angle to avoid screw head prominence and maintain safe clearances with surrounding tissue structures.

[0070] In this example, angle § i, §2 of the first and second screw holes 112A, 112B may both be approximately ±47.5 degrees.

[0071] Referring to FIGS. 8A-8D, which illustrates a top-down (e.g., looking proximal to distally), anterior, lateral, and posterior views of an alternate example of a tibial IM nail 100 implanted within a patient’s tibia, in some examples, angle §1 of the proximal most, first screw hole 112A may be ±30 degrees relative to the medial -lateral plane, and thus relative to the third screw hole (e.g., slot) 112C and angle X of the fourth screw hole 112D may be angled ±35 degrees relative to the medial-lateral plane, and thus relative to the third screw hole (e.g., slot) 112C. In this example, angle §2 of the second screw hole 112b may be ±47.5 degrees relative to the medial-lateral plane, and thus relative to the third screw hole (e.g., slot) 112C. Thus arranged, the first screw inserted into the first screw hole 112A is arranged and configured to reduce the potential for tissue irritation at the level of the first screw due to the proximal most screw being positioned off the tibial tubercle and the fourth screw inserted into the fourth screw hole 112E is arranged and configured to reduce the potential for tissue irritation at the level of the fourth screw due to the fourth screw being rotated off the tibial tubercle, and to increase separation between the third screw positioned within the third screw hole 112C and the fourth screw positioned within the fourth screw hole 112D thereby providing improved fixation when using both a screw positioned within the third screw hole 112C and a screw positioned within the fourth screw hole 112D.

[0072] Referring to FIG. 9, in accordance with one or more features of the present disclosure, the proximal end portion 110 of the tibial IM nail 100 may include a fifth screw hole 112E. As illustrated, in use, the fifth screw hole 112E is arranged and configured as the most distal of the screw holes formed in the proximal end portion 110. As will be appreciated, the fifth screw hole 112E may be used in combination with any of the tibial IM nails disclosed herein or any tibial IM nail developed hereto or hereafter.

[0073] In some examples, as illustrated, the fifth screw hole 112E may be arranged and configured to extend in the medial-lateral plane. Thus arranged, the fifth screw hole 112E is arranged and configured to extend parallel to the medial-lateral plane, and thus parallel to the third screw hole (e.g., slot) 112C, which may be arranged and configured to extend in the medial-lateral direction. In addition, in accordance with one or more features of the present disclosure, the fifth screw hole 112E is separated from the third screw hole 112C (e.g., the two screw holes extending in the medial-lateral plane) via an intermediate screw hole (e.g., the fourth screw hole 112D in the illustrated example). Thus arranged, the fifth screw hole 112E is separated from the third screw hole or compression slot 112C via the fourth screw hole 112D. This is in contrast to current tibial IM nails that include parallel medial-lateral screw holes that are adjacent to each other. By separating the two medial-lateral screw holes from each other, the distance between the two medial-lateral screw holes is increased. In addition, an out-of-plane screw may be positioned between the third and fifth screw holes 112C, 112E. In some examples, the distance between the third and fifth screw holes 112C, 112E may be between 15 mm and 25 mm.

[0074] Generally speaking, a large percent of tibia fractures treated with IM nailing are simple shaft fractures and do not require additional out of plane fixation options as provided by the proximal and distal screw trajectories. By incorporating the fifth screw hole 112E and by orientating the fifth screw hole 112E parallel to the third screw hole 112C and to the medial -lateral plane, the tibial IM nail 100 enables surgeons to quickly and more efficiently obtain simple proximal fixation quickly and in the same radiographic orientation as the proximal compression slot, which is medial-lateral oriented as well and commonly used to treat said shaft fractures, thus enabling the surgeon to reduce operative time as well as radiation exposure as less fluoroscopic imaging is needed since the fifth screw hole 112E and the third screw hole (e.g., compression slot) 112C are orientated in the same plane. In addition, by separating the third and fifth screw holes 112C, 112E, enables the tibial IM nail 100 to provide improved fixation by increasing the distance between the two medial-lateral screw holes, as having two screw holes in the same plane adjacent to each other does not provide optimal stabilization and rotational control of fractures.

[0075] As such, in accordance with various examples, the IM tibial nail 100 may include first, second, third, fourth, and fifth screw holes 112A-112E in the proximal end portion 110 with two screw holes extending medially and two screw holes extending distally. In various examples, the two proximal extending medial-lateral screw holes and the two distal extending medial-lateral screw holes may be angularly orientated relative to each other (e.g., an angular range between 1 to 89 degrees).

[0076] In accordance with one or more features of the present disclosure, a plurality of tibial IM nails may be provided in a kit. For example, a kit may include mutual sets of side-specific anatomic tibial IM nails wherein one tibial IM nail is arranged and configured for implantation into the patient’s left tibia and one of the tibial IM nails is arranged and configured for implantation into the patient’s right tibia. In use, the tibial IM nails may be mirror-images of each other. In accordance with one or more features of the present disclosure, the tibial IM nails may be color-coded to distinguish the tibial IM nails configured for implantation in the patient’s right tibial from the tibial IM nails configured for implantation in the patient’s left tibial.

[0077] The foregoing description has broad application. Accordingly, the discussion of any example or embodiment is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples or embodiments. In other words, while illustrative examples or embodiments of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0078] The term "a" or "an" entity, as used herein, refers to one or more of that entity. As such, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Accordingly, the terms "including," "comprising," or "having" and variations thereof are open-ended expressions and can be used interchangeably herein. The phrases "at least one", "one or more", and "and/or", as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. [0079] All directional references (e.g., proximal, distal, upper, underside, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority but are used to distinguish one feature from another. The drawings are for purposes of illustration only and the dimensions, positions, order and relative sizes reflected in the drawings attached hereto may vary.

Claims

CLAIMS What is claimed is:

1. An anatomic, side-specific tibial IM nail comprising: a body including a proximal end portion and a distal end portion, the distal end portion including a plurality of screw holes arranged and configured to receive a fastener, the plurality of screw holes including a distal most, first screw hole; wherein the distal most, first screw hole is angled in a superior-inferior direction relative to a central longitudinal axis of the distal end portion.

2. The anatomic, side-specific tibial IM nail of claim 1, wherein the distal most, first screw hole is angled by an angle a with angle a being approximately ten- degrees so that a first screw positioned within the distal most, first screw hole can target a patient’s posterior malleolus.

3. The anatomic, side-specific tibial IM nail of any of the preceding claims, wherein the plurality of screw holes formed in the distal end portion further include second, third, and fourth screw holes positioned from a distal end of the body.

4. The anatomic, side-specific tibial IM nail of claim 3, wherein the second screw hole and the fourth screw hole extend substantially parallel to each other.

5. The anatomic, side-specific tibial IM nail of claims 3 and 4, wherein the second screw hole and the fourth screw hole extend substantially parallel to an anterior- posterior plane in situ.

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6. The anatomic, side-specific tibial IM nail of claims 3, 4, and 5, wherein the distal most, first screw hole is angled by an angle co relative to second and fourth screw holes, wherein the angle co is about ±62.5 degrees.

7. The anatomic, side-specific tibial IM nail of claims 3, 4, 5, and 6, wherein the third screw hole is angled by an angle Q relative to second and fourth screw holes, wherein the angle Q is about ±30 degrees.

8. The anatomic, side-specific tibial IM nail of any of the preceding claims, wherein the proximal end portion includes a plurality of screw holes arranged and configured to receive a fastener, the plurality of screw holes including a proximal most, first screw hole; wherein the proximal most, first screw hole includes a downward angle of angle p in a superior-inferior direction.

9. The anatomic, side-specific tibial IM nail of claim 8, wherein the angle p is approximately 10 degrees.

10. The anatomic, side-specific tibial IM nail of claims 8 and 9, wherein the proximal end portion further includes a second screw hole positioned from a proximal end of the body, the first and second screw holes being arranged and configured to exit from an outer surface of a patient’s tibia at substantially a same level or plane.

11. The anatomic, side-specific tibial IM nail of claim 10, wherein the second screw hole is substantially perpendicular to a central longitudinal axis of the proximal end portion.

12. The anatomic, side-specific tibial IM nail of claims 10 and 11, wherein the proximal end portion further includes third and fourth screw holes positioned from the proximal end of the body.

13. The anatomic, side-specific tibial IM nail of claim 12, wherein one or more of the plurality of screw holes is arranged and configured as a slotted hole.

14. The anatomic, side-specific tibial IM nail of claim 12, wherein the third screw opening is arranged and configured as a slotted hole.

15. The anatomic, side-specific tibial IM nail of claims 12-14, wherein the proximal most, first screw hole and the second screw hole are angled relative to the third screw hole by an angle §i, §2, respectively.

16. The anatomic, side-specific tibial IM nail of claim 15, wherein the angles §1, §2 are about ±47.5 degrees.

17. The anatomic, side-specific tibial IM nail of claim 15, wherein the angle §1 is different from the angle §2, wherein the angle §1 is about ±44 degrees and angle §2 is about ±47.5 degrees.

18. The anatomic, side-specific tibial IM nail of claims 12-17, wherein the fourth screw hole is angled in a superior-inferior direction by an angle £, the angle £ is about ±5 degrees.

19. The anatomic, side-specific tibial IM nail of claim 18, wherein the fourth screw hole is angled relative to the third screw hole by an angle X, the angle X being selected from one of about ±25 degrees, about ±35 degrees, and about ±40 degrees.

20. The anatomic, side-specific tibial IM nail of claims 12-19, wherein the proximal end region includes a fifth screw hole.

21. The anatomic, side-specific tibial IM nail of claim 20, wherein the fifth screw hole is parallel to the third screw hole.

22. The anatomic, side-specific tibial IM nail of claims 20 and 21, wherein the third screw hole and the fifth screw hole are separated from each other by the fourth screw hole positioned between the third and fifth screw holes.

23. An anatomic, side-specific tibial IM nail comprising: a body including a proximal end portion and a distal end portion, the proximal end portion including a plurality of screw holes arranged and configured to receive a fastener, the plurality of screw holes including a proximal most, first screw hole; wherein the proximal most, first screw hole includes a downward angle of angle p in a superior-inferior direction.

24. The anatomic, side-specific tibial IM nail of claim 23, wherein the angle p is approximately 10 degrees.

25. The anatomic, side-specific tibial IM nail of claims 23 and 24, wherein the proximal end portion further includes a second screw hole positioned from a proximal end of the body, the first and second screw holes being arranged and configured to exit from an outer surface of a patient’s tibia at substantially a same level or plane.

26. The anatomic, side-specific tibial IM nail of claim 25, wherein the second screw hole is substantially perpendicular to a central longitudinal axis of the proximal end portion.

27. The anatomic, side-specific tibial IM nail of claims 25 and 26, wherein the proximal end portion further includes third and fourth screw holes positioned from the proximal end of the body.

28. The anatomic, side-specific tibial IM nail of claim 27, wherein one or more of the plurality of screw holes is arranged and configured as a slotted hole.

29. The anatomic, side-specific tibial IM nail of claim 27, wherein the third screw opening is arranged and configured as a slotted hole.

30. The anatomic, side-specific tibial IM nail of claims 27-29, wherein the proximal most, first screw hole and the second screw hole are angled relative to the third screw hole by an angle §i, §2, respectively.

32

31. The anatomic, side-specific tibial IM nail of claim 30, wherein the angles

§i, §2 are about ±47.5 degrees.

32. The anatomic, side-specific tibial IM nail of claim 30, wherein the angle §i is different from the angle §2, wherein the angle §1 is about ±44 degrees and angle §2 is about ±47.5 degrees.

33. The anatomic, side-specific tibial IM nail of claims 27-32, wherein the fourth screw hole is angled in a superior-inferior direction by an angle £, the angle £ is about ±5 degrees.

34. The anatomic, side-specific tibial IM nail of claim 33, wherein the fourth screw hole is angled relative to the third screw hole by an angle X, the angle X being selected from one of about ±25 degrees, about ±35 degrees, and about ±40 degrees.

35. The anatomic, side-specific tibial IM nail of claims 27-34, wherein the proximal end region includes a fifth screw hole.

36. The anatomic, side-specific tibial IM nail of claim 35, wherein the fifth screw hole is parallel to the third screw hole.

37. The anatomic, side-specific tibial IM nail of claims 35 and 36, wherein the third screw hole and the fifth screw hole are separated from each other by the fourth screw hole positioned between the third and fifth screw holes.

33

38. An anatomic, side-specific tibial IM nail arranged and configured to be implanted within one of a patient’s right tibial and a patient’s left tibial, but not the other one of the patient’s right and left tibial.

39. A method for treating a patient’s posterior malleolar fracture, the method comprising: selecting 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 depending on a location of the fracture; implanting the selected side-specific tibial IM nail into the patient’s intramedullary canal; and inserting a fastener through a screw hole formed in a distal end portion of the side-specific tibial IM nail, the fastener targeting the patient’s posterior malleolar fracture.

40. A method for treating a patient’s syndesmotic joint fracture, the method comprising: selecting 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 depending on a location of the fracture; implanting the selected side-specific tibial IM nail into the patient’s intramedullary canal; and

34 inserting a fastener through a screw hole formed in a distal end portion of the side-specific tibial IM nail, the fastener targeting the patient’s syndesmotic joint fracture.

35