Universal recon opening in an intramedullary nail

Abstract

An orthopedic intramedullary ("IM") nail, and more specifically, a retrograde femoral IM nail, is disclosed. The IM nail including a universal recon screw opening defining a first screw trajectory and a second screw trajectory. Thus arranged, the IM nail can be anatomically agnostic so that the IM nail can be implanted into either the patient's right bone (e.g., right femur) or the patient's left bone (e.g., left femur). In use, the first screw trajectory receives a fastener when the IM nail is implanted with the patient's left bone, the second screw trajectory receives a fastener when the IM nail is implanted with the patient's right bone. Thus arranged, an anatomically agnostic retrograde femoral IM nail is provided which allows surgeons to target the patient's femoral head and neck while enabling the retrograde femoral IM nail to be implanted within either of a patient's left or right femur.

Description

UNIVERSAL RECON OPENING IN AN INTRAMEDULLARY NAILCROSS-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 / 632,336, filed April 10, 2024, entitled “Universal Recon Opening in an Intramedullary Nail” 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 including a universal recon (e.g., reconstruction) screw opening for stabilizing one or more patient’s bones, bone portions, bone fragments, etc., and more specifically to anatomically agnostic retrograde femoral IM nails including a universal recon screw opening arranged and configured to enable surgeons to target the patient’s femoral head and neck while enabling the retrograde femoral IM nail to be implanted within either of a patient’s left or right femur.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 thebone, 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 IM nail is a retrograde femoral nail. A retrograde femoral IM nail is arranged and configured to be inserted into the medullary canal of a patient’s femur through the distal end of the femur (e.g., inserted adjacent or near the patient’s knee). In use, the retrograde femoral IM nail may extend from the patient’s knee proximally (e.g., superiorly) to the proximal end portion (e.g., superior end portion) of the patient’s femur (e.g., adjacent or near the greater trochanter).

[0006] One disadvantage of current retrograde femoral IM nails is that they are designed and configured to be side agnostic. That is, many current retrograde femoral IM nails are arranged and configured to be implanted into either of the patient’s right femur or the patient’s left femur. As a result, current retrograde femoral IM nails do not allow surgeons to target the patient’s femoral head and neck area. Moreover, if currentretrograde femoral IM nails were used to target a patient’s femoral head and neck area, current retrograde femoral IM nails would necessarily be anatomically side-specific (i.e., anatomically side-specific femoral IM nails are arranged and configured to be exclusively implanted into either the patient’s right femur or the patient’s left femur). This is because, if a current retrograde femoral IM nail was designed and configured to be side agnostic such that it can be implanted into either the patient’s right femur or the patient’s left femur, the retrograde femoral IM nail prevents, or at least limits, the surgeon’s ability to target the patient’s femoral head and neck. If a current retrograde femoral IM nail were used to target a specific area (e.g., patient’s femoral head and neck) in the patient’s left femur, the same retrograde femoral IM nail implanted into the patient’s right femur would be incapable of targeting the corresponding area (e.g., patient’s femoral head and neck).

[0007] Thus, current retrograde femoral IM nails are often provided in kits or systems including a retrograde femoral IM nail arranged and configured to be implanted with a patient’s left femur and a retrograde femoral IM nail arranged and configured to be implanted with a patient’s right femur. As a result, hospitals must carry and manage double inventory (i.e., a first retrograde femoral IM nail designed and configured to be implanted into the patient’s left femur and a second retrograde femoral IM nail designed and configured to be implanted into the patient’s right femur).

[0008] In addition, many surgeons will not prophylactically protect the femoral head and neck. If they do, standalone screws are typically implanted into the femoral head and neck adjacent to and / or around any implanted orthopedic implant (e.g., IM nail or boneplate). That is, generally speaking, high energy femoral shaft fractures often have overlooked or unrecognized neck fractures. For these situations where an IM nail and transverse (anterior-posterior and / or medial-lateral) bone screws are used to address the shaft fracture, surgeons typically also incorporate or implant one or more bone screw(s) into the patient’s femoral neck. This is typically performed by implanting multiple bone screws into the patient’s femoral neck independently of the IM nail.

[0009] It would be beneficial for a retrograde femoral IM nail arranged and configured to facilitate bone screw placement through the IM nail and into the patient’s femoral head and neck. In addition, it would be beneficial for the retrograde femoral IM nail to be arranged and configured to enable implantation into the patient’s left femur or the patient’s right femur. As such, it would be beneficial to provide a retrograde femoral IM nail that is arranged and configured to be implanted into either of the patient’s left femur or the patient’s right femur (e.g., side agnostic), while still enabling surgeons to target specific boney areas (e.g., patient’s femoral head and neck) in either of the patient’s left or right femurs.

[0010] Thus, there remains a need to provide an improved orthopedic retrograde femoral IM nail 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 notintended 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 improved intramedullary (“IM”) nail is disclosed. In some examples, the IM nail is a retrograde femoral IM nail arranged and configured to be implanted into a patient’s femur via a distal end of the femur. In some examples, the retrograde femoral IM nail is arranged and configured to be side agnostic (e g., capable of being implanted into either the patient’s left femur or the patient’s right femur).

[0013] The retrograde femoral IM nail includes a body including a leading proximal end portion and a driven distal end portion opposite the leading proximal end portion. The leading proximal end portion includes a universal recon screw opening defining a first screw trajectory and a second screw trajectory, the first screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s left femur, the second screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s right femur.

[0014] In some examples, an orthopedic intramedullary (“IM”) nail is disclosed. The IM nail includes a body including a proximal end portion and a distal end portion, the proximal end portion including a universal recon screw opening defining a first screw trajectory and a second screw trajectory, the first screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s left bone, the second screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s right bone.

[0015] In any preceding or subsequent example, the body includes a first side and a second side and the universal recon screw opening includes a first opening formed in the first side of the body for receiving a bone screw, and second and third separate and distinct openings formed in the second side of the body for receiving a bone screw, wherein the first opening is in communication with each of the second and third openings, and the first screw trajectory is defined by the first and second openings, and the second screw trajectory is defined by the first and third openings.

[0016] In any preceding or subsequent example, the first opening includes a chamfered surface to facilitate screw clearance.

[0017] In any preceding or subsequent example, the first screw opening formed in the first side of the body comprises a variable-angled opening and includes one of fins, tabs, or ridges for engaging external threads of a bone screw inserted therethrough, and the second and third openings formed in the second side of the body are smooth.

[0018] In any preceding or subsequent example, the second and third openings formed in the second side of the body are circumferentially offset relative to each other.

[0019] In any preceding or subsequent example, the body includes a first side and a second side and the universal recon screw opening includes a first opening formed in the first side of the body for receiving a bone screw, and second and third separate and distinct openings formed in the second side of the body for receiving a bone screw, wherein each of the second and third openings is in communication with the first opening thereby defining the first and second screw trajectories.

[0020] In any preceding or subsequent example, a first bone screw is inserted into the first opening formed in the first side of the body and through the second opening formed in the second side of the body when the IM nail is implanted within one of the patient’s left bone or right bone, or into the third opening formed in the second side of the body and through the first opening formed in the first side of the body when the IM nail is implanted within the other one of the patient’s left bone or right bone.

[0021] In any preceding or subsequent example, the proximal end portion further comprises one or more screw openings extending in an anterior-posterior direction, in use.

[0022] In any preceding or subsequent example, the one or more screw openings includes first and second screw openings, the first screw opening positioned adjacent a proximal tip of the body, the second screw opening positioned inferiorly of the first screw opening, and the universal recon screw opening positioned in-between the first and second openings.

[0023] In any preceding or subsequent example, the one or more screw openings includes first and second screw openings, the universal recon screw opening positioned adjacent a proximal tip of the body, the first screw opening positioned inferiorly of the universal recon screw opening, and the second bone screw opening positioned inferiorly of the first bone screw opening.

[0024] In any preceding or subsequent example, the second bone screw opening comprises an elongated slot.

[0025] In any preceding or subsequent example, the IM nail further includes a superiorly positioned screw opening extending in a lateral-medial direction, in use.

[0026] In any preceding or subsequent example, the patient’s left bone is a left femur and the patient’s right bone is a right femur.

[0027] In any preceding or subsequent example, the IM nail comprises a retrograde femoral intramedullary nail arranged and configured to be implanted into one of the patient’s left femur or right femur via a distal end thereof.

[0028] In any preceding or subsequent example, the retrograde femoral intramedullary nail is arranged and configured to be anatomically side agnostic to be implanted into either the patient’s left bone or the patient’s right bone, the universal recon screw opening enabling a surgeon to target a patient’s femoral head and neck regardless of the retrograde femoral intramedullary nail being implanted within the patient’s left femur or the patient’s right femur.

[0029] In any preceding or subsequent example, the IM nail further includes a bone screw, wherein, in use, the bone screw is inserted medial to lateral through the universal recon screw opening to target the patient’s greater trochanter.

[0030] Exemplary embodiments of the present disclosure provide numerous advantages. For example, by designing and providing a retrograde femoral IM nail utilizing a universal recon screw opening, the retrograde femoral IM nail is arranged and configured to be side agnostic (e.g., capable of being implanted into either the patient’sleft femur or the patient’s right femur) while enabling surgeons to target the patient’s femoral head and neck.

[0031] 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

[0032] By way of example, specific examples of the disclosed device will now be described, with reference to the accompanying drawings, in which:

[0033] FIGS. 1A-1C illustrate various perspective views of an example of a retrograde femoral intramedullary (“IM”) nail in accordance with one or more features of the present disclosure;

[0034] FIGS. 2A and 2B illustrate detailed perspective views of a first side of a leading or proximal end portion of the retrograde femoral IM nail shown in FIGS. 1A- 1C;

[0035] FIGS. 2C and 2D illustrate detailed perspective views of a second side of the leading or proximal end portion of the retrograde femoral IM nail shown in FIGS. 1A- 1C;

[0036] FIG. 2E illustrates a detailed, cross-sectional view of the leading or proximal end portion of the retrograde femoral IM nail shown in FIGS. 1A-1C;

[0037] FIG. 3 illustrates a detailed perspective view of the leading or proximal end portion of the retrograde femoral IM nail shown in FIGS. 1A-1C, FIG. 3 illustratively showing the trajectory of first and second bone screws;

[0038] FIG. 4A illustrates a detailed perspective view of the retrograde femoral IM nail shown in FIGS. 1A-1C implanted with a patient’s right femur;

[0039] FIG. 4B illustrates a detailed perspective view of the retrograde femoral IM nail shown in FIGS. 1A-1C implanted with a patient’s left femur;

[0040] FIG. 5 illustrates a perspective view of the retrograde femoral IM nail used in a surgical procedure to target a fracture in a patient’s greater trochanter;

[0041] FIG. 6 illustrates a perspective view of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure;

[0042] FIG. 7 illustrates a perspective view illustrating the retrograde femoral IM nail used in combination with one or more additional bone screws to target and / or treat the femoral neck prophylactically;

[0043] FIGS. 8A and 8B illustrate various perspective views illustrating the retrograde femoral IM nail used in combination with one or more additional bone screws to target and / or treat the femoral neck prophylactically;

[0044] FIGS. 9A-9D illustrate various perspective views of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure;

[0045] FIGS. 10A-10I illustrate various perspective views of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure;

[0046] FIGS. 11A-11C illustrate various perspective views of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure;

[0047] FIG. 12 illustrates a side perspective view of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure; and

[0048] FIG. 13 illustrates a side perspective view of an alternate example of a retrograde femoral IM nail in accordance with one or more features of the present disclosure.

[0049] 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

[0050] 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.

[0051] Disclosed herein is an example of a retrograde femoral intramedullary (“IM”) nail including one or more features arranged and configured to be implanted within the medullary canal of a patient’s femur. As will be described in greater detail herein, in various examples, the retrograde femoral IM nail is arranged and configured with a universal recon screw opening, which is arranged and configured to allow surgeons to target bony anatomy in the patient’s head and neck regardless if the retrograde femoral IM nail is implanted within the patient’s left or right femur (e.g., recon or reconstruction referring to the ability to enable a surgeon to implant a bone screw through a screw opening in the retrograde femoral IM nail, the bone screw extending into the patient’s femoral head and neck area). As such, the retrograde femoral IM nail is anatomically agnostic (e.g., the retrograde femoral IM nail can be implanted into either the patient’s left femur or the patient’s right femur) while still enabling surgeons to target the femoral head and neck. That is, in use, the retrograde femoral IM nail can be used in either thepatient’s left femur or the patient’s right femur to protect or target the patient’s femoral neck and head area.

[0052] As will be described and illustrated herein, the present disclosure is directed to a retrograde femoral IM nail. However, it should be appreciated that features of the present disclosure, in particular, the universal recon screw opening, may have applicability in other areas and / or in other IM nails such as, for example, in connection with a humeral nail, a hindfoot nail, an antegrade / retrograde combo nail, etc. In addition and / or alternatively, features of the present disclosure such as, for example, the universal recon screw opening, can be used, for example, in an antegrade femoral IM nail. As such, the present disclosure should not be limited to a retrograde femoral IM nail unless explicitly claimed.

[0053] Referring to FIGS. 1A-1C, an example of a retrograde femoral IM nail 100 in accordance with one or more features of the present disclosure is illustrated. In use, as will be readily appreciated by one of ordinary skill in the art, the retrograde femoral IM nail 100 is arranged and configured to be implanted into the medullary canal of a patient’s femur via a distal end of the femur (e.g., inserted adjacent or near the patient’s knee). In some examples, the retrograde femoral IM nail 100 has a length sufficient to extend the retrograde femoral IM nail 100 into the patient’s femur to target the femoral neck and head area H (e.g., extends adjacent or near the patient’s greater trochanter T).

[0054] As illustrated, the retrograde femoral IM nail 100 includes a body 102 such as, for example, a cannulated body (as illustrated in FIG. 2E). The body 102 includes a leading or proximal end portion 110 (leading proximal end portion) and a driven or distalend portion 130 (driven distal end portion) opposite the leading proximal end portion 110.

[0055] As illustrated, the driven distal end portion 130 may include a plurality of screw openings, holes, slots, etc. 132 arranged and configured to receive one or more bone fasteners, screws, etc. (term screw opening used generically herein to encompass holes, slots, etc. without the intent to limit or distinguish). In some examples, the screw openings can be threaded. Alternatively, the screw openings can be non-threaded, or have any other configuration now known or hereafter developed. For example, the screw openings may include one or more fins or ridges as described in International Application Number PCT / US2023 / 022229, published as W020230224905, filed on May 15, 2023, entitled “Intramedullary Tibial Nail with Variable Angle Screw Openings,” the entire disclosure of which is explicitly incorporated herein. In use, the driven distal end portion 130 may have any size and configuration including any number of screw openings now known or hereafter developed. As the present disclosure is directed to features of the leading proximal end portion of a retrograde femoral IM nail, the present disclosure should not be limited to any particular configuration of the driven distal end portion unless explicitly claimed, thus, for the sake of brevity, further description on the driven distal end portion is omitted herefrom.

[0056] In addition, as illustrated, the leading proximal end portion 110 of the retrograde femoral IM nail 100 may include one or more screw openings 140 arranged and configured to receive one or more screws. The screw openings 140 may have any suitable configuration now known or hereafter developed such as, for example, lockingscrew opening (e.g., the screw opening can be threaded), variable angled screw opening (e.g., the screw openings can be non-threaded, or have any other configuration now known or hereafter developed such as, for example, include one or more fins or ridges), etc. In some examples, the leading proximal end portion 110 may include any number of screw openings 140 such as, for example, 0, 1, 2, 3, 4, 5, or more. In addition, and / or alternatively, the screw openings 140 may extend in any suitable trajectory such as, for example, anterior-posterior, medial-lateral, or the like. In addition, and / or alternatively, the screw openings 140 may be arranged and configured to facilitate variability in the angle of inclination or insertion.

[0057] With additional reference to FIGS. 2A-2E, the leading proximal end portion 110 of the retrograde femoral IM nail 100 includes a universal recon screw opening 120 (e.g., a combo or K-shaped screw opening). That is, as illustrated, the leading proximal end portion 110 includes a universal recon screw opening 120, which is arranged and configured as a combo screw opening having, for example, a K-shape. Thus arranged, in use, the universal recon screw opening 120 is arranged and configured to receive a first bone screw 150 from a first side 112 thereof or a second bone screw 152 from a second side 114 thereof depending on which femur of the patient’s body the retrograde femoral IM nail 100 is implanted into. That is, as illustrated, the body 102 at the leading proximal end portion 110 may be characterized as including a first side 112 and a second side 114 . As illustrated in FIGS. 2A and 2B, the universal recon screw opening 120 includes a single opening 120A for receiving a screw formed in the first side 112 of the body 102. However, with reference to FIGS. 2C and 2D, the universal recon screw opening 120 includes two separate and distinct openings 120B, 120C for receiving a screw in thesecond side 114 of the body 102. With reference to FIG. 2E, the opening 120A formed in the first side 112 is in communication with both openings 120B, 120C formed in the second side 114. As such, the array or cluster of openings 120A, 120B, 120C may be referred to herein as a combo or K-shaped hole due to its K-shaped configuration. While a specific example of a universal recon screw opening is described and illustrated herein, it is envisioned that alternate examples may be used. For example, screw openings providing first and second trajectories which do not share a common opening on one side (e.g., separate and distinct openings on both sides of the body).

[0058] Thus arranged, in accordance with one or more features of the present disclosure, the leading proximal end portion 110 of the retrograde femoral IM nail 100 includes a universal recon screw opening 120 including first and second screw trajectories. In some examples, the screw trajectories are anteverted and are positioned so their specific angles and distances from each other intersect on one side (e.g., intersect along the first side 112) of the body 102 of the retrograde femoral IM nail 100 (e.g., as will be described herein in greater detail, where one screw enters, the other screw exits depending on which side of the patient’s body the retrograde femoral IM nail 100 is implanted).

[0059] Thus arranged, with reference to FIG. 3, a first bone screw 150 may be inserted from opening 120A formed in the first side 112, along the first screw trajectory formed in the body 102 of the retrograde femoral IM nail 100, and out opening 120B formed in the second side 114. Alternatively, a second screw 152 may be inserted from the opening 120C formed in the second side 1 14, along the second screw trajectoryformed in the body 102 of the retrograde femoral IM nail 100, and out the opening 120A formed in the first side 112. With additional reference to FIGS. 4A and 4B, the first bone screw 150 may be inserted through the opening 120A formed in the first side 112, through the body 102 of the retrograde femoral IM nail 100, and out the opening 120B formed in the second side 114 when the retrograde femoral IM nail 100 is implanted into a left femur. Alternatively, the second bone screw 152 may be inserted through the opening 120C formed in the second side 114, through the body 102 of the retrograde femoral IM nail 100, and out the opening 120A formed in the first side 112 when the retrograde femoral IM nail 100 is implanted into a right femur.

[0060] In some examples, with reference to FIGS. 3-4B, in use, when implanted within a right femur, the second screw trajectory of the second bone screw 152 inserted into opening 120C formed in the second side 114, through the body 102 of the retrograde femoral IM nail 100, and out the opening 120A formed in the first side 112 of the body 102, may be inserted at an angle 0 of between 120 and 140 degrees, although this is one configuration and other configurations are envisioned. For example, the second screw trajectory may be at an angle 0 of between 120 and 135 degrees. Alternatively, for example, the second screw trajectory may be at an angle 0 of between 130 and 138 degrees relative to a longitudinal central axis of the retrograde femoral IM nail 100, and preferably between 132 and 136 degrees, and more preferably at an angle 0 of approximately 134 degrees. Although these are but one configuration and other configurations are envisioned.

[0061] Meanwhile, when implanted within a left femur, the first screw trajectory of the first bone screw 150 inserted into the opening 120A formed in the first side 112, through the body 102 of the retrograde femoral IM nail 100, and out opening 120B formed in the second side 114 of the body 102, may be inserted at an angle a of between 120 and 135 degrees, although this is one configuration and other configurations are envisioned. For example, the first screw trajectory may be at an angle a of between 124 and 132 degrees relative to a longitudinal central axis of the retrograde femoral IM nail 100, and preferably between 126 and 130 degrees, and more preferably at an angle a of approximately 128 degrees. Although these are but one configuration and other configurations are envisioned. Thus arranged, in some examples, the screw trajectory farther from the leading proximal end of the body has a larger angle to account for the difference in distance from the proximal end of the nail.

[0062] With reference to FIG. 2D, in some examples, the opening 120A of the universal recon screw opening 120 formed in the first side 112 of the body 102 may include a chamfered surface 122 to facilitate screw clearance.

[0063] As illustrated, in some examples, the openings 120B, 120C associated with the universal recon screw opening 120 formed in the second side 114 of the body 102 may be smooth (e.g., non-threaded, devoid of any threads, fins, tabs, or ridges).Meanwhile, opening 120A associated with the universal recon screw opening 120 formed in the first side 112 of the body 102 may be configured as a variable angled opening including, for example, a plurality of fins, tabs, or ridges for engaging the external threads of a bone screw (e.g., the first or second bone screw 150, 152) inserted therein,although this is but one configuration and it is envisioned that the screw openings may have other configurations such as, for example, threaded, non-threaded, fins, tabs, or ridges, or any combination thereof. In addition, the screw openings may be elongated to facilitate easier targeting.

[0064] As best illustrated in FIG. 2C, in some examples, openings 120B, 120C formed in the second side 1 14 of the body 102 of the retrograde femoral IM nail 100 may be circumferentially offset relative to each other. For example, as illustrated, a center of opening 120B may be circumferential offset from a center of opening 120C. In some examples, the openings 120B, 120C may be circumferential offset by 0 to 20mm, preferably 3 -20mm, and more preferably 3 -6mm, although these are but one configuration and any suitable configuration may be utilized.

[0065] In some examples, the universal recon screw opening 120 including opening 120A formed in the first side 112 of the body 102 and screw openings 120B, 120C formed in the second side 114 of the body 102 are positioned as close as possible to the leading end of the body 102 of the retrograde femoral IM nail 100 while maintaining structural integrity of the retrograde femoral IM nail 100. For example, the cluster or array of screw openings defining the universal recon screw opening 120 may be positioned within 50mm of the leading end of the body 102 of the retrograde femoral IM nail 100. Thus arranged, the universal recon screw opening 120 enables surgeons to treat or target extreme fragments.

[0066] As illustrated, the leading proximal end portion 110 of the retrograde femoralIM nail 100 may also include one or more additional screw openings 140 such as, forexample, first and second screw openings 140A, MOB, formed therein aside from the universal recon screw opening 120. As illustrated, in some examples, in use, the first and second screw openings 140A, MOB may extend in the anterior-posterior direction for receiving first and second screws, respectively. In some examples, as best illustrated in FIG. 2E, the additional first and second screw openings 140A, MOB may be positioned on either side (e.g., superiorly and inferiorly) of the universal recon screw opening 120. In some examples, the second (e.g., inferiorly positioned) screw opening MOB may be in the form of an elongated slot. Although this is but one example, and other examples are envisioned. For example, with reference to FIGS. 11A-11C, the leading proximal end portion 110 of the retrograde femoral IM nail 100 may include a universal recon screw opening 120 positioned adjacent to the end or tip of the retrograde femoral IM nail 100. Optionally, one or more additional screw openings 140 may be positioned inferiorly of the end or tip (e.g., farther away from the end or tip of the nail 100). For example, the leading proximal end portion 110 may include first and second screw openings 140A, MOB positioned inferiorly of the universal recon screw opening 120. As illustrated, in some examples, the first and second screw openings 140A, MOB may extend in the anterior-posterior direction for receiving first and second screws, respectively. In some examples, as illustrated in FIGS. 11A-11C, the first screw opening 140A may be in the form of an elongated slot while the second screw opening MOB may be configured as a circular opening for receiving bone screws. Alternatively, as illustrated in FIG. 12, in some examples, the first screw opening 140A may be configured as a circular opening and the second screw opening MOB may be in the form of an elongated slot for receiving bone screws 155. In another example, as illustrated in FIG. 13, each of the screwopenings 140 (e.g., first and second screw openings 140A, MOB) extending in the anterior-posterior direction may be configured as circular openings for receiving bone screws 155, although these are but some of the possible configurations and many other configurations are envisioned. For example, other configurations include a universal recon screw opening followed by a medial-lateral screw opening followed by an anterior- posterior screw opening. Another configuration includes a universal recon screw opening followed by an elongated slot extending in the anterior-posterior direction followed by a screw opening extending in the medial-lateral direction. Alternatively, for example, a single screw opening may be utilized, alternatively three or more screw openings may be utilized. Thus, although particular examples of a leading proximal end portion 110 including the universal recon screw opening 120 in accordance with one or more features of the present disclosure and one or more additional screw openings 140 are illustrated, it should be understood that the leading proximal end portion 110 of the retrograde femoral IM nail 100 may include any number of screw openings configured in any number of different configurations, directions, trajectories, or the like. For example, more or less screw holes extending in the anterior-posterior direction and / or screw holes extending in the medial -lateral direction may be utilized. In addition, the screw holes may include alternate configurations such as, for example, the screw openings may be circular or elongated, threaded or non-threaded, or some combination of threaded holes and nonthreaded holes, or have any other configuration now known or hereafter developed. As such, the leading proximal end portion 110 of the present disclosure should not be limited to any specific configuration of screw openings unless explicitly claimed.

[0067] Thus arranged, as illustrated in FIG. 4A, the retrograde femoral IM nail 100 may be implanted within a right femur of the patient’s body and one of the screw trajectories defined by the universal recon screw opening 120 may be utilized to insert a bone screw 152 from the second side 114 of the body 102 of the retrograde femoral IM nail 100 and into the patient’s femoral head and neck H. Meanwhile, as illustrated in FIG. 4B, the retrograde femoral IM nail 100 may be implanted within a left femur of the patient’s body and the other screw trajectory defined by the universal recon screw opening 120 may be utilized to insert a bone screw 150 from the first side 112 of the body 102 of the retrograde femoral IM nail 100 and into the patient’s femoral head and neck H.

[0068] In accordance with one or more features of the present disclosure, the retrograde femoral IM nail 100 may be used in alternate procedures and / or incorporate additional features or configurations. For example, with reference to FIG. 5, the retrograde femoral IM nail 100 may be used to target fractures in the greater trochanter T of the patient. As illustrated, in use, the universal recon screw opening 120 in the retrograde femoral IM nail 100 may be used to implant a bone screw 154 along a trajectory that moves from high to low as it extends lateral to medial, this is in contrast to conventional screw trajectories that extend from low to high as it moves lateral to medial and into the femoral neck and head area H. In this manner, the bone screw 154 may pass into or target the patient’s greater trochanter T.

[0069] With reference to FIG. 6, the retrograde femoral IM nail 100 may include a superiorly positioned lateral -medial screw opening 170. Thus arranged, a superior bonescrew 160 may be implanted through the retrograde femoral IM nail 100 and into the patient’s femoral neck and head area H. As illustrated, the bone screw 160 may have a slight angled trajectory extending inferiorly-superiorly (e.g., the bone screw 160 may be implanted substantially transverse relative to the axis of the retrograde femoral IM nail 100, although a slight angle may be provided). In use, the bone screw 160 may be used to target the middle portion of the patient’s femoral neck and head area H. In addition, a second bone screw such as, for example, bone screw 150 or bone screw 152, may be implanted through the universal recon screw opening 120 in the retrograde femoral IM nail 100.

[0070] As such, in use, the retrograde femoral IM nail 100 may be configured with two separate holes 120, 170. The superiorly positioned lateral-medial screw opening 170 may be configured with a flatter trajectory thereby enabling the opening to be positioned closer to the proximal end or tip while the bone screw 150, 152 may be configured with an angle of less than 120°. In use, the bone screws may be implanted with converging screw trajectories. Thus arranged, in use, the system may be used to target and / or treat prophylactic fractures or conditions.

[0071] With reference to FIG. 7, the retrograde femoral IM nail 100 may be used in combination one or more additional bone screws 156 to target and / or treat prophylactic fractures and / or conditions. In use, an optional bone plate (not shown) may be used in combination with the retrograde femoral IM nail 100 and the additional bone screws 156. In some examples, the additional bone screws 156 may pass through the bone plate. In addition, and / or alternatively, bone screw 150, 152 may pass through the bone plate priorto passing through the retrograde femoral IM nail 100. As illustrated, in use, the bone screws 150, 156 may define a triangular configuration. In addition, and / or alternatively, the additional bone screws 156 may have the same diameter or a different diameter such as, for example, a larger diameter, than bone screw 150, 152.

[0072] With reference to FIGS. 8A and 8B, the retrograde femoral IM nail 100 may be used in combination one or more additional bone screws 156 to target and / or treat prophylactic fractures or conditions. In contrast to the system illustrated in FIG. 7, in the illustrative example of FIGS. 8A and 8B, the additional bone screws 156 may pass or project at alternate angles or trajectories. Once again, an optional bone plate (not shown) may be used in combination with the retrograde femoral IM nail 100 and the additional bone screws 156. As illustrated, in use, the bone screws 150, 156 may define an inverted triangular configuration. In addition, and / or alternatively, the additional bone screws 156 may have the same diameter or a different diameter such as, for example, a larger diameter, than bone screw 150, 152.

[0073] With reference to FIGS. 9A-9D, an alternate example of a retrograde femoral IM nail 200 is illustrated. In contrast to the previous examples, the retrograde femoral IM nail 200 may be devoid of a universal recon screw opening, although this is but one configuration and a universal recon screw opening may be incorporated. As illustrated, the retrograde femoral IM nail 200 may include a variable angled slot or screw opening 220 arranged and configured to enable variability in screw trajectory in version. For example, as illustrated, the retrograde femoral IM nail 200 may include a variable angled slot or screw opening 220 arranged and configured to enable anteversion and / orretroversion implantation of a bone screw 262 to target the patient’s femoral neck and head area H. Thus arranged, the surgeon can implant a bone screw 262 at an angle in the anterior-posterior direction within the patient’s femoral neck and head area H. In some examples, the variable angled slot or screw opening 220 may be oblong 220A on one side thereof and static (e.g., conventional) 220B on the other side (i.e., two different variable angle hole configurations to facilitate different anteversions).

[0074] With reference to FIGS. 10A-10I, an alternate example of a retrograde femoral IM nail 300 is illustrated. In contrast to the previous examples, the retrograde femoral IM nail 300 may include a universal recon screw opening in the form of an elongated slot 320. That is, in contrast to providing a universal recon screw opening including a single opening in one side thereof and separate and distinct openings in the second side thereof, the retrograde femoral IM nail 300 may include an elongated slot 320 extending through both sides of the body 302 of the retrograde femoral IM nail 300. In use, the elongated slot 320 is arranged and configured to enable the bone screw 350 to pass therethrough from either side to target the patient’s femoral neck and head area H (e g., the retrograde femoral IM nail 300 may include one big long slot rather than individual openings, the slot 320 extending in a medial-lateral direction through the body 302 of the retrograde femoral IM nail 300 to target the patient’s femoral neck and head area H). As illustrated, in some examples, the exit opening of the elongated slot on a first side of the body may be vertically offset from the exit opening of the elongated slot on a second side of the body (e.g., vertically offset by a vertical distance). In use, the elongated slot 320 provides angle variation of the screw trajectory so that the bone screw 350 can be implanted into the patient’s femoral neck and head area H regardless of theretrograde femoral IM nail 300 being implanted into the patient’s right or left femur. That is, as best illustrated in FIGS. 10D-10I, the retrograde femoral IM nail 300 may enable variability in the angle of superior / inferior inclination of a bone screw 350 to target the patient’s femoral neck and head area H. Thus arranged, the surgeon can implant a bone screw 350 at a variable superior / inferior angle within the patient’s femoral neck and head area H to, for example, match the Caput-Collum -Diaphyseal (“CCD”) angle of the femoral head and neck (also known as the neck shaft angle (“NSA”). In some examples, as best illustrated in FIG. 101, the elongated slot 320 may incorporate a bushing, a ball, polymer, plastic, etc. 330 to help support the variable angle for inclination.

[0075] In accordance with one or more features of the present disclosure, in some examples, the proximal or leading end portion of the retrograde femoral IM nail may be manufactured from, or be operatively associated with or include a polymer. Thus arranged, in use, the surgeon can drill through the polymer to provide the in-situ desired screw trajectory. For example, the IM nail, or a portion thereof, may be manufactured from a polymer thereby enabling the surgeon to drill the screw opening as needed in the operating room. Alternatively, in some examples, the IM nail may incorporate a polymer bushing.

[0076] In accordance with one or more features of the present disclosure, in some examples, the retrograde femoral IM nail may be manufactured as an integral or unitary implant. Alternatively, in some examples, the body may be manufactured from multiple segments or portions and coupled together. For example, the leading or proximal end portion may be separately formed from the driven or distal end portion. Thus arranged,the proximal end portion may be modular. As such, the retrograde femoral IM nail may be provided in a kit or system with multiple differently configured leading or proximal end portions and driven or distal end portions thereby enabling surgeons to selectively mix and match. For example, differently configured proximal end portions may be provided, some with a universal recon screw opening, some with variable angled slot or screw opening arranged and configured to enable anteversion and / or retroversion implantation of a bone screw, some with differently angled or positioned screw openings, etc. to enable surgeons to select the best option for a particular patient. In addition, and / or alternatively, in some examples, the proximal end portion may be arranged and configured to rotate relative to the distal end portion to provide surgeons with additional options and / or variability. In use, the proximal end portion may be coupled to the distal end portion by any suitable mechanism now known or hereafter developed including, for example, threads, press-fit, etc.

[0077] In use, the bone screws can be any suitable bone screw now known or hereafter developed. In some examples, as illustrated, the bone screws may be configured with a distal region, a proximal region, and a head portion, wherein the distal region is devoid of any threads and the proximal region, which is position between the head portion and the distal region, includes external threads for engaging bone. In some examples, the distal region may be configured with a blunt tip. Additional information on the illustrated bone screw can be found in United States Patent Application No. 63 / 568,524, filed on March 22, 2024, entitled “Orthopedic System and Corresponding Method for Treating Femoral Fractures in Skeletally Immature Patients,” the entirety of which is incorporated herein by reference.

[0078] As will be readily appreciated by one of ordinary skill in the art, in use, the screw openings formed in the IM nail may be targeted (e.g., located) by any suitable mechanism or method now known or hereafter developed. For example, the screw openings can be targeted utilizing a mechanical drill guide or targeter, a surgical navigational system such as, for example, SURESHOT manufactured and provided by Smith Nephew, Inc., etc.

[0079] 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.

[0080] 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.

[0081] 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

CLAIMSWhat is claimed is:

1. An orthopedic intramedullary (“IM”) nail comprising: a body including a proximal end portion and a distal end portion, the proximal end portion including a universal recon screw opening defining a first screw trajectory and a second screw trajectory, the first screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s left bone, the second screw trajectory being arranged and configured to receive a fastener when the IM nail is implanted with a patient’s right bone.

2. The IM nail of claim 1, wherein the body includes a first side and a second side and the universal recon screw opening includes: a first opening formed in the first side of the body for receiving a bone screw; and second and third separate and distinct openings formed in the second side of the body for receiving a bone screw; wherein the first opening is in communication with each of the second and third openings; and the first screw trajectory is defined by the first and second openings, and the second screw trajectory is defined by the first and third openings.

3. The IM nail of claim 2, wherein the first opening includes a chamfered surface to facilitate screw clearance.

4. The IM nail of claim 2, wherein: the first screw opening formed in the first side of the body comprises a variableangled opening and includes one of fins, tabs, or ridges for engaging external threads of a bone screw inserted therethrough; and the second and third openings formed in the second side of the body are smooth.

5. The IM nail of claim 2, wherein the second and third openings formed in the second side of the body are circumferentially offset relative to each other.

6. The IM nail of claim 1, wherein the body includes a first side and a second side and the universal recon screw opening includes: a first opening formed in the first side of the body for receiving a bone screw; and second and third separate and distinct openings formed in the second side of the body for receiving a bone screw; wherein each of the second and third openings is in communication with the first opening thereby defining the first and second screw trajectories.

7. The IM nail of claim 6, wherein a first bone screw is inserted into the first opening formed in the first side of the body and through the second opening formed in the second side of the body when the IM nail is implanted within one of the patient’s leftbone or right bone, or into the third opening formed in the second side of the body and through the first opening formed in the first side of the body when the IM nail is implanted within the other one of the patient’s left bone or right bone.

8. The IM nail of claim 1, wherein the proximal end portion further comprises one or more screw openings extending in an anterior-posterior direction, in use.

9. The IM nail of claim 8, wherein the one or more screw openings includes first and second screw openings, the first screw opening positioned adjacent a proximal tip of the body, the second screw opening positioned inferiorly of the first screw opening, and the universal recon screw opening positioned in-between the first and second openings.

10. The IM nail of claim 9, wherein the one or more screw openings includes first and second screw openings, the universal recon screw opening positioned adjacent a proximal tip of the body, the first screw opening positioned inferiorly of the universal recon screw opening, and the second bone screw opening positioned inferiorly of the first bone screw opening.

11. The IM nail of claim 10, wherein the second bone screw opening comprises an elongated slot.

12. The IM nail according to any of the preceding claims, further comprising a superiorly positioned screw opening extending in a lateral-medial direction, in use.

13. The IM nail according to any of the preceding claims, wherein the patient’s left bone is a left femur and the patient’s right bone is a right femur.

14. The IM nail according to claim 13, wherein the IM nail comprises a retrograde femoral intramedullary nail arranged and configured to be implanted into one of the patient’s left femur or right femur via a distal end thereof.

15. The IM nail of claim 14, wherein the retrograde femoral intramedullary nail is arranged and configured to be anatomically side agnostic to be implanted into either the patient’s left bone or the patient’s right bone, the universal recon screw opening enabling a surgeon to target a patient’s femoral head and neck regardless of the retrograde femoral intramedullary nail being implanted within the patient’s left femur or the patient’s right femur.

16. The IM nail of claim 1, further comprising a bone screw, wherein, in use, the bone screw is inserted medial to lateral through the universal recon screw opening to target the patient’s greater trochanter.

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