Bone plates and related systems and methods

Abstract

The bone plate includes a first end and a second end that are opposite each other along a longitudinal axis oriented along a longitudinal direction, a first side and a second side that are opposite each other along a transverse direction, and a bone-facing surface and an outer surface that are opposite each other along a transverse direction. The plate defines a first hole and a second hole arrangement extending from the outer side to the bone-facing surface. The second hole arrangement is distal to the first hole, and the first hole is configured to receive a first fixation member, and the second hole arrangement is configured to receive at least one second fixation member for fixation with the underlying bone. The plate is pivotable along an angular range about the first hole. The second hole arrangement transversely intersects the longitudinal axis and defines an angular range, allowing the at least one second fixation member to substantially fixate the plate to the underlying bone at any angle within the angular range.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Non-Provisional Patent Application No. 18 / 171,827, filed February 21, 2023, the contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THE INVENTION The present invention relates to bone plates, and more particularly to bone plates having angular adjustability relative to the underlying anatomical structure. [Background technology]

[0003] Long bone fractures, such as those of the femur and humerus, are often treated with screws or other fixation devices inserted into or through the bone to stabilize the fractured portions of the bone after the fractured portions are properly aligned. Femoral bone fixation treatment may involve inserting an intramedullary (IM) nail into the medullary cavity of the femur, followed by inserting a bone fixation screw into the condylar or trochanteric portion of the femur, depending on whether the IM nail is inserted into the medullary canal via an antegrade or retrograde insertion trajectory. An antegrade insertion trajectory extends from the anatomical proximal end of the femur (i.e., from the hip joint), e.g., from the tip of the greater trochanter or slightly lateral to the tip of the greater trochanter, along the anatomical axis of the femur into the medullary canal toward the anatomical distal end of the femur. A retrograde insertion trajectory extends from the anatomical distal end of the femur (i.e., from the knee joint) toward the anatomical proximal end of the femur, effectively reversing the antegrade insertion trajectory.

[0004] As used herein, the term "retrograde intramedullary nail" refers to an IM nail designed for retrograde insertion into the medullary canal. Retrograde IM nails are known to provide advantageous fixation to the distal portion of the femur (e.g., the distal condyles and intercondylar region), such as for treating distal femoral fractures. For example, retrograde IM nails allow for easier targeting and insertion of locking screws into locking holes in the posterior end of the nail present in the distal femur. When treating distal femoral fractures, particularly when the femur exhibits poor bone quality and / or in periprosthetic situations, retrograde femoral nailing may require additional bone fixation. In such cases, a supplemental locking attachment washer (LAW) or plate may be coupled to the posterior end of the nail via multiple bone screws. For simplicity and brevity, the locking attachment washers described below may each be referred to as a "plate." The plate defines one or more holes for bone screws that interconnect with the IM nail. Additionally, the plate may define one or more additional holes for additional bone screws to secure within the portion of the femur adjacent the posterior end of the IM nail for supplemental bone fixation.

[0005] IM nails and associated plates can be offered in a variety of sizes, shapes, and lengths to facilitate treatment of various types and indications of fractures. Furthermore, physicians can select various IM nail and plate combinations based on the patient's treatment needs. For example, an IM nail can be paired with a plate having an increased length so that the plate can extend from the end region of the bone (e.g., the condylar or trochanteric portion of the femur) to and along the shaft region of the bone. For such plates with increased length, the distal end of the plate should be secured to the bone in alignment with the associated longitudinal portion of the IM nail.

[0006] Targeting and insertion of locking screws in the posterior end of the IM nail and associated plate is generally simplified by the fact that the posterior end of the nail and / or associated plate can be directly engaged with an instrument, such as an insertion handle and / or aiming arm, having an aiming element for targeting the locking holes near the posterior end of the IM nail. However, targeting the locking holes at the distal end of the IM nail becomes more difficult, especially as the nail length increases, due to factors such as nail deflection and deformation that can result from stress and strain. Furthermore, as the plate length increases, the challenges associated with aligning the distal end of the plate with the associated portion of the IM nail increase. Summary of the Invention [Means for solving the problem]

[0007] According to one embodiment of the present disclosure, a bone fixation system includes an intramedullary nail and a bone plate. The intramedullary nail has a nail body elongated along a longitudinal direction. The nail body has a nail head and a distal locking portion spaced distally along the longitudinal direction from the nail head. The nail head defines a nail hole extending through the nail body along a transverse direction offset from the longitudinal direction. The bone plate has a plate body extending along a longitudinal plate axis and having a first side and a second side opposite each other along a transverse direction perpendicular to the longitudinal plate axis. The plate body has an outer surface and a bone-facing surface opposite each other. The plate body is alignable with the nail body such that the longitudinal plate axis is oriented substantially along the longitudinal direction, the outer surface and the bone-facing surface are spaced apart from each other along the transverse direction, and the transverse direction is offset from the longitudinal and transverse directions. The plate body defines a first plate hole and a second plate hole arrangement spaced distally from the first plate hole. The first plate hole and the second plate hole arrangement each extend from the outer surface to the bone-facing surface. The first plate hole is configured to receive a first locking member for insertion through the first plate hole and the nail hole to interconnect the bone plate to the intramedullary nail. The second plate hole arrangement is configured to receive at least one second locking member. The plate body is configured to pivot along an angular range about a central hole axis of the first plate hole when the first locking member extends through the first plate hole and further into the nail hole. The angular range is configured to align the plate body with the distal portion of the nail body along a transverse direction. The angular range is defined between laterally opposite ends of the second plate hole arrangement. The second hole arrangement is configured such that the at least one second locking member is configured to substantially secure the bone plate to the underlying bone at any selected angle within the angular range.

[0008] According to another embodiment of the present disclosure, a bone plate includes a plate body having a first end and a second end opposite each other along a longitudinal axis oriented along a longitudinal direction. The plate body has a first side and a second side opposite each other along a transverse direction offset from the longitudinal direction. The plate body has a bone-facing surface and an outer surface opposite each other along a transverse direction offset from the longitudinal and laterally directions. The plate body defines a first hole and a second hole arrangement, each extending from the outer surface to the bone-facing surface. The second hole arrangement is spaced distally from the first hole along the longitudinal direction. The first hole is configured to receive a first fixation member for attachment to the underlying bone. The second hole arrangement is configured to receive at least one second fixation member for attachment to the underlying bone. The plate body is configured to pivot along an angular range about the first fixation member extending through the first hole and into the underlying bone. The second hole arrangement extends laterally across the longitudinal axis and defines an angular range, and is configured such that the at least one second fixation member is configured to substantially fixate the bone plate to the underlying bone at any selected angle within the angular range.

[0009] According to an additional embodiment of the present disclosure, a method for treating a bone includes inserting an intramedullary nail into a medullary canal of the bone and positioning a bone plate along the bone. The bone plate has longitudinally opposed proximal and distal ends. The method includes inserting a first locking member into the underlying bone through a first plate hole defined in a proximal portion of the bone plate and into at least a nail hole defined in the intramedullary nail, pivoting the bone plate about the first locking member until a portion of the bone plate distal to the proximal portion is aligned with a distal portion of the intramedullary nail, and inserting at least one fixation member into the underlying bone through at least one fixation hole defined in a portion of the bone plate distal to the proximal portion. The method includes inserting at least one second locking member through at least one second plate hole defined in the bone plate and into the underlying bone adjacent the intramedullary nail, and advancing the at least one second locking member through the at least one second plate hole so that a head of the at least one second locking member is fully seated in the at least one second plate hole. The at least one second plate hole is longitudinally spaced distally from the first plate hole. After the pivoting and aligning steps, the method includes further advancing the first locking member until the head of the first locking member is fully seated in the first plate hole. [Brief explanation of the drawings]

[0010] The foregoing summary and the following detailed description of exemplary embodiments of the present application will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the features of the present application, illustrative embodiments are shown in the drawings. It should be understood, however, that the present application is not limited to the precise arrangements and instrumentalities shown. [Figure 1] FIG. 1 is a side view of a bone fixation system including a nail plate construct including an IM nail interconnected with a bone plate according to one embodiment of the present disclosure. [Figure 2] FIG. 2 is a top view of the bone fixing system shown in FIG. 1. [Figure 3] FIG. 2 is a bottom view of the bone fixing system shown in FIG. 1. [Figure 4] FIG. 4 is a side view of a fixation member that can be used in the bone fixation system shown in FIGS. 1 to 3. [Figure 5] 5 and 6 are enlarged top (FIG. 5) and side (FIG. 6) views of the proximal portion (structurally proximal but anatomically distal) of the bone fixation system shown in FIGS. 1 and 2. [Figure 6] 5 and 6 are enlarged top (FIG. 5) and side (FIG. 6) views of the proximal portion (structurally proximal but anatomically distal) of the bone fixation system shown in FIGS. 1 and 2. [Figure 7] FIG. 2 is a planar, partially exploded view of the IM nail and associated proximal portions of the bone plate shown in FIG. 1, which are referred to herein as the "nail head" and "plate head," respectively, according to one embodiment of the present disclosure. [Figure 8] FIG. 8 is an enlarged view of a lock hole in the plate head portion shown in FIG. 7. [Figure 9] 9 is a cross-sectional end view of a portion of the plate head taken along section line IX-IX of FIG. 7, which section line intersects the locking hole shown in FIG. 8. [Figure 10] 10A and 10B are top views of the plate head of FIG. 7 in a first angled position (FIG. 10) and a second angled position (FIG. 11) relative to the underlying anatomy. [Figure 11] 10A and 10B are top views of the plate head of FIG. 7 in a first angled position (FIG. 10) and a second angled position (FIG. 11) relative to the underlying anatomy. [Figure 12] 12A-13C are cross-sectional end views of the plate head taken along section line IX-IX of FIG. 7 in a first angled position (FIG. 12) and a second angled position (FIG. 13) relative to the underlying anatomical structures. [Figure 13] 12A-13C are cross-sectional end views of the plate head taken along section line IX-IX of FIG. 7 in a first angled position (FIG. 12) and a second angled position (FIG. 13) relative to the underlying anatomical structures. [Figure 14] FIG. 1 is a top plan view showing a bone plate angled in first and second angled positions relative to the underlying anatomical structure. [Figure 15] FIG. 10 is a top view of a bone fixation system including a nail plate structure including a bone plate having a modified design according to another embodiment of the present disclosure. [Figure 16] FIG. 16 is a top plan view of the plate head of the bone plate shown in FIG. 15. [Figure 17] FIG. 16 is a bottom plan view of the proximal (structurally proximal but anatomically distal) portion of the nail plate construct shown in FIG. 15. [Figure 18] FIG. 15 is a process diagram illustrating method steps for using the bone fixing system shown in FIGS. [Figure 19] FIG. 18 is a process diagram illustrating method steps for using the bone fixing system shown in FIGS. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present disclosure may be more readily understood by reference to the following detailed description in conjunction with the accompanying drawings and examples, which form a part of this disclosure. It is to be understood that the present disclosure is not limited to the specific devices, methods, applications, conditions, or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing specific embodiments, by way of example, only and is not intended to limit the scope of the present disclosure. Also, as used in the specification, including the appended claims, the singular forms "a," "an," and "the" include plurals, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise.

[0012] The term "plurality," as used herein, means more than one. When a range of values ​​is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed in approximation, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. All ranges are inclusive and combinable.

[0013] When used herein with respect to dimensions, angles, ratios, and other geometric shapes, the terms "approximately," "about," and "substantially" take into account manufacturing tolerances. Furthermore, the terms "approximately," "about," and "substantially" can include 10% greater or less than the stated dimension, ratio, or angle. Furthermore, the terms "approximately," "about," and "substantially" can equally apply to the specific values ​​stated.

[0014] While terms such as first, second, etc. may be used herein in reference to various features, it should be understood that these features are not limited by these terms other than to distinguish one feature from another. For example, a first feature could be referred to as a second feature in another context, and similarly, a second feature could be referred to as a first feature in another context, without departing from the scope of the embodiments disclosed herein.

[0015] Embodiments disclosed herein relate to bone plates adapted to facilitate plate angulation with underlying anatomical structures and / or underlying implant hardware to enhance bone fixation. For example, the bone plates described herein have hole configurations that facilitate plate angulation about a pivot axis and facilitate fixation of the plate at a desired angular orientation relative to the underlying anatomical structures and / or implant hardware. Exemplary embodiments described below include bone fixation systems including an intramedullary (IM) nail and a bone plate having hole configurations that interconnect with the IM nail and angle it relative to the IM nail, allowing the bone plate to be aligned with the IM nail along their length and then attached to the underlying bone and IM nail at a desired plate angle. Bone plates with such angular adjustability are particularly advantageous because they can allow a single bone plate to be used with IM nails of various sizes and different bend angles, thereby significantly simplifying the plate selection process and the overall surgical procedure. Furthermore, the bone plates described herein can also be used without an associated IM nail, with the underlying IM nail still providing angular adjustability.

[0016] 1-3 , an exemplary embodiment of a bone fixation system 100 includes an intramedullary (IM) nail 2 insertable into the medullary canal of a long bone 1, a bone plate 4 fixable to the outer surface of the bone 1 and connectable to the IM nail 2, and a plurality of fixation members 6, 8 for coupling the bone plate 4 to the IM nail 2, thereby forming an interconnected nail-plate construct (NPC) 102, and for securing the nail plate construct 102 to the bone 1. The nail plate construct 102 may also be configured to treat peri-prosthetic conditions, including fixation with an existing implant or prosthesis 3. For example, the nail plate construct 102 is shown in a peri-prosthetic environment providing inter-prosthetic fixation with a femoral stem 3 from a previous osteotomy. It should be understood that the above represents one non-limiting example of a specific treatment the plate-nail construct 102 can provide. Additionally, while the long bone 1 described with reference to the illustrated embodiment is a femur, it should be understood that the bone fixation system 100 may be adapted for use with other long bones, such as, by way of non-limiting example, the tibia, fibula, humerus, radius, and ulna. Additionally, while the IM nail 2 shown in the illustrated embodiment is configured for retrograde femoral insertion, the bone fixation system 100 may be adapted for use with an antegrade insertion trajectory.

[0017] The IM nail 2 has a first end 10 and a second end 12 spaced apart from one another along a longitudinal direction L. In the illustrated embodiment showing a retrograde femoral IM nail, the longitudinal direction L generally extends along the craniocaudal direction of the patient's anatomy. In such an embodiment, the first end 10 is the proximal end of the nail 2 and is configured to temporarily couple with an insertion instrument, such as an insertion arm. The second end 12 is the distal end of the nail 2 and is the leading or anterior end of the nail 2 during insertion into the medullary canal. The second end 12 is spaced apart from the first end 10 in a distal direction D, while the first end 10 is spaced apart from the second end 12 in a proximal direction P opposite the distal direction D. It should be understood that the distal direction D and the proximal direction P are each unidirectional components of the longitudinal direction L, which is bidirectional. The IM nail 2 defines a nail length L1 measured along the longitudinal direction L between the first end 10 and the second end 12. The IM nail 2 also defines a nail width W1 measured along a direction perpendicular to the longitudinal direction. The bone fixation system 100 can include IM nails 2 of various lengths L1 and widths W1 for selective use in various types of fractures, as described below.

[0018] As used herein, the terms “longitudinal,” “longitudinally,” and their derivatives also refer to the longitudinal direction L, the terms “distal,” “distally,” and their derivatives refer to the distal direction D, and the terms “proximal,” “proximally,” and their derivatives refer to the proximal direction P. Furthermore, because a retrograde insertion trajectory essentially reverses the structural (implant) use of the directional terms "proximal" and "distal" from the anatomical use of these terms (e.g., the "proximal" end of the IM nail 2 resides in the "distal" femur, while the "distal" end of the nail is spaced away toward the "proximal" femur), for clarity, the terms "proximal" and "distal," and their derivatives, are used herein to refer to aspects of the orientation of the composite structural components of the bone fixation system 100, unless these terms are used with specific reference to an anatomical structure (e.g., "proximal femur," "distal femur," "distal anatomical direction"), in which case it should be understood that the terms refer to the anatomical direction.

[0019] The IM nail 2 has a nail body 14 extending along a central nail axis X1 generally oriented along the longitudinal direction L. The central nail axis X1 need not be straight; preferably, the central nail axis X1 follows a path substantially coextensive with the anatomical axis of the bone 1. Thus, the central nail axis X1 may have one or more straight sections and one or more curved sections. The nail body 14 includes a proximal locking portion 2a (also referred to herein as the "nail head" 2a) extending distally from the first end 10, an intermediate portion 2b (also referred to herein as the "main shaft portion" 2b) extending distally from the nail head 2a, and a distal locking portion 2c extending from the main shaft portion 2b to the second end 12 of the nail 2. The nail head 2a is configured to be attached to an instrument, such as an insertion handle, for inserting the nail 2 into the medullary canal.

[0020] The nail head 2a also defines one or more proximal locking holes 16 extending through the nail body 14 along one or more respective central bore axes oriented along one or more various directions offset from the longitudinal direction L. These directions may be perpendicular or oblique to the longitudinal direction L. Each proximal locking hole 16 is preferably configured to receive a fixation member, particularly a locking member 8, such as a bone screw or helical blade, that extends through the respective hole 16 and secures the nail head 2a to an adjacent portion of the bone 1, such as the distal femur in the illustrated embodiment. The proximal locking holes 16 and associated bone fixation members can also be used to fixate one or more fractured portions of adjacent bones to one another. The proximal locking holes 16 of the IM nail are described in more detail below. As shown in FIG. 3 , the distal locking portion 2c of the IM nail 2 also defines one or more distal locking holes 18 extending through the nail body 14 along one or more various directions offset from the longitudinal direction L (which may be perpendicular or oblique to the longitudinal direction L). Each distal locking hole 18 is configured to receive a corresponding fixation member 8, such as a bone screw or a helical blade, for securing the distal locking portion 2c of the IM nail 2 to an adjacent portion of the bone 1.

[0021] 1-3, the bone plate 4 has a plate body 20 extending along a longitudinal direction L from a first end 22 to a second end 24 spaced from the first end 22. The bone plate 4 defines a plate length L2 measured along the longitudinal direction L between the first end 22 and the second end 24. The IM nail 2 and bone plates 4 may be provided in a variety of configurations and sizes (e.g., nail length L1, nail width W1, plate length L2) adapted to treat various conditions. For example, the IM nail 2 and bone plate 4 can be tailored to form a variety of nail-plate structures 102 adapted to treat, by way of non-limiting example, supracondylar fractures (including those with intra-articular extension), combined ipsilateral condylar and diaphyseal fractures, ipsilateral femoral / tibial fractures, femoral fractures in polytrauma patients, periprosthetic fractures (including Vancouver Classification System types B1 and C, including interprosthetic fractures), fractures in morbidly obese patients, fractures in osteoporotic and osteopenic bone, impending pathological fractures, malunions, and nonunions. It should be understood that the nail-plate structure 102 can be tailored to treat a variety of other conditions. The nail length L1 can range from approximately 120 mm to approximately 500 mm. The nail width W1 can range from approximately 8 mm to approximately 16 mm. The plate length L2 can range from approximately 120 mm to approximately 550 mm.

[0022] The plate body 20 also has a first side 26 and a second side 28 that are opposed to each other along a transverse direction A that is offset from the longitudinal direction L. In the illustrated embodiment, the transverse direction A of the bone plate 4 generally extends along the anterior-posterior direction of the patient's anatomy. The plate body 20 includes an outer surface 30 and a bone-facing surface 32 that are opposed to each other along a transverse direction T that is offset from the longitudinal direction L and the transverse direction A. In the illustrated embodiment, the transverse direction T of the bone plate 4 generally extends along the medial-lateral direction of the patient's anatomy. Although the illustrated embodiment shows the longitudinal, transverse, and transverse directions L, A, and T as being substantially perpendicular to each other, in other embodiments, the longitudinal, transverse, and transverse directions L, A, and T need not be perpendicular to each other. For example, in such other embodiments, one or more of the longitudinal, transverse, and transverse directions L, A, and T may be oblique to one or both of the other directions L, A, and T. The bone-facing surface 32 of the plate body 20 preferably has a contour corresponding to the outer surface of the bone 1. The plate body 20 defines a plurality of plate fixation holes 34, 36, 38 extending from the outer surface 30 to the bone-facing surface 32. The plate fixation holes 34, 36, 38 are configured to receive various fixation members 6, 8 for securing the bone plate 4 to the IM nail 2 and / or bone 1, as described in more detail below.

[0023] The bone plate 4 defines a longitudinal plate axis X2 extending generally along the longitudinal direction L. As shown, the longitudinal plate axis X2 need not be linear. Preferably, the longitudinal plate axis X2 extends along a path that follows the contour of the outer surface of the bone 1, as shown in FIGS. 1-2. In addition, the longitudinal plate axis X2 also preferably tracks the underlying central nail axis X1 when the bone plate 4 is properly coupled to the nail 2, as described in more detail below. Thus, when viewed along the transverse direction T with the plate and nail properly coupled, the longitudinal plate axis X2 substantially overlaps the central nail axis X1, as shown in FIG. 2.

[0024] Plate body 20 includes a proximal plate portion 4a (also referred to herein as "plate head" 4a) extending distally from first end 22, an intermediate plate portion 4b (also referred to herein as "plate shaft" 4b) extending distally from plate head 4a, and a distal plate portion 4c extending distally from plate shaft 4b to second end 24 of bone plate 4. Plate head 4a, plate shaft 4b, and distal plate portion 4c have respective shapes corresponding to associated bony anatomy. In the illustrated example for fixation to the distal femur, the shape of plate head 4a corresponds to the lateral condyle and epicondyle of the distal femur, the shape of plate shaft 4b corresponds to the femoral shaft, and the shape of distal plate portion 4c corresponds to the subtrochanteric region, transtrochanteric region, and lateral portion of the trochanteric region of the proximal femur. In other embodiments, depending on the plate length L2, the plate shaft 4b and distal plate portion 4c can be adapted to accommodate different anatomical regions of the bone.

[0025] The plate fixation holes 34, 36, 38 include bone fixation holes 34, proximal locking holes 36, and additional holes 38, which have various purposes and are configured to receive various types of fixation members 6, 8, as described below.

[0026] 4-6 , the fixation member includes a locking member 8 configured to extend through the aligned locking holes 36, 16 of the bone plate 4 and the IM nail 2, respectively, thereby forming an interconnected nail plate structure 102. The fixation member also includes a bone fixation member 6 configured to extend through the bone fixation hole 34 into an underlying portion of the bone without extending through the IM nail 2. It should be appreciated that the locking member 8 and the bone fixation member 6 both facilitate fixation of the IM nail 2 and the bone plate 4 with the adjacent bone. The locking member 8 and the bone fixation member 6 may include a bone screw, such as a locking head bone screw 5a, having a head 50 including external threads configured to lock with an internal locking mechanism of the fixation hole when the head 50 is fully seated within the hole. The locking head bone screw 5a includes a threaded shaft 52 extending from the head 50 along a thread axis S and configured to be advanced through and fixed to the bone. The locking head bone screw 5a shown in FIG. 4 is a variable angle locking (VAL) bone screw configured to lock within a fixation hole in either a nominal orientation, in which the thread axis S is substantially collinear with the central bore axis Z (see bone fixation member 6a and bore 34a in FIG. 6 ), or an “angular” orientation, in which the thread axis S is oriented at an acute angle A1 (also referred to herein as “angle” A1) relative to the central bore axis Z (see bone fixation member 6b and bore 34b in FIG. 6 ). However, it should be understood that one or more of the bone fixation members 6 and / or locking members 8 can use a standard type locking screw 5a configured to lock within a fixation hole in only a substantially nominal orientation. Additionally, as shown, one or more of the locking members 8 and / or bone fixation members 6 can be a compression bone screw 5b having a head 70 with a smooth outer surface and a threaded shaft 72 extending from the head 70 along the thread axis S. Additionally or alternatively, one or more of the locking members 8 may be a helical blade, a locking bolt, or another type of locking member for interlocking with the locking holes 16 , 18 of the IM nail 2 .

[0027] 1-3 and 5-6, the bone fixation holes 34 are configured to receive bone fixation members 6 extending from the bone fixation holes 34 into underlying portions of the bone spaced laterally from the IM nail 2 so as not to mechanically interfere with the IM nail 2. To avoid such mechanical interference, the bone fixation holes 34 are preferably offset laterally from the longitudinal plate axis X2 so that the bone fixation members 6 can be inserted through the bone fixation holes 34 along both sides of the IM nail 2 (see FIGS. 1, 3, and 5). Accordingly, the bone fixation holes are also referred to herein as "offset holes" 34. As shown, some of the offset holes 34 may be defined along the plate head 4a for fixation within the condylar and intercondylar regions of the distal femur. Additional offset holes 34 may be defined along the plate shaft 4b for fixation within the femoral shaft. In additional embodiments, one or more additional offset holes 34 can be defined in the distal plate portion 4c, depending on the plate length L2, such as for fixation to the femoral shaft and / or an upper portion of the proximal femur. The plate body 20 can include lateral protrusions or tabs 40 extending outward from the first and second sides 26, 28 along the plate head 4a and plate shaft 4b. The lateral tabs 40 can define a portion of the offset holes 34. In this manner, the lateral tabs 40 can increase the lateral spacing of the offset holes 34 and, therefore, the lateral spacing of the bone fixation members 6. The bone fixation holes 34 are preferably variable angle locking (VAL) holes 34, and the bone fixation members 6 are preferably VAL bone screws, although one or more of the bone fixation holes 34 can be standard locking holes or compression holes.

[0028] As shown in FIG. 2 , the additional fixation holes 38 can include combination holes, such as a combination of a variable angle (VA) hole and a locking compression plate (LCP) hole, which can be referred to as a “VA LCP” combination hole 38. In this manner, each additional fixation hole 38 can be selectively used with a VAL bone screw, a compression bone screw, and / or a locking element (such as to lock with the distal locking hole 18 of the IM nail 2), as needed. The additional fixation holes 38 in the plate shaft 4b are preferably centrally aligned along the longitudinal plate axis X2, although in other embodiments, one or more of the additional fixation holes 38 in the plate shaft 4b can be positioned eccentrically relative to the longitudinal plate axis X2. As shown, the distal plate portion 4c can include one or more additional fixation holes 38, which are preferably positioned eccentrically relative to the longitudinal plate axis X2. The distal plate portion 4c can also include additional features, such as to aid in the reconstruction of an associated portion of bone. In the illustrated example, distal plate portion 4c includes a pair of recesses or notches 42 that extend laterally inward from first side 26 and second side 28 of plate body 20. Notches 42 are configured to enhance the ability of distal plate portion 4c to be manipulated to bend and contour to the associated bony anatomy, in the illustrated example to match the contour of the greater trochanter.

[0029] As shown in FIGS. 5-6 , the proximal locking hole 36 is preferably defined in the plate head 4a and configured to receive a locking member 8 (e.g., a locking screw, a helical blade, a locking bolt, etc.) that extends through the proximal locking hole 36 of the bone plate 4 and interconnects with the nail head 2a. As shown, the locking member 8 can extend from the proximal locking hole 36 of the bone plate 4 and further through the proximal locking hole 16 of the IM nail 2. In this manner, the locking member 8 directly interconnects the plate head 4a with the nail head 2a (and thus also interconnects the bone plate 4 with the IM nail 2). In other embodiments (described below with reference to FIGS. 15-17 ), one or more of the locking members 8 can extend through one or more respective proximal locking holes 36 of the bone plate 4, from which they can extend along one or more respective portions of the nail head 2a in a bracket-like manner, which can provide another mode of direct interconnection between the plate head 4a and the nail head 2a.

[0030] The IM nail 2 and bone plate 4 can use a variety of hole sizes for use with bone fixation members 6 and locking members 8 of various sizes and configurations. For example, the bone fixation members 6 can be locking head bone screws 6 (preferably VAL screws 6) having a shaft major diameter ranging from about 2.5 mm to about 6.0 mm, preferably from about 3.0 mm to about 4.0 mm. The locking members 8 can include a VAL screw and one or more compression screws having a shaft major diameter ranging from about 3.8 mm to about 8.0 mm, preferably from about 4.0 mm to about 5.5 mm. The bone fixation members 6 and locking members 8 can have lengths ranging from about 35 mm to about 125 mm, which can be selected based on various factors, including the underlying area of ​​the bone and the intended thread angle. For example, a longer length can be selected for the bone fixation member 6 and locking member 8 for insertion through the holes 34, 36 in the plate head 4a (and into the underlying condylar or intercondylar region), and a shorter length can be selected for the bone fixation member 6 to be inserted into the bone fixation hole 34 in the plate shaft 4b (and into the underlying bone shaft). It should be understood that the aforementioned dimensions can also be scaled upward or downward in size based on different treatment needs.

[0031] Referring now to FIG. 7 , the proximal locking hole 16 of the nail head 2 includes a first proximal locking hole 16a and a second proximal locking hole 16b configured to facilitate connection with an associated proximal locking hole of the bone plate 4. The first proximal locking hole 16a and the second proximal locking hole 16b of the nail head 2a extend through the nail head 2a along respective central hole axes Z1, Z2, which are preferably parallel but may alternatively be non-parallel. The first and second proximal locking holes 16a, b are spaced apart from each other by a nail hole spacing distance L3, as measured between the respective central hole axes Z1, Z2 along the longitudinal direction L. The proximal locking hole 36 of the plate head 4a includes a first hole 36a adjacent the first end 22 and a second hole arrangement 36b spaced apart from the first hole 36a in the distal direction D. The first hole 36a and the second hole arrangement 36b are configured to facilitate connection with the IM nail 2. The first hole 36a extends through the plate head 4a along a central hole axis Z3. For illustrative purposes, a plate head reference axis X3 is shown intersecting the central hole axes Z3, Z4 of the first hole 36 and the second hole arrangement 36b. The second hole arrangement 36b defines a lateral dimension Y1 measured along an alignment axis Y2 extending generally along the lateral direction A. The second hole arrangement 36b also defines a central lateral axis Z4 extending through the bone plate 4 substantially along the transverse direction T and located at the lateral midpoint of the lateral dimension Y1. In the illustrated embodiment, the plate head reference axis X3 intersects the alignment axis intersection Y2 at substantially its midpoint. The first hole 36a and the second hole arrangement 36b are spaced apart from one another by a plate hole spacing distance L4, as measured longitudinally between a central hole axis Z3 of the first hole 36a and a central transverse axis Z4 of the second hole arrangement 36b. It should be appreciated that the plate head 4a may include one or more additional proximal locking holes 36 for aligning with one or more additional proximal locking holes 16 of the IM nail 2. For example, the plate head 4a may include a third locking hole 36c that may be configured to receive a locking member 8 insertable through the third proximal locking hole 16c of the nail head 2a to enhance locking between the plate head 4a and the nail head 2a.

[0032] The nail hole spacing distance L3 and the plate hole spacing distance L4 can be in the range of about 15 mm to about 40 mm, more specifically in the range of about 20 mm to about 35 mm, and even more specifically in the range of about 25 mm to about 30 mm. In one non-limiting exemplary embodiment, the nail hole spacing distance L3 and the plate hole spacing distance L4 are each about 27.5 mm. The nail hole and plate hole spacing distances L3 and L4 are preferably substantially equidistant, which provides significant advantages for interlocking fixation between the plate head 4a and the nail head 2a. For example, in the illustrated embodiment, such equidistant spacing allows the first holes 36a, 16a of the plate head 4a and the nail head 2a to be aligned with each other, while the second hole arrangement 36b of the plate head 4a is aligned with the second hole 16b of the nail head 2a. In this way, the first locking member 8a can be inserted through the first locking holes 36a, 16a in the plate head 4a and the nail head 2a, and the second locking member 8b can be inserted through the second locking arrangement 36b and further through the second holes 16b in the plate head 4a and the nail head 2a, respectively.

[0033] 7-14 , the proximal locking hole 36 of the bone plate 4 is also configured to provide the bone plate 4 with angular adjustment capability for angular alignment with the IM nail 2. In state-of-the-art IM nail-to-plate fixation procedures, as the nail length and bending angle increase, aligning the plate shaft (particularly its distal portion) with the distal portion of the IM nail becomes difficult. The proximal locking hole 36 described herein provides a solution to this technical challenge by providing a second hole arrangement 36b that allows the surgeon to pivot the bone plate 4 left or right about a pivot axis substantially along the transverse direction T to a desired angular orientation that matches the position of the IM nail 2, and then use the second hole arrangement 36b to secure the plate head 4a to the nail head 2a in the desired orientation. In this embodiment, the bone plate 4 is pivotable left or right to be guided along an angular range A2 substantially along the transverse direction A, which generally corresponds to the anatomical anterior-posterior direction. After the bone plate 4 is angularly oriented to match the position of the IM nail 2, the second hole arrangement 36b further facilitates locking the bone plate 4 to the IM nail 2 in the desired plate orientation. Such plate angle adjustment capability is particularly advantageous because it can allow a single bone plate 4 to be used with a variety of IM nails 2 of different sizes and bend angles, thereby significantly simplifying the associated surgical procedure.

[0034] In this embodiment, the central bore axis Z3 of the first bore 36a substantially defines the pivot axis for the plate angle, and the second bore arrangement 36b guides and controls the pivot angle, as described in more detail below. The first bore 36a is preferably a VAL bore, and the first locking member 8a is preferably a VAL screw, the shaft 52 of which is configured to advance along the thread axis S1 through the first bore 36a, through the underlying bone, and into the first proximal bore 16a of the IM nail 2. The shaft 52 preferably has a length sufficient to extend into the cortical bone beyond the IM nail 2 when the head 50 is fully seated in the first bore 36a, thereby enhancing fixation of the interconnected nail-plate construct with the bone. The use of a VAL locking hole and VAL bone screw in the first hole 36a and first locking member 8a is particularly advantageous because it allows for some tolerance to lock the first locking member 8a through the first hole 36a in the bone plate 4 and the first proximal locking hole 16a in the IM nail 2, even if the holes 36a, 16a are not precisely aligned.

[0035] The second bore arrangement 36b extends along the lateral direction A and provides a first lateral boundary 54a and a second lateral boundary 54b spaced laterally from one another. In this embodiment, the second bore arrangement 36b is a guide slot 36b extending along a slot path along the arrangement axis Y2 between the first lateral boundary 54a and the second lateral boundary 54b, which define the lateral ends of the guide slot 36b. In this embodiment, the central lateral axis Z4 represents the central bore axis Z4 of the guide slot 36b. The guide slot 36b is configured to receive the shaft 72 of the second locking member 8b inserted substantially laterally through the guide slot 36b into the underlying bone. 10-14, when the first locking member 8a extends through the first holes 36a, 16a in the plate head 4a and the nail head 2a, and the second locking member 8b extends through the guide slots 36b and second locking holes 16b in the plate head 4a and the nail head 2a, the guide slots 36b allow the bone plate 20 to toggle back and forth along an angular range A2 between a first angular position M1 and a second angular position M2. At positions M1 and M2, the first and second lateral boundaries 54a, 54b abut on opposite sides of the threaded shaft 72 of the second locking member 8b. Therefore, the first and second lateral boundaries 54a, 54b can be referred to as the "toggle ends" 54a, 54b of the guide slots 36b. For illustrative purposes, FIGS. 10-11 show the relative positions between the plate head reference axis X3 and the anatomical reference axis X0 at a first angular position M1 and a second angular position M2. The angular range A2 provided by the first hole 36a and guide slot 36b can be from about 0 degrees to about 20 degrees, more specifically from about 2 degrees to about 15 degrees, and more specifically from about 6 degrees to about 10 degrees. In one non-limiting exemplary embodiment, the angular range is from about 7 degrees to about 9 degrees. After the bone plate 4 is angled to the desired orientation, the first locking member 8a and the second locking member 8b can be advanced further into the bone until their heads 50, 70 are fully seated within the first hole 36a and guide slot 36b, respectively, thereby firmly securing the bone plate 4 to the underlying bone and IM nail 2 in the desired orientation.Thus, the guide slots 36b are configured to allow the second locking member 8b to substantially secure the bone plate 4 to the underlying bone at any selected angle within the angle range A2.

[0036] As shown in FIGS. 7-8, the guide slot 36b may be a curved guide slot 36b extending along a curved guide path (i.e., along the curved deployment axis Y2) that defines an arc length C1 as measured along the deployment axis Y2 between the first toggle end 54a and the second toggle end 54b (see FIG. 8). The curved deployment axis Y2 preferably has a constant radius R2 measured from the central hole axis Z3 of the first hole 36a. The radius R2 of the deployment axis Y2 is preferably substantially equal to the hole spacing distances L3 and L4, which facilitates accurate orientation of the bone plate 4 relative to the IM nail 2. Therefore, the ratio of the radius R2 of the deployment axis Y2 to the nail hole spacing distance L3 and the plate hole spacing distance L4 may be approximately 1:1. The arc length C1 may be in a range having a minimum value substantially equal to the shaft major diameter of the second locking member 8b and a maximum value of approximately 20.0 mm, more specifically in a range of approximately 5.5 mm to approximately 10.0 mm, and more specifically in a range of approximately 6.5 mm to approximately 8.0 mm. Additionally, the guide slot 36b defines a slot width W2 measured between the opposing slot sidewalls 56a, 56b along a direction perpendicular to the alignment axis Y2 in a plane substantially perpendicular to the central bore axis Z4. The slot width W2 is substantially equal to, but may be slightly greater than, the major diameter of the threaded shaft 72 so that the guide slot 36b facilitates an induced plate angle about the pivot axis Z3.

[0037] As shown in FIGS. 8-9 , the guide slot 36b extends laterally through the plate head 4a from an upper hole perimeter 58 at its interface with the outer surface 30 of the plate body 20 to a lower hole perimeter 60 at its interface with the bone-facing surface 32 of the plate body 20. The guide slot 36b can have a hole geometry similar to that of a compression slot. In such an embodiment, the plate body 20 defines a countersink surface 62 (also referred to herein as a “countersink” 62) within the guide slot 36b, the countersink 62 extending laterally from the upper hole perimeter 60 to a slot wall surface 64, which extends laterally from the countersink 62 toward the lower hole perimeter 60. The guide slot 36b can also include one or more relief or undercut surfaces 66 extending laterally from the slot wall surface 64 to the lower hole perimeter 60. Preferably, the countersink 62 is smooth and unthreaded, and the second locking member 8b is preferably a compression screw having a smooth head 70 defining a head profile complementary to that of the countersink. The shaft 72 of the second locking member 8b extends along the thread axis S2 and is configured to be advanced through the guide slot 62b, through the underlying bone, and into the second proximal bore 16b of the nail head 2a until the screw head 70 is fully seated within the guide slot 36b. Similar to the first locking member 8a, the shaft 72 of the second locking member 8b preferably has a length sufficient to extend into the cortical bone beyond the IM nail 2, thereby enhancing fixation of the interconnected nail plate construct with the bone. Also, similar to the first locking member 8a, the second locking member 8b can preferably be inserted into the guide slot 36b on an angled insertion trajectory (i.e., relative to the central bore axis Z4), which facilitates extension through both the guide slot 36b and the second proximal locking bore 16b of the IM nail even if the bores 36b, 16b are not precisely aligned.

[0038] While the guide slots 36b of this embodiment have countersinks 62 and are configured to receive the compression screws 8b, it should be understood that the guide slots 36b are preferably not configured to facilitate dynamic compression (i.e., longitudinal and / or lateral translation of the plate relative to the compression screws 8b and underlying bone). Instead, the compression screws 8b and guide slots 36b of this embodiment are configured to facilitate plate angulation and subsequently secure the plate 4 in a desired orientation within the angle range A2. It should also be understood that in embodiments in which the guide slots 36b include countersinks 62, the plate angle range A2 may alternatively be bounded by contact between the ends of the countersinks 62 and the head 70 of the second locking member 8b. It should also be understood that in other embodiments, the guide slots 36b need not have countersinks 62 similar to the countersinks of the compression slots, but may have other slot designs.

[0039] In one non-limiting exemplary embodiment of the nail plate construct 102, the plate hole spacing distance L4 and the placement axis radius R2 are each approximately 27.5 mm, the offset holes 34 are each VAL holes, the bone fixation members 6 are each VAL bone screws having a shaft major diameter of approximately 3.5 mm, the first locking member 8a is a VAL bone screw having a shaft major diameter of approximately 5.0 mm, the second locking member 8b is a compression screw having a shaft major diameter of approximately 4.5 mm, the third proximal locking hole 36c is a VAL hole, and the third locking member 8c is a VAL bone screw having a shaft major diameter of approximately 3.5 mm. It is understood that various other hole and fixation member 6, 8 configurations are within the scope of this embodiment. It is understood that these parameters, as well as parameters described elsewhere in this disclosure, can be adapted as needed.

[0040] 15-17, another embodiment of a bone fixation system 100 is now described, in which the bone plate 104 has a plate head 104a with a modified second hole arrangement 136b. The bone plate 104 of this additional embodiment is otherwise similar to the bone plate 4 described above. Furthermore, in this additional embodiment, other features of the bone fixation system 100 are similar to those described above with reference to the embodiment shown in FIGS. 1-14. Accordingly, the same reference numbers are used in FIGS. 15-17 for such similar features. In this embodiment, the second hole arrangement 136b includes a pair of second locking holes 36d, 36e spaced laterally from one another along a deployment axis Y2, which, as noted above, extends generally along the lateral direction A. In this additional embodiment, the first and second lateral boundaries 54a, 54b of the second hole arrangement 136b are defined by the farthest, opposite sides of the second locking holes 36d, 36e along the arrangement axis Y2. The pair of second locking holes 36d, 36e are configured to receive respective second locking members 8d, 8e extending through and along opposite sides of the nail head 2a to bracket or block the opposite sides of the nail head 2a. In this manner, the second locking members 8d, 8e can be positioned in contact with or adjacent to opposite sides of the nail head 2a (see FIG. 17), while the first locking member 8a extends from the first hole 36a in the plate head 104 and interlocks with the first proximal locking hole 16a in the nail head 2a, as described above. Thus, in this embodiment, the first locking member 8a and the pair of second locking members 8e, 8d interconnect the plate head 4a with the nail head 2a (and thus interconnect the bone plate 104 with the IM nail 2).

[0041] The pair of second locking holes 36d, 36e are preferably VAL holes, and the pair of second locking members 8e, 8d are preferably VAL bone screws. The second locking holes 36e, 36d are positioned such that their respective central hole axes Z5, Z6 intersect the deployment axis Y2. As with the previously described embodiment, the deployment axis Y2 preferably extends along a substantially constant, curved path having a radius R2 substantially equal to the nail hole spacing distance L3. The deployment axis Y2 can be configured as described above with reference to FIG. 7. The bone plate 104 of this embodiment is configured to allow for angulation relative to the underlying bone and the IM nail 2. In this embodiment, the first locking member 8a is inserted through the first hole 36a of the plate head 4a and into the first proximal locking hole 16a of the nail head 2a, but as with the previously described method, the screw head 50 is not fully seated within the first hole 36a. With the first locking member 8a partially inserted in this manner, the bone plate 104 can be pivoted about the shaft 50 of the first locking member 8a, optionally with the aid of fluoroscopy, until the plate shaft 4b is aligned with the nail's main shaft 2b and distal locking portion 2c. After the bone plate 104 is angled for proper alignment with the IM nail 2, the pair of second locking members 8d, 8e can be inserted through the pair of second locking holes 8d, 8e at respective thread angles A1 that carry their respective thread shafts 50 along either side of the nail head 2a. In this manner, when fully inserted, the pair of second locking members 8d, 8e can effectively prevent the IM nail 2 from toggling laterally (and thus substantially anterior-posteriorly) after fixation.

[0042] The VAL configuration of the second locking holes 36d, 36e and the second locking members 8d, 8e allows the second locking members 8d, 8e to be inserted at a thread angle that facilitates blocking with the nail head 2a, even at various plate angles within the plate angle range A2. It should be understood that the plate angle range A2 of this embodiment may be substantially equal to that of the above-described embodiment. In this embodiment, the second locking members 8d, 8e may be VAL bone screws having a major diameter of approximately 3.5 mm or approximately 5.0 mm, respectively, although the second locking members 8d, 8e may be sized according to the other screw sizes described above.

[0043] It should also be appreciated that in additional embodiments, the bone fixation system 100 described above may be provided in a kit including a plurality of interchangeable IM nails 2, bone plates 4, 104, and fixation members 6, 8 having different sizes and configurations, thereby allowing a surgeon to select a particular combination of IM nails 2, bone plates 4, 104, and fixation members 6, 8 to treat a particular condition.

[0044] Exemplary methods of using bone fixation system 100 for surgical repair are now described. These methods include surgical repair using a retrograde femoral IM nail 2, although the methods may be adapted for use with antegrade IM nails and / or other long bones, such as the tibia, fibula, humerus, radius, and ulna, by way of non-limiting example. Exemplary method 200 uses bone plate 4 described above with reference to Figures 1-14, and exemplary method 300 uses bone plate 104 described above with reference to Figures 15-17.

[0045] 18, method 200 includes step 202, during which a surgeon selects an IM nail 2 and a bone plate 4 having respective sizes (e.g., nail length and width L1, W1, and plate length L2) and shapes suitable for the femur repair. The surgeon can determine the appropriate nail length L1 and width W1 using techniques known in the art, such as by viewing radiopaque rulers, such as length and diameter rulers, placed adjacent to the femur 1 under fluoroscopy.

[0046] At step 204, the surgeon inserts the IM nail 2 into the medullary canal of the femur 1 from an entry point on the distal femur, such as the top of the intercondylar notch. Prior to step 204, the surgeon may perform various preparatory steps, such as locating the entry point, inserting a guide member such as a guidewire (e.g., a k-wire) through the entry point and into the medullary canal, opening the medullary canal by advancing a canal opening device (e.g., a drill bit and / or awl) along the guidewire, optionally widening or "reaming" the medullary canal in preparation for receiving the IM nail 2, loading the IM nail 2 onto an insertion instrument (e.g., an insertion handle), and optionally loading the IM nail 2 into the guide member or optional reamer. If necessary, the surgeon may use an impact hammer on the insertion instrument to insert the IM nail 2 into the final desired longitudinal position within the medullary canal. During the insertion process, the surgeon may use fluoroscopy to monitor the position of the IM nail 2 to ensure proper alignment and longitudinal placement.

[0047] When the surgeon determines that the IM nail 2 is inserted at the desired longitudinal position within the medullary canal, the surgeon can begin step 206, which involves initial locking, i.e., partially locking the plate head 4a to the nail head 2a in the distal femur. In step 206, the surgeon positions the bone plate 4 along the femur, substantially aligning the first hole 36a of the plate head 4a with the first proximal locking hole 16a of the nail head 2a. This step can be performed with the assistance of fluoroscopy and / or a targeting tool, such as a guide member attachable to the insertion tool. With the first hole 36a of the plate head 4a substantially aligned with the first proximal locking hole 16a of the nail head 2a, the surgeon inserts the first locking member 8a through the first hole 36a into the underlying bone and into the first proximal locking hole 16a of the nail head 2a. In this example, the first locking member 8a is a VAL bone screw. During step 206, the surgeon preferably stops before advancing the first locking member 8a to its fully seated position within the first hole 36a, thereby allowing the bone plate 4 to pivot about the partially inserted first locking member 8a during subsequent steps, as described below.

[0048] At step 208, the surgeon angles the bone plate 4 about the pivot axis (which is the central hole axis Z3 of the first hole 36a through which the shaft 52 of the partially inserted first locking member 8a extends) until the bone plate 4 is at the desired angle relative to the underlying bone and / or the underlying IM nail. For example, the desired angle may be when the plate shaft 4b and / or distal plate portion 4c aligns with the distal locking portion 2c of the IM nail 2 and the offset hole 34 is spaced laterally from the IM nail 2. During step 208, the surgeon can confirm that when the bone plate 4 is at the desired angle, the second hole arrangement 36b (which is the guide slot 36b in this example) is substantially aligned with the second proximal locking hole 16b of the nail head 2a. Similar to step 206, the surgeon can also perform step 208 with the assistance of a targeting instrument.

[0049] With the bone plate 4 at the desired angle relative to the underlying anatomy, the surgeon can provisionally secure the plate shaft 4b to the underlying bone at the desired angle, at step 210. This can include attaching at least one bone fixation member 6 through at least one respective offset hole 34 in the plate shaft 4b and along the IM nail 2 to the underlying bone.

[0050] At step 212, with the bone plate 4 at the desired angle and the second hole arrangement 36b substantially aligned with the second proximal locking hole 16b of the nail head 2a, the surgeon inserts the second locking member 8b through the guide slot 36b, into the underlying bone, and into the second proximal locking hole 16b of the nail head 2a. In this example, the second locking member 8b is a compression bone screw. During step 212, the surgeon may advance the second locking member 8b through the guide slot 36b until the head 70 abuts the countersink 62. Additionally, at step 213, the surgeon may further advance the second locking member 8b such that the head 70 presses the bone plate 4 toward and / or against the underlying bone, thereby minimizing any gap between the bone plate 4 and the bone 1, which may reduce soft tissue irritation at the plate-bone interface.

[0051] If necessary during steps 206 and 212, such as when precise alignment of holes 36a, 16a and / or holes 36b, 16b is not feasible, the surgeon can insert the first locking member 8a and / or second locking member 8b through one or both of the respective holes in the plate head 4a and nail head 2a with an angled screw insertion trajectory.

[0052] In step 214, the surgeon further advances the first locking member 8a until its head 50 is fully seated and locked within the first hole 36a of the plate head 4a. In this example, step 214 involves locking the head 50 of the first locking member 8a with the internal locking structure of the first hole 36a.

[0053] With the plate 4 properly aligned with the underlying IM nail 2 and the first and second locking members 8a, 8b interconnecting the plate head 4a with the nail head 2a, the surgeon can perform a step 216 involving distal locking, which can include inserting one or more distal locking members 8 through one or more aligned pairs of holes 38, 18 in the shaft portions 4b, 2b and / or distal portions 4c, 2c of the plate 4 and IM nail 2. Additionally or alternatively, the distal locking step 216 can include securing a pair of bone fixation members 6 through respective pairs of offset holes 34 in the plate shaft 4b and into the underlying bone along the IM nail 2, thereby preventing the associated portion of the IM nail 2 from moving laterally.

[0054] At step 218, the surgeon may perform a secondary locking, which may include a secondary locking of the plate head 4a and the nail head 2a. During this step, the surgeon may optionally insert a third locking member 8c through the third hole 36c in the plate head 4a and the third proximal locking hole 16c in the nail head 2a. Additionally or alternatively, step 216 may include distally locking the plate shaft 4b and / or the distal plate portion 4c with the distal locking portion 2c of the IM nail 2.

[0055] At step 220, the surgeon may effect fixation of the bone plate 4 with the underlying bone, which may occur at the plate head 4 a, the plate shaft 4 b, and / or the distal plate portion 4 c. This step may include inserting one or more bone fixation members 6 through one or more of the respective offset holes 34 of the bone plate 4 and into the underlying bone along the IM nail 2.

[0056] 19, a method 300 of using the bone fixing system 100 shown in Figures 15-17 will now be described. For brevity, the following description of method 300 will focus on steps that differ from the steps of method 200. Method 300 includes steps 202, 204, and 206 described above.

[0057] In step 308, after the first locking member 8a is inserted through the first hole 36a of the plate head 104a into the underlying bone and into the first proximal locking hole 16a of the nail head 2a, the surgeon substantially aligns the second hole arrangement 136b (which in this example is a pair of second locking holes 8d, 8e) with the second proximal locking hole 16b of the nail head 2a. Substantially aligning the second hole arrangement 136b with the second proximal locking hole 16b may include substantially aligning the alignment axis Y2 between the first lateral boundary 54a and the second lateral boundary 54b with the second proximal locking hole 16b. Similar to step 206, the surgeon may also perform step 308 with the assistance of a targeting instrument.

[0058] In step 310, the surgeon angles the bone plate 104 about the pivot axis (which is the central hole axis Z3 of the first hole 36a through which the shaft 52 of the partially inserted first locking member 8a extends) until the plate shaft 4b and / or distal plate portion 4c is aligned with the distal locking portion 2c of the IM nail 2.

[0059] After such alignment is achieved during step 310, the surgeon performs step 312, which includes distal locking, which may include inserting one or more distal locking members 8 through one or more aligned pairs of holes 38, 18 in the shaft portions 4b, 2b and / or distal portions 4c, 2c of the plate 4 and IM nail 2. Additionally or alternatively, distal locking step 312 may include securing a pair of bone fixation members 6 through respective pairs of offset holes 34 in the plate shaft 4b and into the underlying bone along the IM nail 2, thereby preventing the associated portion of the IM nail 2 from moving laterally.

[0060] Also, after step 310, the surgeon performs step 314, which includes locking the second hole arrangement 136b to the nail head 2a. In step 314, the surgeon inserts a pair of second locking members 8d, 8e through the pair of second locking holes 36d, 36e, respectively, along both sides of the nail head 2a adjacent the second proximal locking hole 16b, at respective thread angles A1 that result in the respective screw shafts 50 being inserted into the underlying bone. In this manner, when the pair of second locking members 8d, 8e are fully seated within the second locking holes 36d, 36e, they can effectively prevent the nail head 2a from toggling laterally (and thus substantially along the anterior-posterior direction) after fixation. In this example, each of the pair of second locking members 8d, 8e is a VAL bone screw.

[0061] In step 315, the surgeon further advances the first locking member 8a until its head 50 is fully seated within the first hole 36a of the plate head 4a. In this example, step 316 involves locking the head 50 of the first locking member 8a with the internal locking structure of the first hole 36a.

[0062] During method 300, preferably after steps 312 and 314, and 315, the surgeon may perform steps 216 and 218 described above.

[0063] It should also be understood that the above-described methods are provided by way of example, and that the surgeon may choose to adjust the order of the various steps, omit one or more of the steps, and / or perform one or more additional steps, as desired.

[0064] It should be further understood that the above-described bone plates 4, 104 can be used to treat bones without the use of an associated IM nail. In such embodiments, the second hole arrangement 36b, 136b can be used to facilitate plate angle A2 (pivoting about the first locking member 8a partially inserted into the underlying bone through the first hole 36a) for proper plate alignment with the underlying bone in a manner similar to that described above. In still further embodiments, the above-described bone plates 4, 104 can be used with other types of implants, such as a second bone plate on the opposite side of the bone, to facilitate angle A2 of the bone plate 4, 104 about the first locking member 8a partially inserted into a hole or other structure of the second bone plate through the first hole 36a.

[0065] Although the present disclosure has been described in detail, it should be understood that various changes, substitutions, and alterations may be made herein without departing from the spirit and scope of the present invention, as defined by the appended claims. Moreover, the scope of the present disclosure is not intended to be limited to the particular embodiments described herein. In particular, one or more of the features from the foregoing embodiments may be used in other embodiments herein. As one skilled in the art would readily appreciate from the process, any now-existing or later-developed machine, manufacture, composition of matter, means, method, or step that performs substantially the same function or achieves substantially the same result as the corresponding embodiment described herein may be utilized in accordance with the present disclosure.

[0066] [Embodiment] (1) A bone fixation system, comprising: an intramedullary nail having a nail body elongated along a longitudinal direction, the nail body having a nail head and a distal locking portion spaced from the nail head in a distal direction along the longitudinal direction, the nail head defining a nail hole extending through the nail body in a transverse direction offset from the longitudinal direction; a bone plate having a plate body extending along a longitudinal plate axis and having first and second opposite sides along a transverse direction perpendicular to the longitudinal plate axis, the plate body having opposite outer and bone-facing surfaces, the plate body being alignable with the nail body such that (1) the longitudinal plate axis is oriented substantially along the longitudinal direction, (2) the outer and bone-facing surfaces are spaced apart along the transverse direction, and (3) the transverse direction is offset from the longitudinal and transverse directions; the plate body defines a first plate hole and a second plate hole arrangement spaced distally from the first plate hole, the first plate hole and the second plate hole arrangement each extending from the outer surface to the bone-facing surface; the first plate hole is configured to receive a first locking member for insertion through the first plate hole and the nail hole to interconnect the bone plate to the intramedullary nail, and the second plate hole arrangement is configured to receive at least one second locking member; the plate body is configured to pivot along an angular range about a central hole axis of the first plate hole when the first locking member extends further through the first plate hole and into the nail hole, the angular range being configured to align the plate body with a distal portion of the nail body along the transverse direction, the angular range being defined between laterally opposite ends of the second plate hole arrangement; the second hole arrangement is configured such that the at least one second locking member is configured to substantially secure the bone plate to the underlying bone at any selected angle within the angular range. (2) The bone fixing system according to claim 1, wherein the angle range is from about 2 degrees to about 15 degrees. (3) The bone fixation system of claim 1, wherein the second hole arrangement of the plate body comprises a single curved guide slot extending between laterally opposed ends along a curved slot axis having at least one directional component along the lateral direction, and the at least one second locking member is a bone screw configured to extend through the curved guide slot and further into a second nail hole defined in the nail body, the second nail hole being spaced apart in the distal direction from the nail hole. (4) The bone fixation system of embodiment 3, wherein the distance between the central hole axis of the first plate hole and the curved slot axis is substantially equal to the distance between the central hole axis of the nail hole and the central hole axis of the second nail hole. (5) The bone fixation system of embodiment 3, wherein the curved slot axis has a radius ranging from about 15 mm to about 40 mm measured from the central hole axis of the first plate hole.

[0067] (6) The bone fixation system of claim 5, wherein the radius is substantially constant along the curved slot axis. (7) The bone fixation system of claim 3, wherein the curved guide slot defines a slot width measured along a direction perpendicular to the curved slot axis, the slot width being slightly greater than a major diameter of the shaft of the bone screw. (8) The bone fixation system of claim 3, wherein the curved guide slot extends through the plate body from an upper hole perimeter at an interface with the outer surface of the plate body to a lower hole perimeter at an interface with the bone-facing surface of the plate body, and the curved guide slot includes a countersink extending from the upper hole perimeter toward the lower hole perimeter. (9) The bone fixation system of claim 1, wherein the second hole arrangement of the plate body comprises a pair of second holes spaced laterally from one another along an arrangement axis, the arrangement axis intersecting central axes of the pair of second holes, and the arrangement axis extending transverse to the longitudinal plate axis. (10) The bone fixation system of embodiment 7, wherein the pair of second holes are variable angle locking (VAL) holes, and the at least one second locking member comprises a pair of variable angle locking (VAL) screws configured to variably lock with the pair of second holes.

[0068] (11) The bone fixation system of embodiment 10, wherein the pair of VAL screws are configured to extend through the pair of second VAL holes and along opposite sides of the nail body into the underlying bone at a position of the nail body distally spaced from the nail hole, and the pair of VAL screws are configured to lock with the plate body to limit lateral movement of the intramedullary nail relative to the bone. (12) A bone plate, a plate body having first and second longitudinally opposed ends, the plate body defining a longitudinal axis extending between the first and second ends along the longitudinal direction, the plate body having first and second opposite sides along a lateral direction offset from the longitudinal direction, the plate body having a bone-facing surface and an outer surface opposite each other along a transverse direction offset from the longitudinal direction and the lateral direction; the plate body defines first and second hole arrangements, each extending from the outer surface to the bone-facing surface, the second hole arrangement spaced distally from the first hole along the longitudinal direction, the first hole configured to receive a first fixation member for fixation with the underlying bone, and the second hole arrangement configured to receive at least one second fixation member for fixation with the underlying bone; the plate body is configured to pivot along an angular range about the first fixation member extending through the first hole into the underlying bone; the second hole arrangement extends laterally across the longitudinal axis and defines the angular range, and the at least one second fixation member is configured to substantially fix the bone plate to the underlying bone at any selected angle within the angular range. (13) The bone fixing system according to claim 1, wherein the angle range is about 10 degrees to about 20 degrees. (14) The bone fixation system of embodiment 1, wherein the second hole arrangement comprises a single curved guide slot extending along a curved slot axis having at least one directional component along the transverse direction, the curved guide slot configured to receive the at least one second locking member. (15) The bone fixation system of claim 3, wherein the curved slot axis has a radius, measured from a central axis of the first hole, in the range of about 25.0 mm to about 30.0 mm, and the radius is substantially constant along the curved slot axis.

[0069] (16) The bone fixation system of claim 1, wherein the second hole arrangement comprises a pair of second holes spaced laterally from one another along an arrangement axis, the arrangement axis intersecting a central axis of the pair of second holes, the arrangement axis extending transversely to the longitudinal axis, and the pair of second holes being variable angle locking (VAL) holes configured to receive variable angle locking (VAL) screws. (17) A method for treating bone, comprising: inserting an intramedullary nail into the medullary canal of the bone; positioning a bone plate along the bone, the bone plate having longitudinally opposed proximal and distal ends; inserting a first locking member into the underlying bone through a first plate hole defined in the bone plate and into at least a nail hole defined in the intramedullary nail, the first plate hole being defined in a proximal portion of the bone plate; pivoting the bone plate about the first locking member until a portion of the bone plate distal to the proximal portion is aligned with a distal portion of the intramedullary nail; inserting at least one fixation member into underlying bone through at least one fixation hole defined in the portion of the bone plate distal to the proximal portion; inserting at least one second locking member through at least one second plate hole defined in the bone plate and into underlying bone adjacent the intramedullary nail, and advancing the at least one second locking member through the at least one second plate hole such that a head of the at least one second locking member is fully seated in the at least one second locking hole, the at least one second plate hole being spaced distally from the first plate hole along the longitudinal direction; further advancing the first locking member after the pivoting and aligning step until a head of the first locking member is fully seated within the first plate hole; A method comprising: (18) The at least one second plate hole is a single curved guide slot extending along a slot axis between opposite lateral ends of the curved guide slot, the slot axis intersecting a longitudinal axis of the bone plate; the at least one second locking member is a bone screw; and the step of inserting the at least one second locking member includes inserting the bone screw through the curved guide slot into the underlying bone and into a second nail hole spaced distally from at least the nail hole; 18. The method of claim 17, wherein the pivoting step slides opposing longitudinal sides of the curved guide slot along opposing longitudinal sides of the bone screw shaft, the curved guide slot defining a pivot angle range bounded by the opposing lateral ends of the curved guide slot abutting opposing laterally opposed sides of the bone screw shaft. (19) The method of embodiment 18, wherein the curved guide slot includes a countersunk hole, the bone screw has a screw head with a smooth, unthreaded outer surface, and the step of further advancing the first locking member seats the smooth, unthreaded outer surface of the screw head against the countersunk hole and presses the bone plate against the underlying bone. (20) The at least one second plate hole is a pair of second variable angle locking (VAL) holes spaced apart along an alignment axis having at least one directional component along a transverse direction substantially perpendicular to the longitudinal direction, and the at least one second locking member is a pair of second variable angle locking (VAL) bone screws; 18. The method of claim 17, wherein the step of inserting the at least one second locking member comprises inserting the pair of second VAL bone screws, respectively, through the pair of second VAL holes and into the underlying bone along opposite sides of the intramedullary nail at a position of the intramedullary nail spaced distally from the nail hole.

Claims

1. 1. A bone fixation system comprising: an intramedullary nail having a nail body elongated along a longitudinal direction, the nail body having a nail head and a distal locking portion spaced from the nail head in a distal direction along the longitudinal direction, the nail head defining a nail hole extending through the nail body in a transverse direction offset from the longitudinal direction; a bone plate having a plate body extending along a longitudinal plate axis and having first and second opposite sides along a transverse direction perpendicular to the longitudinal plate axis, the plate body having opposite outer and bone-facing surfaces, the plate body being such that (1) the longitudinal plate axis is oriented substantially along the longitudinal direction, (2) the outer and bone-facing surfaces are spaced apart along the transverse direction, and (3) the transverse direction is offset from the longitudinal and transverse directions; the plate body defines a first plate hole and a second plate hole arrangement spaced distally from the first plate hole, the first plate hole and the second plate hole arrangement each extending from the outer surface to the bone-facing surface; the first plate hole is configured to receive a first locking member for insertion through the first plate hole and the nail hole to interconnect the bone plate to the intramedullary nail, and the second plate hole arrangement is configured to receive at least one second locking member; the plate body is configured to pivot along an angular range about a central hole axis of the first plate hole when the first locking member extends further through the first plate hole and into the nail hole, the angular range being configured to align the plate body with a distal portion of the nail body along the transverse direction, the angular range being defined between laterally opposite ends of the second plate hole arrangement; the second hole arrangement is configured such that the at least one second locking member is configured to substantially secure the bone plate to the underlying bone at any selected angle within the angular range.

2. The bone fixing system of claim 1 , wherein the angular range is from about 2 degrees to about 15 degrees.

3. 2. The bone fixation system of claim 1, wherein the second hole arrangement of the plate body comprises a single curved guide slot extending between laterally opposed ends along a curved slot axis having at least one directional component along the lateral direction, and the at least one second locking member is a bone screw configured to extend through the curved guide slot and further into a second nail hole defined in the nail body, the second nail hole being spaced apart from the nail hole in the distal direction.

4. 4. The bone fixation system of claim 3, wherein a distance between the central hole axis of the first plate hole and the curved slot axis is substantially equal to a distance between a central hole axis of the nail hole and the central hole axis of the second nail hole.

5. The bone fixation system of claim 3 , wherein the curved slot axis has a radius measured from the central hole axis of the first plate hole in a range of about 15 mm to about 40 mm.

6. The bone fixation system of claim 5 , wherein the radius is substantially constant along the curved slot axis.

7. 4. The bone fixation system of claim 3, wherein the curved guide slot defines a slot width measured along a direction perpendicular to the curved slot axis, the slot width being slightly greater than a major diameter of a shaft of the bone screw.

8. 4. The bone fixation system of claim 3, wherein the curved guide slot extends through the plate body from an upper hole perimeter at its interface with the outer surface of the plate body to a lower hole perimeter at its interface with the bone-facing surface of the plate body, the curved guide slot including a countersink extending from the upper hole perimeter toward the lower hole perimeter.

9. 2. The bone fixation system of claim 1, wherein the second hole arrangement of the plate body comprises a pair of second holes spaced laterally from one another along a deployment axis, the deployment axis intersecting central axes of the pair of second holes, the deployment axis extending transverse to the longitudinal plate axis.

10. 8. The bone fixation system of claim 7, wherein the pair of second holes are variable angle locking (VAL) holes, and the at least one second locking member comprises a pair of variable angle locking (VAL) screws configured for variable angle locking with the pair of second holes.

11. 11. The bone fixation system of claim 10, wherein the pair of VAL screws are configured to extend through the pair of second VAL holes and along opposite sides of the nail body into the underlying bone at a location on the nail body spaced distally from the nail hole, and the pair of VAL screws are configured to lock with the plate body to limit lateral movement of the intramedullary nail relative to the bone.

12. 1. A bone plate comprising: a plate body having first and second longitudinally opposed ends, the plate body defining a longitudinal axis extending between the first and second ends along the longitudinal direction, the plate body having first and second opposite sides along a lateral direction offset from the longitudinal direction, the plate body having a bone-facing surface and an outer surface opposite each other along a transverse direction offset from the longitudinal direction and the lateral direction; the plate body defines first and second hole arrangements, each extending from the outer surface to the bone-facing surface, the second hole arrangement spaced distally from the first hole along the longitudinal direction, the first hole configured to receive a first fixation member for fixation with the underlying bone, and the second hole arrangement configured to receive at least one second fixation member for fixation with the underlying bone; the plate body is configured to pivot along an angular range about the first fixation member extending through the first hole into the underlying bone; the second hole arrangement extends laterally across the longitudinal axis and defines the angular range, and the at least one second fixation member is configured to substantially fix the bone plate to the underlying bone at any selected angle within the angular range.

13. The bone fixing system of claim 1 , wherein the angular range is from about 10 degrees to about 20 degrees.

14. 2. The bone fixation system of claim 1, wherein the second hole arrangement comprises a single curved guide slot extending along a curved slot axis having at least one directional component along the lateral direction, the curved guide slot configured to receive the at least one second locking member.

15. 4. The bone fixation system of claim 3, wherein the curved slot axis has a radius, measured from a central axis of the first hole, in a range from about 25.0 mm to about 30.0 mm, the radius being substantially constant along the curved slot axis.

16. 2. The bone fixation system of claim 1, wherein the second hole arrangement comprises a pair of second holes spaced laterally from one another along a deployment axis, the deployment axis intersecting a central axis of the pair of second holes, the deployment axis extending transversely to the longitudinal axis, and the pair of second holes being variable angle locking (VAL) holes configured to receive variable angle locking (VAL) screws.

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