Bone plates and related systems and methods

Abstract

A bone plate includes opposing first and second ends along a longitudinal axis oriented along the longitudinal direction, opposing first and second sides along a lateral direction, and opposing bone-facing surfaces and outer surfaces along a transverse direction. The plate defines first and second arrangements of apertures extending from the outer surface to the bone-facing surface. The second aperture arrangement is distal to the first aperture, the first aperture configured to receive a first fixation member, and the second aperture arrangement configured to receive at least one second fixation member for attachment with an underlying bone. The plate is pivotable about the first aperture along an angled angular range. The second aperture arrangement laterally passes through the longitudinal axis, defines an angled angular range, and allows the at least one second fixation member to substantially secure the plate to the underlying bone at any angled angle within the angled angular range.

Description

[0001] Cross-references to related applications This application claims the benefit of U.S. Nonprovisional Application Serial No. 18 / 171,827, filed February 21, 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0002] This invention relates to bone plates, and more particularly to bone plates that are angle-adjustable relative to the underlying anatomical structures. Background Technology

[0003] Long bone fractures such as those of the femur and humerus are typically treated with screws or other fixation devices inserted into or through the bone to stabilize the fractured portion once it has been aligned. Femoral osteofixation treatment can involve inserting an intramedullary (IM) nail into the medullary canal of the femur, followed by the insertion of an osteofixation screw into the condyle or trochanteric portion of the femur, depending on whether the IM nail is inserted into the medullary canal along an antegrade or retrograde insertion trajectory. An antegrade insertion trajectory extends from the anatomically proximal end of the femur (i.e., at the hip joint), such as from or slightly laterally to the tip of the greater trochanter, and extends along the anatomically axis of the femur toward the anatomically distal end of the femur into the medullary canal. A retrograde insertion trajectory extends from the anatomically distal end of the femur (i.e., at the knee joint) toward the anatomically proximal end of the femur, effectively opposite to 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 for the distal portion of the femur (e.g., the distal condyle and intercondylar region), such as in the treatment of distal femoral fractures. For example, a retrograde IM nail allows for easier aiming and insertion of a locking screw into a locking hole at the tail end of the nail residing within the distal femur. When treating distal femoral fractures, retrograde femoral nailing may require additional bone fixation, particularly when the femur exhibits poor bone quality and / or is in a periprosthetic setting. In such cases, supplementary locking attachment washers (LAWs) or plates can be attached to the tail end of the nail via multiple bone screws. For simplicity and brevity, the locking attachment washers described below may each be referred to as "plates." A plate defines one or more holes for bone screws interconnected with the IM nail. Additionally, a plate may define one or more additional holes for additional bone screws attached to the portion of the femur adjacent to the tail end of the IM nail to supplement bone fixation.

[0005] IM nails and associated plates are available in various sizes, geometries, and lengths to facilitate the treatment of fractures of various types and indications. Furthermore, physicians can select various combinations of IM nails and plates based on the patient's treatment needs. For example, IM nails can be paired with plates of increased length, allowing the plate to extend from the distal region of the bone (e.g., the condyle or trochanteric portion of the femur) to the diaphysis and alongside it. With such plates of increased length, the distal end of the plate should be aligned and fixed to the bone with the associated longitudinal portion of the IM nail.

[0006] Aiming and inserting locking screws at the tail end of the IM nail and the associated plate is generally simplified by the fact that the nail tail end and / or the associated plate can directly engage with tools such as an insertion shank and / or a pointing arm with a pointing element for aiming at the locking hole near the tail end of the IM nail. However, aiming at the locking hole at the front end of the IM nail becomes more challenging, specifically as the nail length increases, due to factors such as nail deflection and deformation that may be caused by 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 also increase. Summary of the Invention

[0007] According to one embodiment of this disclosure, a bone fixation system includes an intramedullary nail and a bone plate. The intramedullary nail has a nail body extending longitudinally. The nail body has a nail head and a distal locking portion spaced distally from the nail head along the longitudinal direction. The nail head defines a nail hole extending through the nail body in a transverse direction deviating 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 to each other in a lateral direction perpendicular to the longitudinal plate axis. The plate body has an outer surface opposite to each other and a bone-facing surface. The plate body is alignable with the nail body such that: the longitudinal plate axis is substantially oriented longitudinally, the outer surface and the bone-facing surface are spaced apart from each other in a transverse direction, and the lateral direction deviates from both 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 and second plate hole arrangements 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 for interconnecting 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 about the central hole axis of the first plate hole along an angulation range as the first locking member extends through the first plate hole and further into the nail hole. The angulation range is configured to align the distal portions of the plate body and the nail body in a lateral direction. The angulation range is defined between the laterally opposite ends of the second plate hole arrangement. The second hole arrangement is configured such that at least one second locking member is configured to substantially secure the bone plate to the underlying bone at any selected angulation angle within the angulation range.

[0008] According to another embodiment of this disclosure, the bone plate includes a plate body having a first end and a second end opposite to each other along a longitudinal axis oriented in the longitudinal direction. The plate body has a first side and a second side opposite to each other in a lateral direction deviating from the longitudinal direction. The plate body has a bone-facing surface and an outer surface opposite to each other in a transverse direction deviating from both the longitudinal and lateral 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 in 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 about the first fixation member extending through the first hole and into the underlying bone within an angular range. The second hole arrangement extends laterally across the longitudinal axis, defining an angular range, and is configured such that at least one second fixation member is configured to substantially fix the bone plate to the underlying bone at any selected angular angle within the angular range.

[0009] According to an additional embodiment of this disclosure, a method for treating bone includes inserting an intramedullary nail into the medullary canal of the bone and placing a bone plate adjacent to the bone. The bone plate has a proximal end and a distal end opposite each other in a longitudinal direction. The method includes: inserting a first locking member through a first plate hole defined in a proximal portion of the bone plate, into the underlying bone, and at least into 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 through at least one fixation hole defined in the portion of the bone plate distal to the proximal portion and into the underlying bone. 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 to the intramedullary nail; and advancing the at least one second locking member through the at least one second plate hole such that the 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 is spaced distally from the first plate hole in a longitudinal direction. Following the pivoting and alignment steps, the method includes further advancing the first locking member until its head is fully positioned within the first plate hole. Attached Figure Description

[0010] The foregoing description of the invention and the following detailed description of exemplary embodiments of the present application will be better understood when read in conjunction with the accompanying drawings. Exemplary embodiments are shown in the drawings to illustrate the characteristic features of the present application. However, it should be understood that the present application is not limited to the precise arrangements and means shown. In the drawings: Figure 1 This is a side view of a bone fixation system including a nail-plate configuration according to one embodiment of the present disclosure, the nail-plate configuration including IM nails interconnected with a bone plate; Figure 2 yes Figure 1 Top view of the illustrated bone fixation system; Figure 3 yes Figure 1 Bottom view of the illustrated bone fixation system; Figure 4 It is possible Figures 1 to 3 Side view of the fixation components used in the illustrated bone fixation system; Figure 5 and Figure 6 yes Figure 1 and Figure 2 Enlarged top view of the proximal (structurally proximal but anatomically distal) portion of the illustrated bone fixation system ( Figure 5 ) and side view ( Figure 6 ); Figure 7 It is based on one implementation scheme of this disclosure. Figure 1 The planar partial exploded view of the associated proximal portions of the IM nail and bone plate shown, which are referred to herein as the "nail head" and the "plate head," respectively. Figure 8 yes Figure 7 An enlarged view of the locking hole on the illustrated plate head; Figure 9 It is along Figure 7 A cross-sectional end view of a portion of the plate head taken by section line IX-IX, which is consistent with... Figure 8 The illustrated locking holes intersect; Figure 10 and Figure 11 yes Figure 7 The position of the first angle relative to the anatomical structures below ( Figure 10 ) and the position of the second angle ( Figure 11 Top view of the board head at () location; Figure 12 and Figure 13 It is along Figure 7 The section line IX-IX is taken at the first angle relative to the anatomical structure below ( Figure 12 ) and the position of the second angle ( Figure 13 Cross-sectional end view of the plate head at () location; Figure 14 This is a top plan view showing the bone plate angled at the first and second angular positions relative to the anatomical structures below; Figure 15 This is a top view of a bone fixation system including a nail-plate configuration according to another embodiment of the present disclosure, the nail-plate configuration including a bone plate with a modified design; Figure 16 yes Figure 15 Top plan view of the head portion of the illustrated bone plate; Figure 17 yes Figure 15 Bottom plan view of the proximal (structurally proximal but anatomically distal) portion of the illustrated nail-plate structure; Figure 18 It shows the use of Figures 1 to 14 The illustrated process diagram of the bone fixation system method steps; and Figure 19 It shows the use of Figures 15 to 17 The illustrated process diagram shows the steps of the bone fixation system. Detailed Implementation

[0011] This disclosure will be more readily understood with reference to the following detailed description, taken in conjunction with the accompanying drawings and examples that form a part of this disclosure. It should be understood that this disclosure is not limited to the specific apparatus, methods, applications, conditions, or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the scope of this disclosure. Furthermore, unless the context clearly indicates otherwise, as used in this specification (including the appended claims), the singular forms “a” and “the” include the plural, and references to a particular numerical value include at least that particular value.

[0012] As used herein, the term "multiple" means more than one. When referring to a range of values, another embodiment includes from one specific value and / or to other specific values. Similarly, when a value is expressed as an approximation using "about," it should be understood that the specific value of that value constitutes another embodiment. All ranges include end values ​​and are composable.

[0013] As used herein, the terms “about,” “approximately,” and “substantially” relating to dimensions, angles, ratios, and other geometries take into account manufacturing tolerances. Furthermore, the terms “about,” “approximately,” and “substantially” can include being greater than or less than 10% of the stated dimension, ratio, or angle. Additionally, the terms “about,” “approximately,” and “substantially” can be applied equivalently to the specific values ​​stated.

[0014] It should be understood that although the terms first, second, etc., may be used herein with reference to various features, these features should not be limited by these terms, but rather used to distinguish one feature from another. For example, without departing from the scope of the embodiments disclosed herein, a first feature may be referred to as a second feature in another context, and similarly, a second feature may be referred to as a first feature in another context.

[0015] The embodiments disclosed herein relate to bone plates adapted to facilitate angulation of the plate with underlying anatomical structures and / or underlying implant hardware for enhanced bone fixation. For example, the bone plates described herein have a perforated structure that facilitates angulation of the plate about a pivot axis and also facilitates fixation of the plate relative to the underlying anatomical structures and / or implant hardware at a desired angular orientation. Example embodiments described below include a bone fixation system comprising an intramedullary (IM) nail and a bone plate with a perforated structure that allows the bone plate to interconnect with the IM nail, be angled relative to the IM nail to align the bone plate and IM nail along their length, and then attach the bone plate to the underlying bone and IM nail at a desired plate angular angle. Bone plates with such angular adjustability are particularly advantageous because they allow a single bone plate to be used with different IM nails of varying sizes and curvature angles, which can greatly simplify the plate selection process and the entire surgical procedure. Additionally, the bone plates described herein can also be used without associated IM nails and still provide angular adjustability with the underlying structure.

[0016] Now for reference Figures 1 to 3 An exemplary embodiment of the bone fixation system 100 includes an intramedullary (IM) nail 2 capable of being inserted into the medullary canal of a long bone 1, a bone plate 4 capable of being attached to the outer surface of the bone 1 and connected to the IM nail 2, and a plurality of fixation members 6, 8 for connecting the bone plate 4 to the IM nail 2, thereby forming an interconnected nail-plate configuration (NPC) 102 and for attaching the nail-plate configuration 102 to the bone 1. The nail-plate configuration 102 can also be configured to treat periprosthetic conditions, including for attachment to an existing implant or prosthesis 3. For example, the nail-plate configuration 102 is shown in a periprosthetic environment to provide attachment to a prosthesis from a previous osteotomy of the femoral stem 3. It should be understood that the foregoing represents a non-limiting example of a particular treatment that the plate-nail configuration 102 may provide. Furthermore, although the long bone 1 discussed in the illustrated embodiment is the femur, it should be understood that, by way of non-limiting example, the bone fixation system 100 may be adapted for other long bones (such as the tibia, fibula, humerus, radius, and ulna). Additionally, although 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 antegrade insertion trajectories.

[0017] The IM nail 2 has a first end 10 and a second end 12 spaced apart from each other along the longitudinal direction L. In an exemplary embodiment illustrating a retrograde femoral IM nail, the longitudinal direction L generally extends along the craniocaudate direction of the patient's anatomy. In such embodiments, the first end 10 is the proximal end of the nail 2 and is configured to be temporarily coupled to an insertion tool such as an insertion arm. The second end 12 is the distal end of the nail 2 and is the anterior or forward end of the nail 2 during insertion into the medullary canal. The second end 12 is spaced apart from the first end 10 in the distal direction D, while the first end 10 is spaced apart from the second end 12 in the proximal direction P, opposite to 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 may include IM nails 2 having various lengths L1 and widths W1 for selective use in various types of fractures, as described below.

[0018] It should also be understood that, as used herein, the terms “longitudinal,” “longitudinally,” and their derivatives refer to the longitudinal direction L; the terms “distal,” “towards distal,” and their derivatives refer to the distal direction D; and the terms “proximal,” “towards proximal,” and their derivatives refer to the proximal direction P. Furthermore, because the retrograde insertion trajectory substantially reverses the structural (implant) use of the directional terms “proximal” and “distal” with 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 toward the “proximal” femur), for clarity, the terms “proximal” and “distal” and their derivatives are used herein to refer to the directional aspect of the synthetic structural components of the bone fixation system 100; however, unless these terms specifically refer to anatomical structural use (e.g., “proximal femur,” “distal femur,” “distal anatomical direction”), in the latter case, these terms refer to the anatomical direction.

[0019] The IM nail 2 has a nail body 14 extending along a central nail axis X1 oriented generally in the longitudinal direction L. The central nail axis X1 does not need to be linear; preferably, it follows a path substantially co-extending with the anatomical axis of the bone 1. Thus, the central nail axis X1 may have one or more straight portions and one or more curved portions. The nail body 14 includes a proximal locking portion 2a (also referred to herein as the "nail head" 2a) extending distally from a first end 10, an intermediate portion 2b (also referred to herein as the "main axis portion" 2b) extending distally from the nail head 2a, and a distal locking portion 2c extending from the main axis portion 2b to a second end 12 of the nail 2. The nail head 2a is configured to attach to a tool, 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 corresponding central hole axes oriented in one or more different directions deviating from the longitudinal direction L. These directions may be perpendicular to or inclined to the longitudinal direction L. Each proximal locking hole 16 is preferably configured to receive a fixation member, specifically a locking member 8, such as a bone screw or helical blade, extending through the corresponding hole 16 and attaching 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 the associated bone fixation members can also be used to attach one or more fractured portions of adjacent bones to each other. The proximal locking holes 16 of the IM nail are described in more detail below. Figure 3 As shown, the distal locking portion 2c of the IM nail 2 further defines one or more distal locking holes 18 that extend through the nail body 14 in one or more different directions deviating from the longitudinal direction L, these directions may be perpendicular to or inclined 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 attaching the distal locking portion 2c of the IM nail 2 to an adjacent portion of the bone 1.

[0021] Continue to refer to Figures 1 to 3The bone plate 4 has a plate body 20 extending from a first end 22 to a second end 24 spaced apart from the first end 22 along a longitudinal direction L. 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 the bone plate 4 can be provided in various configurations and sizes (e.g., nail length L1, nail width W1, plate length L2) suitable for treating various conditions. For example, by way of non-limiting example, the IM nail 2 and the bone plate 4 can be customized as needed to form various nail-plate configurations 102 suitable for treating supracondylar fractures (including those with intra-articular extension), combinations of ipsilateral condylar and shaft fractures, ipsilateral femoral / tibial fractures, femoral fractures in patients with multiple trauma, periprosthetic fractures (including types B1 and C according to the Vancouver classification system, and also including interprosthetic fractures), fractures in morbidly obese patients, fractures in bones with osteoporosis and osteopenia, potentially pathological fractures, malunion, and nonunion. It should be understood that the nail-plate configuration 102 can be adapted as needed to treat various other conditions. The nail length L1 can range from about 120 mm to about 500 mm. The nail width W1 can range from about 8 mm to about 16 mm. The plate length L2 can range from about 120 mm to about 550 mm.

[0022] The plate body 20 also has a first side 26 and a second side 28 opposite to each other along a lateral direction A, which deviates from the longitudinal direction L. In the illustrated embodiment, the lateral 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 opposite to each other along a transverse direction T, which deviates from the longitudinal direction L and the lateral direction A. In the illustrated embodiment, the transverse direction T of the bone plate 4 generally extends along the lateral-interior direction of the patient's anatomy. Although the illustrated embodiment shows the longitudinal direction L, the lateral direction A, and the transverse direction T as substantially perpendicular to each other, in other embodiments, the longitudinal direction L, the lateral direction A, and the transverse direction T need not be perpendicular to each other. For example, in such other embodiments, one or more of the longitudinal direction L, the lateral direction A, and the transverse direction T may be inclined to one or both of the other directions L, A, T. The bone-facing surface 32 of the plate body 20 preferably has a contoured geometry 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, and 38 are configured to receive various fixation members 6 and 8 for attaching the bone plate 4 to the IM nail 2 and / or to the bone 1, as described in more detail below.

[0023] Bone plate 4 defines a longitudinal plate axis X2 extending generally along the longitudinal direction L. As shown, the longitudinal plate axis X2 does not need to be linear. Preferably, the longitudinal plate axis X2 extends along a path that follows the contour of the outer surface of bone 1, such as... Figures 1 to 2 As shown. Furthermore, when the bone plate 4 is properly attached to the nail 2, the longitudinal plate axis X2 is preferably aligned with the central nail axis X1 below, as described in more detail below. Therefore, when viewed along the transverse direction T with proper plate and nail connection, the longitudinal plate axis X2 substantially overlaps the central nail axis X1, as shown. Figure 2 As shown.

[0024] The plate body 20 includes a proximal plate portion 4a (also referred to herein as the "plate head" 4a) extending distally from a first end 22, an intermediate plate portion 4b (also referred to herein as the "plate shaft" 4b) extending distally from the plate head 4a, and a distal plate portion 4c extending distally from the plate shaft 4b to a second end 24 of the bone plate 4. The plate head 4a, plate shaft 4b, and distal plate portion 4c have corresponding geometries corresponding to associated bone anatomy structures. In an exemplary example for fixation to the distal femur, the geometry of the plate head 4a corresponds to the lateral and epicondyles of the distal femur, the geometry of the plate shaft 4b corresponds to the femoral shaft, and the geometry of the distal plate portion 4c corresponds to the subtrochanteric region, intertrochanteric region, and lateral portion of the trochanteric region of the proximal femur. In other embodiments, and depending on the plate length L2, the plate shaft 4b and distal plate portion 4c may be adapted to correspond to different anatomical regions of the bone.

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

[0026] Now for reference Figures 4 to 6 The fixation component includes a locking member 8 configured to extend through aligned locking holes 36, 16 of the bone plate 4 and the IM screw 2, respectively, forming an interconnected screw-plate configuration 102. The fixation component also includes a bone fixation member 6 configured to extend through a bone fixation hole 34 and into the lower portion of the bone without extending through the IM screw 2. It should be understood that both the locking member 8 and the bone fixation member 6 facilitate fixation to bone adjacent to the IM screw 2 and the bone plate 4. The locking member 8 and the bone fixation member 6 may include bone screws, such as a locking-head bone screw 5a having a head 50 including an externally threaded connection configured to lock with an internal locking feature of the fixation hole when the head 50 is fully seated in the hole. The locking-head bone screw 5a includes a threaded shaft 52 extending from the head 50 along the screw axis S and configured to advance through and attach to the bone. Figure 4The locking head bone screw 5a shown is a variable angle locking (VAL) bone screw, which is configured to lock in a fixed hole in a nominal orientation or "angular" orientation, in which the screw axis S is substantially collinear with the central hole axis Z (see [reference]). Figure 6 In the bone fixation member 6a and hole 34a), in this "angular" orientation, the screw axis S is oriented at an acute angle A1 (also referred to herein as the "angular angle A1") relative to the central hole axis Z (see [reference needed]). Figure 6 (The bone fixation member 6b and hole 34b are shown in the figure). However, it should be understood that one or more of the bone fixation member 6 and / or locking member 8 may be a standard locking screw 5a, which is configured to lock essentially only in the fixation hole in the nominal orientation. Alternatively, as shown, one or more of the locking member 8 and / or bone fixation member 6 may be a compression bone screw 5b, which has a head 70 with a smooth outer surface and a threaded shaft 72 extending from the head 70 along the screw axis S. Alternatively 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] Now for reference Figures 1 to 3 and Figures 5 to 6 The bone fixation hole 34 is configured to receive a bone fixation member 6, which extends from and into the lower portion of the bone laterally spaced from the IM nail 2, so as not to mechanically interfere with the IM nail 2. To avoid such mechanical interference, the bone fixation hole 34 is preferably laterally offset from the longitudinal plate axis X2, such that the bone fixation member 6 can be inserted through it along the opposite side of the IM nail 2 (see [link to relevant documentation]). Figure 1 , Figure 3 and Figure 5Therefore, the bone fixation holes are also referred to herein as “deviation holes” 34. As shown, some of the deviation holes 34 may be defined along the plate head 4a for attachment to the condylar and intercondylar regions of the distal femur. Additional deviation holes 34 may be defined along the plate axis 4b for attachment to the femoral shaft. In an additional embodiment, one or more additional deviation holes 34 may be defined within the distal plate portion 4c, such as for attachment to the femoral shaft and / or the upper portion of the proximal femur according to the plate length L2. The plate body 20 may include lateral projections or flaps 40 extending laterally from the first side 26 and the second side 28 along the plate head 4a and the plate axis 4b. The lateral flaps 40 may define portions of the deviation holes 34. In this way, the lateral flaps 40 may increase the lateral spacing of the deviation holes 34, and thus also increase the lateral spacing of the bone fixation members 6. The bone fixation hole 34 is preferably a variable angle locking (VAL) hole 34, and the bone fixation member 6 is preferably a VAL bone screw, but one or more of the bone fixation holes 34 may be a standard locking hole or a compression hole.

[0028] like Figure 2 As shown, the additional fixation holes 38 may include combination holes, such as those combining variable angle (VA) holes and locking compression plate (LCP) holes, which may be referred to as "VA LCP" combination holes 38. In this way, each additional fixation hole 38 may be selectively employed with VAL bone screws, compression bone screws, and / or locking members (such as the distal locking hole 18 for locking with IM nail 2) as needed. The additional fixation holes 38 of the plate shaft 4b are preferably aligned centrally along the longitudinal plate axis X2, but in other embodiments, one or more of the additional fixation holes 38 of the plate shaft 4b may be positioned eccentrically relative to the longitudinal plate axis X2. As shown, the distal plate portion 4c may 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 may also include additional features, such as associated portions for assisting in bone reconstruction. In the illustrated example, the distal plate portion 4c includes a pair of recesses or notches 42 extending laterally inward from a first side 26 and a second side 28 of the plate body 20. The notches 42 are configured to increase the ability of the distal plate portion 4c to be manipulated for bending and contouring to associated bone anatomy structures, such as for matching the contour of the greater trochanter in the illustrated example.

[0029] like Figures 5 to 6As shown, the proximal locking hole 36 is preferably defined in the plate head 4a and configured to receive locking members 8 (e.g., locking screws, helical blades, locking bolts, etc.) that extend through the proximal locking hole 36 of the bone plate 4 and interconnect 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 way, the locking member 8 directly interconnects the plate head 4a to the nail head 2a (and thus also interconnects the bone plate 4 to the IM nail 2). In other embodiments (see below) Figures 15 to 17 As described, one or more locking members in the locking member 8 may extend through one or more corresponding proximal locking holes 36 of the bone plate 4, and from there they may extend in a supporting manner alongside one or more corresponding portions of the nail head 2a, which may provide another direct interconnection mode between the plate head 4a and the nail head 2a.

[0030] The IM screw 2 and bone plate 4 can have various hole sizes for use with bone fixation members 6 and locking members 8 of various sizes and configurations. For example, the bone fixation member 6 can be a locking head bone screw 6 (preferably a VAL screw 6) having a spindle diameter in the range of about 2.5 mm to about 6.0 mm, and preferably in the range of about 3.0 mm to about 4.0 mm. The locking member 8 can include a VAL screw and one or more compression screws having a spindle diameter in the range of about 3.8 mm to about 8.0 mm, and preferably in the range of about 4.0 mm to about 5.5 mm. The bone fixation member 6 and the locking member 8 can have lengths in the range of about 35 mm to about 125 mm, which can be selected based on various factors, including the underside of the bone and the expected screw angularity. For example, a longer length can be selected for the bone fixation member 6 and the 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 for insertion 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 up or down based on different treatment needs.

[0031] Now for reference Figure 7The proximal locking hole 16 of the pin head 2 includes a first proximal locking hole 16a and a second proximal locking hole 16b configured to facilitate engagement 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 pin head 2a extend through the pin head 2a along respective central hole axes Z1, Z2, which are preferably parallel, but alternatively may not be parallel. The first proximal locking hole 16a and the second proximal locking hole 16b are spaced apart from each other by a pin hole spacing distance L3, as measured along the longitudinal direction L between their respective central hole axes Z1, Z2. The proximal locking hole 36 of the plate head 4a includes a first hole 36a adjacent to 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 engagement with the IM pin 2. The first hole 36a extends through the plate head 4a along the 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 arrangement axis Y2 that extends substantially along the lateral direction A. The second hole arrangement 36b also defines a central transverse axis Z4 that extends substantially along the transverse direction T through the bone plate 4 and is located at the lateral midpoint of the lateral dimension Y1. In the illustrated embodiment, the plate head reference axis X3 intersects the arrangement axis Y2 substantially at the midpoint of the arrangement axis. The first hole 36a and the second hole arrangement 36b are spaced apart from each other by a plate hole spacing distance L4 as measured longitudinally between the central hole axis Z3 of the first hole 36a and the central transverse axis Z4 of the second hole arrangement 36b. It should be understood that the plate head 4a may include one or more additional proximal locking holes 36 for alignment 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, which may be configured to receive a locking member 8 that can be inserted through the third locking hole and further through a third proximal locking hole 16c in the nail head 2a to increase the locking fixation between the plate head 4a and the nail head 2a.

[0032] The nail hole spacing L3 and the plate hole spacing L4 can range from about 15 mm to about 40 mm, and more specifically from about 20 mm to about 35 mm, and more specifically from about 25 mm to about 30 mm. In a non-limiting example embodiment, the nail hole spacing L3 and the plate hole spacing L4 are each about 27.5 mm. The nail hole spacing L3 and the plate hole spacing L4 are preferably substantially equidistant, which provides significant benefits for the interlocking fixation between the plate head 4a and the nail head 2a. For example, in the currently 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 and 16a of the plate head 4a and the nail head 2a, and the second locking member 8b can be inserted through the second locking arrangement 36b of the plate head 4a and the nail head 2a and further through the second hole 16b.

[0033] Now for reference Figures 7 to 14 The proximal locking hole 36 of the bone plate 4 is also configured to provide angular adjustability to the bone plate 4 for angular alignment with the IM nail 2. In the prior art IM nail-to-plate fixation process, as the nail length and bending angle increase, the difficulty of aligning the plate axis (specifically its distal portion) with the distal portion of the IM nail also increases. 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 and right about a pivot axis substantially along the lateral direction T to a desired angular orientation that matches the positioning of the IM nail 2, and then attach the plate head 4a to the nail head 2a with the desired orientation using the second hole arrangement 36b. In this embodiment, the bone plate 4 is capable of pivoting left and right in a guided manner along an angular angle range A2 substantially along the lateral direction A, which generally corresponds to the anterior-posterior anatomical direction. After the bone plate 4 is angularly oriented to match the position of the IM nail 2, the second hole arrangement 36b also facilitates locking the bone plate 4 to the IM nail 2 with the desired plate orientation. The adjustable angle of this type of plate is particularly advantageous because it allows a single bone plate 4 to be used with a variety of IM nails 2 of different sizes and curvature angles, which can greatly simplify the associated surgical procedures.

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

[0035] The second hole arrangement 36b extends along the lateral direction A and provides a first lateral boundary 54a and a second lateral boundary 54b that are laterally spaced apart from each other. In this embodiment, the second hole arrangement 36b is a guide slot 36b extending 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 transverse axis Z4 represents the central hole axis Z4 of the guide slot 36b. The guide slot 36b is configured to receive the shaft 72 of the second locking member 8b, which is inserted substantially laterally through the guide slot 36b and into the underlying bone. Figures 10 to 14 As shown, when the first locking member 8a extends through the first holes 36a, 16a of the plate head 4a and the nail head 2a, and the second locking member 8b extends through the guide slot 36b of the plate head 4a and the second locking hole 16b of the nail head 2a, the guide slot 36b allows the bone plate 20 to swing back and forth between a first angular position M1 and a second angular position M2 along an angular angle range A2, at which the first lateral boundary 54a and the second lateral boundary 54b are adjacent to the opposite sides of the screw shaft 72 of the second locking member 8b. Therefore, the first lateral boundary 54a and the second lateral boundary 54b can be referred to as the "swinging ends" 54a, 54b of the guide slot 36b. For illustrative purposes, Figures 10 to 11The relative positions of the plate head reference axis X3 and the anatomical reference axis X0 at the first angular position M1 and the second angular position M2 are shown. The angular angle range A2 provided by the first hole 36a and the guide slot 36b can be about 0 degrees to about 20 degrees, and more specifically about 2 degrees to about 15 degrees, and more specifically about 6 degrees to about 10 degrees. In a non-limiting example embodiment, the angular angle range is about 7 degrees to about 9 degrees. After the bone plate 4 is angularized to the desired orientation, the first locking member 8a and the second locking member 8b can be further advanced into the bone until their heads 50, 70 are fully seated in the first hole 36a and the guide slot 36b, respectively, thereby rigidly attaching the bone plate 4 to the underlying bone and the IM nail 2 in the desired orientation. Thus, the guide slot 36b is configured such that the second locking member 8b can substantially fix the bone plate 4 to the underlying bone at any selected angular angle within the angular angle range A2.

[0036] like Figures 7 to 8 As shown, the guide slot 36b can be a curved guide slot 36b extending along a curved guide path (i.e., along the curved arrangement axis Y2), which defines an arc length C1, as measured along the arrangement axis Y2 between the first swing end 54a and the second swing end 54b (see [reference]). Figure 8 The curved arrangement axis Y2 preferably has a constant radius R2, as measured from the central hole axis Z3 of the first hole 36a. The radius R2 of the arrangement axis Y2 is preferably substantially equal to the hole spacing distances L3 and L4, which facilitates accurate guiding angulation of the bone plate 4 relative to the IM nail 2. Therefore, the ratio of the radius R2 of the arrangement axis Y2 to the nail hole spacing distance L3 and the plate hole spacing distance L4 can be approximately 1:1. The arc length C1 can range from a minimum value substantially equal to the major axis diameter of the second locking member 8b to a maximum value of approximately 20.0 mm, and more specifically from approximately 5.5 mm to approximately 10.0 mm, and more specifically from approximately 6.5 mm to approximately 8.0 mm. Additionally, the guide slot 36b defines a slot width W2, as measured between the opposing slot sidewalls 56a and 56b in a direction perpendicular to the arrangement axis Y2 in a plane substantially orthogonal to the central hole axis Z4. The slot width W2 can be substantially equal to but slightly larger than the large diameter of the screw shaft 72, so that the guide slot 36b can be angled around the guide plate about the pivot axis Z3.

[0037] like Figures 8 to 9As shown, the guide slot 36b extends laterally from the upper hole periphery 58, which demarcates to the outer surface 30 of the plate body 20, through the plate head 4a, to the lower hole periphery 60, which demarcates to the bone-facing surface 32 of the plate body 20. The hole geometry of the guide slot 36b can be similar to that of a compression slot. In such embodiments, the plate body 20 defines a countersunk hole surface 62 (also referred to herein as a "countersunk hole") within the guide slot 36b, which extends laterally from the upper hole periphery 60 to a slot wall surface 64, which in turn extends laterally from the countersunk hole 62 toward the lower hole periphery 60. The guide slot 36b may also include one or more embossed or undercut surfaces 66 extending laterally from the slot wall surface 64 to the lower hole periphery 60. Preferably, the countersunk hole 62 is smooth and unthreaded, and the second locking member 8b is preferably a compression screw with a smooth head 70 that defines a head profile complementary to the countersunk hole profile. The shaft 72 of the second locking member 8b extends along the screw axis S2 and is configured to advance through the guide slot 62b, through the underlying bone, and into the second proximal hole 16b of the screw 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 distal to the IM screw 2, thereby enhancing the fixation of the interconnected screw-plate structure to the bone. Also similar to the first locking member 8a, the second locking member 8b is preferably capable of being inserted into the guide slot 36b with an angled insertion trajectory (i.e., relative to the central hole axis Z4), which facilitates extension through both the guide slot 36b and the second proximal locking hole 16b of the IM screw, even if the holes 36b, 16b are not precisely aligned.

[0038] It should be understood that although the guide slot 36b of this embodiment has a countersunk hole 62 and is configured to receive the compression screw 8b, the guide slot 36b is preferably not configured to facilitate dynamic compression (i.e., translation of the longitudinal and / or lateral plates relative to the compression screw 8b and the underlying bone). Instead, the compression screw 8b and the guide slot 36b of this embodiment are configured to facilitate plate angularity, and subsequently attach the plate 4 in a desired orientation within the angularity range A2. It should also be understood that in embodiments where the guide slot 36b includes a countersunk hole 62, the plate angularity range A2 may alternatively be defined by the contact between the end of the countersunk hole 62 and the head 70 of the second locking member 8b. It should also be understood that in other embodiments, the guide slot 36b does not need to have a countersunk hole 62 similar to that of the compression slot, but may have other slot designs.

[0039] In a non-limiting example embodiment of the pin-plate configuration 102, the plate hole spacing L4 and the arrangement 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 with a spindle diameter of approximately 3.5 mm, the first locking member 8a is a VAL bone screw with a spindle diameter of approximately 5.0 mm, the second locking member 8b is a compression screw with a spindle 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 with a spindle diameter of approximately 3.5 mm. It should be understood that various other hole and fixation member 6, 8 configurations are possible within the scope of this embodiment. It should be understood that these parameters, as well as those described elsewhere in this disclosure, can be adjusted as needed.

[0040] Now for reference Figures 15 to 17 Another embodiment of the bone fixation system 100 will now be described, wherein the bone plate 104 has a plate head 104a having 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 otherwise similar to those referenced above. Figures 1 to 14 The illustrated embodiment describes the feature in a similar manner. Therefore, for such similar feature, [the following will be discussed / details to be added]. Figures 15 to 17 The same reference numerals are used in the figures. In this embodiment, the second hole arrangement 136b includes a pair of second locking holes 36d, 36e, which are laterally spaced apart from each other along an arrangement axis Y2, as described above, which extends generally along the lateral direction A. In this additional embodiment, the first lateral boundary 54a and the second lateral boundary 54b of the second hole arrangement 136b are defined by the farthest opposing 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 corresponding second locking members 8d, 8e, which extend through the pair of second locking holes and further extend beside the opposing sides of the nail head 2a in a manner that supports or blocks the opposing sides of the nail head 2a. In this way, the second locking members 8d, 8e can be positioned to contact or be adjacent to the opposing sides of the nail head 2a (see Figure 1). Figure 17 The first locking member 8a extends from the first hole 36a of the plate head 104 and interlocks with the first proximal locking hole 16a of the nail head 2a, as described above. Thus, in this embodiment, the first locking member 8a and a 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] A pair of second locking holes 36d, 36e are preferably VAL holes, and a 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 with the arrangement axis Y2. Similar to the embodiment described above, the arrangement axis Y2 preferably extends along a curved path with a radius R2, which is substantially constant and substantially equal to the screw hole spacing distance L3. The arrangement axis Y2 can be referenced as above. Figure 7 The bone plate 104 of this embodiment is configured to allow angularity relative to the underlying bone and IM nail 2. In this embodiment, a first locking member 8a is inserted through a first hole 36a in the plate head 4a and into a first proximal locking hole 16a in the nail head 2a, but the screw head 50 is not fully positioned in the first hole 36a, similar to the manner described above. With the first locking member 8a partially inserted in this manner, optionally with the aid of fluoroscopic examination, the bone plate 104 can be pivoted as needed about the axis 50 of the first locking member 8a until the plate axis 4b is aligned with the nail main axis 2b and the distal locking portion 2c. After the bone plate 104 is angularly aligned with the IM nail 2, a pair of second locking members 8d, 8e can be inserted through a pair of second locking holes 8d, 8e at a corresponding screw angularity A1 next to the opposite side of the nail head 2a. In this way, once fully inserted, the pair of second locking members 8d, 8e can effectively prevent the IM nail 2 from swinging in the lateral direction (and therefore essentially in the front-back direction) after it has been secured.

[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 an angular angle with the screw head 2a's blocking configuration, even at various plate angular angles within the plate angular angle range A2. It should be understood that the plate angular angle range A2 of this embodiment can be substantially equal to that of the embodiment described above. In this embodiment, the second locking members 8d, 8e can each be a large-diameter VAL bone screw with a diameter of approximately 3.5 mm or approximately 5.0 mm, but the second locking members 8d, 8e can be sized according to other screw sizes described above.

[0043] It should also be understood that, in an additional embodiment, the bone fixation system 100 described above may be provided in a kit comprising multiple interchangeable IM nails 2, bone plates 4, 104 and fixation members 6, 8 of different sizes and configurations, thereby allowing surgeons to select specific combinations of IM nails 2, bone plates 4, 104 and fixation members 6, 8 to treat specific conditions.

[0044] Example methods using a bone fixation system 100 for surgical repair will now be described. While these methods involve surgical repair using a retrograde femoral IM nail 2, by way of non-limiting example, these methods can be adapted for use with an antegrade IM nail and / or other long bones (such as the tibia, fibula, humerus, radius, and ulna). Example method 200 adopts the above reference. Figures 1 to 14 The bone plate 4 is described; and example method 300 adopts the above reference. Figures 15 to 17 The bone plate 104 is described.

[0045] Now for reference Figure 18 Method 200 includes step 202, during which the surgeon selects an IM nail 2 and a bone plate 4 having appropriate sizes (e.g., nail length L1 and nail width W1, and plate length L2) and geometries suitable for femoral repair. The surgeon may determine the appropriate nail length L1 and width W1 using techniques known in the art, such as by observing radiopaque scales (e.g., length scales and diameter scales) placed adjacent to the femur 1 under fluoroscopic examination.

[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 at the top of the intercondylar fossa). Prior to step 204, the surgeon may perform various preparatory steps, such as locating the entry point, inserting a guiding member, such as a guidewire (e.g., a Kirschner wire), into the medullary canal through the entry point, opening the medullary canal by advancing a canal opening device (e.g., a drill and / or awl) along the guidewire, optionally dilating or “reaming” the medullary canal to prepare 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 guiding member or optional reamer. If necessary, the surgeon may use an impact hammer for the insertion instrument to insert the IM nail 2 into the final desired longitudinal position within the medullary canal. During the insertion procedure, the surgeon may use fluoroscopic examination to monitor the position of the IM nail 2 to ensure proper alignment and longitudinal positioning.

[0047] Once the surgeon has determined the desired longitudinal position of the IM nail 2 within the medullary canal, the surgeon can begin step 206, which includes initial locking, i.e., partially locking the plate head 4a to the nail head 2a at the distal femur. In step 206, the surgeon places and secures the bone plate 4 adjacent to the femur, aligning the first hole 36a of the plate head 4a substantially with the first proximal locking hole 16a of the nail head 2a. This step can be performed with the aid of aiming tools, such as a fluoroscopic examination and / or guide member capable of attaching to an insertion instrument. 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 a 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 the first locking member 8a is fully positioned 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 a pivot axis (which is the central hole axis Z3 of the first hole 36a, through which the axis 52 of the partially inserted first locking member 8a extends) until the bone plate 4 is at the desired angular angle relative to the underlying bone and / or the underlying IM nail. For example, the desired angular angle could be such that the offset hole 34 is laterally spaced from the IM nail 2 when the plate axis 4b and / or the distal plate portion 4c are aligned with the distal locking portion 2c of the IM nail 2. During step 208, the surgeon can confirm that when the bone plate 4 is at the desired angular angle, the second hole arrangement 36b (which in this example is the guide slot 36b) is substantially aligned with the second proximal locking hole 16b of the nail head 2a. Similar to step 206, step 208 can also be performed by the surgeon with the aid of an aiming tool.

[0049] At step 210, with the bone plate 4 at a desired angular angle relative to the underlying anatomical structure, the surgeon may temporarily attach the plate shaft 4b to the underlying bone at the desired angular angle. This may include attaching at least one bone fixation member 6 through at least one corresponding offset hole 34 in the plate shaft 4b and attaching it to the underlying bone adjacent to the IM nail 2.

[0050] At step 212, with the bone plate 4 at the desired angular angle and the second hole arrangement 36b substantially aligned with the second proximal locking hole 16b of the screw 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 screw 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 countersunk hole 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 bone 1, which reduces soft tissue irritation at the plate-bone junction.

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

[0052] At step 214, the surgeon further advances the first locking member 8a until its head 50 is fully positioned 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 locking member 8a and the second locking member 8b interconnecting the plate head 4a with the nail head 2a, the surgeon can perform step 216, which includes distal locking. Distal locking may include inserting one or more distal locking members 8 through one or more pairs of aligned holes 38, 18 in the axial portions 4b, 2b and / or distal portions 4c, 2c of the plate 4 and IM nail 2. Alternatively, distal locking step 216 may include attaching a pair of bone fixation members 6 through corresponding pairs of offset holes 34 in the plate axial portion 4b and into the underlying bone adjacent to the IM nail 2, thereby preventing lateral movement of the associated portion of the IM nail 2.

[0054] At step 218, the surgeon may perform supplementary locking, which may include supplementary 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 a third hole 36c in the plate head 4a and a third proximal locking hole 16c in the nail head 2a. Alternatively, step 216 may include distally locking the plate shaft 4b and / or the distal plate portion 4c to the distal locking portion 2c of the IM nail 2.

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

[0056] Now for reference Figure 19 Now we will describe the use of Figures 15 to 17 Method 300 of the bone fixation system 100 shown. For the sake of brevity, the following description of method 300 will focus on steps that differ from those of method 200. Method 300 includes steps 202, 204, and 206 as described above.

[0057] At step 308, after the first locking member 8a has been 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 aligns the second hole arrangement 136b (which in this example is a pair of second locking holes 8d, 8e) substantially with the second proximal locking hole 16b of the nail head 2a. Aligning the second hole arrangement 136b substantially with the second proximal locking hole 16b may include aligning the arrangement axis Y2 between the first lateral boundary 54a and the second lateral boundary 54b substantially with the second proximal locking hole 16b. Similar to step 206, the surgeon may also perform step 308 with the aid of an aiming tool.

[0058] At 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 axis 52 of the partially inserted first locking member 8a extends) until the plate axis 4b and / or the distal plate portion 4c are 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. Distal locking may involve inserting one or more pairs of aligned holes 38, 18 through the axial portions 4b, 2b and / or distal portions 4c, 2c of the plate 4 and the IM nail 2. Alternatively, distal locking step 312 may involve attaching a pair of bone fixation members 6 through corresponding pairs of offset holes 34 in the plate axial portion 4b and into the underlying bone adjacent to the IM nail 2, thereby preventing lateral movement of the associated portion of the IM nail 2.

[0060] Following step 310, the surgeon performs step 314, which involves locking the second hole arrangement 136b into the screw head 2a. In step 314, the surgeon inserts a pair of second locking members 8d, 8e through a pair of second locking holes 36d, 36e, respectively, into the underlying bone at a corresponding screw angular angle A1, such that the corresponding screw axis 50 is positioned next to the opposite side of the screw head 2a adjacent to the second proximal locking hole 16b. In this way, once fully positioned in the second locking holes 36d, 36e, the pair of second locking members 8d, 8e effectively prevents the screw head 2a from swinging laterally (and therefore substantially anteroposteriorly) after fixation. In this example, each of the pair of second locking members 8d, 8e is a VAL bone screw.

[0061] At step 315, the surgeon further advances the first locking member 8a until its head 50 is fully positioned in the first hole 36a of the plate head 4a. In this example, step 316 includes 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 as described above.

[0063] It should also be understood that the foregoing method is provided as an example, and the shell doctor may choose to adjust the order of the steps, omit one or more steps, and / or perform one or more additional steps as needed.

[0064] It should also be understood that the bone plates 4, 104 described above can be used to treat bone without the use of accompanying IM nails. In such embodiments, the second hole arrangements 36b, 136b can be used to facilitate plate angular angle A2 (pivoting about the first locking member 8a, which is partially inserted through the first hole 36a and into the underlying bone) to properly align the plate with the underlying bone in a manner similar to that described above. In another embodiment, the bone plates 4, 104 described above can be used together with other types of implants (such as a second bone plate on the opposite side of the bone) to facilitate the angular angle A2 of the bone plates 4, 104 about the first locking member 8a, which is partially inserted through the first hole 36a and into the hole or other structure of the second bone plate.

[0065] Although this disclosure has been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of this disclosure is not intended to be limited to the specific embodiments described herein. Specifically, one or more features from the foregoing embodiments may be used in other embodiments herein. Those skilled in the art will readily appreciate that existing or future processes, machines, manufactures, material compositions, apparatuses, methods, or steps may be developed based on this disclosure to perform substantially the same function or achieve substantially the same results as the corresponding embodiments described herein.

Claims

1. A bone fixation system, comprising: An intramedullary nail having a nail body extending in a longitudinal direction, the nail body having a nail head and a distal locking portion spaced apart 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 deviating from the longitudinal direction. A bone plate having a plate body extending along a longitudinal plate axis and having a first side and a second side opposite to each other in a lateral direction perpendicular to the longitudinal plate axis, the plate body having an outer surface opposite to each other and a bone-facing surface, wherein the plate body is alignable with the nail body such that (1) the longitudinal plate axis is oriented substantially along the longitudinal direction, (2) the outer surface and the bone-facing surface are spaced apart from each other in the transverse direction, and (3) the lateral direction deviates from the longitudinal direction and the transverse direction; 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 for interconnecting 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 about the central hole axis of the first plate hole along an angular range as the first locking member extends through the first plate hole and further into the nail hole. This angular range is configured to align the distal portions of the plate body and the nail body along the lateral direction, and is defined between the 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 angular angle within the range of the angular angle.

2. The bone fixation system according to claim 1, wherein, The angular range is from approximately 2 degrees to approximately 15 degrees.

3. The bone fixation system according to claim 1, wherein, The second hole arrangement of the plate body includes a single curved guide slot extending along a curved slot axis between the laterally opposite ends, the curved slot axis having at least a directional component along the lateral direction, the at least one second locking member being 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. The bone fixation system according to claim 3, wherein, The distance between the axis of the center hole of the first plate hole and the axis of the curved slot is substantially equal to the distance between the axis of the center hole of the nail hole and the axis of the center hole of the second nail hole.

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

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

7. The bone fixation system according to claim 3, wherein, The curved guide slot defines a slot width measured along a direction perpendicular to the axis of the curved slot, and the slot width is slightly larger than the large diameter of the axis of the bone screw.

8. The bone fixation system according to claim 3, wherein, The curved guide slot extends from the periphery of the upper hole at the junction with the outer surface of the plate body through the plate body to the periphery of the lower hole at the junction with the bone-facing surface of the plate body, and the curved guide slot includes a countersunk hole extending from the periphery of the upper hole toward the periphery of the lower hole.

9. The bone fixation system according to claim 1, wherein, The second hole arrangement of the plate body includes a pair of second holes laterally spaced apart from each other along an arrangement axis, the arrangement axis intersecting the central axis of the pair of second holes, and the arrangement axis extending across the longitudinal plate axis.

10. The bone fixation system according to claim 7, wherein, The pair of second holes are variable angle locking (VAL) holes, and the at least one second locking member includes a pair of variable angle locking (VAL) screws configured to be variable angle locked with the pair of second holes.

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

12. A bone plate, comprising: The plate body has a first end and a second end opposite to each other along a longitudinal direction, the plate body defining a longitudinal axis extending between the first end and the second end along the longitudinal direction, the plate body has a first side and a second side opposite to each other along a lateral direction deviating from the longitudinal direction, and the plate body has a bone-facing surface and an outer surface opposite to each other along a transverse direction deviating from both the longitudinal and lateral 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 being distally spaced from the first hole along the longitudinal direction. The first hole is configured to receive a first fixation member for attachment to underlying bone, and the second hole arrangement is configured to receive at least one second fixation member for attachment to underlying bone. The plate body is configured to pivot along an angular range about the first fixing member extending through the first hole and into the underlying bone, and The second hole extends laterally across the longitudinal axis, defines the angular angle range, and is configured such that the at least one second fixation member is configured to substantially fix the bone plate to the underlying bone at any selected angular angle within the angular angle range.

13. The bone fixation system according to claim 1, wherein, The angular range is approximately 10 degrees to approximately 20 degrees.

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

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

16. The bone fixation system according to claim 1, wherein, The second hole arrangement includes a pair of second holes that are laterally spaced apart from each other along an arrangement axis intersecting the central axis of the pair of second holes, wherein the arrangement axis extends across the longitudinal axis, and the pair of second holes are variable angle locking (VAL) holes configured to receive variable angle locking (VAL) screws.

17. A method for treating bone, comprising: The intramedullary nail is inserted into the medullary canal of the bone; A bone plate is placed next to the bone, the bone plate having a proximal end and a distal end opposite each other along the longitudinal direction; The first locking member is inserted through a first plate hole defined in the bone plate, into the underlying bone, and at least into a nail hole defined in the intramedullary nail, the first plate hole being defined in the proximal portion of the bone plate; Pivot the bone plate around the first locking member until a portion of the bone plate located distal to the proximal portion is aligned with the distal portion of the intramedullary nail; At least one fixation member is inserted through at least one fixation hole defined in the portion of the bone plate located distal to the proximal portion and into the underlying bone; At least one second locking member is inserted through at least one second plate hole defined in the bone plate and into the bone below adjacent to the intramedullary nail. The at least one second locking member is advanced through the at least one second plate hole such that the head of the at least one second locking member is fully positioned in the at least one second locking hole, wherein the at least one second plate hole is spaced distally from the first plate hole along the longitudinal direction. as well as Following the pivoting and alignment steps, the first locking member is further advanced until the head of the first locking member is fully positioned in the first plate hole.

18. The method of claim 17, wherein: 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 the 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 and into the underlying bone, and at least into a second screw hole spaced distally from the screw hole. The pivoting step causes the longitudinally opposite side of the curved guide slot to slide alongside the longitudinally opposite side of the axis of the bone screw, wherein the curved guide slot defines a range of pivoting angles defined by the laterally opposite ends of the curved guide slot adjacent to the laterally opposite side of the axis of the bone screw.

19. The method according to claim 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 causes the smooth, unthreaded outer surface of the screw head to abut against the countersunk hole and press the bone plate toward the underlying bone.

20. The method of claim 17, wherein: The at least one second plate hole is a pair of second variable angle locking (VAL) holes spaced apart from each other along an arrangement axis having at least a directional component along a lateral 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. The step of inserting the at least one second locking member includes inserting the pair of second VAL bone screws through the pair of second VAL holes at a position of the intramedullary nail spaced distally from the nail hole and inserting them into the underlying bone on the opposite lateral side of the intramedullary nail.

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