Adjustable joint optimization

Abstract

A method for manufacturing a device for bone fixation includes the steps of mating a first plate with a second plate, the first plate including screw slots and the second plate including through-holes corresponding to the screw slots; and installing a screw body into the screw slots and the through-hole. The screw body includes a screw portion and an insert portion. The screw body is installed into the screw slot using the insert portion of the screw body. The method further includes removing the insert portion of the screw body. The screw portion remains in the screw slot and the through-hole after the insert portion is removed.

Description

[Technical Field]

[0001] Priority claim This application claims priority to U.S. Provisional Patent Application No. 63 / 440,605, filed January 23, 2023, the entire contents of which are incorporated herein by reference and relied upon. [Background technology]

[0002] The human skeleton is made up of 206 individual bones that perform a variety of important functions, including support, movement, protection, mineral storage, and blood cell formation. These bones can be grouped into two categories: the axial skeleton and the appendicular skeleton. The axial skeleton is made up of 80 bones that make up the body's center of gravity, and the appendicular skeleton is made up of 126 bones that make up the body's appendages. The axial skeleton includes, among other things, the skull, vertebral column, ribs, and sternum, while the appendicular skeleton includes, among other things, the long bones of the upper and lower limbs, as well as the clavicle and other bones that attach these long bones to the axial skeleton.

[0003] To ensure the skeleton retains its ability to perform its vital functions and to reduce pain and disfigurement, fractured bones should be repaired promptly and properly. Typically, fractured bones are treated using fixation devices, which reinforce the bone and keep the bone fragments aligned during healing. Fixation devices can take a variety of forms, including casts for external fixation and bone plates for internal fixation, among others. A bone plate is an implantable device that can be placed over the bone, with the plate spanning the fracture. To use a bone plate to repair a fractured bone, a surgeon (1) selects an appropriate plate, (2) reduces (sets) the fracture, and (3) attaches the plate to both sides of the fracture using appropriate fasteners (e.g., bone screws) so that the bone pieces are fixed relative to one another.

[0004] Bone plates are often integrally formed as one piece and then bent intraoperatively by a surgeon to custom fit the bone plate to the subject's bone. However, bending a unitary bone plate has various disadvantages. For example, bending can be time consuming, can weaken the bone plate, can be difficult to control for small changes to the plate shape, and / or can be particularly difficult for in-plane deformation of the bone plate, where plates are generally most resistant to deformation. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Serial No. 17 / 464,108 [Patent Document 2] U.S. Patent Application Serial No. 16 / 140,362 [Patent Document 3] U.S. Patent Application Serial No. 14 / 746,722 [Patent Document 4] U.S. Patent Application Serial No. 14 / 792,522 [Patent Document 5] U.S. Patent Application Serial No. 15 / 216,646 [Patent Document 6] U.S. Patent No. 10,080,596 [Patent Document 7] U.S. Patent Application Serial No. 15 / 990,633 [Patent Document 8] U.S. Patent Application No. 16 / 001,867 [Patent Document 9] U.S. Provisional Patent Application No. 62 / 016,883 [Patent Document 10] U.S. Provisional Patent Application No. 62 / 020,691 [Patent Document 11] U.S. Provisional Patent Application No. 62 / 110,220 [Patent Document 12] U.S. Patent Application Serial No. 14 / 565,105 [Patent Document 13] U.S. Patent No. 9,463,055 [Patent Document 14] U.S. Patent Application Serial No. 14 / 565,116 [Patent Document 15] U.S. Patent No. 9,433,448 [Patent Document 16] U.S. Patent Application Serial No. 14 / 566,350 [Patent Document 17] U.S. Patent No. 9,433,451 [Patent Document 18] U.S. Patent Application Serial No. 14 / 706,922 [Patent Document 19] U.S. Patent No. 9,526,542 [Patent Document 20] U.S. Provisional Patent Application No. 61 / 913,593 [Patent Document 21] U.S. Provisional Patent Application No. 61 / 913,611 [Patent Document 22] U.S. Provisional Patent Application No. 61 / 914,180 [Patent Document 23] U.S. Provisional Patent Application No. 61 / 989,662 Summary of the Invention [Means for solving the problem]

[0006] The present disclosure provides new and innovative systems, devices, and methods for bone fixation. In some examples, an apparatus for bone fixation can include a first plate including a screw slot and a second plate connected to the first plate at an overlap region by a hinge joint, the hinge joint configured to allow rotation of the first and second plates relative to each other about a pivot axis. The second plate can include a through-hole portion corresponding to the screw slot. The screw slot and the through-hole portion can be disposed in the overlap region. The apparatus can further include a screw disposed in the screw slot and the through-hole portion. The screw can include a threaded portion. The first plate, the second plate, and the screw can define a range of rotation for the first and second plates about the pivot axis.

[0007] In some examples, a method of manufacturing a device for bone fixation according to the present disclosure is provided. The method can include the steps of mating a first plate with a second plate, where the first plate can include screw slots and the second plate can include through-holes corresponding to the screw slots; and installing a screw body into the screw slots and through-holes. The screw body can include a screw portion and an insert portion. The screw body can be installed into the screw slots using the insert portion of the screw body. The method can further include removing the insert portion of the screw body. The screw portion can remain in the screw slots and through-holes after the insert portion is removed.

[0008] In some examples, another method of manufacturing a bone fixation device is provided. The method can include mating a first plate with a second plate, where the first plate can include screw slots and the second plate can include through-holes corresponding to the screw slots; installing screws into the screw slots and through-holes; and striking the screws. The striking the screws can cause at least partial deformation of at least one of the screws and a portion of the first plate or the second plate connected to the screws, thereby preventing the screws from backing out of the screw slots and through-holes.

[0009] Additional features and advantages of the disclosed systems, devices, and methods are described in, or will be apparent from, the following detailed description and figures. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic diagram of an exemplary bone plate having a movable joint connecting a pair of plate members and attached to a fractured bone, illustrating the movement of the exemplary plate members permitted by the joint of the present disclosure. [Figure 2] FIG. 1 is a plan view of an exemplary bone plate for fixation of a clavicle, according to an embodiment of the present disclosure, the bone plate having a pair of rotatable joints spaced apart from each other along the bone plate, each joint being a hinge joint movable about an axis of rotation disposed transversely to a plane defined by the bone plate, allowing adjustment of the longitudinal shape of the bone plate. [Figure 3] FIG. 3 is a side view of the bone plate of FIG. 2. [Figure 4] 4 is a partial bottom view of an end portion of the bone plate of FIG. 2 taken generally along line 4-4 of FIG. 3. [Figure 5]3 is an exploded view of the bone plate of FIG. 2 showing the three segments (plate members) of the bone plate attached to each other by hinge joints. [Figure 6] 6A-6C are schematic cross-sectional views of the bone plate of FIG. 2 taken generally along line 6-6 of FIG. 2 through one of the hinge joints of the bone plate before (Panel A) and after (Panel B) the axial rod of the joint is deformed to capture another plate member of the bone plate on the axial rod, according to an embodiment of the present disclosure. [Figure 7] FIG. 1 is a partial plan view of an exemplary bone plate having a hinge joint that is lockable by a locking member positioned at a location spaced from the pivot axis of the hinge joint, according to aspects of the present disclosure. [Figure 8] 8 is a longitudinal cross-sectional view of the bone plate of FIG. 7 taken generally along line 8-8 of FIG. 7 through the hinge joint and locking member. [Figure 9] 9 is a longitudinal cross-sectional view taken similar to FIG. 8, with the hinge joint locked by a different locking member. [Figure 10] FIG. 1 is a partial plan view of an exemplary bone plate having a hinge joint locked by a connector, the plate members of which are fitted together via a pair of arc-shaped complementary mating regions that bracket around the pivot axis of the hinge joint. [Figure 11] 11 is a longitudinal cross-sectional view of the bone plate of FIG. 10 taken generally along line 11-11 of FIG. 10. [Figure 12] FIG. 10 is a partial bottom view of a bone plate having a hinge joint with a range of pivotal motion determined by a pin received in a slot that prevents rotational disassembly of mated plate members of the hinge joint, such that the plate members are permanently connected to one another, according to an example of the present disclosure. [Figure 13]13 is a partial cross-sectional view of the bone plate of FIG. 12 taken generally along line 13-13 of FIG. 12 through the joint after installation of connectors into a pair of aligned apertures defined by the plate members according to an example of the present disclosure. [Figure 14] 1 is a schematic diagram of an exemplary device for fixing bones, according to one example of the present disclosure. [Figure 15] FIG. 15 is a cross-sectional view of the device of FIG. 14. [Figure 16A] 1 is a schematic diagram of an exemplary screw for a device for fixating bone, according to one example of the present disclosure; [Figure 16B] 1 is a schematic diagram of an exemplary screw body for a device for bone fixation, according to one example of the present disclosure; FIG. [Figure 16C] 1 is a schematic diagram of an exemplary screw body for a device for bone fixation, according to one example of the present disclosure; FIG. [Figure 17] FIG. 15 is a cross-sectional view of the device of FIG. 14 with a screw body installed therein. [Figure 18] 1 is an exploded view of an exemplary device for fixing bone, according to one example of the present disclosure. [Figure 19] FIG. 19 is a cross-sectional view of the device of FIG. 18. [Figure 20] 1 is a graph showing the average measured resistance / friction between plates connected together using screws made from a plastic material (e.g., PEEK) versus the number of autoclave cycles. [Figure 21] 1 is a schematic diagram of an exemplary screw for a device for fixating bone, according to one example of the present disclosure; [Figure 22A] FIG. 1 illustrates an exemplary automated compression tool according to an example of the present disclosure. [Figure 22B] FIG. 1 illustrates an exemplary automated compression tool according to an example of the present disclosure. [Figure 23A] 22C is a perspective close-up view of the punching rod of the automatic compression tool of FIG. 22B. FIG. [Figure 23B] FIG. 22C is an enlarged front view of the punching rod of the automated compression tool of FIG. 22B. [Figure 24] 1 is a schematic diagram of an exemplary device for fixating bone with a screw installed therein and a punching rod in contact with the screw. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present disclosure provides systems, devices, and methods for bone fixation. FIG. 1 shows a schematic diagram of an exemplary bone plate 80 having a movable joint 82 (also referred to as a movable connection) connecting a pair of plate members 84, 86. Each plate member can be attached (e.g., separately) to a bone 88 using one or more fasteners 90 (e.g., bone screws, pins, wires, rivets, etc.). Each fastener can be received into a through-hole (interchangeably referred to as an opening) defined by the plate member and extend into the bone. (The plate members can be interchangeably referred to as plates, plate pieces, or attachment members.) The bone 88 can have at least one discontinuity (e.g., a fracture 93 or a cut) spanned by the bone plate. The joint 82 can overlap the discontinuity, as shown here, or can be offset along the bone from the discontinuity. The bone plate 80 can be interchangeably referred to as a fixation device or a bone plate assembly.

[0012] Exemplary relative movement of plate members 84, 86 may be permitted by movable joint 82 and is shown in phantom and identified by motion arrows 94, 96. The plate members may be movable relative to one another in at least one plane and / or about at least one axis of rotation (indicated by rotation arrow 94), changing the angular orientation of the plate members relative to one another. The rotation may be in-plane or out-of-plane relative to the plane defined by the bone plate, and may be about the longitudinal axis of the bone plate and / or plate members or about another axis. The plate members may also or alternatively be adjustable relative to one another along at least one displacement axis (indicated by displacement arrow 96). The displacement axis may or may not be linear and provides a net translational displacement with or without rotation of the plate members relative to one another.

[0013] "In-plane" rotation or movement of the plate members relative to one another can occur in a plane that is at least generally parallel to a plane defined by one or more of the plate members. In-plane movement can be, for example, within about 20 degrees, 10 degrees, 5 degrees, 2 degrees, or 1 degree of perfectly parallel to a plane defined by one or more of the plate members. Single-axis joints (e.g., hinge joints) and multi-axis joints can allow in-plane rotation.

[0014] Each axis of rotation (and / or plane within which the rotation occurs) can have any suitable location and orientation relative to the bone plate. The axis of rotation can be fixed or variable relative to one or both plate members. If variable, the location of the axis of rotation can change before or during rotation of the plate members to change their angular orientation. The axis of rotation may or may not pass through the bone plate 80 and / or joint 82. Whether or not the axis of rotation passes through the bone plate or joint, the axis of rotation can have any suitable relationship to the plane (e.g., length-width plane) and / or longitudinal axis defined by the bone plate and / or at least one plate member. The axis of rotation can be transverse (e.g., substantially or at least generally perpendicular) to the plane or longitudinal axis, or substantially or at least generally parallel to it. For example, the axis of rotation can be within about 20 degrees, 10 degrees, 5 degrees, 2 degrees, or 1 degree of being perfectly parallel or perfectly perpendicular.

[0015] Each translational displacement axis can have any suitable orientation relative to the bone plate. The displacement axis can be at least generally or substantially parallel, transverse (e.g., perpendicular), or oblique to the plane and / or longitudinal axis defined by the bone plate and / or at least one plate member. Thus, a net movement of the plate members relative to one another parallel to the displacement axis can change the longitudinal and / or transverse offset of the plate members relative to one another. When the displacement axis is oblique to each of the characteristic orthogonal axes defined by the bone plate or its plate members, both offsets can be changed simultaneously. In any case, the transverse offset can be adjustable in a plane at least generally parallel or substantially parallel to the plane defined by the bone plate and / or at least generally perpendicular or substantially perpendicular to the plane defined by the bone plate.

[0016] A bone plate can have any suitable number of plate members and any suitable number and location of movable joints connecting the plate members to one another (e.g., connecting the plate members end-to-end). For example, a bone plate can have two, three, four, or more plate members and / or one, two, three, or more movable joints. In some examples, a bone plate can have N plate members and N-1 movable joints. When a bone plate has two or more movable joints, the joints can have any suitable location relative to one another, such as, for example, spaced apart from one another along the longitudinal axis of the bone plate, or spaced apart diagonally or perpendicularly to the longitudinal axis. Each movable joint can be located at any suitable location relative to a pair of plate members connected to one another by the joint. The joints can be located near each end of the plate members or can be substantially spaced apart from opposite ends of at least one of the plate members.

[0017] The plate members may or may not be permanently connected to each other at the movable joint. The permanent connection between the plate members can be created during the manufacture of the bone plate so that the plate members always remain connected to each other during normal handling and installation. Plate members that are permanently connected to each other are designed to never be accidentally disassembled by the user. The plate members cannot be completely separated from each other without damaging the bone plate (e.g., by cutting, breaking, plastically deforming, or melting areas of the bone plate) or without using one or more tools unrelated to the installation or adjustment of the bone plate. Bone plates with plate members permanently connected to each other at a hinge joint provide the benefits of hinged bone plates without the risk of dropping or losing pieces of the hinge joint (e.g., connectors) during surgery.

[0018] Each plate member can have any suitable structure. The plate members can be elongated or non-elongated. The plate members can have an outer surface (interchangeably referred to as an outer side or a top side) opposite an inner surface (interchangeably referred to as an inner side or a bottom side). The plate members can collectively form the outer surface (interchangeably referred to as an upper surface) and the inner surface (interchangeably referred to as a bottom surface) of the bone plate. The inner and outer surfaces of the bone plate (and each plate member) face toward and away from the bone, respectively, when the bone plate is attached to the bone. The inner surface can be configured to contact the bone.

[0019] Each plate member can be one piece and have no parts that move relative to each other without deformation of the plate member. A one-piece plate member can be integrally formed such that the entire plate member is continuous (monolithic). The plate members have a length, width, and thickness, and the thickness is less than the length and width (e.g., less than 50%, 20%, or 10% of the length and / or width). The length is typically greater than the width, but in some instances the length and width may be equal.

[0020] Each plate member may define at least one opening 92 having any suitable structure and location. Each opening 92 may be a through-hole (interchangeably referred to as an aperture) extending through the plate member from its outer surface to its inner surface. The through-hole may have a closed perimeter (completely bounded circumferentially) or an open perimeter. The through-hole or other opening may define an axis that is substantially perpendicular or oblique to the plane of the plate member. Each through-hole or other opening may or may not be elongated within the plane of the plate member. Thus, the through-hole may or may not be circular. The through-hole or other opening may or may not have an attachment structure formed by its wall, which allows a fastener (e.g., an externally threaded fastener) to be attached to the plate member at the through-hole. The attachment structure may be, for example, an internal thread or at least one linear lip.

[0021] The plate member can have any suitable number of openings 92. If the plate member has more than one opening, the openings can be dispersed from one another along and / or across the bone plate.

[0022] Each movable joint 82 may have any suitable structure. The joint may be formed in the region of overlap of a pair of plate members, where the plate members overlap and the joint surfaces of the plate members face each other and contact each other. The joint surfaces may be at least generally complementary to each other, with one joint surface being concave and the other being convex. In some examples, one or both joint surfaces may include surface features that improve the stability of the locked joint by resisting sliding of the joint surfaces relative to each other. The surface features may include one or more protrusions and / or one or more voids, each of which may or may not be deformable. In some examples, the surface features may include a uniform array of protrusions and / or recesses, such as a set of teeth defined by one or both joint surfaces. In some examples, the surface features of one joint surface may be complementary to one or more of the surface features of the other joint surface, allowing the joint surfaces to interdigitate and resist sliding.

[0023] In some examples, the joint surfaces can be mated in multiple distinct registers offset from one another by the spacing of a surface feature of at least one of the joint surfaces. For example, one of the joint surfaces can define multiple teeth, and the other joint surface can form at least one tooth. The teeth of one joint surface can be mated with at least one tooth of the other joint surface in multiple distinct and distinct registers. Each of the teeth can be symmetrical or asymmetrical in cross section. If symmetrical, the teeth can allow movement of the joint surfaces relative to one another in both opposing rotational or translational displacement directions of the joint. If asymmetrical, the teeth of the joint surfaces can collectively form a ratchet that selectively allows movement of the joint surfaces in only one of the two opposing rotational or translational displacement directions of the joint. In some examples, the joint surfaces can define surface features that are not complementary to one another, and the surface features can deform, among other things, when the joint is compressed.

[0024] One of the joint surfaces of the joint can be at least partially formed by a one-piece body portion of one of the plate members. The body portion can also define one or more through holes for receiving fasteners. In some examples, the joint surface can be formed by a body portion of one of the plate members and at least one deformable element 98 (also called an anti-slip element) associated with the body portion. The deformable element can be softer than the body portions of both plate members and can be selectively deformed by contact with the other joint surface. For example, the deformable element can be formed from a polymer and the respective body portions can be formed from a metal, or the deformable element can be formed from a softer metal and the respective body portions can be formed from a harder metal, among others. In either case, the deformable element can deform when the joint is compressed and resist slippage of the plate members relative to each other.

[0025] Surface features of at least one of the joint surfaces can facilitate deformation of the deformable element. For example, one or more of the surface features (e.g., one or more ridges) can form or deepen one or more depressions in the deformable element when the joint is compressed. The deformable element can be at least partially disposed in a recess formed in one of the joint surfaces and can protrude from the recess toward the other joint surface for contact therewith. The deformable element can be an insert formed separately and then attached to one of the plate member body portions, or the deformable element can be formed in contact with one of the body portions, such as by overmolding or otherwise applying a material to the body portion to create the deformable element. The deformable element can alternatively be considered distinct from the plate members. Thus, the deformable element can be rigidly attached to one of the plate members of the joint and movable relative to the other plate member of the joint.

[0026] Bone plate 80 can include individual connectors 100 that connect the plate members to one another at the joint. The connectors can be described as locking members (which can, in some examples, be described as fasteners and / or locking screws) that control whether joint 82 is in a movable or fixed (locked) configuration. The terms "movable" and "fixed" can be relative terms.

[0027] A fixed configuration may require substantially more force (e.g., at least about 5 times, 10 times, 25 times, 50 times, or 100 times more force, among others) to create movement of the plate members relative to one another. In the fixed configuration, the bone plate can be rigid at the joint, with the plate members rigidly connected to one another, allowing the bone plate to function like a conventional (non-jointed) bone plate.

[0028] The connector can extend from one plate member to another through the joint surfaces of the plate members. For example, the connector can define a pivot axis of the joint (i.e., can be coaxial with the pivot axis) or can be offset from the pivot axis. Each plate member can define an aperture for receiving a portion of the connector.

[0029] In some examples, the connector can have external threads for attaching the connector to one of the plate members at its aperture. The connector can be rotatable to adjust the compression of the plate members at the joint, thereby determining whether the joint is fixed or mobile. In some applications, the joint may not be lockable, for example, if the deformation forces act in a different plane than the adjustability (e.g., as with clavicle fixation). Movement in a locked joint can be limited by any suitable mechanism, including any combination of friction, an obstruction, or interfitment.

[0030] 2-6 illustrate an exemplary bone plate 120 having a pair of hinge joints 122a, 122b disposed along the longitudinal axis of the bone plate and permanently connecting plate members 124, 126, and 128 to one another. (Plate member 126 is a central plate member, and plate members 124 and 128 are end plate members.) Each hinge joint is capable of resisting out-of-plane bending and torsional forces while allowing movement about a single pivot axis (shown at 130 in FIG. 2 ) disposed transversely (e.g., perpendicularly) to the plane defined by at least one plate member of the bone plate and / or hinge joint. This pivotal movement allows adjustment of the longitudinal shape of the bone plate through in-plane movement of the plate members, enabling a surgeon to customize the bone plate to the longitudinal shape of a subject's bone. In some examples, bone plate 120 may have only two plate members connected by a single hinge joint (or four or more plate members connected by three or more joints). Bone plate 120 may be used to fixate a clavicle or any other suitable bone (e.g., femur, tibia, fibula, radius, ulna, humerus, or rib, etc.).

[0031] The bone plate 120 can be marked with one or more surface markings 132 to define a longitudinal region of the bone plate (the “fracture zone”) (see FIGS. 2 and 3 ) that is to overlie the fractured or cut portion of the bone to be fixed. The surface markings can be formed by etching, machining, molding, coating, electrolyzing, etc., the bone plate in the area to be marked, making the area or its boundaries visually distinguishable. In some examples, the marked area can have a different color than the rest of the bone plate. In either case, the central plate member 126 can be positioned on the bone to longitudinally span the fractured or cut portion of the bone. However, in some examples, the bone plate 120 can be positioned on the fractured bone with the bone fracture overlapping one of the end plate members 124 or 128, the hinge joints 122 a or 122 b, and / or an area of ​​the central plate member 126 outside the marked area of ​​the bone plate.

[0032] In the depicted embodiment, each hinge joint lacks the ability to be adjustably compressed along a pivot axis to change the hinge joint between a movable and a fixed configuration. Instead, rotational movement at each joint can be limited by securing the bone plate to an intact (contiguous) portion of the bone with a pair of fasteners installed into the intact portion on either side of each hinge joint, with the intact portion extending from one fastener to the other fastener of the pair. In some examples, the hinge joint can be positioned between a pair of through-holes 134a, 134b having fastener attachment structures (e.g., internal threads, etc.) for the fasteners, rigidly attaching each fastener to the bone plate. In any case, the bone plate 120 can allow at least two or three fasteners to be installed into the intact bone on each side of the fracture zone.

[0033] The hinge joint can be formed as a movable half-lap joint (see FIGS. 3-6). The central plate member 126 can form a tab 136 of reduced thickness at each of its ends. Axial rods 138 (interchangeably referred to as protrusions or posts) can project orthogonally from the tabs. Each end plate member 124, 128 can define an undercut region 140 at one of its ends. The end plate member can define an aperture 142 sized to receive the axial rod (e.g., sized slightly larger in diameter than the axial rod), while the undercut region 140 can be sized to receive the tab 136 without increasing the thickness of the bone plate. The end of the axial rod 138 can be deformed (e.g., swaged) to form a retainer or head 144 that captures one of the end plate members on the axial rod (see panels A and B of FIG. 6), preventing the plate members from separating from one another without damaging the bone plate. The retainer 144 can occupy the widened region 145 of the aperture 142.

[0034] In some examples, the height of each of the tab 136, the aperture 142 excluding the widened region 145, and the widened region 145 can be approximately one-third of the overall height (thickness) of the bone plate at the hinge joint. The retainer 144 can protrude from the top surface of the plate member, or the retainer 144 can be flush with or recessed relative to the top surface. In some examples, the retainer 144 can be welded to the axial rod. In some examples, the entire bone plate (including the hinge joint) can be produced by 3D printing, optionally followed by deformation at the hinge joint (e.g., at the retainer) to increase frictional resistance to rotation of the plate member. In some examples, the retainer 144 can be formed by a separate element (e.g., a nut attached to a threaded version of the axial rod, among others). In some examples, the configuration of the hinge joint can be inverted. For example, the center plate member 126 may form an undercut region that overlies the tabs formed by the end plate members at the hinge joint, and / or the end plate members may provide a pivot rod.

[0035] The axial rod can have any suitable characteristics. The axial rod may or may not be elongated along the pivot axis. The axial rod can be cylindrical or have at least a cylindrical portion disposed in the aperture of the other plate member. The axial rod can have a pre-formed through-hole before the axial rod is installed in the aperture, or the through-hole can be formed after the retainer is produced, among other things. In some examples, the through-hole can be pre-formed and then modified after the retainer is produced. Modifying the through-hole can include creating an internal thread in the through-hole and / or correcting the through-hole to eliminate distortion, if any, created when the retainer is produced.

[0036] Each hinge joint 122 a, 122 b may have a frictional resistance that is not adjustable at the joint by a user (e.g., a surgeon). In other words, the hinge joint may not be configured to be adjustable away from the bone between a movable configuration and a fixed configuration. The frictional resistance can be set during manufacture of the bone plate by securely engaging the retainer 144 with one of the plate members (e.g., a wall region of the aperture 142 and / or an outer surface of the plate member). A bone plate having a hinge joint that lacks distinct movable and fixed configurations (and, optionally, does not have separate connectors) may make the bone plate easier and faster to install, less likely to experience mechanical malfunction or failure (e.g., caused by separate connectors loosening over time), and more resistant to accidental disassembly.

[0037] The range of motion at each hinge joint may be determined by contact between stop areas 146 and 148 (see FIGS. 2 and 5) and / or stop areas 150 and 152 (see FIG. 4), which may be formed by the vertical walls of center plate member 126 and end plate members 124 or 128. The hinge joints may have any suitable range of angular motion (e.g., at least about 5 or 10 degrees, and / or less than about 45, 30, or 20 degrees, among others).

[0038] 7 and 8 show a bone plate 160, which is a version of bone plate 120 having a hinge joint 122b that can be locked away from the bone. The overlapping regions of center plate member 126 and end plate member 128 can define a pair of aligned apertures 162, 164 for receiving a fastener that functions as a locking member 166. The locking member can be a set screw. Upper aperture 162 can be elongated transversely to the long axis of the bone plate (and elongated within the plane of the bone plate) to form a slot. Lower aperture 164 can have an internal thread 168.

[0039] The locking member 166 can have external threads 170 for attaching the locking member to the plate member 126 at the lower aperture 164. The head 172 of the locking member can be disposed within a wider upper region of the upper aperture 162 and moves along the longitudinal axis of the upper aperture 162 when the plate members of the bone plate are pivoted relative to one another at the hinge joint 122b. The lower surface of the head 172 can be fastened against a wall region 174 of the upper aperture 162 to urge the plate member 128 into secure engagement with the plate member 126 and fix the angular orientation of the plate members relative to one another at a selected rotational position. The locking member 166 can define a central throughbore portion 176 for receiving a fastener (e.g., a bone screw 178) that extends into the bone.

[0040] 9 shows a bone plate 160 locked by a different locking member 182 that is not cannulated and is configured to extend below the bone plate into the bone. In other examples, the non-cannulated locking member 182 may not extend substantially below the inner surface of the bone plate.

[0041] 10 and 11 show an exemplary bone plate 200 having a hinge joint 202 locked by a connector 204. The plate members 206, 208 of the bone plate are fitted together via a pair of arcuate, complementary mating regions 210, 212 that bracket around a pivot axis 214 of the hinge joint 202.

[0042] Each complementary region 210, 212 can include mating features. For example, the complementary region can include a track 216 defined as an arcuate channel and an end region (e.g., a flange 218) that fits into and is complementary to the track (see FIG. 11 ). Each track 216 can have an undercut region 220 that retains the flange within the track and resists separation movement of the plate members 206, 208 from one another in opposite directions parallel to the pivot axis 214. More generally, the complementary mating features prevent translational disassembly of the mated plate members. However, each flange 218 can slide within a plane within the track when the plate members 206, 208 are pivoted relative to one another about the pivot axis 214.

[0043] The plate members can be mated together by first placing their respective flanges 218 into their corresponding tracks with the plate members positioned at an angle to one another (e.g., at an angle of at least about 20 degrees, 40 degrees, or 60 degrees from coaxial with one another, among others). The plate members can then be rotationally mated together by pivoting the plate members into coaxial alignment with one another. The plate members will remain connected to one another in this mated configuration unless they are pivoted sufficiently out of alignment to remove their respective flanges from their corresponding tracks. In some examples, the hinge joint can have only one flange and one track formed on only one side of the pivot axis 214. In some examples, one of the plate members in the hinge joint can form flanges on both sides of the pivot axis, and the other plate member can define both tracks for receiving both flanges.

[0044] The plate members 206, 208 can define a pair of aligned apertures 222, 224 for receiving the connector 204. The connector can be attached to the lower aperture 224 by a threaded engagement, ensuring that the plate members cannot be inadvertently separated from one another. The connector can also function as a lag screw, including a head that can be tightened against the upper plate member near the hinge joint to create a secure engagement between the plate members and lock the hinge joint in a selected position. The connector 204 can optionally include a threaded leading region 226 that is configured to project below the bone plate and into the underlying bone.

[0045] 12 and 13 show another exemplary bone plate 370 having a hinge joint 372 formed by a pair of plate members 374, 376 and a connector 378. (Connector 378 is only shown in FIG. 13.) The bone plate can have any suitable combination of the features of the present disclosure.

[0046] Plate members 374, 376 can be permanently connected to one another by pin 380, regardless of whether connector 378 is installed. Pin 380 can be attached to one of the plate members (e.g., rigidly coupled to plate member 374) and extend into an arcuate slot 382 defined by the other plate member (e.g., plate member 376). The pin can travel along the slot when the plate member is pivoted relative to another plate member about pivot axis 260, and is stopped by opposite ends of the slot, defining a range of rotation for the plate member about the pivot axis. The pin can extend into the bone plate from a location near the inner (or outer) surface of the bone plate.

[0047] The pin 380 can have a head 386 and a shaft 388. The pin can be attached to the plate member 374 via the head 386, and the shaft 388 can extend into the slot 382. In some examples, the pin can be press-fit into an opening 390 defined by the plate member 374 to attach the pin to the plate member.

[0048] The plate members may have various mating features. The mating features may include complementary rotational mating features 354 formed by plate members 374 and 376 at hinge joint 372. The mating features may also or alternatively include complementary mating features 392 that cooperate with pin 380 to permanently connect the plate members to one another. The mating feature 392 may include a protrusion (such as a boss 394) that is received in a complementary recess 396. Both the boss and recess may be coaxial with pivot axis 260.

[0049] The plate members can be assembled together as follows: The plate members can be translationally mated together along pivot axis 260 by installing bosses 394 into recesses 396. The translational mating can be performed with plate members 374 and 376 at an angle relative to one another such that the complementary mating features 354 are not yet mated with one another. In other words, the mating features 354 do not yet overlap because they are rotationally offset from one another. The angle can be, for example, at least 30 or 45 degrees from coaxial alignment of the plate members with one another.

[0050] The plate members can then be rotationally mated to one another by rotating the plate members relative to one another about pivot axis 260 into coaxial alignment so that the complementary mating features 354 mate with one another. The mating features 354 are considered mated when at least a portion of each male region is received within each corresponding track.

[0051] The plate members can be rotationally adjusted while still engaged so that opening 390 can be aligned with slot 382. Pin 380 can then be installed into opening 390, attaching the pin to plate member 374, with the pin shaft extending into slot 382 in plate member 376. The plate members are now permanently connected to each other and can pivot about pivot axis 260 through a range of rotation determined by the pin in the slot. This arrangement is advantageous because no separate connectors (besides the pin) are required to keep the plate members connected, and because the range of motion can be determined internally of the bone plate without affecting the external geometry of the bone plate.

[0052] The connector 378 can be installed into the aligned apertures 398, 400 defined by the plate members at any appropriate time. The connector can be installed through the aperture 398 and into threaded engagement with the aperture 400 before or after the pin 380 is installed. The connector 378 can be manipulated to adjust the hinge joint 372 between a movable configuration and a fixed configuration, as described elsewhere herein. In some examples, the bone plate 370 can be supplied to a user (e.g., a surgeon) with the connector 378 already installed and, optionally, with the hinge joint 372 in a fixed configuration (e.g., with the plate members coaxially aligned with one another). The orientation of the plate members relative to one another can be adjusted via the hinge joint (in the movable configuration), and the plate members can be attached to the bone with fasteners.

[0053] The connector 378 can be interchangeable with a corresponding fastener 402, which has a longer shaft than the connector and is configured to extend into the bone after the bone plate is placed on and / or attached to the bone. The fastener 402 can be disposed in threaded engagement with the plate member 374 and can be adjustable to place the hinge joint in a fixed configuration with the fastener extending into the bone. In other examples, the connector 378 can be cannulated to define a through-hole with or without internal threads. In these examples, the fastener can be placed through the through-hole into the bone along the pivot axis 260 while the connector 378 remains attached to the plate member 374.

[0054] In some examples, methods of fixating bone using any of the bone plates disclosed herein are provided. The steps presented herein may be performed in any suitable order and combination, and may be modified by or combined with any of the other procedures and features disclosed elsewhere herein.

[0055] At least one bone to be fixed can be selected. The bone can be any suitable bone of a vertebrate species, such as, for example, an arm bone (e.g., humerus, ulna, or radius), a leg bone (e.g., femur, tibia, or fibula), a hand / wrist bone (e.g., carpals, metacarpals, or phalanges), a foot / ankle bone (e.g., tarsus, metatarsus, calcaneus, or phalanges), a rib, a sternum, a scapula, a clavicle, a pelvis, a skull, a facial bone, or a vertebra, or any combination of adjacent bones thereof. The bone can have any suitable discontinuity or structural weakness (e.g., at least one fracture, at least one cut, or nonunion), or two or more adjacent bones can be selected to be fused together.

[0056] An incision can be made through the overlying soft tissue to access at least one selected bone. The selected bone can be manipulated (e.g., to set a fracture) to reposition the bone fragments (e.g., to approximate the relative anatomical locations of the fragments). Manipulation of the bone fragments (or two or more selected bones) can be performed before or after the incision is made.

[0057] A bone plate can be selected to stabilize a selected bone and can have at least two plate members connected by at least one movable joint as disclosed herein.

[0058] The bone plate can be placed on the selected bone through an incision, which can be at least approximately the same length as the bone plate or shorter than the bone plate.

[0059] The bone plates can be attached to the bone by fasteners (e.g., bone screws) that are placed into one or more through holes in each plate member and extend into the bone.

[0060] The rotational and / or translational positions of the plate members relative to one another can be adjusted before and / or after the bone plate is attached to the bone. The adjustment can be performed with the bone plate joints in a movable configuration (which allows movement of the plate members relative to one another). The bone plate can be installed in a fixed configuration after the adjustment to fix the positions of the plate members relative to one another. The incision can then be closed.

[0061] Bone plates with single or multiple joints can be adjusted at different times during a bone fixation procedure. The longitudinal shape of a hinged bone plate having one or more hinge joints can be adjusted before the entire bone plate is attached to the bone, or at least before each plate member is attached to the bone. In some cases, the orientation of first and second plate members connected by a hinge joint can be adjusted after attaching the first plate member to the bone and before attaching the second plate member to the bone. The second plate member can be rotated to the desired orientation relative to the first plate member, and then attached to the bone. If the hinged bone plate has three or more plate members, this process can be performed again for each additional plate member before that plate member is attached to the bone. In other words, the plate members of the hinged bone plate can be sequentially aligned with the bone and then attached. The orientation of the plate members of a bone plate having a polyaxial joint can be adjusted after the plate members are attached to different pieces of bone to change the orientation of the bone pieces (e.g., to improve fracture reduction).

[0062] Alternative or additional exemplary systems, devices, and / or methods for fixating bones are disclosed in U.S. Patent Application No. 17 / 464,108, entitled "BONE PLATE WITH MOVABLE JOINT," filed September 1, 2021, the disclosure of which is incorporated herein by reference in its entirety. U.S. Patent Application No. 17 / 464,108 is a continuation of U.S. Patent Application No. 16 / 140,362, filed September 24, 2018, which is a continuation-in-part of the following: U.S. Patent Application No. 14 / 746,722, filed June 22, 2015; U.S. Patent Application No. 14 / 792,522, filed July 6, 2015; U.S. Patent Application No. 15 / 216,646 (now U.S. Patent No. 10,080,596), filed July 21, 2016; U.S. Patent Application No. 15 / 990,633, filed May 26, 2018; and U.S. Patent Application No. 16 / 001,867, filed June 6, 2018.

[0063] U.S. Patent Application No. 14 / 746,722 is based on and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62 / 016,883, filed June 25, 2014. U.S. Patent Application No. 14 / 792,522 is based on and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 62 / 020,691, filed July 3, 2014; and U.S. Provisional Patent Application No. 62 / 110,220, filed January 30, 2015. In turn, U.S. Patent Application No. 15 / 216,646 is a continuation-in-part of the following U.S. Patent Applications: U.S. Patent Application No. 14 / 565,105, filed December 9, 2014 (now U.S. Patent No. 9,463,055); U.S. Patent Application No. 14 / 565,116, filed December 9, 2014 (now U.S. Patent No. 9,433,448); U.S. Patent Application No. 14 / 566,350, filed December 10, 2014 (now U.S. Patent No. 9,433,451); and U.S. Patent Application No. 14 / 706,922, filed May 7, 2015 (now U.S. Patent No. 9,526,542).

[0064] U.S. Patent Application No. 14 / 565,105 is based on and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61 / 913,593, filed December 9, 2013. U.S. Patent Application No. 14 / 565,116 is based on and claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61 / 913,611, filed December 9, 2013. U.S. Patent Application No. 14 / 566,350 is a continuation-in-part of U.S. Patent Application No. 14 / 565,105, filed December 9, 2014, and U.S. Patent Application No. 14 / 565,116, filed December 9, 2014, with the above-listed priority claims, and is based on U.S. Provisional Patent Application No. 61 / 914,180, filed December 10, 2013, and claims the benefit thereof under 35 U.S.C. §119(e). U.S. Patent Application No. 14 / 706,922 is based on U.S. Provisional Patent Application No. 61 / 989,662, filed May 7, 2014, and claims the benefit thereof under 35 U.S.C. §119(e).

[0065] All patents, patent applications, publications, or other disclosure materials mentioned herein are incorporated by reference in their entirety, as if each individual reference were expressly incorporated by reference. All references and any material, or portions thereof, said to be incorporated herein by reference are incorporated herein only to the extent that the incorporated material does not contradict existing definitions, descriptions, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as set forth herein supersedes any conflicting material incorporated herein by reference, and the disclosure expressly set forth in this application controls.

[0066] 14 and 15 illustrate an exemplary device 500 (e.g., a bone plate) for fixating a bone according to one example of the present disclosure. The device 500 can include a first plate 510 and a second plate 520. The first and second plates 510, 520 can be attached to a bone (e.g., bone 88) using one or more fasteners (e.g., bone screws, pins, wires, rivets, etc.). In some examples, the device 500 can be used to fix a clavicle or any other suitable bone (e.g., femur, tibia, fibula, radius, ulna, humerus, or rib, etc.).

[0067] The first plate 510 can include one or more openings 512, 514, 516. The one or more openings can include a screw slot 512, a connector hole 514, and a bone fastener hole 516. The screw slot 512 can be formed through the entire thickness of the first plate 510.

[0068] The second plate 520 can be coupled to the first plate 510 at the region of overlap 530 by, for example, a hinge joint 540. The first and second plates 510, 520 can move relative to one another in at least one plane and / or about at least one axis of rotation to change the angular orientation of the plates relative to one another. The hinge joint 540 can be configured to allow rotation of the first and second plates 510, 520 relative to one another about the pivot axis 535. The rotation of the first and second plates 510, 520 relative to one another can occur in a plane at least generally parallel to a plane defined by the first plate 510 and / or second plate 520.

[0069] The hinge joint 540 can resist out-of-plane bending and torsional forces while allowing movement about a pivot axis 535 that is disposed transversely (e.g., perpendicularly) to the plane defined by the device 500 and / or at least one of the plates 510 / 520. This pivotal movement allows adjustment of the longitudinal shape of the device 500 through in-plane movement of the plates 510, 520, which can enable a surgeon to customize the device 500 to the longitudinal shape of a subject's bone.

[0070] The second plate 520 can include one or more openings. The one or more openings can include through-holes 522, connector holes 524, and bone fastener holes 526. The through-holes 522 of the second plate 520 can correspond to the screw slots 512 of the first plate 510. The screw slots 512 of the first plate 510 and the through-holes 522 of the second plate 520 can be disposed in an area 530 where the first plate 510 and the second plate 520 overlap. The through-holes 522 can include internal threads 523.

[0071] In some examples, the first plate 510 and / or the second plate 520 can be shaped like an elongated rod. In other examples, the first plate 510 and / or the second plate 520 can have any other suitable shape. In some examples, the first plate 510 and / or the second plate 520 can be made of a metallic material (e.g., titanium). In other examples, the first plate 510 and / or the second plate 520 can be made of any other suitable biocompatible / implantable material (e.g., any other suitable metallic material).

[0072] The bone fastener holes 516, 526 can be configured to receive bone fasteners. For example, one or more bone fasteners can be received in the bone fastener holes 516, 526 of the first and second plates 510, 520 and extend into the bone. The first and second plates 510, 520 can each have any suitable number of bone fastener holes. In some examples, if the first / second plates 510 / 520 have two or more bone fastener holes, the bone fastener holes can be distributed from one another along and / or across the plates.

[0073] The connector holes 514, 524 can be configured to receive a connector (e.g., connectors 100, 204, 378). The connector can act as a locking device (which, in some examples, can be described as a fastener and / or locking screw) that controls whether the joint is in a movable or fixed (locked) configuration. The terms "movable" and "fixed" can be relative terms. For example, the fixed configuration can require a substantially greater force (e.g., at least about 5 times, 10 times, 25 times, 50 times, or 100 times more force) to create movement of the plates 510 / 520 relative to one another than the movable configuration. In the fixed configuration, the device 500 can be rigid at the joint, with the plates 510, 520 rigidly coupled to one another, allowing the device 500 to function like a conventional (jointless) bone plate.

[0074] In some examples, the connector can define the pivot axis 535 of the joint (i.e., can be coaxial with the pivot axis 535) or can be offset from the pivot axis 535. The connector can have external threads for attaching the connector to one of the plates 510, 520 at its connector hole 514 / 524. The connector can be rotatable to adjust the compression of the plates 510, 520 at the joint, thereby determining whether the joint is fixed or movable. Movement in a locked joint can be limited by any suitable mechanism, including any combination of friction, an obstruction, or interlocking.

[0075] In some examples, the connector of device 500 can be of a movable configuration. In other examples, the connector of device 500 can be of a fixed configuration. Other configurations / features / attributes of the connector and connector holes 514 / 524 can be similar and / or the same as those described above with respect to connectors 100, 204, 378 and corresponding connector holes / openings, and therefore, redundant description may be omitted.

[0076] In some examples, the length L1 of the screw slot 512 in the first plate 510 can be greater than the length L2 of the through-hole portion 522 in the second plate 520. In some examples, the screw slot 512 can be curved. In other examples, the screw slot 512 can have any other suitable shape.

[0077] 16A , in some examples, the apparatus 500 can further include a screw 560 disposed in the screw slot 512 of the first plate 510 and the through-hole 522 of the second plate 520. The screw 560 can include a non-threaded portion 562 and a threaded portion 564. The threaded portion 564 of the screw 560 can have a threaded engagement with the internal threads 523 of the through-hole 522 of the second plate 520. The screw 560 can be fixed in the through-hole 522 of the second plate 520 and can be movable within the screw slot 512 of the first plate 510. Within the screw slot 512, the screw 560 can have a clearance fit with the sides of the screw slot 512.

[0078] In some examples, the screw 560 can be a set screw. In other examples, the screw 560 can be any other suitable device that functions as a screw. In some examples, the first and second plates 510, 520 can be permanently connected to one another by the screw 560, regardless of whether connectors are installed (in the connector holes 514, 524).

[0079] In some examples, the screw 560 can be tightened to create friction within the device 500 (e.g., between the first plate 510 and the second plate 520). That is, the torque applied to the screw 560 can dictate the friction. For example, a higher torque on the screw 560 may require an increased force to rotate the first plate 510 relative to the second plate 520. In some examples, a torque can be applied to the screw 560 intended to adjust the rotational resistance, which can allow the joint to be articulated by intentional force by a user (e.g., a surgeon) but prevent unintentional articulation.

[0080] In some examples, the first plate 510, the second plate 520, and the screw 560 can define a range of rotation for the first and second plates 510, 520 about the pivot axis 535. For example, the screw 560 can travel along the screw slot 512 and be stopped by opposite ends of the screw slot 512 when the plates 510, 520 are pivoted relative to one another about the pivot axis 535, defining a range of rotation for the first and second plates 510, 520 about the pivot axis 535.

[0081] The first and second plates 510, 520 can have various (complementary) mating features, such as those described above with respect to the bone plates illustrated in Figures 1-13. Accordingly, redundant descriptions of the mating features may be omitted.

[0082] 16B , in some examples, the screw 560 can be part of a screw body 550, which can include a break feature. The screw body 550 can include a threaded portion (e.g., a screw) 560 and an insert portion 570. The insert portion 570 can include a graspable portion 572 and a connecting portion 574, which is disposed between the graspable portion 572 and the screw portion 560. The connecting portion 574 can include a first end portion 573 adjacent to the graspable portion 572 and a second end portion 575 adjacent to the screw portion 560. In some examples, the connecting portion 574 can be tapered. In this case, the diameter of the connecting portion 574 can gradually increase from the second end portion 575 to the first end portion 573. The diameter D4 of the insertion portion 570 (e.g., the graspable portion 572) can be larger than the diameter of the screw portion (e.g., D2-1 or D1-1). In this example, the threaded portion 564 can be disposed closer to the insertion portion 570 than the non-threaded portion 562.

[0083] In this disclosure, the term "diameter" is used for simplicity and does not require that a component described using "diameter" have a circular shape. When a component is non-circular, the term "diameter" can instead refer to any measurement (e.g., width) similarly used across the component, as would be understood by one of ordinary skill in the art.

[0084] 16C illustrates another exemplary screw body 550 according to the present disclosure. In this example, the non-threaded portion 562 may be disposed closer to the insertion portion 570 than the threaded portion 564. Additionally, the screw portion 560 may further include a head 565 having a larger diameter than the non-threaded portion 562 and the threaded portion 564. Other configurations / features / attributes (e.g., components, dimensions, shape) of the screw body 550 of FIG. 16C may be similar and / or the same as those described above with respect to the screw body 550 of FIG. 16B, and therefore, redundant description may be omitted.

[0085] In some examples, the screw 560 and / or the screw body 550 can be made of a polyetheretherketone (PEEK) material or a high molecular weight polyethylene (HMWPE) material. In other examples, the screw 560 and / or the screw body 550 can be made of any other suitable material (e.g., any other suitable plastic / polymer material having properties similar to PEEK or HMWPE). The screw 560 made of the materials discussed above (e.g., PEEK or HMWPE) can provide a smoother bearing surface, which can create a smoother feel when articulating the plates 510, 520.

[0086] In some examples, the major diameter D1-1 of the screw 560 can be larger than the diameter D1-2 of the corresponding portion of the internal thread 523. In some examples, the minor diameter D2-1 of the screw 560 can be larger than the diameter D2-2 of the corresponding portion of the internal thread 523. In some examples, a pitch mismatch exists between the screw 560 and the internal thread 523. For example, the pitch D3-1 of the screw 560 can be different (e.g., smaller or larger) than the distance D3-2 of the corresponding portion of the internal thread 523. Because plastic is deformable, a screw made of a plastic material (e.g., PEEK or HMWPE) can have a major diameter, minor diameter, and / or pitch that are different from the distance D3-2 of the corresponding portion of the internal thread 523 of the second plate 520. In this manner, the screw 560 (e.g., the threaded portion 564) can have an interference fit with the through-hole portion 522 of the second plate 520, thereby preventing movement of the first and second plates 510, 520 relative to one another unless a predetermined amount of force (e.g., intentional force by the user's hand) is applied, for example, after a desired / targeted resistance / friction is set.

[0087] 17 illustrates an exemplary device 500 for fixating bone, in which a screw body 550 (shown in FIG. 16C ) is inserted into a screw slot 512 of a first plate 510 and a through-hole 522 of a second plate 520. As shown in FIG. 17 , a threaded portion 564 of a screw portion 560 can be engaged with the internal threads 523 of the through-hole 522 of the second plate 520, and a non-threaded portion 562 and a head 565 of the screw portion 560 can be engaged with the screw slot 512 of the first plate 510.

[0088] When the screw 560 is made of a plastic material (e.g., PEEK), it can be difficult to install the screw 560 into the first and second plates 510, 520 using a driver. This is because the driver-receiving recess of the screw made of a plastic material can easily break or crack, and therefore, sufficient torque cannot be applied to the screw to set the desired / targeted drag / friction between the plates 510, 520. Therefore, the insert portion 570 can be provided to ensure that the screw 560 has sufficient torsional strength (to install the screw 560 into the screw slot 512 and through-hole portion 522) to achieve the desired torque to set the desired drag / friction between the first plate 510 and the second plate 520. For example, the targeted torque can be applied to the insert portion 570 (e.g., the graspable portion 572) by rotating the insert portion 570, which can be transmitted to the screw portion 560. In some examples, the insert portion 570 can be removed after the screw portion 560 is inserted into the screw slot 512 of the first plate 510 and the through-hole 522 of the second plate 520. For example, once a desired drag / friction is established between the first plate 510 and the second plate 520, the insert portion 570 can be fractured under a lateral load. In some examples, the cut surface of the screw portion 560 can include protrusions and / or depressions after the insert portion 570 is removed. In other examples, the cut surface of the screw portion 560 can be flat and / or smooth.

[0089] 18 and 19 illustrate another exemplary device 600 (e.g., a bone plate) for fixating bone, according to one example of the present disclosure. Device 600 can include a first plate 610 and a second plate 620. First plate 610 can include one or more openings 612, 614. The one or more openings can include screw slots 612, connector holes 614, and bone fastener holes.

[0090] The second plate 620 can be coupled to the first plate 610 in the region of overlap 630 by, for example, a hinge joint 640. The hinge joint 640 can be configured to allow rotation of the first and second plates 610, 620 relative to one another about a pivot axis 635. The second plate 620 can include one or more openings. The one or more openings can include through-holes 622, connector holes 624, and bone fastener holes 626. The through-holes 622 of the second plate 620 can correspond to the screw slots 612 of the first plate 610. The screw slots 612 of the first plate 610 and the through-holes 622 of the second plate 620 can be disposed in the region 630 where the first plate 610 overlaps the second plate 620. The through-holes 622 can include internal threads 625.

[0091] The screw slots 612 of the first plate 610 can be formed on the bottom surface of the first plate 610 in the overlap region 630 and do not need to extend through the thickness of the first plate 610. In some examples, the length of the screw slots 612 of the first plate 610 can be greater than the length of the through-hole portions 622 of the second plate 620. In some examples, the screw slots 612 can be curved. In other examples, the screw slots 612 can have any other suitable shape.

[0092] The second plate 620 can include a first end portion 621 and a second end portion 623. The second end portion 623 can be disposed in the overlap region 630. The screw slots 612 of the first plate 610 and the through holes 622 of the second plate 620 can be disposed closer to the second end portion 623 than the connecting holes 614, 624 of the first and second plates 610, 620.

[0093] In some examples, device 600 may further include screws (e.g., screws 560 shown in FIGS. 16A and / or 16B ) disposed in screw slots 612 of first plate 610 and through-holes 622 of second plate 620. Other configurations / features / attributes (e.g., components, materials, dimensions) of device 600 may be similar and / or the same as those described above with respect to device 500, and thus, redundant description may be omitted.

[0094] In some examples, methods of fixating bone using any of the bone plates disclosed herein are provided. The steps presented herein may be performed in any suitable order and combination, and may be modified by or combined with any of the other procedures and features disclosed elsewhere herein.

[0095] The method can include mating a first plate with a second plate and installing screw bodies into the screw slots of the first plate and the through-holes of the second plate. For example, the first plate 510 / 610 can be mated with the second plate 520 / 620, and the screw bodies 550 can be installed into the screw slots 512 / 612 of the first plate 510 / 610 and the through-holes 522 / 622 of the second plate 520 / 620, for example, using the insertion portion 570 of the screw body 550.

[0096] The method can further include removing the insert portion of the screw body. For example, the insert portion 570 of the screw body 550 can be removed after the screw portion 560 is inserted into the screw slot 512 / 612 and the through-hole portion 522 / 622. The screw portion 560 can remain in the screw slot 512 / 612 and the through-hole portion 522 / 622 after the insert portion 570 is removed.

[0097] In some examples, when installing the screw body 550 into the screw slots 512 / 612 and through-holes 522 / 622, the screw body 550 can be tightened such that the torque applied to the screw portion 560 reaches a first predetermined torque value. The first predetermined torque value can correspond to a first amount of force / moment required to rotate the first plate 510 / 610 and the second plate 520 / 620 relative to one another.

[0098] In some examples, the method may also include heating the first plate 510 / 610 and the second plate 520 / 620 (while the plates 510 / 610, 520 / 620 are coupled to one another via the screw portion 560) in one or more heating cycles (e.g., during autoclave sterilization / processing). When the screw 560 is made of a plastic material (e.g., PEEK), the screw 560 may be loosened during the heating cycles. In this case, the amount of force / moment required to rotate the first and second plates 510 / 610, 520 / 620 relative to one another may be reduced below the first force / moment amount, thereby resulting in the drag / friction being reduced below a targeted value. For example, as shown in Figure 20 (which illustrates the average measured resistance / friction between plates connected together using screws made of a plastic material (e.g., PEEK) versus the number of autoclave cycles), the amount of force / moment required to rotate the plates relative to one another decreases as the number of autoclave cycles is increased.

[0099] Thus, in some examples, after the heating step / cycle, the screw body 550 can be re-tightened such that the torque applied to the screw portion 560 reaches a second predetermined torque value. The second predetermined torque value can correspond to a second amount of force / moment required to rotate the first plate 510 / 610 and the second plate 520 / 620 relative to one another. The amount of the second force / moment can be (substantially) the same as the amount of the first force / moment, thereby ensuring that the targeted drag / friction is achieved.

[0100] In some examples, multiple heating steps / cycles (autoclaving / treatments) can be repeated. In this case, the screw body 550 can be retightened after each or only some of the heating steps / cycles. In some examples, the screw body 550 can be retightened after the final heating step / cycle. In some examples, the screw body 550 can be retightened (only) after a certain number of heating steps / cycles (e.g., 2, 3, 4, 5, 6, 7, 8, 9, or 10).

[0101] In some examples, the temperature to which the first plate 510 / 610, the second plate 520 / 620, and the screw portion 560 are heated can be in the range of about 250° C. to about 270° C. In other examples, the first plate 510 / 610, the second plate 520 / 620, and the screw portion 560 can be heated at any other suitable temperature (e.g., below 250° C. or above 270° C.).

[0102] In some examples, when installing the screw body 550 into the screw slot 512 / 612 and the through-hole 522 / 622, the screw body 550 can be over-tightened so that the torque applied to the screw portion reaches a third predetermined torque value. The third predetermined torque value can correspond to a third amount of force / moment required to rotate the first plate 510 / 610 and the second plate 520 / 620 relative to one another. The third amount of force / moment can be greater than the first and second amounts of force / moment.

[0103] The first plate 510 / 610 and the second plate 520 / 620, which are coupled to each other (overtightened) via the screw portion 560, can then be heated in one or more heating cycles. After heating, the torque of the screw portion 560 can reach a fourth predetermined torque value. The fourth predetermined torque value can correspond to a fourth amount of force / moment required to rotate the first plate 510 / 610 and the second plate 520 / 620 relative to each other. The third amount of force / moment can be greater than the fourth amount of force / moment. In this manner, overtightening the screw can ensure that the apparatus 500 maintains a targeted drag / friction between the first plate 510 / 610 and the second plate 520 / 620.

[0104] In some instances, when the screw is overtightened (before the heating step / cycle), the screw may not need to be retightened after the heating step. In other instances, the screw is overtightened (before the heating step / cycle), but the screw body 550 can be retightened, for example, after a particular and / or final heating step / cycle.

[0105] In some examples, the fourth force / moment amount can be (substantially) the same as the first / second force / moment amount, thereby ensuring that the targeted drag / friction is achieved. In some examples, the target (first / second / fourth) amount of force / moment required to rotate the first and second plates 510 / 610, 520 / 620 relative to one another can be in the range of about 0.5 in-lb to about 15 in-lb. In some examples, the target torque value (e.g., first, second, fourth torque value) applied to the screw portion 560 can be in the range of about 1 in-lb to about 10 in-lb.

[0106] Thus, aspects of the present disclosure can provide improved bone plate assemblies that can be easily, cost-effectively, and consistently fabricated using plastic (e.g., PEEK) screws.

[0107] 21 illustrates another exemplary screw 700 according to one example of the present disclosure. The screw 700 can include a threaded portion 710 and a non-threaded portion 720. The screw 700 can further include a recess 730. The recess 730 can be formed in the center of the top surface of the screw 700. The recess 730 can be a driver-receiving recess configured to receive a driver.

[0108] In some examples, the screw 700 can be made of a metallic material (e.g., titanium). In other examples, the screw 700 can be made of any other suitable metallic material. In some examples, the screw 700 can be a set screw. In other examples, the screw 700 can be any other suitable device that functions as a screw. The screw 700 can be sized or shaped to be inserted into the first plate 510 / 610 and the second plate 520 / 620 of the apparatus 500 / 600 for bone fixation.

[0109] 22A illustrates an exemplary automated compression tool 800 according to one example of the present disclosure. The automated compression tool 800 can be used with the screw 700 to prevent the screw 700 from backing out of the screw slot 512 / 612 and the through-hole portion 522 / 622. The automated compression tool 800 can include a casing body 810, a hammer body 820, a first biasing device 830, an intermediate rod 840, a second biasing device 850, and a punching rod 860.

[0110] The casing body 810 may include a first end portion 812 and a second end portion 814. The first end portion 812 may include a cap. The second end portion 814 may have an opening 816 through which the punching rod 860 extends. The casing body 810 may further include an internal protrusion 818. The internal protrusion 818 may be provided to block the hammer body 820.

[0111] Hammer body 820 can include a first end portion 822 and a second end portion 824. Second end portion 824 of hammer body 820 can include a groove 826. Groove 826 can be provided to receive an upper portion of intermediate rod 840.

[0112] The first biasing device 830 may be disposed between the first end portion 812 (e.g., a cap) of the casing body 810 and the first end portion 822 of the hammer body 820. In some examples, the first biasing device 830 may be a spring. In other examples, the first biasing device 830 may be any other suitable biasing device (e.g., rubber or any other suitable elastic material). The first biasing device 830 may bias the hammer body 820 toward the intermediate rod 840.

[0113] The intermediate rod 840 can be disposed between the hammer body 820 and the punching rod 860. The intermediate rod 840 can include a first (top) portion 842, a second (middle) portion 844, and a third (bottom) portion 846. The diameter of the third portion 846 can be larger than the diameter of the first portion 842. The second portion 844 can be tapered.

[0114] The second biasing device 850 may be provided on the intermediate rod 840. For example, the second biasing device 850 may cover the first and second portions 842, 844 of the intermediate rod 840. In some examples, the second biasing device 850 may be a spring. In other examples, the second biasing device 850 may be any other suitable biasing device (e.g., rubber or any other suitable elastic material). The second biasing device 850 may bias the intermediate rod 840 toward the punching rod 860.

[0115] The punching rod 860 can include a first end portion 862 adjacent to the intermediate rod 840 and a second end portion 864. In some examples, the second end portion 864 of the punching rod 860 (e.g., its bottom surface) can include one or more punching pins 865 a, 865 b. In some examples, the one or more punching pins 865 a, 865 b can be formed at or near an edge portion of the bottom surface of the punching rod 860. The one or more punching pins 865 a, 865 b can protrude from the bottom surface of the punching rod 860 at or near the edge portion of the bottom surface.

[0116] FIG. 22B illustrates another exemplary automated compression tool 800 according to one example of the present disclosure. The punching rod 860 of the automated compression tool 800 can further include an alignment guide 867. FIGS. 23A and 23B are enlarged views of the punching rod 860 with the alignment guide 867. The alignment guide 867 can be formed at or near the center of the bottom surface of the punching rod 860. The alignment guide 867 can protrude from the bottom surface of the punching rod 860 at or near the center of the bottom surface. In some examples, the height of the alignment guide 867 can be greater than the height of one or more punching pins 865a, 865b. In some examples, the alignment guide 867 can be sized and shaped according to the (expected) dimensions of the recess 730 of the screw 700.

[0117] The automated compression tool 800 can be used, for example, to drive the screws 700 (e.g., metal screws) after the first plate 510 / 610 and the second plate 520 / 620 have been mated to one another and after the screws 700 have been installed into the screw slots 512 / 612 and through-holes 522 / 622. Driving the screws 700 with the automated compression tool 800 can cause at least partial deformation of the screws 700 and / or portions of the first plate 510 / 610 or second plate 520 / 620 connected to the screws 700. In this way, the screws 700 can be prevented from backing out of the screw slots 512 / 612 and through-holes 522 / 622.

[0118] When striking the screw with the punching rod 860, the alignment guide 868 of the punching rod 860 can help align the punching rod 860 with the screw 700. For example, when the punching rod 860 is pressed against the screw 700, the alignment guide 868 (located at the center of the bottom surface of the punching rod 860) can be slid / placed into the recess 730 (located at the center of the top surface of the screw 700) of the screw 700, thereby aligning the punching rod 860 with the screw 700.

[0119] After / while the punching rod 860 is aligned with the screw 700, and as the casing body 810 continues to press against the screw 700, the punching rod 860 can move into the casing body 810, which can cause the intermediate rod 840 to push the hammer body 820 away from the protrusion 818. At this time, the first and second biasing devices 830, 850 can be compressed. Then, when the upper portion 842 of the intermediate rod 840 is slid / inserted into the groove 826 of the hammer body 820, the first biasing device 830 can push the hammer body 820 toward the intermediate rod 840, thereby striking the intermediate rod 840. The impact of the intermediate rod 840 being struck by the hammer body 820 can be transmitted to the punching rod 860, and the punching rod 860 can be transmitted to the screw 700.

[0120] Striking the screw 700 with the punching rod 860 can include striking the screw 700 at the joint of the screw 700 and / or the first / second plate with one or more punching pins 865 a, 865 b. For example, as shown in FIG. 24 , when the punching rod 860 approaches the screw 700, the alignment guide 867 can be slid / inserted into the recess 730 of the screw 700, and the joint / edge portion of the upper surface of the screw 700 (and / or the second plate 620) can be struck by the one or more punching pins 865 a, 865 b. Force from the hammer body 820 can be transmitted to the joint / edge portion of the upper surface of the screw 700 via the one or more punching pins 865 a, 865 b.

[0121] In some examples, at least two of the first plate 510 / 610, the second plate 520 / 620, and the screw 700 can be anodized. The thickness of the anodized surface (e.g., oxide layer) of at least two of the first plate 510 / 610, the second plate 520 / 620, and the screw 700 can be in a range from about 0.2 μm to about 2.5 μm. In some examples, all three of the first plate 510 / 610, the second plate 520 / 620, and the screw 700 can be anodized.

[0122] When the first plate 510 / 610, the second plate 520 / 620, and the screw 700 are all made of a metal material (e.g., titanium), this can cause galling and can lead to an inconsistent feel when articulating the first / second plates 510 / 610, 520 / 620. The inventors surprisingly found that when at least two of the first plate 510 / 610, the second plate 520 / 620, and the screw 700 are anodized to form an oxide layer (e.g., a titanium oxide layer) having a thickness ranging from about 0.2 μm to about 2.5 μm, galling is prevented and the device 500 / 600 has smooth articulation. The first plate 510 / 610, the second plate 520 / 620, and the screw 700 can be anodized before they are assembled together.

[0123] Embodiment Various aspects of the subject matter described herein are set forth in the following numbered embodiments.

[0124] Embodiment 1. A device for fixating bones, comprising: a first plate including screw slots; a second plate connected to the first plate at an overlapping region by a hinge joint, the hinge joint configured to allow rotation of the first and second plates relative to one another about a pivot axis, the second plate including through-hole portions corresponding to the screw slots, the screw slots and through-hole portions being disposed in the overlapping region; and a screw disposed within the screw slots and through-hole portions, the screw including a threaded portion, the first plate, the second plate, and the screw defining a range of rotation for the first and second plates about the pivot axis.

[0125] Embodiment 2. The device of embodiment 1, wherein the screw comprises a set screw.

[0126] Embodiment 3. The device of any one of embodiments 1-2, wherein the screw is made of at least one of polyetheretherketone (PEEK) material or high molecular weight polyethylene (HMWPE) material.

[0127] Embodiment 4. The device of any one of embodiments 1 to 3, wherein the through-hole portion includes an internal thread.

[0128] Embodiment 5. The device of embodiment 4, wherein the major diameter of the screw is greater than the diameter of the corresponding portion of the internal thread.

[0129] Embodiment 6. A device according to any one of embodiments 4 to 5, wherein the minor diameter of the screw is larger than the diameter of the corresponding portion of the internal thread.

[0130] Embodiment 7. A device according to any one of embodiments 4 to 6, wherein there is a pitch mismatch between the screw and the internal thread.

[0131] Embodiment 8. A device according to any one of embodiments 1 to 7, wherein the length of the screw slot is greater than the length of the through-hole portion, and the screw slot is curved.

[0132] Embodiment 9. The device of any one of embodiments 1 to 8, wherein the screw is fixed in the through-hole portion and movable in the screw slot.

[0133] Embodiment 10. The device according to any one of embodiments 1 to 9, wherein the screw is made of a metal material.

[0134] Embodiment 11. The device of any one of embodiments 1 to 10, wherein at least two of the first plate, the second plate, and the screw are anodized.

[0135] Embodiment 12. The device of embodiment 11, wherein the thickness of the anodized surface of at least two of the first plate, the second plate, and the screw is in the range of about 0.2 μm to about 2.5 μm.

[0136] Embodiment 13. The device of any one of embodiments 1 to 12, wherein the screw further comprises a non-threaded portion.

[0137] Embodiment 14. A method for manufacturing a device for fixing bones, comprising the steps of: mating a first plate with a second plate, the first plate including screw slots and the second plate including through-hole portions corresponding to the screw slots; installing a screw body into the screw slots and through-hole portion, the screw body including a screw portion and an insert portion, the screw body being installed into the screw slot using the insert portion of the screw body; and removing the insert portion of the screw body, the screw portion remaining in the screw slot and through-hole portion after the insert portion is removed.

[0138] Embodiment 15. The method of embodiment 14, wherein the screw body is made of at least one of a polyetheretherketone (PEEK) material or a high molecular weight polyethylene (HMWPE) material.

[0139] Embodiment 16. The method of any one of embodiments 14-15, wherein the diameter of the insertion portion is greater than the diameter of the screw portion.

[0140] Embodiment 17. The method of any one of embodiments 14 to 16, wherein the step of installing the screw body portion into the screw slot and through-hole portion includes tightening the screw body portion so that the torque applied to the screw portion reaches a first predetermined torque value, the first predetermined torque value corresponding to a first amount of force required to rotate the first plate and the second plate relative to each other.

[0141] Embodiment 18. The method of any one of embodiments 14-17, further comprising heating the first plate and the second plate, which are connected to one another via the screw portion, in one or more heating cycles.

[0142] Embodiment 19. The method of any one of embodiments 14 to 18, further comprising the step of re-tightening the screw body such that the torque applied to the screw reaches a second predetermined torque value, the second predetermined torque value corresponding to a second amount of force required to rotate the first plate and the second plate relative to one another.

[0143] Embodiment 20. The method of embodiment 19, wherein the first predetermined torque value is the same as the second predetermined torque value.

[0144] Embodiment 21. The method of any one of embodiments 18-20, wherein the first plate, the second plate, and the screw section are heated to a temperature ranging from about 250°C to about 270°C.

[0145] Embodiment 22. The method of any one of embodiments 14 to 21, wherein the step of installing the screw body into the screw slot and through-hole includes overtightening the screw body so that the torque applied to the screw portion reaches a third predetermined torque value, the third predetermined torque value corresponding to a third amount of force required to rotate the first plate and the second plate relative to each other.

[0146] Embodiment 23. The method of embodiment 22, further comprising heating the first plate and the second plate coupled to each other via the screw portion in one or more heating cycles, wherein the torque of the screw reaches a fourth predetermined torque value after the heating step, the fourth predetermined torque value corresponding to a fourth amount of force required to rotate the first plate and the second plate relative to each other, and the third amount of force is greater than the fourth amount of force.

[0147] Embodiment 24. A method for manufacturing a device for fixating bone, comprising the steps of: mating a first plate with a second plate, the first plate including a screw slot and the second plate including a through-hole portion corresponding to the screw slot; installing a screw into the screw slot and the through-hole portion; and striking the screw, the step of striking the screw causing at least partial deformation of at least one of the screw and a portion of the first plate or the second plate connected to the screw, thereby preventing the screw from backing out of the screw slot and the through-hole portion.

[0148] Embodiment 25 The method of embodiment 24, wherein the screw is made of a metallic material.

[0149] Embodiment 26. The method of any one of embodiments 24-25, wherein striking the screw comprises striking the screw using a compression tool.

[0150] Embodiment 27. The method of embodiment 26, wherein the compression tool includes an alignment guide and at least one punching pin, the screw includes a recess on its upper surface, and the step of striking the screw includes the steps of placing the alignment guide into the recess of the screw, thereby aligning the compression tool with the screw; and striking the screw at the joint of the screw and the first / second plate with at least one punching pin.

[0151] Embodiment 28. The method of any one of embodiments 24 to 27, wherein the screw comprises a set screw.

[0152] As used herein, "about," "approximately," and "substantially" are understood to refer to numbers within a numerical range, e.g., a range of -10% to +10% of the referenced number, preferably a range of -5% to +5% of the referenced number, more preferably a range of -1% to +1% of the referenced number, and most preferably a range of -0.1% to +0.1% of the referenced number. Moreover, these numerical ranges should be interpreted as providing support for claims directed to any number or subset of numbers within that range. For example, a disclosure of 1 to 10 should be interpreted as supporting a range of 1 to 8, a range of 3 to 7, a range of 1 to 9, a range of 3.6 to 4.6, a range of 3.5 to 9.9, etc.

[0153] Throughout the specification, references to "various aspects," "some aspects," "some examples," "other examples," "some cases," or "one aspect" mean that a particular feature, structure, or characteristic described in connection with that aspect is included in at least one example. Thus, the appearances of the phrases "various aspects," "some aspects," "particular embodiments," "some examples," "other examples," "particular other embodiments," "some cases," or "in one aspect" in various places throughout this specification do not necessarily all refer to the same aspect. Moreover, particular features, structures, or characteristics illustrated or described in connection with one example can be combined, in whole or in part, with features, structures, or characteristics of one or more other aspects, without limitation.

[0154] When a positional relationship between two parts is described using terms such as "above," "upper," "below," "under," and "adjacent," one or more parts may be positioned between the two parts unless those terms are used in conjunction with the terms "directly" or "directly." Similarly, as used herein, the terms "coupled," "attachable," "mounted," "connectable," "connected," or any similar term can include "directly or indirectly coupled," "directly or indirectly attachable," "directly or indirectly attached," "directly or indirectly connectable," and "directly or indirectly connected."

[0155] It should be understood that at least some of the figures and descriptions herein have been simplified to illustrate relevant elements for a clear understanding of the present disclosure, while excluding other elements for purposes of clarity. However, one skilled in the art will recognize that these and other elements may be desirable. However, because such elements are well known in the art and because they do not facilitate a better understanding of the present disclosure, a discussion of such elements is not provided herein.

[0156] The terminology used herein is intended to describe particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless otherwise indicated. It will be further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the terms "at least one of X or Y" or "at least one of X and Y" should be interpreted as X, or Y, or X and Y.

[0157] It should be understood that various changes and modifications to the examples described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims. [Explanation of symbols]

[0158] 80 bone plates 82 Movable joint 84 Plate member 86 Plate member 88 bones 90 Fasteners 92 Opening 93 Fracture 94 Movement Arrow 96 Movement Arrow 98 Deformable Elements 100 Connectors 120 Bone Plate 122a, 122b Hinge joint 124 End plate member 126 Center plate member 128 End plate member 130 Movement about a single pivot axis 132 Surface Marking 134a, 134b through hole section 136 tabs 138 Axial rod 140 Undercut Area 142 aperture 144 Retainer, head 145 Widened Area 146 Stop Area 148 Stop Area 150 stop area 152 Stop Area 160 Bone Plate 162 Upper Aperture 164 Lower Aperture 166 Locking member 168 internal thread 170 external thread 172 head 174 Wall area 176 Central through-hole 178 Bone Screw 182 Locking member 200 bone plates 202 Hinge Joint 204 Connector 206 Plate member 208 Plate member 210 complementary regions 212 complementary regions 214 Pivot axis 216 trucks 218 Flange 220 Undercut area 222 Aperture 224 aperture 226 threaded leading area 260 pivot axis 354 Complementary Rotational Mating Features 370 Bone Plate 372 Hinge Joint 374 Plate members 376 Plate Members 378 Connector 380 pins 382 Slots 386 head 388 Shaft 390 Opening 392 complementary mating features 394 Boss 396 Recess 398 Aperture 400 aperture 402 Fasteners 500 devices 510 First Plate 512 screw slot 514 Connector hole 516 Bone fastener hole 520 Second Plate 522 Through hole 523 internal thread 524 Connector hole 526 Bone fastener hole 530 Area of ​​overlap 535 Pivot axis 540 Hinge Joint 550 screw body 560 Screw 562 Non-threaded part 564 Threaded part 565 head 570 Insertion Part 572 Graspable Part 573 First end portion 574 Connection part 575 Second End Portion 600 equipment 610 First Plate 612 screw slot 614 Connector hole 620 Second Plate 621 first end portion 622 Through hole section 623 Second end portion 624 Connector hole 625 internal thread 626 Bone fastener hole 630 Area of ​​overlap 635 Pivot axis 640 Hinge Joint 700 screw 710 threaded part 720 Non-threaded part 730 recess 800 Auto Compressor 810 Casing body 812 first end portion 814 Second end portion 816 Opening 818 Internal protrusion 820 Hammer body 822 first end portion 824 Second end portion 826 Groove 830 first biasing device 840 Intermediate rod 842 First (Upper) Part 844 Second (middle) part 846 Third (bottom) part 850 second biasing device 860 Punching Rod 862 first end portion 864 Second end portion 865a, 865b Punching pins 867 Alignment Guide 868 Alignment Guide D1-1 Large diameter screw 560 D1-2 Diameter of the corresponding part of the internal thread 523 D2-1 Small diameter screw 560 D2-2 Diameter of the corresponding part of the internal thread 523 D3-1 Screw 560 pitch D3-2 Distance between the corresponding parts of the internal thread 523 D4 insert diameter 570 L1 Length of screw slot 512 L2: Length of the through-hole portion 522

Claims

1. 1. A method of manufacturing a device for bone fixation, comprising: mating a first plate with a second plate, the first plate including screw slots and the second plate including through-holes corresponding to the screw slots; installing a screw body into the screw slot and the through-hole portion, the screw body including a screw portion and an insertion portion, and the screw body being installed into the screw slot using the insertion portion of the screw body; removing the insert portion of the screw body, the screw portion remaining in the screw slot and the through-hole portion after the insert portion is removed; A method comprising:

2. 10. The method of claim 1, wherein the screw body is made of at least one of a polyetheretherketone (PEEK) material or a high molecular weight polyethylene (HMWPE) material.

3. The method of claim 1 , wherein the diameter of the insert portion is greater than the diameter of the screw portion.

4. 2. The method of claim 1, wherein installing the screw body into the screw slot and the through-hole comprises tightening the screw body so that a torque applied to the screw portion reaches a first predetermined torque value, the first predetermined torque value corresponding to a first amount of force required to rotate the first plate and the second plate relative to one another.

5. The method of claim 4, further comprising heating the first plate and the second plate coupled together via the screw portion in one or more heating cycles.

6. 6. The method of claim 5, further comprising the step of retightening the screw body such that the torque applied to the screw reaches a second predetermined torque value, the second predetermined torque value corresponding to a second amount of force required to rotate the first plate and the second plate relative to one another.

7. The method of claim 6 , wherein the first predetermined torque value is the same as the second predetermined torque value.

8. 6. The method of claim 5, wherein the first plate, the second plate, and the screw section are heated to a temperature in the range of about 250°C to about 270°C.

9. 2. The method of claim 1, wherein installing the screw body into the screw slot and the through-hole comprises overtightening the screw body such that a torque applied to the screw portion reaches a third predetermined torque value, the third predetermined torque value corresponding to a third amount of force required to rotate the first plate and the second plate relative to one another.

10. 10. The method of claim 9, further comprising the step of heating the first plate and the second plate coupled to one another via the screw portion in one or more heating cycles, wherein the torque of the screw reaches a fourth predetermined torque value after the heating step, the fourth predetermined torque value corresponding to a fourth amount of force required to rotate the first plate and the second plate relative to one another, and the third amount of force being greater than the fourth amount of force.

11. The method of claim 1 , wherein the through-hole portion includes an internal thread.

12. 12. The method of claim 11, wherein the major diameter of the screw portion is greater than the diameter of a corresponding portion of the internal thread.

13. 12. The method of claim 11, wherein the minor diameter of the screw portion is greater than the diameter of the corresponding portion of the internal thread.

14. 12. The method of claim 11, wherein there is a pitch mismatch between the screw portion and the internal thread.

15. The method of claim 1 , wherein the length of the screw slot is greater than the length of the through-hole portion, and the screw slot is curved.

16. 1. A method of manufacturing a device for bone fixation, comprising: mating a first plate with a second plate, the first plate including screw slots and the second plate including through-holes corresponding to the screw slots; placing a screw into the screw slot and the through-hole; striking the screw, the striking the screw causing at least partial deformation of at least one of the screw and a portion of the first plate or the second plate connected to the screw, thereby preventing the screw from slipping out of the screw slot and the through-hole portion; A method comprising:

17. The method of claim 16, wherein the screw is made of a metallic material.

18. 17. The method of claim 16, wherein striking the screw comprises striking the screw using a compression tool.

19. The compression tool includes an alignment guide and at least one punching pin, the screw includes a recess in an upper surface thereof, and the step of striking the screw includes: placing the alignment guide into the recess of the screw, thereby aligning the compression tool with the screw; striking the screw at a joint between the screw and the first / second plate with the at least one punching pin; 20. The method of claim 18, comprising:

20. The method of claim 19, wherein the screw comprises a set screw.

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