# Patent

## Title
Bone plate shaping system

## Abstract

Removable guide tips are pre-assembled into threaded holes of a fracture fixation plate. The guide tips may be used with or without drill guides to guide a drill along the axes of threaded holes defined in the plate. In addition, the tips may be used with bending tools to contour the plate laterally, longitudinally and with twist. More particularly, such plate contouring can be performed while the plate is located on the bone.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. Ser. No. 11/459,824, filed Jul. 25, 2006 now U.S. Pat. No. 7,935,126, which is a continuation-in-part of U.S. Ser. No. 11/384,841, filed Mar. 20, 2006, now U.S. Pat. No. 7,771,433, both of which are hereby incorporated by reference herein in their entireties.


BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to surgical devices. More particularly, this invention relates to orthopedic implants, and specifically to elements to implant and shape a bone plate.
2. State of the Art
Alignment and fixation of a fracture are typically performed by one of several methods: casting, external fixation, pinning, and plating. Casting is non-invasive, but may not be able to maintain alignment of the fracture where many bone fragments exist. Therefore, as an alternative, external fixators may be used. External fixators utilize a method known as ligamentotaxis, which provides distraction forces across the joint and permits the fracture to be aligned based upon the tension placed on the surrounding ligaments. However, while external fixators can maintain the position of the wrist bones, it may nevertheless be difficult in certain fractures to first provide the bones in proper alignment. In addition, external fixators are often not suitable for fractures resulting in multiple bone fragments. Pinning with K-wires (Kirschner wires) is an invasive procedure whereby pins are positioned into the various fragments. This is a difficult and time consuming procedure that provides limited fixation if the bone is comminuted or osteoporotic.
Plating utilizes a stabilizing metal plate typically placed against the bone, fixed-angle fasteners (which may have threaded or non-threaded shafts) positioned through the plate and entering drilled holes adjacent an articular bone surface, and cortical screws extending from the plate into holes drilled in the bone to provide stabilized fracture fixation. For example, co-owned U.S. Pub. No. 20040193164 A1 to Orbay, which is hereby incorporated by reference herein in its entirety, discloses a plate particularly adapted to treat dorsally displaced metaphyseal fractures from the volar side of the wrist.
When fixed-angle fasteners are utilized in conjunction with a bone plate, it is necessary to ensure that the pilot holes drilled for the fasteners are co-axial with the hole axes. Otherwise, the shaft of the fasteners will not properly align with the anatomy, and the head of the fasteners will not properly align with the threaded holes of the plate, potentially resulting in cross-threading. As a result, with the plate placed upon the bone, prior to drilling each hole in the bone in alignment with a threaded hole, a drill guide is attached to the plate at the threaded hole. The guide defines a tubular passage which directs the drill bit in the proper orientation for a fastener through the particular threaded hole. After drilling each hole, the drill guide is removed, the fastener is inserted in the threaded hole, and the drill guide is coupled to a subsequent threaded hole.
The process of attaching the drill guide during the surgical procedure is laborious. It can be difficult to locate the appropriate angle for threadably coupling the guide to the peg hole during the procedure, given that each threaded hole may have a discrete axis angle from the other threaded holes. Such difficulty can unnecessarily prolong the surgical procedure.
Fragment plates are commonly used to fixate fractures along a bone, e.g., along the diaphysis or at specific diaphyseal-metaphyseal or metaphyseal locations. Such plates are generally elongate, L-shaped, Y-shaped or have another shape which is suited for placement on a portion of a bone. The plates can be of varying length depending upon the intended fixation application. When fragment plates are provided with threaded holes they are subject to the same practical labor intensity for use as presented above with respect to the volar plate; i.e., it is laborious to attach a drill guide at each threaded hole for drilling a hole in alignment with the axis of the hole for receiving the fixed angle fastener therethrough.
In addition, the anatomy for which the fragment plates are designed often differs from the exact contours of the bone contacting surfaces of the plates. Some fragment plates have been designed to be shaped away from the bone for a better anatomical fit. However, presently available plating systems are not well adapted for in situ reconfiguration. Therefore, it has been necessary to shape a plate off the target bone with bending tools, remove the bending tools, place the plate in position on the bone to which the plate will eventually be attached, approximate the additional amount of reconfiguring required, remove the plate, and repeat the process until the plate approximately conforms to the shape of the bone. Moreover, in order to best fit the anatomy a plate may need to be re-contoured along three axes, and it has been difficult to transfer the contours of the anatomy to a stiff metal plate, especially when such reshaping is done at a distance from the bone.
Moreover, the problems with shaping a plate are compounded when the plate has threaded holes for receiving fasteners. In distinction from non-fixed angle fragment plates, inserting bending tools into the threaded holes of the plate and applying a force to the plate with the bending tools may distort the threads making such holes unaccepting to their threaded fasteners.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to facilitate the drilling of holes in bone in alignment with the threaded holes in a bone plate.
It is another object of the invention to obviate the difficulties presented in connecting a drill guide in alignment with a threaded fixed angle hole in a bone plate at the time of surgery.
It is also an object of the invention to provide a system to reshape a plate while the plate is located on the bone.
It is a further object of the invention to provide a system which permits reshaping of the plate in three dimensions.
It is yet another object of the invention to provide a system which protects the threads of fixed angle holes during plate reshaping.
In accord with these objects, which will be discussed in detail below, drill guide tips are pre-assembled into at least one and preferably each of the threaded holes of the plate, so that the surgeon does not have to thread the drill guide with the plate positioned on the bone. The pre-assembly can be done by the operating room technician or at the factory. The drill guide tips may be reusable or disposable. The tips are sufficiently short that they do not interfere with adjacent tips or adjacent structure on the plate or intended to be inserted through the plate.
In a preferred method of pre-assembling the tips to the plate, a nest of short pins is placed beneath the plate such that the pins extend through the holes in the plate along the same angles as the axes of the holes. The pins then guide the tips to be threaded into the holes at the correct angle. Alternatively, no nest is utilized and the tips are individually guided into the holes at the appropriate angle. With respect to a fragment plate, such angle is typically normal to the bone contacting surface of the plate.
There are two options for using the tips as drill guides. One is to attach a drill guide extension. The tip and extension together function as a conventional drill guide. After drilling, the extension is used to remove the tip from the plate. According to another use, the tip is used as a guide for a drill bit without any additional extension and then removed with a separate tool.
In addition, the guide tips have purpose other than for guiding a drill. The guide tips can also be used in conjunction with plate bending tools, and are particularly advantageous when the guide tips are pre-assembled on a fragment plate having a plurality of spaced apart fixed angle holes separated by a plate portion which can be deformed under force. Preferably two bending tools are used together to bend the plate, and the bending tools have first and second ends which are at least partially inserted into guide tips in two holes in the plate. Torque is applied by coupling the first ends of each of the tools to the guide tips inserted in threaded holes and manipulating the tools, lateral bending forces (i.e., bending within the plane of the plate) are applied with the second ends in the guide tips, and longitudinal bending forces are applied with the first ends or a combination of the first and second ends in the guide tips. The bending tools can be operated and forces can be applied to reshape the plate with the plate positioned directly on the bone to reshape the plate in close conformance to the bone surface. As the plate is shaped at each set of two holes, bending tools are removed and the guide tips can be used as discussed above as drill guides to drill holes into bone beneath that portion of the plate. Fixed angle screws are then used to couple that portion of the fragment plate to the bone. The adjacent portion of the plate is then shaped and fixed to the bone in a like manner with the process repeated until the entire plate is shaped and coupled to the bone.
Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a bone plate and a drill guide tip being inserted or removed from the plate with a tool;
FIG. 2 is an exploded perspective view of drill guide tip and tool;
FIG. 3 is a perspective view of the bone plate loaded with drill guide tips and K-wires;
FIG. 4 is a front end view of a head portion of the plate showing that the drill guide tips do not protrude through the bottom surface of the plate;
FIG. 5 is a perspective view of a drill guide tip and drill guide extension;
FIG. 6 is a side elevation of a first embodiment of a drill guide tip;
FIG. 7 is a top view of the first embodiment of the drill guide tip;
FIG. 8 is a side elevation of a second embodiment of a drill guide tip;
FIG. 9 is a side elevation view of an embodiment of a drill guide extension;
FIG. 10 is a top view of a third embodiment of a drill guide tip;
FIG. 11 is a side elevation of a fourth embodiment of a drill guide tip;
FIG. 12 is a bottom view of an embodiment of a drill guide extension engageable with the drill guide tip of FIG. 11;
FIG. 13 is an exploded side elevation view of a fragment plate with guide tips;
FIG. 14 is an exploded perspective view of the fragment plate and guide tips of FIG. 13;
FIG. 15 is a set of benders, shown in side elevation and perspective view;
FIG. 16 is a top perspective view of the benders imparting a bend along an x-axis to impart a twist to the fragment plate along its longitudinal axis;
FIG. 17 is a perspective view of the benders imparting a bend along a y-axis to impart a lateral bend to the fragment plate;
FIG. 18 is an enlarged view similar to FIG. 17;
FIG. 19 is a side elevation view of the benders imparting a bend along a z-axis to impart a longitudinal bend to the fragment plate;
FIG. 20 is a perspective view of a fragment plate provided with another embodiment of a guide tip;
FIG. 21 is a top perspective view of the guide tip shown on the plate in FIG. 20;
FIG. 22 is a bottom perspective view of the guide tip shown on the plate in FIG. 20;
FIG. 23 is a side elevation of an assembly of FIG. 20 with another embodiment of bender;
FIG. 24 is a broken bottom view of the assembly of FIG. 23;
FIG. 25 is a broken bottom perspective of the bender shown in FIG. 23;
FIG. 26 is a broken perspective view of the assembly of FIG. 23, shown applying a bend along the y-axis to a bone plate;
FIG. 27 is a broken bottom view showing the benders applying a bend along the y-axis to the bone plate;
FIG. 28 is a top view of the plate with bend in the y-axis applied;
FIG. 29 is an end view of the plate, guide tip, and bender assembly, with the benders applying a bend along the x-axis to the bone plate;
FIG. 30 is a broken side elevation of the assembly of FIG. 29 in which the benders are applying a bend along the z-axis to the bone plate;
FIG. 31 shows a single bender applying a plate bend along the z-axis;
FIG. 32 shows a single bender applying a plate bend along the y-axis;
FIG. 33 is a broken side elevation of the assembly of the benders being used from the bottom of the plate to apply a bend along the z-axis to the bone plate;
FIG. 34 is a side elevation of an assembly of another plate with guide tips, being bent along the x-axis by the benders;
FIG. 35 is a side elevation of the assembly of FIG. 34, in which the plate is further bent along the y-axis by the benders;
FIG. 36 is another plate according to the invention in the form of a volar T-plate; and
FIG. 37 is another plate according to the invention in the form of a clavicle plate.



DETAILED DESCRIPTION
Turning now to FIG. 1, a bone plate 10 is shown. The bone plate 10, and all plates described herein, includes inner or lower (bone-facing) and outer or upper (bone-opposing) surfaces 10a, 10b. One or both of these surfaces may be contoured generally to follow a surface of a target bone (or bones) for which the bone plate is intended, so that the bone plate maintains a low profile and fits onto the bone(s). For example, the inner surface 10a of the plate may be generally complementary in contour to the bone surface. The outer surface 10b may correspond in contour to the bone surface and may be generally complementary to the inner surface of the plate.
Bone plate 10 shown is particularly for placement over the volar side of the distal radius. The bone plate 10 includes a plurality of threaded peg holes 12 for threadably receiving the heads of pegs or locking screws (not shown) therein and relatively smaller alignment holes 14 sized to closely receive K-wires in a fixed angle orientation. In a preferred bone plate, the axes of the peg holes are all oblique relative to each other. In one of the peg holes, a drill guide tip 16 is shown being pre-assembled into the hole with an insertion tool 18. Referring to FIGS. 1 and 2, in a preferred embodiment, the engagement between the insertion tool 18 and tip 16 is a tapered square 20 engaging a circular opening 22, with the edges of the square driver providing sufficient frictional force to rotate the tip into and out of engagement with the plate 10. Other suitable engagements may be used as well.
Pre-assembly of the tips 16 into the peg holes of the plate 10 is preferably performed so that the surgeon does not have to thread the drill guide tips 16 with the plate once the plate 10 is positioned on the bone during the procedure. The pre-assembly can be done by the operating room technician or at the factory. In a preferred method of pre-assembly, a nest of short pins 24 is placed beneath the plate such that the pins extend through the holes in the plate along the same angles as the axes of the holes. The pins 24 then guide the tips to be threaded into the holes at the correct angle. With respect to a fragment plate, such angle is typically normal to the bone contacting surface of the plate. The pins 24 and insertion tool 18 are sized such that they do not interfere with each other. Alternatively, no nest is utilized and the tips 16 are individually guided into the holes at the appropriate angle. The drill guide tips 16 may be reusable or disposable.
Referring to FIGS. 2 and 3, the tips 16 have a frustoconically tapered upper portion 30 and lower threaded portion 32, and are sufficiently short so that they do not interfere with adjacent tips, adjacent structure on the plate, or structure intended to be inserted through the plate, e.g., K-wires 50 through alignment holes 14. Alternatively, the upper portion 30 may be cylindrical. The lower threaded portion 32 of the tips does not have to be as long as conventional drill guides, as the threading into the plate is done away from the surgical environment under easier conditions, whether at the factory (best case) or pre-implantation at the medical facility. Shortening the threaded portion reduces protrusion of the guide tip below the plate relative to convention drill guides, allowing the plate 10 to sit closer to the bone while drilling, as discussed further below.
The drill guide tips also eliminate the need to “countersink” holes for a drill guide for the distal row of holes in a distal radius plate. More particularly and for the following reasons, in the prior art it is initially necessary to drill holes in bone through the distal row of threaded peg holes with a drill bit larger than the diameter of the peg shaft which will eventually be inserted through the peg holes. The plate is very thin at the distal row. The prior art drill guide has a “nose” section which is cylindrical and unthreaded and approximately 0.030′′ long, which is slightly longer than the pitch of the peg-hole thread (0.023′′). The nose section diameter is just under the inner diameter of thread so that it guides itself with one full turn of the thread and establishes the direction of the hole before the threads are engaged. If the plate thread depth is very small (as is the case for distal holes) there is no room below the plate for the nose section of the drill guide because the bone blocks entry. Thus, countersink holes must be drilled.
In accord with the invention, the drill guide tips do not require a “nose” section since they will be assembled with some other guidance (e.g., the above described nest of pins 24) or freehand. The drill guide tips can be made very short since they need just to hold on to the threads of the peg holes of a distal radius plate. One and one-half threads of engagement has been shown to provide a satisfactory coupling of the tip to the plate, and referring to FIG. 4 provides that the drill guide tip 16 does not protrude through the bottom 52 of the plate 10. In addition to eliminating the requirement for countersinking, the fact that drill guide tips are so short results in the plate seating almost completely flush on the bone. Furthermore, the cylindrical unthreaded nose portion of the conventional drill guide, whose only job is to help the surgeon find by feel the current angle of the peg hole, is not required. A preferred size for each tip is preferably approximately 0.150-0.250 inch in length and certainly less than one inch. As such, the tip extends a short distance (maximum one inch and preferably not more than 0.25 inch) above the upper surface (the surface opposite the bone contacting surface) of the plate.
There are two options for using the tips as drill guides. According to a first option, the tips 16 are used as the sole guide for a drill bit and then removed with a tool similar to the insertion tool 18. The length of the tips provides sufficient guidance for the drill bit. In this use, the inner surface of the tip is preferably hard, e.g., metal. Thus, the tips 16 may be made entirely of metal or have an outer plastic body with an insert molded metal tube, e.g. hypotube, which is hard and readily available with thin walls.
Referring to FIG. 5 and according to a second option, a drill guide extension 34 may be attached to the top of the tip 16. The tip 16 and extension 34 together function as a full length drill guide. The engagement between the drill guide extension 34 over the tip 16 is preferably such that a continuous constant diameter path is provided through the interiors of the extension and tip. To that end, the end 36 of the extension 34 is preferably stepped to fit the upper portion of the tip. The surgeon drills through the drill guide extension and tip, thereby taking advantage of the longer guidance which may be used in conjunction with a scale and/or gauge to measure the depth of the drilled hole for peg length selection. After drilling, the extension 34 and tip 16 are removed from the plate 10, and the extension 34 may also function as a tool for tip 16 removal. In fact, the taper at the upper portion 30 (FIG. 2) of the tip provides a means for axial and frictional engagement by the extension 34 which permits rotational engagement. Once removed from the plate, the tip is then is pulled of the extension by hand or may be dispensed into a container without manual contact.
It is desirable to have some provision within the surgical set to collect the tips for counting as they are removed; i.e., to ensure that all tips from the plate are removed from the surgical site. In order to facilitate collection of the tips, it is desirable that the drill guide tips have a very conspicuous color, e.g., green or blue. If made out of metal, it may be desirable to make them out of titanium or aluminum and anodize them in a bright color that contrasts with the background in the surgical wound and the bone plate. A specialized container may be provided, or a dummy plate with threaded holes may be used to attach the tip thereto.
For drilling through the tips 16 where no drill guide extension is used, it may be desirable to modify the flutes of the drill bit, e.g. shortening and/or increasing twist, to reduce the play within the tip.
Other embodiments of the tips and extensions may be provided. For example, referring to FIGS. 6 and 7, the tips 116 may have an upper portion 130 with an exterior hex shape, or any non-circular exterior cross-sectional shape that will facilitate torque transmission. To remove the tip from the plate the surgeon rotates the extension, unthreading the tip.
Turning now to FIGS. 8 and 9, according to another embodiment of the invention, the tips 216 may be joined to the extension via one or more lateral protrusions 240 on the body 230 of the tip and corresponding “key slots” 242 in the extension 234.
Referring to FIG. 10, according to a further embodiment of the invention, the tips 316 may be joined to the extension by providing one or more corners 344 to the inner circular opening 322 of the tip, and one or more outer corresponding corners on the extension which frictionally engage in the tip.
Turning to FIGS. 11 and 12, according to another embodiment of the invention, the tips 416 may include upper radially arranged slots 446 (e.g., 180° or 120° separation) and the extension 434 includes corresponding radially arranged pegs 448 which engage the tips 416 at the slots 446.
Turning to FIGS. 13 and 14, the tips can also be used to facilitate bending of a fragment plate 500 in a manner that does not distort the threads at the holes 502 at which the tips 516 are coupled, as described below. The tips 516 are cylindrical having inside corners (similar to corners 344 in FIG. 10) to aid removal and/or extension guide coupling. Such distortion would otherwise prevent the holes 502 from accepting fixed angle fasteners with threaded heads which are later threadably coupled into the threaded holes.
Bendable plates, as described in more detail below, according to the invention may have at least one, and generally two or more, distinct anchor (or bone-attachment) portions including a threaded hole and at which the plate is configured to be secured to bone. Each anchor portion may be structured for a specific portion of a bone, generally to fit against a surface region of a specific or general bone. For example, the bone plate may include a proximal anchor portion for attachment to a more proximal region of a bone, and a distal anchor portion for attachment to a more distal region of the same bone. In some embodiments, the bone plates may include a support (or buttress) portion connected to an anchor portion. The support portion may lack connective features that permit a direct connection of the support portion to the bone with one or more fasteners. Such a support portion may limit movement of a bone fragment using contact between the support portion and the fragment, and may include projections or prongs to engage the fragment more effectively.
The bone plates described herein may be configured for use on any suitable bone of the human body and/or of another vertebrate species. Exemplary bones may include bones of the arms (radius, ulna, humerus), legs (femur, tibia, fibula, patella), hands, feet, the vertebrae, scapulas, pelvic bones, cranial and mandibular bones, the ribs and/or the clavicles, among others.
The fragment plate 500 is generally elongate, preferably designed with a series of alternating round anchor portions 504 and relatively narrower bridge portions 506 that connect the anchor portions together. The anchor portions 504 have a diameter DA and a height HA, and the bridge portions 506 have a length LB, a width WB, and height HB. By way of example, and not by limitation, the following dimensions are provided for a plate for use on a radius bone: diameter DA=0.22 inch, HA=0.060 inch, LB=0.065 inch, WB=0.085 inch, and HB=0.50 inch. To maintain structural integrity and desired stiffness, while facilitating bendability, the length LB of each bridge portion is preferably less than one half, and more preferably less than forty percent, of the anchor diameter DA. The plate includes an inner (bone-facing) surface 512 and an outer (bone-opposing) surface 514. In use, a long axis Ap defined through the plate 500 may be aligned with the long axis of a corresponding bone or may extend obliquely or transversely relative to the long axis of the bone. The dimensions of the anchor and bridge portions 504, 506, and the number of anchor and bridge portions, may be varied according to the intended use, for example, to match the plate with a preselected region of bone(s) and/or to a particular injury to the bone. The plates may be generally linear for use on the shaft of a long bone or may have a nonlinear shape, such as for use near an end of a bone. For example, the plate may be generally T-shaped, with a longer axis for attachment to a shaft portion of a bone, and a transverse portion connected to the longer axis portion, to provide a wider platform for attachment near an end of the bone. Also, by way of example, the transverse portion may be of a different construct, e.g., a plate portion without any bridge portions but multiple threaded holes, as shown in FIG. 1. The plate may also be Y-shaped. In some embodiments, each bone plate may be configured for use on both sides of the body, such as when the bone plates are bilaterally symmetrical. In some embodiments, each bone plate may be asymmetrical and configured for use on either the left or the right side of the body.
Threaded holes 502 are provided in the anchor portions 504, and preferably each threaded hole 502 is provided with a guide tip 516. However, the tips may be strategically pre-assembled at locations that are recognized to commonly benefit from contour shaping for the plate 500 depending on the shape of the plate and to best fit on the bone.
Referring to FIG. 15, two preferably identical plate benders (shaping tools) 550a, 550b have ends which can be coupled to the tips 516 and can be used alone or together to contour the plate 500 (FIGS. 13 and 14). As described in more detail below, the benders 550a, 550b and tips 516 permit such plate contouring to occur with the plate 500 positioned directly on the bone. Each tool, described with respect to tool 550a, includes a handle portion 552a and first and second ends 554a, 556a which can be at least partially inserted into the guide tips 516. The first end 554a includes a preferably axially directed (or preferably at least directed generally parallel to the longitudinal axis AL of the handle portion 552a) peg element 558a which closely corresponds in size to the inner diameter of a guide tip 516. The second end 556a is provide with four peg elements 560a, 562a, 564a, 566a, with two such pegs extending transversely to the longitudinal axis AL of the handle on each side 568a, 570a of the second end 556a. At one such side 568a, the endmost peg element 560a closely corresponds in size to the inner diameter of a guide tip 516 and the inner peg element 562a has a stepped down nipple portion 572a, whereas on the opposite side 570a of the second end the endmost peg element 564a has a stepped down nipple portion 574a stepped down in diameter and the inner peg element 566a closely corresponds in size to the interior of the guide tip 516. All the peg elements are preferably generally cylindrical, but may be polygonal or slightly tapered.
As described as follows, the benders 550a, 550b can be coupled to a fragment plate at the guide tips 516 to apply torque, lateral and longitudinal bending forces to contour the plate; i.e., to bend the plate along x-, y- and z-axes. In the present embodiment it is preferred that the benders be coupled at adjacent guide tips for localized control of plate shaping. The plate is then shaped through a series of shaping steps in which adjacent portions of the plate are sequentially shaped, as needed. Additionally all such shaping, as also discussed further below, can be performed while the plate is positioned on the bone.
Referring to FIG. 16, in order to apply torque to the plate to cause the plate to twist, the peg elements 558a, 558b (FIG. 15) at the first ends 554a, 554b of the benders 550a, 550b are inserted into preferably adjacent guide tips 516a, 516b. The handle portions 552a, 552b of the benders are then forced laterally relative to each other so as to apply a torque along the bridge portion 506 of the plate between the benders. Such torque results in defining a twist in the plate without deformation to the threaded holes to bend the plate along the x-axis.
Referring to FIGS. 17 and 18, lateral bending forces (i.e., bending within the plane of the plate) are applied with the second end 556a, 556b of the benders 550a, 550b coupled to the guide tips 516a, 516b, and then manipulating the benders to bend the plate about the y-axis. Referring to FIG. 18, more particularly, on bender 550a, peg element 566a (see FIG. 15) is inserted into guide tip 516a and the nipple portion 574a of peg element 564a functions as fulcrum (rotational stop) against the bridge portion 506a of the plate to transfer rotational forces applied by the handle portion 552a of bender 550a. On bender 550b, peg element 560b (not shown, see FIG. 15) is inserted into guide tip 516b and the nipple portion 572b of peg element 562b functions as a fulcrum (rotational stop) against the bridge portion 506b of the plate to transfer rotational forces applied by the handle portion 552b of bender 550b. As benders 550a, 550b are operated together, the resulting force subjects the plate to lateral bending at the bridge portion 506a located between the plate portions 504a, 504b at which the guide tips are coupled.
Referring to FIG. 19, longitudinal bending forces are applied by inserting the peg element at the first end 554a of bender 550a into guide tip 516c and a peg element, e.g. peg element 560b, at the first 554b or second ends 556b (shown) of the second bender 550b into the guide tip 516d. With the second end 556b coupled at guide tip 516d, the handle portion 552b thereof can be stabilized relative to the bone. The handle portion of tool 550a is then manipulated to bend the plate 500 at the bridge portion 504 between the two benders to bend the plate relative to the z-axis.
It is also appreciated that a single bender can be used to shape the plate once at least a portion of the plate is fixed relative to the bone. Such is described in more detail below with reference to another embodiment of a bender.
Because the benders are not coupled at any locations below the surface of the plate nor do they have any portion which would otherwise interfere with the bone or bone contacting surface, plate shaping can occur directly on the bone. In one method of operation, a hole is first drilled through a guide tip at an end of the plate. The guide tip is then removed and a threaded fastener is inserted through the threaded hole of the fragment plate and into the drilled hole to couple the plate to the bone. The benders are then worked along the plate, moving hole by hole away from the first coupled hole to shape the plate to the bone as described above. As the plate is shaped at each hole, if needed, a hole is drilled through the respective guide tip, the guide tip is removed and a threaded fastener is inserted to hold the plate to the bone. One or both of the benders are then moved to subsequent holes along the plate for shaping until the plate is fully contoured and coupled to the bone. In another method, after the plate is coupled to the bone at an end, the plate is shaped along its entire length prior to coupling to the bone at remaining holes. In yet another embodiment, the plate may be shaped to the bone before it is attached at any screw hole. It is recognized that other variations on shaping and coupling can be used.
Turning now to FIG. 20, a shapeable bone plate 600 is shown with another embodiment of the guide tips 616. The plate is substantially as described above with respect to plate 500, including an alternating arrangement of anchor and bridge portions 604, 606. Each anchor portion 604 is preferably curved along a constant radius for at least 100° adjacent its adjacent bridge portion, and more preferably approximately 120°, for cooperation with another embodiment of a plate bending tool 650a, 650b, described hereinafter.
Referring to FIGS. 20 through 22, the guide tips 616 each have a first end 618 assembled in a threaded hole in the anchor portion 604, a second end 620 extending above an outer surface 614 of the anchor portion, and a circumferentially extending shoulder 622 disposed between the first and second ends, and preferably in contact with outer surface 614 of the plate 600. The shoulder 622 doubles the load carrying capacity of the guide tips 616 relative to the prior guide tips by reducing the load carrying from the thread/thread interface and transferring load carrying to the shoulder/plate interface. The second end 620 of the guide tip 616 preferably extends no more than 0.5 inch, and more preferably is located not more than approximately 0.25 inch above the outer surface 614 of the anchor portion.
Referring to FIG. 23, a pair of plate benders 650a, 650b is shown coupled to adjacent anchor portions 604a, 604b of the plate 600. The plate benders 650a, 650b each include a first end 652a, 652b, a second end 654a, 654b, and a handle 656a, 656b extending therebetween, with the respective handles 656a, 656b preferably extending in generally opposing directions. Referring to FIGS. 23 through 25, the first end 652a defines a socket 660a sized to closely receive a guide tip 616, and means for rotationally fixing the first end 652a relative to a portion of the bone plate 600, such as the bridge portion 606. In a preferred embodiment, the means for rotationally fixing the first end relative to the bone plate are two feet 662a, 664a that straddle the bridge portion 606 of the bone plate. The two feet 662a, 664a include curved inner surfaces 666a, 668a that seat about the radiused portions 670, 672 of the anchor portion 604a to quickly and easily align the bender 656a on the plate. The feet 662a, 664a each have a toe end 674a, 676a that abuts the bridge portion 606 at an optimal location to function as a fulcrum for the bender. Referring back to FIG. 23, the second ends 654a, 654b of the benders define pegs 678a, 678b that are cylindrical and that step down in diameter from the adjacent portion of the handle. The handle 656a, 656b is preferably L-shaped and extends between the respective first and second ends. Each handle, e.g., 656a, includes a first longitudinal axis A1 extending through its first end 652a and an adjacent portion of the handle and a second longitudinal axis A2 extending through the second end 654a and its adjacent portion of the handle. The handle 656a is preferably bent to offset the two axes relative to each other. Most preferably, the socket 660a at the first end 652a is offset relative to the second axis A2 by at least approximately 0.25 inch, more preferably at least 0.5 inch (to provide for guide tip and tissue clearance), but preferably by not more than approximately 3 inches (to maintain handle stability and control). It is noted that the benders 650a, 650b are preferably identical with the exception that the handles are bent in opposite directions from each other. The handles are coupled to the plate such that the longitudinal axis A1 of each handle overlies the respective longitudinal axis of the plate portions surrounding the plate segment which is to be bent. An exception is provided at the anchor portion 604a at the end of the plate, where the appropriate bender should be coupled so that the handle extends outward from the plate, rather than over the plate.
The plate 600 is generally bent so that its inner surface 612 thereof approximates the shape of the bone surface generally in the manner described above. More particularly, referring to FIGS. 26 and 27, a bend in the y-axis may be imparted to the plate at the bridge 606 between anchor portions 604a, 604b to which the benders 650a, 650b are coupled by applying a relative rotational force. In imparting such a bend, the feet 662b, 664b of bender 650b stabilize anchor 604b, while the toe 674a of foot 662a functions as a fulcrum and the inner surface 668a of the opposite foot 664a applies the force to the anchor portion 604a to impart the desired bend. Without relocating the bender, force could be applied in an opposite rotational direction and the opposite feet would perform reverse functions. Each foot also functions as a stop to limit angular displacement to approximately 40°. The ‘stop’ function is effected in that the toe end of the foot operating as a fulcrum contacts the adjacent anchor portion after approximately 40° of angular displacement and limits any further angular movement of the anchor portions relative to each other. FIG. 28 shows the plate 600 with a lateral bend imparted between anchor portions 604a and 604b after the benders have been removed from the plate.
In addition, the pegs 678a, 678b at the second ends of the benders can be inserted into the guide tips 616 at preferably adjacent anchor portions and can be manipulated to bend the plate relative to x- and z-axes; i.e., to impart torque and a resulting twist to the plate (x-axis displacement) and to longitudinally bend the plate up and/or down (z-axis displacement). FIG. 29 shows the benders 650a, 650b imparting a twist to the plate 600; i.e., to rotate anchor portion 604a in the x-axis relative to anchor portion 604b. It is appreciated that the benders may similarly be used to bend the plate along the z-axis.
However, it is also recognized that the benders could possibly interfere with each other when the necessary z-axis bend requires moving the benders toward each other in the same plane. Referring to FIG. 30, one way to overcome any potential interference is to move the benders 650a, 650b out of plane, but this may impart an x-axis twist to the plate 600, which could be undesired. Turning to FIG. 31, one solution when working in from the end of the plate (the ends of which are already fixed to the bone 680 by screws 682) is to use a single bender 650a to impart a bend along the z-axis. Similarly, referring to FIG. 32, a bend along the x-axis can likewise be imparted. Referring to FIG. 33, another solution is to insert the pegs 678a, 678b (FIG. 23) of the benders into the guide tips 616 from the bottom 612 of the plate and then manipulate the benders 650a, 650b away from each other to effect a bend about the z-axis without any bend about the x-axis. While it is recognized that the plate cannot be coupled to the bone during this type of bending, it nevertheless may be desirable to make certain gross contour adjustments with the plate located off the bone, e.g., prior to applying the plate to the bone.
In most instances, it is preferred that the bridge portion of the plate be substantially narrower than the anchor portion to facilitate bending, particularly a lateral bend along the y-axis. Nevertheless, it is appreciated that plates with smaller ratios of anchor to bridge widths can also be bent and shaped using the guide tips and tools described herein, and there are circumstances where an overall relatively stiffer plate may be desirable. For example, referring to FIGS. 34 and 35, a Y-shaped plate 700 with such a smaller ratio is shown first being torqued along the x-axis to impart a twist (FIG. 34) and then being bent along the z-axis to impart a longitudinal bend (FIG. 35) in accord with the methods described above. In such a stiffer plate 700, it is preferable to position the benders 650a, 650b in guide tips that are spaced apart by at least one threaded hole.
Also, while shapeable plates described above have a construct of alternating anchor and bridge portions, it is recognized that hybrid plates may be provided that have both shapeable and relatively stiffer non-shapeable portions. Such plates are anticipated to be fracture specific and are rigid where the anatomy is relatively constant in contour across patients and shapeable where there may be individual variations in bone surface anatomy. For example, referring to FIG. 36, a volar T-plate 800 is shown in which the axial shaft portion 802 is shapeable and provided with guide tips 816. In addition, the relatively transverse head portion 803 is substantially non-shapeable, with the exception of an anchor portion 804 coupled by a bridge 806 to the remainder of the head portion 803. The anchor portion 804 is thus adapted to be shaped relative to the rest of the head portion to direct a fastener toward the volar marginal fragment. Preferably all the holes in the head portion are provided with guide tips 817. Guide tips 816 and 817 may be different sizes to accommodate relatively different diameter threaded holes in the respective portions of the plate. When the guide tips are removed from the head portion 803 and subchondral supports 818 (e.g., threaded pegs or screws) are inserted into the threaded holes therein, any load on the subchondral supports is transferred back to the axial shaft portion 802 of the plate 800. The same principal can be applied to other metaphyseal plates. By way of another example, a clavicle plate 900 is shown in FIG. 37. The clavicle plate 900 has a relatively rigid non-shapeable central portion 902, and end portions 903 that are shapeable. The same principal can be applied to other diaphyseal places.
There have been described and illustrated herein several embodiments of a bone plate with pre-assembled guide tips, benders for use with a plate with guide tips, and methods of using the same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while the tips and benders have been shown with respect to a volar plate for dorsally displaced fractures and several fragment plates, it will be appreciated that the tips may be used in conjunction with threaded holes on other bone plates as well. For example, the tips may be used in conjunction with any plate for which they would provide advantage. In addition, one or more benders may be used to customize a fracture fixation plate for other bones, e.g., the clavicle, the ulna, the olecranon, the jaw, the skull, whether such plates are pre-formed flat or contoured to fit the anatomy. Furthermore, a distal radius plate having radial and ulnar sides provided with threaded fixed angle holes, the radial and/or ulnar sides being provided with guide tips and being shapeable with the benders, is considered within the scope of the invention. Also, a distal radius plate having shapeable segment(s) for capturing a volar marginal fragment is also within the scope of the invention. Optionally, such shapeable segment(s) may be removable from the plate if not used, e.g., by repeated bending, and provide a relatively clean break with the plate. In addition, while particular engagements between the tips and the insertion/removal tool and the tips and drill guide extension have been disclosed, it will be understood that other suitable engagements, including non-destructive press-fit, snap-in, bayonet lock, etc. can also be used. Also, while the guide tips are described as threaded into the threaded holes, it is appreciated that non-threaded assemblies, including non-destructive press-fit, snap-in, bayonet lock, etc., which maintain the tips in alignment with the axes of the peg holes can also be used. While different benders have been shown, each can be used with multiple embodiments of the guide tips. With respect to the benders with multiple peg elements, preferred orientations of the peg elements have been described, but other configurations are possible within the scope of the invention. For example, the four peg elements can be located two each at, e.g., 90° apart. In addition, such benders may only have two peg elements at a second end, each with a different configuration of larger and smaller size peg elements. Furthermore, while it is preferred to work a plate for shaping by coupling the benders at guide tips at adjacent holes, it is appreciated that not all holes of a shapeable plate need be provided with a guide tip and that the benders may be used relatively more spaced apart along the plate regardless of whether all holes of a shapeable plate include guide tips. Moreover, while it is preferable that the plate be coupled to be bone with bone screws while it is shaped relative to the bone, it is appreciated that the plate may be coupled to the bone with temporary fixation, such as with one or more clamps, during shaping. Furthermore, while the bendable plate segments are preferably bridge portions narrower than the surrounding anchor portions, it is appreciated that the one or more bendable segments may be of a different configuration than shown, provided that they are less rigid than the surrounding plate portions and are structured to deform prior to destruction of the plate threads in which the guide tips are threaded. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its scope.

## Claims

1. A fracture fixation plate shaping kit, comprising:
a) a bone plate including a plurality of longitudinally displaced threaded holes;
b) a plurality of tubular elements which can be coupled in the threaded holes and removed therefrom;
c) a first shaping tool having a handle portion and an end portion sized and shaped to engage with one of the tubular elements; and
d) a second shaping tool having a handle portion and an end portion sized and shaped to engage with another of the tubular elements, the first and second shaping tools being capable of engaging the tubular elements for the manual application of force to the bone plate to bend the bone plate.

2. A kit according to claim 1, in which the plate has a bone contacting surface and an opposite surface, and each of the tubular elements has a first end which is coupled to the plate and an end opposite the first end which is located not more than approximately 0.25 inch from the opposite surface of the bone plate.

3. A kit according to claim 2, in which the first end of each of the tubular elements is a threaded end.

4. A kit according to claim 2, in which the tubular elements having an inner diameter, and the end portion of each of the first and second shaping tools includes a portion which closely corresponds in size to the inner diameter for insertion therein.

5. A kit according to claim 2, in which the end portion of at least one of the shaping tools includes a peg extending parallel to a longitudinal axis of the shaping tool, the peg having a diameter which closely corresponds in size to an inner diameter of the tubular elements.

6. A kit according to claim 2, in which the end portion includes two parallel spaced apart peg elements, at least one of which closely corresponds in size to an inner diameter of the tubular elements.

7. A kit according to claim 6, in which one of the pegs is stepped in diameter.

8. A kit according to claim 7, in which the peg stepped in diameter is spaced closer to an end of the end portion.

9. A kit according to claim 7, in which the peg which is stepped in diameter is spaced further from an end of the end portion.

10. A kit according to claim 6, in which the end portion includes four pegs arranged in first and second sets of two, in which one of the pegs of the first set is stepped in diameter, and in which one of the pegs of the second set is stepped in diameter and spaced further from the end of the end portion than the stepped peg of the first set.

11. A kit according to claim 10, in which the four pegs are arranged so that they are approximately parallel to one another.

12. A kit according to claim 6, in which the first shaping tool includes another end portion including a peg extending parallel to a longitudinal axis of the shaping tool.

13. A kit according to claim 1, in which the end portion of at least one of the shaping tools defines a socket into which a portion of the tubular element is received.

14. A kit according to claim 13, in which the socket is sized relative to the portion of the tubular element so that the portion of the tubular element is closely received in the socket.

15. A kit according to claim 14, in which each of the first and second shaping tools defines a respective socket.

16. A kit according to claim 1, in which the bone plate includes alternating anchor portions and narrower bridge portions bridging the anchor portions, the threaded holes located in the anchor portions.

17. A kit according to claim 16, in which the anchor portions are rounded.

18. A kit according to claim 16, wherein when the first and second shaping tools are engaged to the tubular elements, sufficient manual application of force to the shaping tools results in bending of the bone plate across a bridge portion located between the anchors portions at which the tubular elements are coupled.

19. A fracture fixation plate shaping kit, comprising:
a) a bone plate including a longitudinal displacement of alternating anchor portions and narrower bridge portions bridging the anchor portions, and a threaded hole located in each of the anchor portions;
b) a plurality of tubular elements which can be threadedly engaged in the threaded holes and removed therefrom;
c) a first shaping tool having a first end portion defining a socket sized and shaped to engage with one of the tubular elements; and
d) a second shaping tool having a first end portion defining a socket sized and shaped to engage with another of the tubular elements, the first and second shaping tools being capable of engaging the tubular elements for the manual application of force to the bone plate to bend the bone plate at a bridge portion between the anchor portions at which the tubular elements are threadedly engaged.

20. A kit according to claim 19, in which the plate has a bone contacting surface and an opposite surface, and each of the tubular elements has a threaded end which is coupled to the plate and a guiding end opposite the threaded end which is located not more than approximately 0.25 inch from the opposite surface of the bone plate.

21. A kit according to claim 19, in which the plate has a bone contacting surface and an opposite surface, and each of the tubular elements has a threaded end which is coupled to the plate and a guiding end opposite the threaded end, the tubular element defining a body portion between the plate and the guiding end that has a cylindrical exterior surface.

22. A kit according to claim 19, in which the first shaping tool includes a second end having a peg with a diameter which closely corresponds in size to an inner diameter of the tubular elements and the second shaping tool includes a second end with a peg which closely corresponds in size to an inner diameter of the tubular elements.

23. A kit according to claim 22, in which the first shaping tool defines a longitudinal axis and the peg at the second end thereof extends parallel to the longitudinal axis of the first shaping tool, and second shaping tool defines a longitudinal axis, and the peg at the second end thereof extends parallel to the longitudinal axis of the second shaping tool.