# Patent

## Title
Bone plate with pre-assembled drill guide tips

## Abstract

Removable drill guide tips are pre-assembled into threaded holes of a bone plate. The tips may be used with an extension to together function as a conventional drill guide. After drilling, the extension or another tool is used to remove the tips 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 tool.

## Background
RELATED CASES
This application is a continuation of U.S. Ser. No. 11/011,917, filed Dec. 14, 2004, which is hereby incorporated by reference herein in its entirety.


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 bone plates and drill guides.
2. State of the Art
Fracture to the metaphysis of a long bone can be difficult to treat. Improper treatment can result in deformity and long-term discomfort.
By way of example, a Colles' fracture is a fracture resulting from compressive forces being placed on the distal radius, and which causes backward or dorsal displacement of the distal fragment and radial deviation of the hand at the wrist. Often, a Colles' fracture will result in multiple bone fragments which are movable and out of alignment relative to each other. If not properly treated, such fractures may result in permanent wrist deformity and limited articulation of the wrist. It is therefore important to align the fracture and fixate the bones relative to each other so that proper healing may occur.
Alignment and fixation of a metaphyseal 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 pegs (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. Ser. No. 10/664,371, 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 pegs are utilized in conjunction with a bone plate, it is necessary to ensure that the pilot holes drilled for the pegs are co-axial with the hole axes. Otherwise, the shaft of the pegs will not properly align with the anatomy, and the head of the pegs 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 peg hole, a drill guide is attached to the plate at the peg hole. The guide defines a tubular passage which directs the drill bit in the proper orientation for a peg through the particular peg hole. After drilling each hole, the drill guide is removed, the peg is inserted in the peg hole, and the drill guide is coupled to a subsequent peg 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 peg hole may have a discrete axis angle from the other peg holes. Such difficulty can unnecessarily prolong the surgical procedure.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide facilitate the drilling of holes in bone in alignment with the peg 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 hole in a bone plate at the time of surgery.
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 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 enough so 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 thread 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.
There are two options for using the tips. 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.
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 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; and
FIG. 12 is a bottom view of an embodiment of a drill guide extension engageable with the drill guide tip of FIG. 11.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Turning now to FIG. 1, a bone plate 10 is shown. The bone plate 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 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 thread into the holes at the correct angle. 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 preferably 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. The lower threaded portion 32 of the tips do 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 the 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 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 block 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. One and 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.
There are two options for using the tips. 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 provide 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 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 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 a 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 an 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 46.
There have been described and illustrated herein several embodiments of a bone plate with pre-assembled drill 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 have been shown with respect to a volar plate for dorsally displaced fractures, it will be appreciated that the tips may be used for threaded holes on other bone plates as well. 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 can also be used. Also, while the drill guide tips are described as threaded into the peg holes, it is appreciated that non-threaded assemblies which maintain the tips in alignment with the axes of the peg holes can also be used. 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 spirit and scope as claimed.

## Claims

1. A bone plate kit, comprising:
a) a plurality of fasteners, each fastener having a shaft defining a longitudinal axis and a threaded head, the threaded head having a first recessed non-cylindrical tool engagement feature, the tool engagement feature located in an upper surface of the head for receiving a distal end of a torque driver;
b) a bone plate having a plurality of threaded holes, each threaded hole configured to threadedly engage said threaded head of one of said fasteners and defining a respective fixed hole axis, said plate having a bone contacting first surface, an opposite second surface, and a thickness extending in a dimension between said first and second surfaces;
c) a plurality of removable tubular drill guide tips threadedly engaged within said plurality of threaded holes of said bone plate in axial alignment with said fixed hole axes,
each drill guide tip having an external surface, an internal surface defining a bore, a proximal guiding end, a distal externally threaded end for engagement with said threaded holes, and a longitudinal axis extending through a radial center of said bore,
said external surface of said drill guide tip having a body portion with a length that extends above said second surface of said bone plate by more than said thickness of said bone plate, yet said length is sufficiently short so that said body portion does not interfere with a body portion of an adjacent drill guide tip, said external surface defining a non-circular cross-section transverse to said longitudinal axis,
each drill guide tip having a non-cylindrical tool engagement feature positioned above said second surface of said bone plate; and

d) an elongate instrument that is engageable in a rotationally fixed position relative to said external surface of said drill guide tip.

2. A bone plate system according to claim 1, wherein:
said external surface of said drill guide tip at said body portion has a non-circular shape in cross-section transverse to said longitudinal axis.

3. A bone plate system according to claim 2, wherein:
said non-circular shape of said external body is a polygon.

4. A bone plate system according to claim 3, wherein:
said non-circular shape of said external body is a hexagon.

5. A bone plate system according to claim 3, wherein:
said internal surface of said drill guide tip includes a second recessed non-cylindrical tool engagement feature for receiving the distal end of the same torque driver that engages the fasteners.

6. A bone plate system according to claim 5, further comprising:
said rotational driver for torqueably engaging the fasteners and said drill guide tips.

7. A bone plate kit, comprising:
a) a plurality of fasteners, each fastener having a shaft defining a longitudinal axis and a threaded head, the threaded head having a first recessed non-cylindrical tool engagement feature, the tool engagement feature located in an upper surface of the head;
b) a bone plate having a plurality of threaded holes, each threaded hole configured to threadedly engage said threaded head of one of said fasteners and defining a respective fixed hole axis, said plate having a bone contacting first surface, an opposite second surface, and a thickness extending in a dimension between said first and second surfaces;
c) a plurality of removable tubular drill guide tips threadedly engaged within said plurality of threaded holes of said bone plate in axial alignment with said fixed hole axes,
each drill guide tip having an external surface, an internal surface defining a bore, a proximal guiding end, a distal externally threaded end for engagement with said threaded holes, and a longitudinal axis extending through a radial center of said bore,
said external surface of said drill guide tip having a body portion with a length that extends above said second surface of said bone plate by more than said thickness of said bone plate, yet said length is sufficiently short so that said body portion does not interfere with a body portion of an adjacent drill guide tip, said external surface defining a non-circular cross-section transverse to said longitudinal axis,
each drill guide tip having a non-cylindrical tool engagement feature positioned above said second surface of said bone plate; and

d) an elongate instrument that applies a torque to release said drill guide tip from threaded engagement with said bone plate, and dispenses said drill guide tips into a container without manual contact.

8. A bone plate kit, comprising:
a) a plurality of fasteners, each fastener having a shaft defining a longitudinal axis and a threaded head, the threaded head having a first recessed non-cylindrical tool engagement feature, the tool engagement feature located in an upper surface of the head for receiving a distal end of a torque driver;
b) a bone plate having a plurality of threaded holes, each threaded hole configured to threadedly engage said threaded head of one of said fasteners and defining a respective fixed hole axis, said plate having a bone contacting first surface, an opposite second surface, and a thickness extending in a dimension between said first and second surfaces;
c) a plurality of removable tubular drill guide tips threadedly engaged within said plurality of threaded holes of said bone plate in axial alignment with said fixed hole axes,
each drill guide tip having an external surface, an internal surface defining a bore, a proximal guiding end, a distal externally threaded end for engagement with said threaded holes, and a longitudinal axis extending through a radial center of said bore,
said external surface of said drill guide tip having a body portion with a length that extends above said second surface of said bone plate by more than said thickness of said bone plate, yet said length is sufficiently short so that said body portion does not interfere with a body portion of an adjacent drill guide tip, said external surface defining a non-circular cross-section transverse to said longitudinal axis,
each drill guide tip having a non-cylindrical tool engagement feature positioned above said second surface of said bone plate; and

d) an elongate instrument that applies a torque to remove said drill guide tips from threaded engagement with said bone plate.

9. A kit according to claim 8, wherein:
said elongate instrument torqueably engages said exterior surface of a respective said drill guide tip so that rotation of said elongate instrument causes rotation of said drill guide tip.

10. A kit according to claim 8, further comprising:
a container into which said removed drill guide tips are dispensed.

11. A bone plate kit, comprising:
a) a plurality of fasteners, each fastener having a shaft defining a longitudinal axis and a threaded head, the threaded head having a first recessed non-cylindrical tool engagement feature, the tool engagement feature located in an upper surface of the head for receiving a distal end of a torque driver;
b) a bone plate having a plurality of threaded holes, each threaded hole configured to threadedly engage said threaded head of one of said fasteners and defining a respective fixed hole axis, said plate having a bone contacting first surface, an opposite second surface, and a thickness extending in a dimension between said first and second surfaces;
c) a plurality of removable tubular drill guide tips threadedly engaged within said plurality of threaded holes of said bone plate in axial alignment with said fixed hole axes,
each drill guide tip having an external surface, an internal surface defining a bore, a proximal guiding end, a distal externally threaded end for engagement with said threaded holes, and a longitudinal axis extending through a radial center of said bore,
said external surface of said drill guide tip having a body portion with a length that extends above said second surface of said bone plate by more than said thickness of said bone plate, yet said length is sufficiently short so that said body portion does not interfere with a body portion of an adjacent drill guide tip, said external surface defining a non-circular cross-section transverse to said longitudinal axis,
each drill guide tip having a non-cylindrical tool engagement feature positioned above said second surface of said bone plate; and

d) an elongate instrument that applies a torque to remove said drill guide tips from threaded engagement with said bone plate.

12. A bone plate system for use with a plurality of fasteners, each fastener having a shaft defining a longitudinal axis and a threaded head, the threaded head having a first recessed non-cylindrical tool engagement feature, the tool engagement feature located in an upper surface of the head for receiving a distal end of a torque driver, said bone plate system comprising:
b) a bone plate having a plurality of threaded holes, each threaded hole configured to threadedly engage said threaded head of one of said fasteners and defining a respective fixed hole axis, said plate having a bone contacting first surface, an opposite second surface, and a thickness extending in a dimension between said first and second surfaces;
c) a plurality of removable tubular drill guide tips threadedly engaged within said plurality of threaded holes of said bone plate in axial alignment with said fixed hole axes,
each drill guide tip having an internal surface defining a bore, a proximal guiding end, a distal externally threaded end for engagement with said threaded holes, and a longitudinal axis extending through a radial center of said bore,
said drill guide tip having a body portion extending between said guide end and said plate, said body portion having a length that extends above said second surface of said bone plate by more than said thickness of said bone plate, yet said length is sufficiently short so that said body portion does not interfere with a body portion of an adjacent drill guide tip, said body portion defining a non-cylindrical external surface,
each drill guide tip having a recessed tool engagement feature positioned above said second surface of said bone plate and extending; and

d) an elongate instrument that is engageable in a rotationally fixed position relative to said drill guide tip.

13. A bone plate system according to claim 12, wherein:
said external surface of said body portion defines a non-circular cross-section transverse to said longitudinal axis.